Portaria 118 - 2015-03-06 (English)

Sheet 2 of Order no.
118 /President 06/03/2015
Public Federal Service
MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE

NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY – INMETRO
Order no. 118, of March 6, 2015.
THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY

– INMETRO, exercising his powers, conferred in § 3 of article 4 of Law no. 5,966, of December 11,
1973, in sections I and IV of article 3 of Law no. 9,933, of December 20, 1999, and in section V of
article 18 of the Regimental Structure of the Municipality, approved by Decree no. 6,275, of
November 28, 2007;
Whereas paragraph f of item 4.2 of the Terms of Reference of the Brazilian System of
Conformity Assessment, approved by Conmetro Resolution no. 04 of December 2, 2002, which
attributes Inmetro with the competence to establish the guidelines and criteria for the conformity
assessment activity;
Whereas the growing demand for the establishment of Conformity Assessment Programs
and the need to rethink and streamline the way that they are handled;
Whereas the need to give greater standardization and conciseness in the establishment of
Conformity Assessment Programs;
Whereas the importance of the continuous improvement in the macro-process for the
Assisted Implementation of Conformity Assessment Programs;
Whereas the existence of conformity assessment requirements which are common to any
object submitted to the assessment process;
Whereas the existence of general requirements for each of the different conformity
assessment mechanisms to make the interpretation of the Conformity Assessment Programs
clearer;
Whereas the General Requirements for Product Certification are aimed at establishing the
common provisions for all Conformity Assessment Programs which adopt the certification
mechanism;
Whereas the General Requirements for Product Certification are complemented by the
Conformity Assessment Requirements, specific to each object that can receive certification;
Whereas the need to improve the General Requirements for Product Certification, the
following provisions are resolved:
Art. 1 Approve the improvement of the General Requirements for Product Certification
(RGCP), provided on the website www.inmetro.gov.br or at the address:
National Institute of Metrology, Quality and Technology – Inmetro

Division of Technical Regulations and Conformity Assessment Programs – Dipac
Rua da Estrela n° 67 - 3° andar - Rio Comprido
20251-900 - Rio de Janeiro/RJ
Sheet 3 of Order no. 118 /President 06/03/2015
Art. 2 Certify that the Public Consultation, which gathered contributions from the public for
preparing the now approved General Requirements, was published by Inmetro Order No. 544 of
November 18, 2013, published in the Official Gazette of the Union on November 20, 2013, section
01, page 97.
Art. 3 Certify that the Conformity Assessment Requirements to be prepared for each object
only contain the specific requirements, complementary to the General Requirements for Product
Certification, respecting the specificities of the object to be certified.
§1 The Conformity Assessment Requirements must define the following items:
I – Objective (specific to the certification program);

II – Acronyms (only those which are not included in this document);
III – Reference and complementary documents (only those which are not included in this
document);
IV – Definitions (only those which are not included in this document);
V – Conformity Assessment Mechanism;
VI – Stages of the Conformity Assessment (which must contain, when applicable, at least
the following items, complementing the RGCP):
• Definition of the Certification Model(s) used;
• Initial Assessment;
- Request for Certification;
- Analysis of the Request and of the Conformity of Documentation;
- Initial Audit of the Quality Management System and Assessment of the
Production Process (when applicable);
- Initial Test Plan (when applicable);
- Handling of non-conformities in the Initial Assessment stage;
- Issue of the Certificate of Conformity;
• Maintenance Assessment of the Quality Management System and Assessment of
the Production Process (when applicable);
- Maintenance Audit (when applicable);
- Maintenance Test Plan (when applicable);
- Handling of non-conformities in the Maintenance Assessment stage;
- Maintenance Confirmation;
• Recertification Assessment (when applicable);
• Special Cases;
VII – Handling of Claims;

VIII – Activities performed by OCP certified by a member of the IAF MLA;
IX – Transfer of Certification;
X – Closure of Certification;
XI – Identification Seal of Conformity;
XII – Authorization for the Use of the Identification Seal of Conformity;
XIII – Responsibilities and Obligations;
XIV – Market Follow-up;
XV – Penalties; and
XVI – Complaints.
Sheet 3 of Order no. 118 /President 06/03/2015
§2 As an exception, the provisions contained in the Requirements now approved may be

changed, following the specificities of the object to be assessed, by means of the Conformity
Assessment Requirements, prepared for each object to be certified.
§3 In cases in which the conditions provided for in the previous paragraph occur, they must
be clearly defined in the Conformity Assessment Requirements.
Art. 4 Certify that the Conformity Assessment Programs which do not use the RGCP will be
gradually made suitable to it while being improved.
Art. 5 Determine that all product certification processes which have already adopted the
RGCP must be made suitable by the OCPs from the maintenance or recertification following the
publication of this Order as long as they do not occur in a period of less than 6 (six) months, when
they may still be following the previous version of the RGCP.
Art. 6 Repeal Inmetro Order no. 361 of September 6, 2011, published in the Official Gazette
of September 9, 2011, section 01, page 76, within a period of 6 (six) months after the publication of
this Order.
Art. 7 This Order will enter into force on the day on which it is published in the Official
Gazette.
JOÃO ALZIRO HERZ DA JORNADA
President
ATTACHMENT TO INMETRO ORDER NO. 118/2015
GENERAL REQUIREMENTS FOR PRODUCT CERTIFICATION
1 OBJECTIVE
This document establishes the General Requirements for Product Certification

common to all Conformity Assessment Programs which use the Product
Certification Mechanism. The specificities of each of the Conformity Assessment
Programs will be expressed in the Conformity Assessment Requirements
prepared for each product to be certified, and which will detail the matters,
considering their specificities.
1.1 The term "product" in this RGCP applies to a product, service or process.
2 ACRONYMS
ABNT Associação Brasileira de Normas Técnicas (Brazilian Association of

Technical Standards)
Cgcre Coordenação Geral de Acreditação (General Accreditation Coordination)
Conmetro Conselho Nacional de Metrologia, Normalização e Qualidade Industrial
(National Institute of Metrology, Standardization and Industrial Quality)
Dipac Divisão de Regulamentação Técnica e Programas de Avaliação da
Conformidade (Division of Technical Regulations and Conformity
Assessment Programs)
Dconf Diretoria de Avaliação da Conformidade (Board for Conformity
Assessment)
DOU Diário Oficial da União (Official Gazette)
DPDC Departamento de Proteção e Defesa do Consumidor (Department of
Consumer Protection and Defense)
IAAC Interamerican Accreditation Cooperation
IAF International Accreditation Forum
IEC International Electrotechnical Commission
ILAC International Laboratory Accreditation Cooperation
INI Instrução Normativa Inmetro (Inmetro Normative Ruling)
Inmetro Instituto Nacional de Metrologia, Qualidade e Tecnologia (National
Institute of Metrology, Quality and Technology)
ISO International Organization for Standardization
MLA Multilateral Recognition Arrangement
MoU Memorando de Entendimento (Memorandum of Understanding)
NBR Brazilian Standard
OCP Organismo de Certificação de Produto (Product Certification Body)
OCS Organismo de Certificação de Sistema de Gestão da Qualidade (Quality
Management System Certification Body)
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PAC Programa de Avaliação da Conformidade (Conformity Assessment

Program)
RAC Requisitos de Avaliação da Conformidade (Conformity Assessment
Requirements)
RGCP Requisitos Gerais de Certificação de Produtos (General Requirements for
Product Certification)
RTQ Regulamento Técnico da Qualidade (Technical Quality Regulation)
SB AC Sistema Brasileiro de Avaliação da Conformidade (Brazilian System of
Conformity Assessment)
Senacon Secretaria Nacional do Consumidor (National Consumer Bureau)
SGQ Sistema de Gestão da Qualidade (Quality Management System)
3 DOCUMENTS
3.1 REFERENCE DOCUMENTS
Law no. 8078/1990 Provisions for consumer protection and other measures.
Law no. 9933/1999 Provisions on the competencies of Conmetro and Inmetro,

establishing the "Taxa de Serviços Metrológicos"
(Metrological Service Rate) and other measures.
Standard ABNT NBR ISO Quality Management Systems – Requirements.

9001
Standard ABNT NBR Conformity Assessment – Vocabulary and General Principles.

ISO/IEC 17000
Standard ABNT NBR General Requirements for the Competence of Test and
ISO/IEC 17025 Calibration Laboratories.
ISO IEC 17067:2013 Conformity assessment – Fundamentals of product

certification and guidelines for product certification
schemes.
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3.2 COMPLEMENTARY DOCUMENTS
Inmetro Order no. 274/2014 Approves the Regulations for the Use of
and substituting orders. Trademarks, Inmetro's Symbols, Seals and
Labels.
Inmetro Order no. 453/2013 Approves the Inmetro Vocabulary for Conformity
and substituting orders. Assessment with terms and definitions usually
used by the Inmetro Board of Conformity
Assessment.
Ministry of Justice Order no. Discipline the calling procedure of consumers or

487/2012 the recall of products and services which, after
their introduction in the consumer market, are
considered harmful or dangerous.
4 DEFINITIONS
In the PAC established by Inmetro which use the Certification mechanism, the
definitions given in the Inmetro Order which approves Inmetro Conformity Assessment
Vocabulary are applied. Specific definitions used in each PAC will be described in the
specific CAR for the object.
5 CONFORMITY ASSESSMENT MECHANISM
The Conformity Assessment Mechanism handled in this document is Certification.
6 CONFORMITY ASSESSMENT STAGES
The conformity assessment process is made up of several stages. Each stage must
comply with a procedures sequence, in accordance with the adopted Certification
Model(s).
6.1 Definition of the Certification Model(s) used
The Certification Models will be explained in the CAR specific to the object being
assessed, which are defined in the Inmetro Conformity Assessment Vocabulary.
The specific CAR may include more than one Certification Model.
6.1.1 Certification Model Stages
Each model is made up of a sequence of stages described in Table 1. These stages must
be included in the CAR, separately for each model, when the specific CAR considers
more than one Certification Model.
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Table 1: Certification Model Stages
PRODUCT CERTIFICATION PROCESS STAGES MODELS

1a 1b 2 3 4 5 6
Initial Assessment Certification Request X X X X X X X
Analysis of the Request and of the Conformity of X X X X X X X

