SANAS Accreditation Toolkit PDF

ACCREDITATION
TOOLKIT
for conformity assessment bodies
Developed to assist
new conformity assessment bodies
that wants to get accredited.
SANAS 2013 ©. All rights reserved.

CONTENTS
A INTRODUCTION o3
B TERMINOLOGY 08
C ABOUT SANAS 11
D ACCREDITATION BENEFITS 16
E REQUIREMENTS 22
F ACCREDITATION PROCESS 26
G ACCREDITATION COSTS 36
H MANAGEMENT SYSTEM MANUAL 38
I KEY REQUIREMENTS 52
J OPERATIONAL REQUIREMENTS 65
K TECHNICAL REQUIREMENTS 68
CONTACT DETAILS 99
ACCREDITATION TOOLKIT SANAS 2013 ©. All rights reserved.

CONTENTS A B C D E F G H I J K 3
INTRODUCTION
ACCREDITATION TOOLKIT ©SANAS

INTRODUCTION CONTENTS A B C D E F G H I J K 4
FOREWORD
When new conformity assessment bodies apply for accreditation or they are
in the process of acquiring accreditation they often find it difficult to
understand what is required for SANAS accreditation. The aim of the toolkit is
to assist applicants by introducing them to accreditation and to explain some
of the terminology that we use.
The toolkit serves as a general source of information. We take you through
the whole accreditation process, i.e. explaining about where you start, the
phases of the application process as well as tell you about the cost of
accreditation.
You are also introduced to the SANAS procedures and forms. The toolkit
provides you with tips on how to prepare a Quality Manual and tell you about
the two approaches that can be used.
Your feedback on the usefulness of the toolkit and recommendations for
improvements can be submitted to Dr Elsabe Steyn at elsabes@sanas.co.za.

HAVE YOU BEEN ASKED TO GET SANAS

ACCREDITED BY A CLIENT OR A REGULATOR?
Do you want to know what accreditation is?

Do you want to know why you need to get accredited?
Do you want to know what the benefits are?
Do you want to know what the cost will be for accreditation?
Do you want to know what the process is to get accredited?

WHAT IS ACCREDITATION? As the sole national accreditation body for South Africa
responsible for carrying out accreditation in respect of conformity
assessment, SANAS provides accreditation services for the
accreditation fields shown in the table below.
ACCREDITATION FIELDS ACCREDITATION STANDARD USED

Laboratories (calibration and ISO/IEC 17025
testing)
• In general accreditation is a formal process of assessing and recognising whether Medical laboratories ISO/IEC 17025 and/or ISO 15189 (the
international standard specifically for
a conformity assessment body that offers services is competent to provide such medical laboratories)
services. Verification laboratories

Proficiency testing schemes
SANS 10378 (the national standard)
ISO/IEC 17043
Certified reference material ISO Guide 34
• The recognition is provided by an Accreditation Body that is often formally Certification
recognised at a national level, in the case of SANAS it is recognised at both a Quality Management System (QMS) ISO/IEC 17021
Environmental Management System ISO/IEC 17021
national and international level. If the conformity assessment body is accredited (EMS)
GHG emission validation and ISO/IEC 14063
it is recognised for its competence including knowledge, skills and ability to verification
provide the service. The recognition is usually guided by minimum requirements Product certification systems
Note: These include sector-specific
ISO/IEC 17065
outlined by relevant as well as accreditation requirements. industry schemes whose requirements are
maintained by the industries themselves.
Eurepgap, the British Retail Consortium
• The recognition by an Accreditation Body is used by the accredited conformity (BRC) and the Global Food Safety
Initiative (GFSI) are all examples of these.
assessment bodies to illustrate to their clients, regulators and government that Personnel certification systems ISO/IEC 17024
Inspection bodies ISO/IEC 17020 and relevant national
they are competent to provide the services as stated on the schedule of standards.
accreditation issued by the Accreditation Body. Good Clinical Practice Veterinary
(GCPV)
ISO/IEC 17025 (compliance monitoring
of veterinary laboratories conducting
animal clinical trials)
• Clients of accredited conformity assessment bodies use the certificates and test Good Laboratory Practice (GLP) According to the OECD’s principles of
GLP for facilities conducting non-
reports issued by the accredited bodies to prove that their products or services clinical environmental health and
were competently tested and comply with requirements of compulsory technical Broad-based Black Economic
safety studies
SANAS R47 and the B-BBEE Codes of
regulations or private specifications. Empowerment (B-BBEE) Good Practice.
accreditation of verification
agencies
Disclaimer
This toolkit is intended only to serve as a guideline in pursuit of seeking accreditation and does not
guarantee automatic qualification for accreditation. SANAS accepts no liability for the content of the
ACCREDITATION TOOLKIT toolkit, or for the consequences of any action(s) taken on the basis of the content of this toolkit. ©SANAS
WHAT’S THE DIFFERENCE BETWEEN