Documentation
Initial Audit of the Quality Management System and X X
Assessment of the Production Process
Initial Test Plan X X X X X X
Issue of the Certificate of Conformity X X X X X X X
Maintenance Maintenance Audit of the Quality Management X X
Assessment System and Assessment of the Production Process
Maintenance Test Plan X X X X
Maintenance Confirmation X X X X X
Recertification Recertification Assessment X X X X X
Assessment
6.2 Initial Assessment
This item describes the process stages which attest the conformity of the object.
6.2.1 Certification Request
6.2.1.1 Certification must be exclusively requested by the Supplier, who should follow
what is established in this RGCP and in the specific CAR for the object to be assessed.
6.2.1.2 The start of the certification process is restricted to a formal expression from
the Supplier requesting the certification, and which must be made directly to one of
the Product Certification Bodies certified and/or designated by Inmetro, at their
choice, which must be legally established in the country, for the product being
assessed, accompanied by the delivery of the documents, while complying with the
following requirements:
a) List of the model(s) subject to certification, when certification is per model,

mentioning their technical description(s) and including the list of all brands sold.
b)List of the model(s) which make up the family subject to certification, following the
family formation rules established in the specific CAR, when the certification is per
family, mentioning their technical description(s) and including the list of all brands
sold;
c) List of the service scope(s) for which the certification is being requested, when
dealing with service certification;
d)Photographic documents of the object: external and internal photos of all sides,
detailing labels, logos, warnings, inputs, outputs, activation buttons, when applicable;
e) Descriptive memorandum considering the project of the object in its construction
and operating details, and the list of its critical components, including their suppliers
and possible existing certifications, translated into Portuguese when in a language
other than English or Spanish;
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f) User manual with instructions in Portuguese;

g) Design or artwork of packaging (primary, secondary and / or tertiary), when
applicable (if there is packaging);
h) Certification Model option, within those mentioned in the specific CAR for the
object;
i) Information regarding company name, address and CNPJ (Tax no.) of the Supplier
requesting certification;
j) Name of contact, telephone number and email of the Supplier requesting

certification;
k) Identification of the manufacturer with full address, including production plant(s) to

be certified, based in another country, when applicable;
l) Information regarding outsourced activities/processes which may affect the conformity of

the product subject to certification;
m) Documents which prove compliance with item 7 of this document (Handling Claims) for all
brands sold;
n) Documents referring to the manufacturer's Quality Management System, applicable

to the object to be certified, in the case of certification using models 5 and 6, as
provided for in tables 2 and 3 of item 6.2.3.1. Even if they need to be audited by OCP,
as provided for in this document;
o) Valid certificate issued on the basis of the edition in force of Standard ISO 9001 or
Standard ABNT NBR ISO 9001, which covers the production process of the object of
certification, if it exists;
p) Identification of the certification batch, in the case of Model 1b, including quantities and
manufacturer batches of the model(s) to be certified.
q) Import License or, in its absence, Declaration of Imports, in the case of Model 1b in
the case of imported products;
r) Other documents needed for the request process, described in the specific CAR.
Note 1: If the brands mentioned in a) and b) are not owned by the Supplier requesting
the certification, they must have authorization to use them. OCP is responsible for the
legal qualification of the authorization instrument and the document establishing the
owner(s) of the brand(s).
Note 2: The photos mentioned in d) must have a minimum resolution of 800 x 600 dpi.
Note 3: OCP is responsible for assessing the list of components considered as critical
mentioned in e), and may include others.
Note 4: The User Manual, mentioned in f), is considered to be information regarding

the product relating to: assembly, installation, disassembly, uninstallation, handling,
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operating, cleaning, maintenance instructions, warnings and other information of

relevance to the user.
6.2.1.3 When, given the characteristics of the product, a user manual is not applicable,
OCP must validate and record this information on the certification process.
6.2.1.4 If the Supplier requesting the certification is an integrator, packer and/or

distributor who makes modifications to the already certified product packaging, or
changes the form of presentation for selling the product in relation to the original
certification process, the certification request must follow the requirements defined in
Attachment B of this RGCP.
6.2.2 Request and Documentation Conformity Analysis
6.2.2.1 When receiving the specified documents, OCP must open a concession process
for the Conformity Certificate and perform an analysis of the relevance of the request,
in addition to an assessment of the conformity of the documents sent by the Supplier
requesting the certification.
6.2.2.2 If any non-conformity is identified in the documents received, it will be formally

passed onto the Supplier requesting the certification to be corrected and duly
formalized with OCP so as to have it implemented into a new analysis.
6.2.2.3 If some of the documents mentioned in 6.2.1 are not presented in their
definitive form by the Supplier requesting the certification, at the time of the delivery
of the document, and as long as this fact does not interfere with the other stages of the
Initial Assessment process, this fact should be explained by OCP and the conclusion to
the certification will only be carried out once all documents are in their final format
and have been duly approved by OCP.
6.2.3 Initial Audit of the Quality Management System and Assessment of the
Production Process
The QMS audit must be performed when the certification model so defines, regardless
of whether the manufacturer or the service provider has a certified Quality
Management System based on the edition in force of Standard ISO 9001 or Standard
ABNT NBR ISO 9001. According to the model adopted, OCP assesses the QMS
document and records, and conducts an audit on the branches of the service provider
or manufacturing plant, with the objective of checking the conformity of the
production process, including installations and personnel skills. The QMS audit must
seek the objective demonstration that the production process is systematized and
efficiently monitored, providing evidence of the compliance with the product
requirements established in the CAR. Therefore, the QMS requirements are
complementary to the requirements defined in the specific CAR for the object.
Records of conformity in the compliance with these requirements must be consistently

obtained.
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The date for the audit visit must be agreed upon and scheduled with the Supplier
requesting the certification.
6.2.3.1 The QMS assessment must be performed by OCP based on the coverage of the
certification process and as per the requirements provided for in the edition in force of
Standard ISO 9001 or Standard ABNT NBR ISO 9001, with the minimum requirements
defined in Tables 2 and 3 below:
Table 2: Minimum verification requirements of the QMS for manufacturers or service

providers with valid certification in the Standard ISO 9001 or Standard ABNT
NBR ISO 9001
QMS REQUIREMENTS Standard ISO 9001 or

ABNT NBR ISO 9001
Registration control 4.2.4
Product realization planning 7.1
Communication with the client 7.2.3
Acquisition process 7.4.1
Checking the product purchased 7.4.3
Production and service provision control 7.5.1
Identification and traceability 7.5.3
Client property 7.5.4
Product storage 7.5.5
Monitoring and measuring equipment control 7.6
Monitoring and measuring of processes 8.2.3
Product monitoring and measuring 8.2.4
Control of non-conforming products 8.3
Corrective action 8.5.2
Table 3: Minimum verification requirements of the QMS for manufacturers or service

providers without certification in Standard ISO 9001 or Standard ABNT NBR
ISO 9001
QMS REQUIREMENTS Standard ISO 9001 or

ABNT NBR ISO 9001
Document control 4.2.3
Registration control 4.2.4
Critical analysis by the Board 5.6.1/ 5.6.2 / 5.6.3
Skills, training and awareness 6.2.2
Infrastructure 6.3
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Product realization planning 7.1

Communication with the client 7.2.3
Production and service provision control 7.5.1
Validation of production and service provision processes 7.5.2
Client property 7.5.4
Monitoring and measuring equipment control 7.6
Client satisfaction 8.2.1
Internal audit 8.2.2
Monitoring and measuring of processes 8.2.3
Product monitoring and measuring 8.2.4
Control of non-conforming products 8.3
Data analysis 8.4 (b), (c), (d)
6.2.3.2 Even with the presentation of a valid certificate, according to the edition in
force of Standard ISO 9001 or Standard ABNT NBR ISO 9001, issued by an OCS certified
by Inmetro or a member of the IAF MLA, for the scope of the respective certification,
OCP must carry out an initial audit of the QMS at the manufacturing plant or at the
service provider during the initial assessment stage, in accordance with Table 2 of this
RGCP, with the objective of checking the conformity of the production process.
Note: Certificates issued by a foreign OCS must be accompanied by a sworn translation

into Portuguese when they are issued in a language other than English or Spanish.
Other documents related to the Management System, which are in a language other
than English or Spanish, must be translated into Portuguese.
6.2.3.3 During the audit, the Supplier requesting the certification must provide OCP
will all documents corresponding to the certification of the Quality Management
System based on the edition in force of Standard ISO 9001 or Standard ABNT NBR ISO
9001 and present the records of the production process where the object of the
certification is clearly identified. OCP must analyze the relevant documents to ensure
that the requirements described in Table 2 of item 6.2.3.1 have been met.
6.2.3.4 After the audit, OCP must issue a report, registering its result, using this RGCP
and the CAR specific to the object as a reference.
6.2.3.5 The audit report must be signed by at least the auditing team, and a copy must
be given to the Supplier requesting the certification.
6.2.3.6 OCP must be informed of any change made to the production process and, if it
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has an impact on the conformity of the product, it may imply a new audit.
6.2.3.7 In the case of certification based on prototypes, during the audit, OCP must
ensure that the product produced to scale corresponds to the prototype tested.
6.2.4 Initial Test Plan
The initial tests must prove that the object of the conformity assessment meets the
requirements defined in the base standards.
OCP is responsible for preparing a test plan which must contain, at least, the initial tests
to be performed, a clear definition of the testing methods, number of samples and
acceptance/rejection criteria for these tests. In the case of certification per family, the
test plan must be prepared so that it includes, at least, the models which contain the
largest number of requirements pre-set by the base standard of reference. OCP is
responsible for conducting the critical analysis of the laboratory test reports, checking
them against the previously established test plan.
OCP must demand that the laboratory test reports provide information regarding
uncertainties in measures taken.
Test reports issued prior to the start of the certification process will not be accepted,
unless clearly defined in the specific CAR for the object.
OCP must be informed of any changes to critical component(s) and this will lead to the
performing of new tests.
6.2.4.1 Definition of Tests to be performed
The tests, their methods and acceptance/rejection criteria must be defined in the CAR
specific to the object and must be performed in accordance with the requirements
pre-set by the base standard of reference.
The body of the test report must include the complete identification of the model of
the object to be certified, so that the test report is clearly traced back to the sample
collected.
OCP is responsible for assessing whether the data in the descriptive memorandum and
in the project or product specification are in accordance with the technical
identification of the model in the test report presented.
6.2.4.2 Definition of Sampling
OCP is responsible for selecting and sealing the samples of the object to be certified.
The collection of samples to be sent to the laboratory must be agreed upon between
the Supplier requesting the certification and OCP. The quantity of samples,
acceptance/rejection criteria and exceptional cases must be included in the specific CAR
for the object. Table 4 presents an example of the sample handling applicable to
Models 1a, 2, 3, 4 and 5.
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In conducting the selection and sealing of the samples, OCP must prepare a sampling
report, detailing the date, location, storage conditions, identification of the sample
(model/brand, manufacturing batch and date of manufacture, quantities sampled,
etc.).
Note 1: The Sampling Plan does not apply when the specific CAR for the object allows
the acceptance of reports prior to the start of certification.
Note 2: When applicable, additional parts, components or parts of the product which
are complementary to the sample(s) must be sealed, identified and sent to the
laboratory along with the product.
Note 3: When dealing with model 1b of the certification, the selection and sealing of
the samples must occur on national territory.
Table 4: Presentation model of sample sizes required for initial tests
SAMPLE SIZE
ACCEPTANCE /
REJECTION
TESTS STANDARD TEST COUNTER WITNESS CRITERIA
BASE TEST
(corresponding
(denomination of standard base item) (quantity (quantity (quantity of (criteria for
test) of units of of units of units of the acceptance/rejection
the product) the product) product) sample)
Note: Counter and witness test samples must, necessarily, be performed by the same
laboratory which conducted the test sample.
6.2.4.2.1 If there is approval in the test samples, the sample is considered as being
approved. If there are non-conformities in the test sample, the test(s) must be
performed on the counter sample and witness sample.
a) If there are non-conformities in the counter sample, the sample will be considered
as being rejected;
b) If the counter sample does not have any non-conformities, the witness sample must
be tested;
c) If the witness sample has any non-conformities, the sample will be considered as
being rejected;
d) If the witness sample does not have any non-conformities, the sample will be
considered as being approved.
Note: The specific CAR of the object will define the need to repeat all the tests
provided for in the base standard in counter samples and witness samples.
6.2.4.2.2 At the criteria of the Supplier requesting the certification, upon formalization
from OCP, the counter samples and witness samples will not necessarily have to be
tested. In this case, the results obtained from the test sample cannot be contested.
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6.2.4.2.3 Prototypes can be sent directly to the laboratory. In this case, the initial
sample will only be made up of a sample of the product, with no need for counter
sample and witness sample.
6.2.4.2.4 OCP must ensure that the prototype tested is the product which will be
produced to scale. If OCP finds a discrepancy between the prototype tested and the
product produced to scale or, still, of the project of the object, if deemed relevant,
new tests may be conducted, as per the test plan, with new samples.
6.2.4.3 Definition of the Laboratory
6.2.4.3.1 OCP must adopt test laboratories considering the order of priorities defined
below:
1 Laboratory designated by Inmetro;
2 3rd party laboratory, national or foreign, certified by Inmetro/Cgcre or signatory of

the ILAC or IAAC mutual recognition agreements, entirely in the specific scope;
3 1st party laboratory, national or foreign, certified by Inmetro/Cgcre or signatory of

the ILAC or IAAC mutual recognition agreements, entirely in the specific scope;

the ILAC or IAAC mutual recognition agreements, partially (above 70% of the total
tests provided for in the base standard) in the specific scope;

the ILAC or IAAC mutual recognition agreements, partially (above 70% of the total
tests provided for in the base standard) in the specific scope;

the ILAC or IAAC mutual recognition agreements, in another scope, in the same area
of activity and class of test in the specific scope;

the ILAC or IAAC mutual recognition agreements, in another scope, in the same area
of activity and class of test in the specific scope;

the ILAC or IAAC mutual recognition agreements, in another scope;

the ILAC or IAAC mutual recognition agreements, in another scope;
10 3rd party laboratory, national or foreign, not certified;
11 1st party laboratory, national or foreign, not certified.
6.2.4.3.2 For the purposes of the use of the priority mentioned, any one of the
hypothesis below should be considered:
a) Inexistence of the laboratory defined in the previous priority;
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b) When the laboratory defined in the previous priority does not provide a quote for
the tests within a maximum of 10 (ten) working days after the request made by OCP or
cannot comply, within a maximum of 30 (thirty) consecutive days from the OCP
acceptance date, with the deadline to start the tests forecast in the Conformity
Assessment Requirements (CAR) or cannot perform them, within a maximum of one
and a half times of the regular time of the tests described in the base standard;
c) When OCP shows that the price of tests performed, plus the costs from the
assessment/follow-up of OCP, in comparison to what is defined in the previous priority
is, at least, 50% less.
Note 1: OCP must register, using supporting documents, the reasons that led them to
select the adopted laboratory.
Note 2: Depending of the specificities of the product, at the time of preparing the
specific CAR or in its implementation phase, Inmetro may authorize, through an Order,
the use of certified first party laboratories, as an alternative to certified third party
laboratories.
Note 3: If there is only a third party laboratory certified in the specific scope abroad,
but there is a first party laboratory certified integrally in the specific scope within the
country, this one may be used.
Note 4: When provided for in the specific CAR of the object for the performing of
toxicity tests, OCP may, as an alternative to certification, select a testing laboratory
recognized by Inmetro/Cgcre in the Principles of Good Laboratory Practice (BPL), in the
scope of the Mutual Acceptance of Data System of the Organization for Economic
Cooperation and Development (OECD).
6.2.4.3.3 If a laboratory is used which is certified by being a signatory of the ILAC or

IAAC mutual recognition agreements, OCP is responsible for observing and
documenting the equivalence of the method and testing parameters.
6.2.4.3.4 In any of the cases of using a 1st party laboratory certified in the specific
scope, fully or partially, OCP must monitor and record the performing of all the tests.
This monitoring consists of at least following the sample selection and preparation
stages and later obtaining of results.
6.2.4.3.5 In any of the cases of using a 1st or 3rd party laboratory certified for another
test scope, OCP must, after recognizing and recording the qualifications and
infrastructures (including equipment) of the laboratory, monitor and record the
performing of all the tests. This monitoring consists of at least following the sample
selection and preparation stages, the start of the tests and later obtaining of results.
6.2.4.3.6 In any of the cases of using a 1st or 3rd party laboratory which is not certified,
OCP must, after assessing and recording the requirements listed in Attachment A of
this document, monitor and record the performing of all the stages of all the tests. The
assessment performed by OCP must be conducted by an OCP professional who has
recorded training of, at least, 16 hours/class, in the Standard ABNT NBR ISO IEC 17025
in force, in addition to formal proof of experience and specific technical knowledge of
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the tests to be assessed.
6.2.4.3.7 The definition of the laboratory must be jointly agreed upon between OCP
and the Supplier requesting the certification as long as what is provided for in 6.2.4.3 is
respected.
6.2.5 Handling of non-conformities in the Initial Assessment stage
6.2.5.1 If any non-conformity is identified in the Initial Assessment stage, the Supplier
requesting the certification must send OCP, within a maximum of 60 (sixty)
consecutive days, proof of the implementation of the corrective measures for the non-
conformities identified.
6.2.5.2 The Supplier requesting the certification is responsible for the critical analysis
of the causes of the non-conformities, as well as the proposal of corrective actions.
6.2.5.3 If the Supplier requesting the certification does not meet the given deadline,
the Certification process must be cancelled or interrupted, and may be restarted if
there is an interest to do so from the Supplier requesting the certification and from
OCP.
6.2.5.4 New timings may be agreed upon as long as they are formally requested and
justified by the Supplier requesting the certification, and considered relevant by OCP.
These timings also apply to non-conformities or pending issues identified in the
request analysis.
6.2.5.5 OCP must assess the efficiency of the corrective actions implemented, accepting
them or not.
6.2.5.6 It is up to OCP as to whether there is a need for a new audit on the QMS and/or
the performing of new tests to confirm the implementation of the corrective actions.
6.2.5.7 The Supplier requesting the certification must identify and separate the non-
conforming product(s) in separate areas so that there is no chance that they can get
mixed up with conforming products and sent to market. A record of this action must be
kept.
6.2.5.8 Objective proof of the handling of non-conformities is a requirement for the

issue of the Certificate of Conformity.
6.2.6 Issue of Certificate of Conformity
6.2.6.1 Critical Analysis and Certification Decision
6.2.6.1.1 OCP must designate at least one person to critically analyze the information
and results related to the assessment. The critical analysis must be performed by
people who are not involved in the assessment process.
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6.2.6.1.2 The critical analysis must include all information regarding documents,
audits, test results and the handling of non-conformities.
6.2.6.1.3 Certification recommendations based on the critical analysis must be

documented.
6.2.6.1.4 OCP is responsible for the decisions related to Certification.
6.2.6.1.5 The Certification decision will be made by a person or by a group of people

who are not involved in the assessment process.
6.2.6.1.6 OCP must notify the Supplier requesting the certification if they decide not to
grant Certification, giving the reasons for this decision.
6.2.6.1.7 If OCP decides to use a Certification Committee, there must be formal rules
for nomination, terms of reference and operation for its use.
6.2.6.1.7.1 The Certification Committee must be free from any interest, commercial or
financial pressures and others which may influence their decisions.
6.2.6.1.7.2 OCP is responsible for nominating and excluding members of the

Certification Committee.
6.2.6.2 Issue of Certificate
Once the requirements demanded in this RGCP and in the specific CAR for the object
have been met, OCP issues an exclusive Conformity Certificate, with different
numbers, for each model or family, object of the request.
6.2.6.2.1 If the certification is per family, the certificate must list all models covered by
the family.
6.2.6.2.2 If more than one page is needed for the certificate, all the pages must be
numbered referring to their own number and to the total number of pages, stating on
each one the number of the certificate and issue date. The front page must state the
number of pages which make up the complete certificate. In this case, the certificate
must have the expression “Certificate of Conformity only valid when accompanied by
pages 01 to N” (state the number of pages from start to finish of the certificate).
6.2.6.3 Certificate of Conformity
The validity of the Certificate of Conformity is defined in the specific CAR and must
contain the following wording when dealing with certificates according to Models 2, 3,
4, 5 and 6: “The validity of this Certificate of Conformity is tied to the performing of
the maintenance assessments and handling of any non-conformities in accordance
with OCP guidelines provided for in the specific CAR. To check the current condition of
regularity of this Certificate of Conformity, the database of products and services
certified by Inmetro must be consulted”.
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6.2.6.3.1 The Certificate of Conformity, as a formal tool issued by the OCP, must
contain, at least:
a) Numbering of the certificate of conformity;

b)Company name, Tax No. (CNPJ), complete address and, when applicable, brand name
of the Supplier requesting the certification (certificate holder);
c) Company name, complete address and, when applicable, brand name of the
manufacturer;
d)Name, address, certification registration number and signature of the person
responsible for OCP;
e) Date of issue and validity (except in the case of Models 1a and 1b) of the Certificate
of Conformity;
f) Certification model adopted;
g) Identification of the model of the certified product, in the case of certification per
model, including the list of all brands sold;
h) Identification of the certified product family and of all the models covered, in the
case of certification per family, including the list of all brands sold;
i) Identification of the manufacturing batch (compulsory in the case of certification

using Model 1b);
j) Scopes of service, when dealing with service certification;
k) CAR Order based on which the certificate was issued (scope of certification);
l) Barcode of the models included in g) or h), when they exist;
m) Number, date and identification of the laboratory which issued the test report(s);
n) Date of the audit, applicable to Models 5 and 6.
Note 1: One certificate must be issued for each certified family, in the case of
certification per family or for each certified model, in the case of certification per
model.
Note 2: Any additional items which are needed for the issue of the Certificate of
Conformity must be mentioned in the specific CAR.
6.3 Maintenance Assessment
Following the granting of the Certificate of Conformity, the control of the Certification
is performed by OCP to confirm whether the technical-organizational conditions which
gave rise to the initial granting of the certificate are still being complied with.
The maintenance assessment must be programmed by OCP, according to the frequency