ACCREDITATION AND CERTIFICATION?
• Accreditation and Certification are regularly wrongfully used

interchangeably. However, in the conformity assessment industry both
terms have very specific meanings. In layman’s terms accreditation gives
recognition of a conformity assessment body’s competence to perform
specific services. Whereas certification gives recognition to a companies
compliance with requirements such as ISO9000 or ISO14000
• Certification Bodies, are accredited after they successfully undergo a
process of assessment by an Accreditation body like SANAS, to ensure
they meet international standards that among other things assess the
bodies impartiality and competence.
• Certification is undertaken by Certification Bodies and is a process by
which an independent third party certifies that a product, system or
person, conforms to specific requirements.
Note! Not only certification bodies are accredited.

TERMINOLOGY

TERMINOLOGY CONTENTS A B C D E F G H I J K 9
THE TERMINOLOGY USED IN THE WORLD OF

ACCREDITATION
“Conformity Assessment Body (CAB)” means a conformity
assessment body, which is a body that performs Conformity
Assessments and that can be the object of Accreditation and
• Conformity Assessment Bodies (CAB) includes an Applicant and/or accredited body, which shall in
turn include calibration, testing and verification laboratories,
certification bodies, inspection bodies, rating agencies and
any other type of body that may be added to SANAS’ scope of
activity;
“A Standard” is a document that provides requirements,

specifications, guidelines or characteristics that can be used
• International Standards (ISO/IEC) consistently to ensure that materials, products, processes and
services are fit for their purpose.
“Assessment” means a process undertaken by SANAS to

• Assessment assess the competence of a CAB, based on particular
standard(s) and /or other normative documents and for a
defined scope of accreditation; Assessing the competence of a
CAB involves assessing the competence of the entire
operations of the CAB, including the competence of the
• South African National Standards (SANS) personnel, the validity of the conformity methodology and the
validity of the conformity assessment results.
“Accreditation Requirements” means any and all

requirements relating to Accreditation, including those
specified in any accreditation standard, guide, regulation
• Accreditation Requirements and/or any IAF/ILAC mandatory document which applies to a
CAB, the Act and any policies, procedures and requirements of
SANAS which applies to a CAB.

ABOUT SANAS

ABOUT SANAS CONTENTS A B C D E F G H I J K 11
WHO IS SANAS?
• SANAS is the South African National Accreditation

System. It is the only body in South Africa mandated by
the Accreditation for Conformity Assessment, Calibration
and Good Laboratory Practice Act No. 19 of 2006 to
provide accreditation services to conformity assessment
service providers in South Africa.
• In term of the act SANAS’s primary role is to serve the
national and public interest by facilitating the provision of
a reliable internationally recognised accreditation
infrastructure to government, industry and the wider
community.

WHO DOES SANAS ACCREDIT?
• Testing laboratories
• Calibration laboratories
• Certification bodies
• Inspection bodies
• Proficiency testing schemes
• Certified reference material

WHAT IS SANAS’ RESPONSIBILITY?
SANAS assess factors relevant to a CAB’s ability to produce precise,

accurate test, calibration, certification, inspection results, including
measurement, verification and validation data.
SANAS promotes the acceptance of such results nationally, regionally
and internationally.
FACTORS TO BE ASSESSED
• Technical competency of staff;

• Validity and appropriateness of methods;
• Traceability of measurements to national and international standards;
• Suitability, calibration and maintenance of equipment;
• Suitable environmental conditions;
• Handling of test / inspection calibration and verification items;
• Quality assurance processes ; and
• Reporting of results.
Note! Not all of the above factors are applicable to certification bodies.

WHAT SANAS ACCREDITATION IS NOT?
• With the now common and broad use of the term ‘accreditation’ and some
long standing misconceptions of what SANAS accreditation involves, it is
important that there is clarity about what SANAS accreditation is not.
• It is not merely a means of registering or listing of personnel or products
and processes.
• It is not a management system assessment/audit dressed up with some
scientific/technical elements.
• It is not the recognition of reputation/affiliation -these things change over
time.
• It is not the recognition of future capabilities.
• It is not the recognition of an individual’s qualifications.
• It is not broad approval of every activity that a CAB might do.