and criteria established in the specific CAR for the object in question. The periods must
be counted from the issue date of the certificate. All stages must be completed within
the periods defined in the specific CAR for the object.
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Note 1: The frequency of the maintenance audits and the maintenance tests may be
fixed or variable, as defined in the CAR.
Note 2: The variable frequency allows the increase in the spacing of the time interval
between the maintenance audits and/or tests. The increase in spacing is solely
connected to the non-identification of non-conformities. If any non-conformity is
found, the spacing is reduced, thereby restarting a new cycle. The opposite occurs
when no non-conformities are identified. The CAR defines the application or not of a
variable frequency.
Note 3: The presence of non-conformities with later handling does not lead to the
application of an increase in the spacing of time between the two maintenances,
forecast in the maintenance with variable frequency.
OCP is responsible for formally asking the certificate holder to notify them of any
change in the project, descriptive memorandum or production process.
In the case of certification per family, the inclusion of a new model in the certified
family may be carried out, at any time, on the same certificate, maintaining the original
validity of the certificate issued, which must contain information of the date of
inclusion of the new model(s).
In cases in which the same certificate holder wishes to certify a new family (in the case
of certification per family) or a new model (in the case of certification per model), OCP
must conduct a new certification process starting from 6.2.
6.3.1 Maintenance Audit of the Quality Management System and Assessment of the
Production Process
6.3.1.1 OCP must schedule the performing of periodical maintenance audits in the
production process of the manufacturer or in the service provider, considering at least
the following stages:
a) checking of the original documents provided for in item 6.2.1, in particular

regarding their availability, organization and recovery, and
b) analysis of records, especially those related to the compliance with the
requirements stated in Tables 2 and 3.
6.3.1.2 The date for the maintenance audit visit must be agreed upon and scheduled
with the Supplier requesting the certification. However, when explicitly defined by
Inmetro/Dconf, OCP must conduct maintenance audits or extraordinary audits without
prior notice.
6.3.2 Maintenance Test Plan
Maintenance tests must prove the maintenance of conformity, after the initial
assessment, with the requirements stated in the specific CAR for the object.
As with the Initial Assessment, OCP is responsible for preparing the Test Plan which
must contain, at least, maintenance tests, testing methods, sampling, criteria for
16
acceptance/rejection and frequency, in accordance with what is established in the

specific CAR for the object. OCP must demand that the laboratory test reports provide
information regarding uncertainties in measures taken.
The Test Plan must be planned so that, throughout the maintenance, there is a
rotation of the members of the family, when the certification is per family.
6.3.2.1 Definition of tests to be performed
The tests must be in accordance with the criteria set out in subitem 6.2.4.1 of this
document.
6.3.2.2 Definition of maintenance sampling
The requirements set out in subitem 6.2.4.2 of this document must be followed.
6.3.2.2.1 For certification models 2, 4 and 5, in the phase of collecting/purchasing

samples, for both national products and imported products, for performing
maintenance tests, OCP must collect/purchase them from the trade, and for each new
rotation of tests, the samples must be collected/purchased from different points-of-
sale. If the certification holder proves, through a tax note, that the product, of national
or foreign production, was not taken from the shelf, the expedition of the production
process or distribution centers may be considered as collection points by OCP.
Note 1: For shelf products, the absence of these at the point-of-sale to the consumer
implies the cancellation of the Certificate of Conformity of the model or of the family.
Note 2: For shelf products, the area of expedition of the manufacturing plant cannot
be considered trade, even if the tax note of the product has already been issued.
6.3.2.2.2 The collection, for performing maintenance tests, must be carried out by OCP
in samples which were manufactured within the issue date of the certificate and the
first maintenance assessment. Afterwards, the collection must be carried out with
samples of the products manufactured in the interval between the two sequential
maintenances or between the last maintenance and the recertification.
6.3.2.3 Definition of the laboratory
The guidelines described in subitem 6.2.4.3 of this document must be followed.
6.3.3 Handling non-conformities in the Maintenance Assessment stage
6.3.3.1 If any non-conformity is identified during the maintenance assessment, the

certificate holder is responsible for the critical analysis of the causes of the non-
conformities, as well as the proposal of corrective actions.
6.3.3.2 The certificate holder must send OCP, within a maximum period of 15 (fifteen)
consecutive days, the corrective actions plan, which must have 60 (sixty) consecutive
17
days as the maximum period to prove the implementation of the corrective actions.
6.3.3.3 The certificate holder must take immediate control actions, at the plant, to
prevent the model/family which failed the maintenance test from being placed out into
the market.
6.3.3.4 OCP must assess the efficiency of the corrective actions proposed in the plan
and also confirm if they were implemented.
6.3.3.5 It is up to OCP to assess whether there is a need for a new audit to confirm the
implementation of the corrective actions and/or the performing of new tests.
6.3.3.6 The non-presentation of the corrective actions plan within the period defined
in 6.3.3.2 or the identification of any non-conformity, without proof of being dealt
with, will lead to the immediate suspension of the Certificate of Conformity for the
non-conforming model/family. OCP must notify the certificate holder, in writing,
informing that the certification process will only be resumed when the non-
conformities have been corrected.
6.3.3.6.1 In the case of certification per model, if the non-conformity noted

jeopardizes other already certified models, the suspension of the certification may be
extended to these models, at the criteria of OCP.
6.3.3.6.2 In the case of certification per family, if the non-conformity is noted in one of
the family models, the suspension of the certification will apply to all the models
which make up that family and may be extended to other families, at the criteria of
OCP.
6.3.3.7 The certificate holder must present the corrective action plan within 15 (fifteen)
consecutive days of the suspension of its certification. The certification will become
valid again once the corrective actions have been considered effective by OCP. The
effectiveness of the corrective actions must be confirmed by means of tests, an audit
and/or documental analysis, at the criteria of OCP.
6.3.3.8 New timings may be agreed upon as long as they are formally requested and
justified by the certificate holder, and considered relevant by OCP.
6.3.3.9 If the certificate holder does not meet the timings established, and as long as a
new timing has not been agreed upon, the certification will be cancelled.
6.3.3.10 If the certificate holder refuses to implement the corrective actions, OCP must
cancel the Certificate of Conformity for the model(s)/family(ies) of products certified
and formally inform Inmetro.
6.3.3.11 If the product cannot be collected as defined in the specific CAR for the
object, the certificate must be cancelled.
6.3.3.12 In the case of the occurrence of non-conforming products on the market and,
considering the commitment that the non-conformity identified may impose on the
18
use of the product, OCP must formally notify Inmetro and recommend, to the
certificate holder, the need to remove the product from the market, with the
certificate holder being responsible for this action.
6.3.4 Maintenance Confirmation
OCP must issue the maintenance confirmation after the critical analysis, including
information on documents, audits, tests, handling of non-conformities, market follow-
up and handling of complaints, following the relevant requirements in subitem 6.2.6,
stating that the maintenance of meeting these requirements has been proven.
Once the requirements demanded in this RGCP and in the specific CAR for the product
have been met, OCP issues the document denominated "Confirmation of
Maintenance", formalizing that the certification has been maintained.
6.3.4.1 The Confirmation of Maintenance, as a formal tool issued by OCP, must

contain, at least:
a) Reference to the certificate of conformity being maintained;

b)Company name, Tax No. (CNPJ), complete address and, when applicable, brand
name of the certificate holder;
c) Name, address, certification registration number and signature of the person
responsible for OCP;
d)Issue date of the Confirmation of Maintenance;
e) Certification model adopted;
f) Identification of the model of the certified product, in the case of certification per
model, including the list of all brands sold;
g) Identification of the certified family and all of the models covered, in the case of
certification per family, including the list of all brands sold;
h) Scopes of service, when dealing with service certification;
i) CAR Order based on which the certificate was issued (scope of certification);
j) Barcode of the models included in f) or g), when they exist;
k) Number and date of the maintenance test report(s) issued by the laboratory;
l) Date of the audit, applicable to Models 5 and 6;
m) Date for the next maintenance assessment, in the case of maintenance

assessments with variable frequency, depending on whether or not they found non-
conformities in the audit and in the tests performed in accordance with the specific
CAR for the object.
6.4 Recertification Assessment
The recertification assessment must be programmed by OCP in accordance with the

criteria established in item 6.2 of this document and in the specific CAR of the object.
19
If the specific CAR provides for a maintenance assessment with variable frequency,
OCP must, in the recertification, give continuity to the spacing practiced from the last
assessment performed, depending on the existence, or not, of non-conformities.
The collection for performing tests must be carried out by OCP in samples which were
manufactured within the date of the last maintenance and the recertification date.
After the critical analysis, including information on documents, audits, tests, handling
of non-conformities, market follow-up and handling of complaints, OCP must decide
on the recertification.
Once the requirements demanded in this RGCP and in the specific CAR for the product
have been met, OCP issues the new Certificate of Conformity.
One certificate, with separate numbering, must be issued by OCP for each model or for
each family, for each recertification.
Note: Any additional items which are needed for the issue of the new Certificate of
Conformity must be mentioned in the specific CAR for the object.
6.5 Special Cases
6.5.1 The certification of a product subject to multiple certifications (hybrid products)

must consider all of the use functions subject to compulsory certification, meaning, all
the functions subject to certification must be concomitantly certified (initial
assessment, maintenance and recertification) even if they are carried out in separate
certification processes. If the certification process is conducted by a single OCP, it must
be certified for all the scopes subject to certification.
Hybrid products must only bear one Identification Seal of Conformity.
Note: For the purposes of this RGCP, a hybrid product is characterized as a single
product, non-decoupled, designed to perform the function of two or more products
subject to compulsory certification.
6.5.2 If, after the granting of the certificate, an improvement order is published for the
Conformity Assessment Requirements, with the forecast withdrawal of the valid CAR,
OCP must conduct a new certification process.
6.5.2.1 The new certification process, based on the new published Requirements, must
be initiated at 6.2 and concluded by the end of the adequacy period provided for
manufacture and imports, defined in the new Order.
6.5.2.2 After the conclusion of the new certification process, OCP must issue a new
certificate, with new numbering.
7 HANDLING COMPLAINTS
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The handling of complaints described in this document applies to the Supplier

requesting the certification and to the OCP.
7.1 The complaints handling process must include:
a) A system for handling complaints, signed by the person formally designated as

being responsible for this, who proves that the Supplier requesting certification and the
OCP:
• Value and effectively handle complaints presented;

• Have knowledge, commit to comply and will be subject to the penalties
provided for by the law, specifically Law no. 8078/1990;
• Critically analyze the results, and also take the necessary precautions
regarding the complaints received;
• Define responsibilities regarding the handling of complaints;
• Commit answering to Inmetro, regarding any complaint, within 15 (fifteen)
consecutive days;
• Commit answering those making the complaint regarding the reception,
handling and conclusion of the complaint, within the periods set internally.
b) A system for handling complaints containing a record for each one, how it was
handled and its current status;
c) A formal indication of a person or team who is duly qualified and has the freedom
to handle the complaints;
d) A telephone number or other means to receive complaints and a complaint
registration form which includes a code or protocol number provided to the consumer
so that he may follow up his complaint.
7.2 The Supplier requesting certification and the OCP must also perform, annually, a
critical analysis of the complaints received and proof of implementation of the
corresponding corrective actions, as well as improvement opportunities with the
recording of the results.
7.3 The OCP must audit all locations where the Complaints Handling activity is
performed, to check the compliance with the requirements previously established,
regardless of the certification model adopted, in the initial assessment, for
maintenance or recertification, when they exist.
8 ACTIVITIES PERFORMED BY OCP CERTIFIED BY A MEMBER OF THE IAF MLA
8.1 The conformity assessment activities, performed by a body certified by a member of

the IAF MLA, may be accepted as long as all the conditions below are followed:
a) The body must have a MoU with a Brazilian OCP certified by Inmetro/Cgcre;
b) The body must be certified under the same international rules adopted by Inmetro,
i.e., certified by the signatory member of the IAF MLA, for the same scope, or
equivalent;
21
c) The activities performed by OCP must be equivalent to those regulated by Inmetro;
d) There can be no restriction by the Regulating Authority of the object submitted to

certification.
8.2 The MoU will be subject to confirmation in periodical certification assessments

carried out by Inmetro/Cgcre and must meet, at least, the conditions below:
a) The parties must agree to keep the signatories informed of any change to the
situation of their certification in the country of origin;
b) The parties must agree which of the documents of the certification process issued in
a language other than English or Spanish should be accompanied by a sworn
translation into Portuguese;
c) The parties must clarify the activities which are covered by the MoU, such as, for
example, the audit, test plan, test report assessment, audit report assessment.
8.3 The Body legally established in the country and certified by Inmetro/Cgcre will be
responsible for the awarding and issue of the certificates in compliance with the
Brazilian law, assuming all responsibilities for activities performed abroad and related
to this issue, as if they had carried out all activities themselves.
8.4 Foreign bodies certified by Inmetro/Cgcre in the specific scope may conduct
certification processes in the scope of the specific CAR for the object, as long as they
are legally established in Brazil. In this case, all documents from the certification
process must be available in Brazil and in Portuguese, observing the exceptions
provided for in 6.2.1.2 "e" and in the note in subitem 6.2.3.2.
9 TRANSFER OF CERTIFICATION
9.1 The transfer of valid certifications, issued in accordance with what is established in
the specific CAR, from an issuing OCP to a receiving OCP, is allowed, and can be
initiated by the issuing OCP or by the certificate holder.
9.2 The receiving OCP must be legally established in the country and certified by
Inmetro/Cgcre.
9.3 Each OCP must include in contracts with their clients the availability to provide the
information needed to other OCP at the time of the transfer of a certificate issued by
them, still valid and considering what is established in 9.1 of this RGCP.
9.4 A qualified person from the receiving OCP must perform a critical analysis of the
certification process of the new client. This critical analysis must be led by an
examination of the documents/records and/or a visit to the manufacturer or service
provider, and be duly recorded. The critical analysis must cover, at least, the following
aspects:
22
a) The stages of the process performed to date and the situation in the stage of the
current certification process;
b) Test reports;
c) Test plan performed, correlating with the family or model;
d) Reasons for the transfer request;
e) Validity of the certificate pertaining to authenticity and duration, covering the
scope which is the object of the transfer;
f) Validity of the certification and situation of non-conformities with correction(s)
still pending. This check should preferably be performed together with the
issuing OCP, unless they have closed their activities;
g) Report(s) from the last audit (certification, maintenance and recertification),
from extraordinary audit(s) and any non-conformity not yet resolved;
h) Complaint(s), appeal(s) received and action(s) taken;
i) The current stage of the certification.
9.5 Certifications which have been suspended, cancelled or have an expired validity
cannot be accepted for transfer purposes.
9.6 If the critical analysis identifies pending non-conformities or potential risks, or

when there are doubts regarding the adequacy of the existing certification, the
receiving OCP must, depending on the degree of the doubt:
a) Not accept the transfer process and start a new certification process; or,
b) Accept the transfer process after proving, through an audit or test, that the original
certification can be maintained.
The decision regarding the actions requested will depend on the nature and the extent
of the non-conformities found, and must be duly recorded and explained to the
certificate holder.
9.7 If the critical analysis identifies pending non-conformities or potential risks, the
receiving OCP must accept the certification transfer.
9.8 Once the transfer has been accepted, the receiving OCP will issue a new certificate,
dated after the critical analysis and with the remaining validity in relation to the
original certificate, and considering all the items provided for in 6.2.6 of this RGCP.
9.9 The following maintenance assessment or recertification must occur in accordance

with the criteria established in the specific CAR for the object and be carried out within
the periods provided for in the original certification process performed by the receiving
OCP.
9.10 The receiving OCP must retain all documents and records related to the
certification transfer for the time established in their quality management system.
10 CLOSING THE CERTIFICATION
23
The closure of certification will occur in the event of the closure of the
manufacture/import of products or service provision services, compulsorily certificated,
or by the choice of the certificate holder in the case of voluntary certifications.
The OCP must ensure that the objects certified prior to this decision conform to the
specific CAR for the object.
10.1 The OCP must program an extraordinary audit to confirm and record the
following requirements:
a) date of manufacture and size of the last batches of the certified object;
b) material available in stock;
c) quantity of the finished product in stock and forecast for the distribution of this
batch;
d) compliance with the requirements provided for in the specific CAR for the object
from the last follow-up audit;
e) routine tests performed to the last batches produced;
f) stock of seals purchased.
10.2 When deemed necessary, the OCP may also program the collection of samples and
the performing of tests to assess the conformity of the products in stock.
10.3 If the results of these tests present any non-conformity, the OCP must, before
considering the process closed, request appropriate treatment from the relevant
certificate holder, defining the provisions and the implementation periods.
10.4 In the case of the occurrence of non-conforming products on the market, before
considering the process closed, and depending on the involvement that the non-
conformity identified may impose on the use of the product, the OCP must consider
the need to remove the product from the market, with the certificate holder being
responsible for this action.
10.5 After the closing of the compulsory certification, the product can no longer be
manufactured or imported, and the distribution and sale of the stock produced will be
allowed strictly within the validity of the certification. Similarly, the closure of
compulsory certification of a service implies the prevention of the provision of
services.
10.6 Once the abovementioned stages have been completed, the OCP must cancel the
certificate, update the certified products and services database provided by Inmetro,
and also give notice of the closure to Inmetro/Dconf, by issuing a document which
includes the information provided for in subitem 10.1.
10.7 If the certificate holder does not allow OCP to comply with requirements 10.1 to
10.5 above, the OCP must cancel the certificate, update the certified products and
services database provided by Inmetro, and also give notice of the closure to
Inmetro/Dconf, explaining the abovementioned prevention.
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11 IDENTIFICATION SEAL OF CONFORMITY
The Identification Seal of Conformity is aimed at identifying that the object of

certification was submitted to the conformity assessment process and meets the
requirements contained in this document and in its respective CAR.
11.1 The model, characteristics, traceability and ways to place the Identification Seal of
Conformity will be defined in the specific CAR of the object, following the provisions
contained in Inmetro Order no. 274/2014.
11.2 The Identification Seal of Conformity may be printed on the Certificate of

Conformity, marked or placed on the product and/or printed or placed on the
packaging, in accordance with the specific CAR for the object.
11.3 In the case of imported products, with the exception of those certified by Model
1b, the Identification Seal of Conformity must be marked or placed on the product
and/or printed or placed on the packaging, in accordance with the specific CAR for the
object before it enters the country.
12 AUTHORIZATION FOR THE USE OF THE IDENTIFICATION SEAL OF CONFORMITY
The Authorization for the use of the Identification Seal of Conformity is granted after
all the requirements in this document and in the specific CAR for the object have been
met.
12.1 For certified products which can have the Object Record, the authorization for
the use of the Identification Seal of Conformity and sale of the product or provision of
the service are restricted to the obtaining of the Object Record.
12.2 In other cases, the authorization is granted when the product conforms to the
criteria established in this document and in the specific CAR for the object, with the
Record being waived by Inmetro.
12.3 The authorization, whether for products which may be recorded or not, will have
its validity bound to the validity of the certification and with the condition that it is not
suspended or cancelled.
12.4 References to characteristics not included in the referenced base standard,

included in the instructions for use or user information, cannot be associated with the
Authorization for the Use of the Identification Seal of Conformity or lead the user into
believing that these characteristics are covered by the Certification process.
13 RESPONSIBILITIES AND OBLIGATIONS
13.1 Certificate Holder Obligations
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13.1.1 Only provide the services or produce, import and sell products subject to
certification which are in accordance with the specific CAR of the object, proven
through the Certificate of Conformity.
13.1.2 Comply with all conditions established in this document, in the specific CAR for
the object in question, in legal provisions and in contractual provisions relating to the
authorization, regardless of its transcription.
13.1.3 Apply the Identification Seal of Conformity to all certified products, as per the
criteria established in this document and in the specific CAR for the object.
13.1.4 Comply with the relevant decisions of Certification taken by the OCP, using
Inmetro, in cases of complaints and appeals, via Inmetro's Ombudsman.
13.1.5 Facilitate OCP, or a contracted party upon proof of this condition, with auditing
and follow-up works, as well as the performing of other tests and other Certification
activities provided for in this document and in the specific CAR for the object.
13.1.6 Maintain the technical-organizational conditions which were used as a basis for
obtaining the certificate of conformity, informing the OCP previously, of any
modification they intend to make to the product for which the given certificate was
granted.
13.1.7 Immediately inform the OCP in the case of the definitive ceasing of the
provision of services or manufacture or import of the certified product.
13.1.8 Not use the same code (commercial denomination) for a certified and non-
certified product.
13.1.9 For authorization, provide Inmetro with all of the advertising material where
the Identification Seal of Conformity will be placed.
13.1.10 The certificate holder has technical, civil and criminal responsibility relating to
the certified objects, as well as all documents relating to the Certification. This
responsibility cannot be transferred.
13.1.11 The certificate holder must reimburse the OCP with all costs from market
follow-up actions performed by Inmetro, as provided for in item 14 of this RGCP.
13.1.12 When announcing the recall of certified products with non-conformities, they
must follow the rules provided in Order MJ487/2012.
13.1.13 Inform Inmetro, within 48 hours, when they identify that a certified object
placed on the market presents non-conformities which put the health and safety of the
user and the environment at risk, so that they can request the removal of the product
from the market and the recall from Senacon/DPDC of the Ministry of Justice, and also
arrange the removal of the product from the market and give it its final destination, in
compliance with the legislation in force.
26
13.1.14 Reply to notifications from Inmetro, within the periods set, which request
clarifications related to the investigation processes of non-conformities detected in the
certified object.
13.1.15 Request the Object Record from Inmetro, in cases in which regulations demand
it, providing all information required for the Record process.
13.1.16 Provide Inmetro with all information requested, related to the certification
process of the product object of the CAR, providing, when needed and requested,
supporting documents.
13.1.17 Present, to the OCP, the process to be used in the disclosure of information, in
a systematic manner, to all of its clients, regarding the adequacy period destined for
the sale, to provide its products without the Identification Seal of Conformity, during
this period.
13.1.18 The certificate holder must consider the periods given by the OCP, by the test
laboratory and by Inmetro for the entering, in good time, with the Maintenance and
Recertification Assessments.
13.1.19 The certificate holder must notify the OCP, at any time, of any change to the
product, descriptive memorandum or the production process of the certified object.
13.1.20 In the event of the cancellation of the issuing OCP, the certificate holder must
migrate to another OCP by the time of the next maintenance or recertification,
whichever happens first.
13.2 OCP Obligations
13.2.1 Have qualified personnel, maintain a record of qualifications and training