ACCREDITATION
BENEFITS

ACCREDITATION BENEFITS CONTENTS A B C D E F G H I J K 16
WHAT ARE THE BENEFITS OF SANAS

ACCREDITATION TO THE ACCREDITED
CONFORMITY ASSESSMENT BODY?
Successful accreditation can reap many benefits for the

conformity assessment bodies. The following is a list of
typical benefits of bodies becoming accredited:
BENEFITS MORE BENEFITS
• Improved management policies • Improved documentation

• More effective and efficient operations • Improved consistency
• Stronger risk management strategies • Improved access to markets
• Reduction in incidents • Improved supplier relations
• Enhanced team awareness • Improved productivity
• Credibility with government and customers • Improved employee morale
• Marketing edge (Competitive advantage) • Improved customer services
• Greater customer trust (Customer intimacy) • Greater customer focus
• Professional self-respect
• International recognition

WHAT ARE THE BENEFITS OF SANAS

ACCREDITATION TO THE CLIENTS OF AN
ACCREDITED CONFORMITY ASSESSMENT BODY?
Government bodies and regulators are constantly called

upon to make decisions related to:
• Protecting the health and welfare of consumers and the public;

• Protecting the environment;
• Developing new regulations and requirements;
• Measuring compliance with regulatory and legal requirements; and
• Allocating technical and financial resources.

BENEFITS FOR GOVERNMENT BODIES AND

REGULATORS
• In order to make informed decisions, Government bodies and regulators

must have confidence in the results generated by conformity assessment
bodies carrying out conformity assessments activities in these fields. Using
an accredited conformity assessment body can help establish and assure
this confidence.
• When a conformity assessment body is accredited by a recognised
accreditation body, it has demonstrated that a prescribed level of technical
competence to perform specific types of conformity assessment activities
has been achieved.
• The result is assurance that the conformity assessment body is capable of
producing results that are accurate, traceable and reproducible which is a
critical component in governmental decision-making.

BENEFITS FOR CUSTOMERS IN THE PRIVATE

SECTOR
Private sector are constantly called upon to comply with

technical regulations or specifications when they provide a
service or a product. These technical requirements include:
• Government regulations to protecting the health and welfare of

consumers and the public;
• Government regulations to protecting the environment;
• Technical specifications required by the country that they export to; and
• Technical specification that the purchaser require

BENEFITS FOR CUSTOMERS IN THE PRIVATE

SECTOR
The use of accredited conformity It also helps to identify best

assessment services gives confidence practice since the conformity
that the service meets the assessment body is required to
requirements; have appropriate sector specific
knowledge;
The use of accredited conformity
assessment services is increasingly a It also assists with costs control
requirement from both the public and with the help of knowledge
private sector; transfer since accredited
conformity assessment bodies
It is also becoming increasingly can be a good source of
important as it is used to gain access impartial advice;
to overseas markets since certificates lt offers market differentiation
issued by bodies that are accredited and leadership by showing to
by an International Accreditation others credible evidence of good
Forum (IAF) or International practices; and
Laboratory Accreditation
Cooperation (ILAC) MLA signatory lt demonstrates due diligence in
are recognised and accepted the event of legal action.
throughout the world;

REQUIREMENTS

REQUIREMENTS CONTENTS A B C D E F G H I J K 22
WHAT ARE THE REQUIREMENTS FOR

ACCREDITATION?
• The requirements for accreditation is set out in:

• International Standards also called ISO/IEC standards;
• South Africa National Standards also called SANS; and
• SANAS additional accreditation requirements.
• There are different standards for different conformity
assessment bodies.
• The additional accreditation requirements as set by
For example:
SANAS can be found on the SANAS website, R03, R04, R51, TR81, TR54, etc.
www.sanas.org.za.

SOME EXAMPLES OF ACCREDITATION

STANDARDS
• If you set up Medical Laboratories the bodies will have to comply with ISO 15189
and/or ISO/IEC 17025.
• If you set up Certification bodies the bodies will have to comply with ISO/IEC
17021,or ISO/IEC 17024, or ISO/IEC 17065, or ISO/IEC 14065 (and the IAF
interpretation thereof).
• If you set up Testing and Calibration laboratories the bodies will have to comply
with ISO/IEC 17025.
• If you set up Inspection bodies the bodies will have to comply with ISO/IEC 17020
standards.
• GLP facilities are inspected for compliance to OECD GLP principles.
• If you set up Verification laboratories the bodies will have to comply with SANS
10375.
• If you provide Proficiency testing schemes your body will have to comply with
ISO/IEC 17043.
• If you provide Certified reference material your body will have to comply with
ISO Guide 34.

WHERE DO I GET THE STANDARDS?
These ISO/IEC and SANS standards can be bought at the

South African Bureau of Standards in Groenkloof, Brooklyn,
Pretoria.
www.sabs.co.za

ACCREDITATION
PROCESS

ACCREDITATION PROCESS CONTENTS A B C D E F G H I J K 26
MY ORGANISATION WANTS TO BECOME

ACCREDITED. WHERE DO WE START?
• The stages of the accreditation process is spelt out in the

next slide.
Click on the button at the bottom of the
• A detailed timeframe is available on the SANAS website, home page that says “accreditation
www.sanas.co.za. timeframes”.
• The timeframes indicates where SANAS controls the time

and where you as the client controls the time.
Note! For more information, please see the SANAS document A03
on the SANAS website, www.sanas.co.za.

STAGES OF ACCREDITATION PROCESS
APPLICATION STAGE
The first stage of the accreditation process is for the CAB to complete and return their application, including relevant
documentation requested within the application form, along with payment to SANAS.
DOCUMENT REVIEW STAGE

The second stage involves the Document Review where SANAS reviews the application documents against the relevant
accreditation criteria and provides a report to the applicant. The next stage of assessment will not proceed until the
documented systems meet requirements.
ASSESSMENT STAGE
The third stage involves the Assessment where SANAS selects an assessment team who undertake an on-site
assessment at the applicant's offices. The assessment team also witnesses the applicant's team undertaking assessment
activity at their client's premises. At the completion of the assessments the assessment team write a report of their
findings along with recommendations.
REVIEW OF THE ASSESSMENT

The fourth stage involves a Review of Assessment Report where SANAS forms an Accreditation Approval Advisory
Committee (AAC). Members of this committee are individuals who have expertise in the scope of accreditation sought.
The AAC reviews the report and makes a recommendation regarding accreditation to the CEO.
ACCREDITATION DECISION STAGE

The fifth stage involves the Accreditation Decision where the CEO make a decision to approve or not approve
accreditation based on the evaluation report of the AAC. If approval is granted a Certificate of Accreditation issued.
If accreditation is not approved, the applicant is advised of the reasons for the decision. A further application may be
considered at a later date.

WHAT CAN YOU EXPECT FROM THE

ACCREDITATION PROCESS AND THE
ASSESSORS?
• The accreditation assessment team will come to your facility on the day of the assessment.
• They will meet as a team to prepare for the assessment in a room that you will make available.
• The lead assessor will have an opening meeting with the facility management staff with a view
to brief them on how the process will unfold.
• The assessment will then take place and various staff members will participate in the
assessment process.
• During the assessment assessors may record findings that facility staff will be required to
acknowledge by signing.
• Once the assessment is completed the assessment team will meet to finalise the assessment
conclusions on which they will base the recommendation concerning accreditation.
• The lead assessor will then have a closing meeting with the staff where the final
recommendation will be presented to the facility management.
• After the assessment the lead assessor will submit a report to SANAS.
• An accreditation approval advisory committee will evaluate the assessment report and any
corrective actions submitted by the facility to correct non-conformances records at the
assessment. The accreditation approval advisory committee evaluates the report to see that
the report documentation generated by the assessment team reflects the recommendation
made by the team. The accreditation approval committee will make a recommendation to the
CEO based on their evaluation.

WHAT WILL HAPPEN DURING AN

ACCREDITATION ASSESSMENT?
The accreditation assessment have two main components

namely:
• The assessment of the CAB’s management system/quality manual.

• The assessment of the performance of the CAB activities (technical
competence).

THE DOCUMENTAL ANALYSIS INCLUDES:
An assessment of the documentation of the CAB that specifies the criteria for the
competence of personnel, including records for the conduct of competence
analysis;
An assessment of specific procedures, guidelines, check-lists, instructions etc.
addressing specific requirements for the different conformity assessment activities
included in the accreditation scope (if any);
An assessment of the procedures followed and the personnel available for the
contract reviews, the allocation of resources for the conformity assessment
activities and reporting of results;
An assessment of records showing that the CAB has processes in place for the
maintenance and review of the above criteria, on a periodic basis; and
An assessment of documented evidence supporting the CAB’s personnel

competence.