activities so as to be able to lead the whole certification process provided for in the
specific CAR of the object in a competent manner.
13.2.2 Perform the certification of the product in accordance with the requirements
established in this document and in the specific CAR for the object, passing on all
doubts to Inmetro.
13.2.3 Introduce and update, within 5 (five) working days, the certified products and
services database provided by Inmetro with the information related to the certificate,
including issue, adequacy of the scope, suspension and cancellation.
13.2.4 In addition to item 13.2.3, notify Inmetro/Dconf, within 5 (five) working days, in
the case of a suspension or cancellation of certification, by physical or electronic
means. In the case of products regulated by another Regulating Authority associated
with certification processes coordinated by Inmetro, this notification must also be
passed on to them.
27
13.2.5 Submit the Memoranda of Understanding in the scope of this document and in
the specific CAR, established with other Certification Bodies to Inmetro/Cgcre, for
analysis and approval for use.
13.2.6 Select, in joint agreement with the Supplier requesting certification, the
laboratory to be used in the certification process, based on the requirements
established in this document and in the specific CAR for the object.
13.2.7 Collect, at any time, as determined by Inmetro, in the case of suspicions or duly
substantiated complaints, samples on the market for performing tests defined in the
specific CAR for the object, following the provided sampling criteria, bearing the costs
of the collection and testing, following what is provided for in item 14 of this RGCP.
13.2.8 Have a System to Handle Complaints which follows the provisions in Chapter 7
of this RGCP.
13.2.9 Not have any outstanding issues with Inmetro.
13.2.10 Immediately inform Inmetro, within a maximum of 48 hours, of any

information regarding recalls, even if only preliminary, meaning, in investigation
phases, provided by companies that have their object certified.
13.2.11 Inform Inmetro/Cgcre of the existence of non-conformities detected during

the QMS audit performed at any manufacturer that holds an ABNT NBR ISO 9001 or
ISO 9001 certificate.
13.2.12 Formally inform its clients with Authorization for the Use of the Identification
Seal of Conformity of changes to technical standards and documents issued or
recognized by Inmetro which may interfere with the requirements of this document.
13.2.13 The interpretation of the results contained in the test reports issued by the
laboratories is the sole responsibility of the OCP, as the laboratory cannot do this.
13.2.14 Demand that the laboratories inform them of measurement uncertainties

inherent in the tests performed.
13.2.15 If the OCP has its certification cancelled, it must:
a) Immediately inform its clients of this condition and instruct them in the process of
transition to another OCP which has its certification active, emphasizing that
certificates already issued will remain valid until the end of the maintenance or
renewal periods, whichever happens first;
b) Provide, when requested, Inmetro/Dconf with all records and information related
to certification processes performed by them;
c) Provide its clients with all records, certificates, reports and other documents related
to their certification process(es) to assist them at the time of the contracting of
28
another certified OCP for their certification to be continued;
d) Inform Inmetro/Dconf of all actions carried out during the migration process of
companies with certificates so as to prevent damage to suppliers and consumers;
e) Facilitate the migration of the certification process to another OCP defined by the
certification holder.
13.2.16 The cancelled OCP cannot perform activities related to the maintenance or
renewal of issued certificates for the Conformity Assessment Programs established by
Inmetro.
13.2.17 The suspended OCP must inform its clients of this condition and, while in this
condition, cannot perform any initial certification granting activity nor grant
recertifications or extension of scope to certifications in force. During the suspension
period, the OCP must perform all activities related to the maintenance of the
certificates in force, as long as there is no expansion to their scope.
14 MARKET FOLLOW-UP
The certified objects are submitted to a market follow-up through Inspection,

Conformity Check, Technical Inspection, among others.
14.1 The certificate holder is responsible for replacing the samples of the certified
object taken from the market by Inmetro or its delegated bodies, for market follow-up
purposes.
14.2 A certificate holder who has the certified object submitted to a market follow-up
must provide Inmetro and the OCP, when requested or administratively notified, with
all information regarding the Certification process and the internal production quality
control process, within a period of 5 (five) working days.
14.3 If Inmetro identifies non-conformities in the market follow-up actions, it will

notify the certificate holder and the OCP, establishing the need for measures and
respective timings.
14.4 The non-conformities identified by the market follow-up may lead to the
application of the penalties provided for in item 15 of this RGCP.
14.5 If any non-conformity is found, and considered by Inmetro to be systematic or a

potential risk to the health and safety of the consumer or to the environment, Inmetro
may determine the removal of the product from the market.
14.6 If any non-conformity is found, and considered by Inmetro to be systematic or a

potential risk to the health and safety of the consumer or the environment, Inmetro
must critically analyze each case and may decide to inform Senacon/DPDC of the
Ministry of Justice of the fact, who in turn will analyze the need for the obligation to
recall by the certificate holder.
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14.7 Whenever determined by Inmetro, in the event of a duly founded complaint, the
OCP may receive samples collected by Inmetro from the market, at any time, for
performing tests defined in the specific CAR, following the sampling criteria provided.
The OCP must forward the samples on to a certified laboratory, defined together with
Inmetro, bearing the costs related to the tests and, upon their completion, send the
test reports to Inmetro. Inmetro may determine that its technicians follow up the tests
performed.
14.8 The collection of the samples may, as an exception and when defined by Inmetro,
be performed by OCP, who will arrange their delivery to the laboratory. In this case,
the OCP will be responsible for collecting the samples and sending them to the
laboratory, in addition to the cost of the tests.
15 PENALTIES
Non-compliance with the requirements included in the Orders, in this document and in
the specific CAR will lead to the application of warning penalties, suspension and
cancellation of the Certification.
16 COMPLAINTS
The Inmetro Ombudsman receives communications, complaints and suggestions

through the following channels:
• e-mail: ouvidoria@inmetro.gov.br
• telephone: 0800 285 18 18
• website: www.inmetro.gov.br/ouvidoria
• address for mail:
Ouvidoria - Instituto Nacional de Metrologia, Qualidade e
Tecnologia (Inmetro) Rua Santa Alexandrina, 416 - térreo Rio
Comprido - Rio de Janeiro - RJ CEP 20261-232
30
ATTACHMENT A – REQUIREMENTS FOR THE ASSESSMENT OF LABORATORIES NOT

ACCREDITED BY PRODUCT CERTIFICATION BODIES
1 CONFIDENTIALITY
The laboratory must have documented and implemented procedures to maintain

confidentiality protection and the integrity of information, considering, at least:
a) Access to archives, including computer files;

b) Restricted access to the laboratory;
c) Laboratory staff awareness regarding the confidentiality of information.
2 ORGANIZATION
2.1 The laboratory must designate signatories to sign the test reports and have full
technical responsibility for their content.
2.2 The laboratory must have a managing technician and a deputy (regardless of the
title) with global responsibility for their technical operations.
2.3 When the laboratory belongs to the first party, the responsibilities of the
organization's key staff that are involved in or have an influence on the laboratory
tests must be defined, so as to identify potential conflicts of interest.
2.3.1 The organizational arrangements should also be such that the departments
which have potential conflicts of interest, such as production, sales or financial
marketing, do not negatively influence the compliance of the laboratory with the
requirements of this Attachment.
3 MANAGEMENT SYSTEM
3.1 All documents needed for the correct performance of the laboratory's activities
must be identified in an unequivocal manner and contain their issue date, revision
number and the authorization for their issue.
3.2 All documents needed for the correct performance of the laboratory's activities
must be up-to-date and accessible to its staff.
3.3 The laboratory must document the attributions and responsibilities of the
technical manager and the technical staff involved in the tests, considering at least the
responsibilities related to:
a) Execution of tests;
b) Test planning, result assessment and issuing of test reports;
c) Modification, development, description and validation of new test methods;
d) Management activities.
31
3.4 The laboratory must have the identification of the authorized signatories (where
this concept is appropriate).
3.5 The laboratory must have documented and implemented procedures for
obtaining the traceability of the measurements.
3.6 The laboratory must have the coverage of its services and provisions formalized to
ensure that it has appropriate facilities, staff and resources.
3.7 The laboratory must have documented and implemented procedures for handling
test items.
3.8 The laboratory must have a list of equipment and reference standards used,
including their respective identification.
3.9 The laboratory must have documented and implemented procedures for feedback
and corrective actions, whenever non-conformities are detected in the tests.
3.10 The laboratory must report measurement uncertainties inherent in the tests
performed.
4 STAFF
4.1 The laboratory must have enough staff, with the necessary level of education,
training, technical knowledge and experience for the designated functions.
4.2 The laboratory must have procedures for the use of technicians in training
processes, establishing, for this, records of supervision for this training and creating
mechanisms to guarantee that their use does not jeopardize the test results.
4.3 The laboratory must have records of all technical staff involved in the tests and
keep them up-to-date. These records must have the date of authorization, for at least:
a) Performing different types of sampling, when applicable;

b) Performing different types of tests;
c) Analyzing test reports;
d) Operating the different types of equipment.
5 ACCOMMODATION AND ENVIRONMENTAL CONDITIONS
5.1 The laboratory accommodation, test areas, power sources, lighting and ventilation
must allow the appropriate execution of the tests.
5.2 The laboratory must have facilities with the effective monitoring, control and
registration of environmental conditions, whenever necessary.
5.3 The laboratory must maintain an effective separation between neighboring areas
when there are incompatible activities.
32
5.4 The laboratory must provide facilities which ensure safety for conducting the tests,
as well as PPEs relevant to the protection of its staff.
6 REFERENCE EQUIPMENT AND MATERIALS
6.1 The laboratory must have all the equipment, including reference materials needed,
for the correct execution of the tests.
6.2 Before conducting the test, the laboratory must check to see if any item of the
equipment is presenting suspicious results. If this occurs, the equipment must be placed out-
of-order, identified as such, repaired and demonstrated through calibration, check or
test, that it is operating satisfactorily before being used again.
6.3 Each piece of equipment must be labeled, marked or identified to indicate the state
of calibration. This state of calibration must visibly indicate the last and next
calibration.
6.4 Each piece of equipment must have a record which indicates, at least:
a) Name of the piece of equipment;