THE ASSESSMENT OF THE PERFORMANCE OF

THE CAB’S ACTIVITIES:
• Confirm that the procedures and criteria established by

the CAB for ensuring the competence of the personnel
have been effectively and consistently implemented.
• Determine whether the required competence is actually
demonstrated during the assessments, both in conducting
CAB activities and in reporting the results.

REGULAR VISITS AND RE-ASSESSMENTS
• Once accredited, regular visits are made to the CAB to

assess on-going demonstration of competence and
compliance with accreditation requirements
• SANAS also selects a sample of the CAB’s personnel for
witnessing of technical activities
• A re-assessment takes place when then accreditation
cycle requires it.

SANAS FORMS THAT ARE IMPORTANT
• Terms and conditions of Accreditation F147.

• Terms and conditions of GLP/GCP Compliance F199.
• Application forms, programme specific F14’s.
Forms are available on the SANAS website under publications.

ACCREDITATION
COSTS

ACCREDITATION COSTS CONTENTS A B C D E F G H I J K 35
HOW MUCH WILL IT COST MY COMPANY TO

BECOME SANAS ACCREDITED?
• Until we receive an application for accreditation which

details the size of your operation it is very difficult to
provide you with an accurate estimate as to what it will
cost you to become SANAS accredited.
Click on Publications, View the Database
• However, the current fee can be found via this link Document No P14.
www.sanas.co.za
• The fees include:
• Application fees
• Document review fees
• Pre-assessment fees (if applicable)
• Assessment fees
• Annual fees

MANAGEMENT SYSTEM MANUAL

MANAGEMENT SYSTEM MANUAL CONTENTS A B C D E F G H I J K 37
PREPARING MANAGEMENT SYSTEM

DOCUMENTATION
This part of the toolkit can be used when you prepare your
systems documentation which will help you to meet the
management requirements of the appropriate standard on
which your accreditation application is based, e.g. ISO/IEC
17025, ISO/IEC 17024, ISO/IEC 17020, ISO/IEC 17021.
Typically the system documentation consists of a Policy

Manual (previously known as the Quality Manual) which
gives direction from management and then supporting
Technical documentation, procedures, instructions,
method, etc. (the procedural aspects of the documentation
manual).

WHEN PREPARING YOUR MANAGEMENT

SYSTEM, TWO RECOMMENDED
APPROACHES CAN BE USED:
Management is required to take
responsibility and control of the
You can start by first looking at your management Management System.
requirements (see slides 39 - 50)
OR
If you start with the technical requirements
it is an exercise to determine what you have
You can start with your technical requirements (see or not have in place.
slides 65 - 80)

WHY DO YOU NEED A MANAGEMENT

SYSTEM?
• Conformity assessment bodies that seek accreditation

have to meet specific management and technical
requirements as per the relevant standards on which
accreditation is based.
• A management system is useful because it can be used by
the management of the conformity assessment body to
express its organisational structure, procedures,
processes, documentation of methods and resources
needed to perform the conformity assessment
services.
• The intention of a Policy Manual/Quality Manual is to give
directives regarding an organisation’s activities to
employees in order to achieve effectiveness and
efficiency within the organisation.

THE VALUE OF DOCUMENTING A

MANAGEMENT SYSTEM ALSO CALLED YOUR
QUALITY MANUAL IS TO:
• Ensure consistency of practices, activities, processes and systems;
• Clear transmission of information resulting from a minimal loss of
information;
• Permanent, written and dependable information results in improved
understanding, by:
• Providing basic control;
• Eliminating uncertainty and confusion;
• Providing direction;
• Improved control and the management of changes prevents ‘shortcuts’;
and
• Improved analysis helps the writer to think more clearly.

THE ELEMENTS OF A MANAGEMENT SYSTEM
• Organisational structure
• Responsibilities
• Methods
• Management of results
• Processes - including purchasing
• Resources - including natural resources and human capital
• Maintenance
• Sustainability - including efficient resource use and responsible
environmental operations
• Internal audits
• Management reviews

TIPS FOR WRITING THE QUALITY MANUAL
• The systems documentation manual serves as a working

document for the entire operation.
• Its application to day-to-day work results in uniformity
and consistency. This will result in the meeting of specific
requirement improvement in the operations of the body.
• This documentation gives clear direction on what must be
done and how operations must be carried out.