b)Name of manufacturer, identification of type, serial number or other specific
identification;
c) Condition of receipt, when appropriate;
d)Copy of manufacturer instructions, when appropriate;
e) Dates and results of calibrations and/or checks and date of next calibration and/or
check;
f) Details of maintenance performed and planned for the future;
g) History of each damage, modification or repair.
6.5 Each reference material must be labeled or identified to indicate certification or

standardization. The label must contain, at least:
a) Name of the reference material;

b) Person responsible for certification or standardization (company or person);
c) Composition, when appropriate;
d) Validity date.
6.5.1 For long life reference materials, the laboratory must have a record containing
the information indicated in item 6.5.
7 TRACEABILITY OF MEASUREMENTS AND CALIBRATIONS
7.1 The laboratory must have a program established for the calibration, verification
and maintenance of its equipment, so as to guarantee the use of calibrated and/or
checked equipment, on the date of the execution of the tests.
7.2 The calibration certificates of the reference standards must be issued by:
33
a) National metrology laboratories referred to in 7.2;

b) Calibration laboratories certified by Inmetro/Cgcre;
c) Laboratories integrated in the National Metrology Institutes of other countries, in the
following cases:
- When traceability is obtained directly from an institution which has an associated

primary standard of magnitude, or;
- When the institution participates in inter-laboratory comparison programs, together
with Inmetro/Cgcre, obtaining compatible results;
- Laboratories accredited by Certification Bodies from other countries when there is an
agreement of mutual recognition or of cooperation between Inmetro/Cgcre and those
bodies.
7.3 The certificates of the measurement and testing equipment of the test laboratory
must meet the requirements provided for in the previous point.
7.4 The reference standards maintained by the laboratory must only be used for
calibrations, unless it can be shown that their performance as a reference standard has
not been invalidated.
8 CALIBRATION AND TEST METHOD
8.1 All instructions, standards and reference data related to the work of the laboratory
must be documented, kept up-to-date and be readily available to laboratory staff.
8.2 The laboratory must use documented procedures and appropriate statistical
techniques for the selection of samples when performing sampling as part of the test.
8.3 The laboratory must submit the calculations and data transfers to appropriate
checks.
8.4 The laboratory must have procedures for the security of the data on computer
records.
9 HANDLING ITEMS
9.1 The laboratory must unambiguously identify the items to be tested, so that there is
no doubt, at any time, as to their identification.
9.2 The laboratory must have documented procedures and suitable facilities to
prevent deterioration of or damage to the test item during storage, handling and
preparation of the test item.
10 RECORDS
10.1 The laboratory must maintain a records system which is adequate to its particular
circumstances and must comply with applicable regulations, as well as recording all
34
original observations, calculations and data obtained, records and copy of test reports
for a period of at least four years.
10.2 Alterations and/or errors in records must be crossed out, not removing or making
the previous wording or annotation illegible, and the new annotation must be
recorded beside the crossed out previous one, in a legible manner which does not lead
to a dubious interpretation. It must also contain the signature or initials of the person
responsible.
10.3 Test data records must contain, at least:
a) Identification of the laboratory;

b)Identification of the sample;
c) Identification of the equipment used;
d)Relevant environmental conditions;
e) Results of measurements and their uncertainties, when appropriate;
f) Date and signature of the staff that performed the work.
10.4 All records printed by computer or calculators, graphs and others must be dated,
initialed and attached to the measurement records.
10.5 All records (technical and quality) must be kept secure and confidential by the
laboratory.
11 TEST REPORTS
11.1 The results of each test or series of tests performed by the laboratory must be
reported in a precise, clear and objective manner, without ambiguities, in a test report
and must include all the information needed to interpret the test results, as demanded
by the method used.
11.2 The laboratory must record all information needed to repeat the test and those
records must be made available to the client.
11.3 All test reports must include at least the following information:
a) Title;
b)Name and address of the laboratory;
c) Unique identification of the report;
d)Name and address of the client;
e) Description and identification, without ambiguity, of the item tested;
f) Description and condition of the item tested;
g) Date of receipt of the item and date of the execution of the test;
h)Reference to the sampling procedures, when relevant;
i) Any deviations from, additions to or exclusions from the test method and any other
information relevant to a specific test, such as environmental conditions;
j) Measurements, checks and results, supported by tables, graphs, diagrams and
photographs;
35
k) Estimated uncertainty statement of the test result (where relevant);

l) Signature, title or equivalent identification of staff responsible for the content of the
report and date of issue;
m)Where relevant, a statement that the results relate only to the items tested;
n) Statement that the report can only be reproduced in full and with the client's
approval;
o) Identification of the item;
p) Reference to the specification of the standard used.
12 SUPPORT SERVICES AND EXTERNAL SUPPLIES
12.1 The laboratory must maintain records related to the acquisition of equipment,
materials and services, including:
a) Specification of the purchase;

b) Inspection of receipt;
c) Calibration or check;
d) Registration of suppliers.
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ATTACHMENT B – CRITERIA FOR CERTIFICATION OF SETS OF CERTIFIED OBJECTS (KIT)

OR CERTIFICATION TRANSFER
1 OBJECTIVE
This Attachment is applied in the case of an integrator, packer and/or distributor who
substitutes or makes modifications to the original packaging of an already certified
product or who changes the form of presentation for selling the product in relation to
the original certification process, using or making the most of the original certification
of the product, to be later sold to the end consumer.
This attachment does not apply to the case of already certified products which, in
addition to having their original packaging changed, have their characteristics changed,
a condition which will lead, when authorized by Inmetro, to a new certification
process.
Note 1: To simplify the text, integrators, packers and/or distributors who make
changes to repackage or form kits already certified at the origin will be denominated as
"packers".
Note 2: The certification transfer process must be requested for each unit of the
packer's operation.
2 DEFINITIONS
2.2.1 Forming the Kit
The forming of the kit is described when the packer (transferee) includes, in the same
package, two or more already certified products.
2.2.2 Fractioning
Operation described when the packer (transferee) performs a fractioning operation

from the bulk packing of the product in addition to the changing of the display package.
3 CONFORMITY ASSESSMENT STAGES
Packers who do not make any modification to the original packaging of already
certified products, but who change the form of presentation for selling the product in a
new packaging will be subject to certification considering all of the items below, with
the exception of the Test Plan included in this Attachment.
Packers who made modifications to the original packaging of an already certified

product will be subject to certification considering all of the items described below. In
this case, the final packaging must contain all of the obligatory markings provided for in
the specific CAR for the object.
37
For cases where there in an integration of two or more certified products in the same
packaging, the OCP responsible for the certification transfer process must be certified,
at least, for the scope of the main product. In cases where the products are similar,
therefore, rendering the main product unclear, the OCP responsible for the
certification transfer process must be certified in at least one of the scopes which
make up the kit.
For the purposes of marking the packaging of kits which contain certified products
which have not had their original packaging changed, the following wording must be
placed on the new packaging: "CONTAINS PRODUCTS REGISTERED AT INMETRO".
For kits which contain certified products which have had their original packaging
changed, the following possibilities are considered:
a) The main product is clear: in this case, the new packaging must have the
Identification Seal of Conformity of the main product, with the Registration
number of the kit.
b) The main product is unclear: in this case, the new packaging must have the
Identification Seal of Conformity of the product from which the OCP is certified,
with the Registration number of the kit.
In both situations, OCP must also assess item 7 of this RGCP – Handling of Complaints.
3.1 Initial Assessment
3.1.1 Certification Transfer Request
The request to be sent to the OCP must be accompanied by the following documents:
a) Address of the packer unit, Supplier requesting certification;

b) Tax No. – CNPJ, and the Articles of Association of the company, containing, in
the object, the description of its activities;
c) Documents which prove compliance with item 7 of the RGCP (Handling of
Complaints) for all the brands sold;
d) Description of the fractioned product or of the products which make up the kit;
e) Authenticated copies of the Certificate(s) of Conformity of the product
submitted to fractioning or of the products which make up the kit, within their
validity;
f) Specific authorization of the certification transfer, signed by the certificate
holder(s) of the product(s) mentioned in e);
g) Photographic documentation of the product(s) listed in d): external and
internal photos of all sides, detailing labels, logos, warnings, inputs, outputs,
activation buttons, when applicable;
h) Design or artwork of packaging (primary, secondary and/or tertiary);
i) User manual with instructions in Portuguese, when applicable;
j) Authorization for the use of the brand(s), if the packer uses the brand(s) of the
original certification.
38
Note: In the case of what is provided for in j), the OCP is responsible for the legal
qualification of the authorization instrument and the document establishing the
owner(s) of the brand(s).
Note: When the user manual is not applicable in the original certification, the OCP
must validate and record this information in the certification process.
3.1.1.1 In the case of a certification transfer process for imported products, a copy of
the Import License (LI) must be sent along with the certification transfer request.
3.1.1.2 The documents listed in subitem 3.1.1 must have their authenticity confirmed
by the OCP, in relation to the original documents.
3.1.2 Analysis of the Request and of the Conformity of Documentation
3.1.2.1 Before starting the certification transfer process, the OCP must analyze the
viability of responding to the request, and also check the documents sent. If the
request is considered to be non-viable, the OCP must formally state the reason for the
non-viability of the request and return all documents presented.
3.1.2.2 If any non-conformity is identified in the documents received, it should be

handled as stated in subitem 6.2.2 of this RGCP.
3.1.3 Initial Audit to the Management System
3.1.3.1 After the analysis and approval of the request and documentation, the OPC
must, with the agreement of the packer, applicant of the certification transfer,
program the performance of the initial audit on the packer unit, complementarily
assessing the requirements of the Quality Management System applicable to the re-
packaging processes, in accordance with Table 1 below:
Table 1: Requirements for checking the QMS applicable to the packer based on
Standard ISO 9001 or Standard ABNT NBR ISO 9001
QMS REQUIREMENTS Standard ISO 9001 or ABNT NBR ISO 9001

Control of non-conforming product 8.3
Note: This assessment must occur regardless of whether the packer has a certified quality
management system or not.
3.1.3.2 If, during the audit, the OCP assesses the possibility that the original certified
product may have its conformity affected by the re-packaging process, the product
39
must be tested in the items provided for in the CAR of the object.
3.1.3.3 The OCP must issue the audit report, registering its result, using this
Attachment as a reference. The audit report must be signed by the packer and the
OCP. A copy of this report must be given to the packer.
3.1.4 Initial Packaging Test Plan
The OCP is responsible for preparing a Test Plan which must, at least, clearly define
the sampling, the initial tests to be performed on the packaging of the product subject
to transfer and the acceptance/rejection criteria for these tests.
If OCP assesses that the original certified product has had its conformity affected by
the re-packaging, process, the test plan must include all of the tests provided for the
product in the CAR of the object.
3.1.4.1 Definition of tests to be performed on the Packaging
3.1.4.1.1 Tests on packaging must be conducted on the basis of the specific CAR.
3.1.4.1.2 The test laboratory must keep a photographic record of the assessment.
3.1.4.2 Definition of Packaging sampling
3.1.4.2.1 For the certification transfer, the OCP must establish the procedure for
collecting samples (test, counter and witness) of the packaging subject to certification
transfer, so as to allow the performing of the tests provided for in the specific CAR.
3.1.4.2.2 The OCP is responsible for collecting the samples for the tests, in accordance
with its procedures.
3.1.4.2.3 The OCP must sample all of the models of the packaging and send them to the
test laboratory for analysis in accordance with what is provided for in the CAR.
3.1.4.2.4 The sampling for the test samples must be of 2 (two) units of each model of
the packaging subject to assessment.
3.1.4.2.5 To conduct the testing of the counter and witness samples, the same sample
quantity defined in 3.1.4.2.4 must be repeated.
3.1.4.3 Definition of laboratories for Packaging Testing
The tests on packaging must be performed in laboratories as per the requirements

defined in this RGCP and in the specific CAR.
Note: If the assessment of the packaging provided for in the CAR of the object is
limited to its visual assessment (checking of markings, instructions and manual), this
may be performed by the OCP.
40
3.1.4.4 Packaging Acceptance and Rejection Criteria
3.1.4.4.1 All of the units tested must conform to the requirements

established in the specific CAR for the object.
3.1.4.4.2 If there are approvals in the test samples, the sample is considered as being
approved. If there are non-conformities in the test sample, all tests must be repeated
on the counter sample and witness sample.
a) If there are non-conformities in the counter sample, the sample will be considered
as being rejected;
b) If the counter sample does not have any non-conformities, the witness sample must
be tested;
c) If the witness sample has any non-conformities, the sample will be considered as
being rejected;
d) If the witness sample does not have any non-conformities, the sample will be
considered as being approved.
3.1.4.4.3 At the criteria of the Supplier requesting the certification, upon formalization
from the OCP, the counter samples and witness samples will not necessarily have to be
tested. In this case, the results obtained from the test sample cannot be contested.
3.1.4.4.4 If there are fails in the tests, the certification transfer process will be
cancelled.
3.1.5 Handling of non-conformities in the Initial Assessment stage
If any non-conformity is identified in the initial assessment stage, it should be handled

as stated in subitem 6.2.5 of this RGCP.
3.1.6 Issue of Certificate of Conformity
3.1.6.1 Once all the requirements demanded in this Attachment have been met, the
OCP issues the Certificate of Conformity.
3.1.6.2 The Certificate of Conformity, as a formal instrument issued by the OCP, must
contain, at least:
a) Company name, complete address, brand name and Tax No. (CNPJ) of the packer of
the object of the certification transfer;
b)Date of issue and validity of the Certificate of Conformity;
c) Name, certification registration number and signature of the person responsible for
the OCP;
d)Number(s) of the certificate(s), validity and name of the OCP of all certified products
in the original process and included in the certification transfer;
e) Model(s) of the product(s) which make up the kit or fractioned packaging;
f) Number, date and identification of the issuer of the packaging test report issued by
41
the laboratory.
Note: The Certificate of Conformity must clearly indicate the operating unit of the
packer to which it applies.
Note: When dealing with a kit, the description of the product on the certificate must
be preceded by the term Kit. When dealing with the fractioning of a bulk product, the
description of the product on the certificate must be preceded by the term Fraction.
3.1.6.3 When the certificate issued is the result of the transfer of more than one
original certification, its validity must be equal to the shortest validity of the certificates
of the products which make up the packaging to be sold to the final consumer. When
the certificate issued is the result of the transfer of only one original certification, its
validity must be the same as the remaining validity of the original certificate.
3.1.6.4 The Certificate must contain the following wording: "The validity of this
Certificate is tied to the performing of the maintenance assessments and handling of
any non-conformities in accordance with the OCP guidelines".
3.2 Maintenance Assessment
3.2.1 Maintenance Assessment Planning
3.2.1.1 Following the granting of the Certificate of Conformity, the OCP must plan the
audits and maintenance tests of the packaging, so as to confirm whether the technical-
organizational conditions which gave rise to the initial granting of the certificate are
still being complied with.
3.2.1.2 The frequency of the maintenance assessment of the packer is 12 (twelve)

months.
3.2.1.3 The OCP responsible for the certification transfer must monitor the
maintenance validity of each of the components of the kit, as the maintenance validity
of the certified kit will depend on the certification validity of each of its components.
3.2.1.4 The transfer certifying OCP must request, from each of the OCPs responsible for
the certification of each of the product components of the kit or product with new
packaging, that they be informed in the case of the suspension or cancellation of the
original certification, so that it may take the necessary measures regarding the
certification of the kit or product with new packaging. The opposite is also applicable,
i.e., a suspension, recall action or cancellation of the certificate of the kit must be
passed on to all the OCPs of the original products.
3.2.2 Maintenance Audit
The OCP must program the maintenance audits in accordance with what is established
in subitem 3.1.3 of this Attachment.
3.2.3 Packaging Maintenance Test Plan
42
The OCP must prepare the packaging maintenance test plan in accordance with what
is established in subitem 3.1.4 of this Attachment.
For performing maintenance tests, the OCP must collect/purchase them from the
trade, and for each new round of tests, the samples must be collected/purchased from
different points-of-sale.
3.2.4 Handling of non-conformities in the Maintenance Assessment stage
If any non-conformity is identified in the maintenance assessment stage, it should be

3.2.5 Maintenance Confirmation
The OCP must issue the maintenance confirmation after the critical analysis, including
information on documents, audits, tests, handling of non-conformities, market follow-
up and handling of complaints, following the relevant requirements in subitem 3.1.6 of
this Attachment, stating that the conformity with these requirements has been
proven.
The OCP must request from the OCPs of the original certifications, the respective
Maintenance Confirmation(s) of each product submitted to fractioning or of the
products which make up the kit.
Once the requirements demanded in this Attachment have been met, the OCP issues
the document denominated "Maintenance Confirmation", formalizing that the
certification has been maintained.
3.2.5.1 The Maintenance Confirmation, as a formal instrument issued by the OCP,

must contain, at least:
a) Company name, complete address, brand name and Tax No. (CNPJ) of the packer of
the object of the certification transfer;
b)Name, certification registration number and signature of the person responsible for
the OCP;
c) Number(s) of the certificate(s), validity and name of the OCP of all certified products
in the original process and included in the certification transfer;
d)Model(s) of the product(s) which make up the kit or fractioned packaging;
e) Date of issue and validity of the Certificate of Conformity;
f) Number, date and identification of the issuer of the packaging test report(s) issued by
the laboratory;
g) Date of issue of the Maintenance Confirmation.
Note: The Certificate of Conformity must clearly indicate the unit of the packer to
which it applies.
Note: When dealing with a kit, the description of the product on the certificate must
be preceded by the term Kit. When dealing with the fractioning of a bulk product, the
description of the product on the certificate must be preceded by the term Fraction.
43
3.3 Recertification Assessment
The recertification assessment must be programmed by the OCP in accordance with the
criteria established in item 3.1 of this Attachment.
3.3.1 Handling of non-conformities in the Recertification Assessment stage
If any non-conformity is identified in the recertification assessment stage, it should be

3.3.2 Recertification Confirmation
The recertification confirmation from the OCP is based on a decision made after the
critical analysis, including information on documents, audits, tests, handling of non-
conformities and complaints, stating that the conformity with these requirements has
been proven.
Once all the requirements established in this Attachment have been met, the OCP
issues the new Certificate of Conformity.
One certificate, with separate numbering, must be issued for each recertification.
Note: any additional items which are needed for the issue of the new Certificate of
Conformity will be described in the CAR.
44

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Sheet 2 of Order no.

118 /President 06/03/2015

Public Federal Service

MINISTRY OF DEVELOPMENT, INDUSTRY AND FOREIGN TRADE

Order no. 118, of March 6, 2015.

THE PRESIDENT OF THE NATIONAL INSTITUTE OF METROLOGY, QUALITY AND TECHNOLOGY

National Institute of Metrology, Quality and Technology – Inmetro

§1 The Conformity Assessment Requirements must define the following items:

I – Objective (specific to the certification program);

VII – Handling of Claims;

§2 As an exception, the provisions contained in the Requirements now approved may be

JOÃO ALZIRO HERZ DA JORNADA

GENERAL REQUIREMENTS FOR PRODUCT CERTIFICATION

This document establishes the General Requirements for Product Certification

ABNT Associação Brasileira de Normas Técnicas (Brazilian Association of

PAC Programa de Avaliação da Conformidade (Conformity Assessment

Law no. 9933/1999 Provisions on the competencies of Conmetro and Inmetro,

Standard ABNT NBR ISO Quality Management Systems – Requirements.

Standard ABNT NBR Conformity Assessment – Vocabulary and General Principles.

ISO IEC 17067:2013 Conformity assessment – Fundamentals of product

3.2 COMPLEMENTARY DOCUMENTS

Ministry of Justice Order no. Discipline the calling procedure of consumers or

5 CONFORMITY ASSESSMENT MECHANISM

The Conformity Assessment Mechanism handled in this document is Certification.

6 CONFORMITY ASSESSMENT STAGES

6.1 Definition of the Certification Model(s) used

6.1.1 Certification Model Stages

Table 1: Certification Model Stages

PRODUCT CERTIFICATION PROCESS STAGES MODELS

Analysis of the Request and of the Conformity of X X X X X X X

6.2 Initial Assessment

6.2.1 Certification Request

a) List of the model(s) subject to certification, when certification is per model,

f) User manual with instructions in Portuguese;

j) Name of contact, telephone number and email of the Supplier requesting

k) Identification of the manufacturer with full address, including production plant(s) to

l) Information regarding outsourced activities/processes which may affect the conformity of

n) Documents referring to the manufacturer's Quality Management System, applicable

Note 4: The User Manual, mentioned in f), is considered to be information regarding

operating, cleaning, maintenance instructions, warnings and other information of

6.2.1.4 If the Supplier requesting the certification is an integrator, packer and/or

6.2.2 Request and Documentation Conformity Analysis

6.2.2.2 If any non-conformity is identified in the documents received, it will be formally

Records of conformity in the compliance with these requirements must be consistently

Table 2: Minimum verification requirements of the QMS for manufacturers or service

QMS REQUIREMENTS Standard ISO 9001 or

Table 3: Minimum verification requirements of the QMS for manufacturers or service

QMS REQUIREMENTS Standard ISO 9001 or

Product realization planning 7.1

Note: Certificates issued by a foreign OCS must be accompanied by a sworn translation

6.2.4 Initial Test Plan

6.2.4.1 Definition of Tests to be performed

6.2.4.2 Definition of Sampling

Table 4: Presentation model of sample sizes required for initial tests

6.2.4.3 Definition of the Laboratory

1 Laboratory designated by Inmetro;

2 3rd party laboratory, national or foreign, certified by Inmetro/Cgcre or signatory of

3 1st party laboratory, national or foreign, certified by Inmetro/Cgcre or signatory of

4 3rd party laboratory, national or foreign, certified by Inmetro/Cgcre or signatory of