General guidelines
• The quality manual generally needs to be written by top management.
• It is better if the procedural manuals are written by the personnel performing the actual technical
procedures, then edited/fine-tuned by those personnel delegated to review and approve the
systems documentation.
• Write the manual in the present tense and do not use ‘shall’ or ‘will’ in the manual as to give
direction on what must be done and how it must be done.
• Be cautious of copying content from the standard you have to comply with.
• Use simple and concise language aimed at the level of personnel for which the documentation is
written.
Get to the point of the clauses.

• Address each clause/sub clause of the standard briefly in the quality manual. If you need to spell
out too much detail, make a separate numbered document and refer to the document number in
the quality manual.
• You may, if practical, also cross reference clause. For example, address the clause on impartiality
and then cross reference that clause to the appropriate procedure.
• Avoid wordiness and unnecessary language.
• Make the manual user-friendly for the personnel who have to work with it.

• Make a start. Do not get scared. Do not procrastinate.

• Go through the Standard.
• As you go through the standard, concentrate on, contemplate and
comprehend each clause.
• Try to understand what the standard requires for your operation.
• If your body has been functioning for a while, some kind of quality system
must already be in place.
• Perhaps some modification, some reorientation and some refinement is
needed.
• Try to fine-tune the system that you already have.
• Document the procedures of what is already happening in your CAB.
• Do a gap analysis between the procedures and what the standard requires.
• Fill in the gaps.

TYPICAL CONTENTS OF A QUALITY MANUAL
Typical contents of a Quality Manual: Why:
• Introduction / Foreword • This is not mandatory. To give personnel an

insight on why the system is to be
implemented and why the documentation is
important.
• Index for the Quality Manual • To provide ease of reference for the user.
• Organisation Profile • To give an overview of the organisation’s

history and company profile.
• Policy Statement and Organisational • A statement by top management to provide
Objectives the organisation’s overall intentions
(objectives) and direction – what must be
included in the management system
documentation and how the system should
be implemented.
• Organisational Structure • To outline the organisation’s reporting
structures, responsibilities and authorities.
• Policies addressing the requirements of the • To provide an understanding of the
Standard organisation’s guiding principles.

THE POLICY STATEMENT
• Your Policy Statement can be a fairly brief statement by management

giving direction and the intent of implementing the applicable standard.
• This statement will include the policy of the facility e.g. management’s
commitment to the implementation of the appropriate standard and
accreditation requirements and the objectives/goals to be achieved
through implementing this system.
• From an accreditation point of view one of the main goals/objectives of
management will be to supply customers/clients with consistently accurate
results.
• Note: it is commonly accepted that goals are looked upon as long term and
objectives short term. E.g. one of management’s goals will be to meet
customer requirements (that is long term and never change) but they will
set objectives (maybe on a yearly basis) to ensure that they stay aligned to
their goals.
• One of the goals can also be to meet the business objectives of the facility.

ORGANISATIONAL STRUCTURE
• Design and record your organisations organogram which illustrates clearly

the structure of your organisation and the relationships in the
organisation.
• If the facility is part of a larger organisation there is typically a ‘Global’
organogram indicating where the facility is situated in relation to the rest
of the organisation and its relationship with the other departments and
support services e.g. the purchasing function may be a department on it’s
own serving the whole of the organisation, not just the facility in question.
• A ‘facility specific’ organogram will show the management structure and
the interrelationship of the personnel within the facility. This could also
serve as an indication of authorities.

SYSTEM DOCUMENTATION STRUCTURE
Your policy manual indicates the structure that you have

adopted for your documentation. This is for the
understanding of personnel within the facility. The most
popular structure is a four tier structure of:
• Policy documentation which gives direction from management of what

they want the system to contain and how it should be implemented. This
should include the main policy statement, the organograms (authorities
and responsibilities), and the policies addressing the clauses of the relevant
standard.
• Procedures which indicate what and how activities within the facility, other
than the testing/inspection/verification activities, must be carried out.
• Instructions / Methods / Forms / Standards and Specifications which
indicate how the CAB’s technical activities must be carried out.
• Forms will be referred from various procedures or instructions on which
information will be recorded and consequently become records.

FOUR TIER STRUCTURE
Dynamic
POLICIES Documents
PROCEDURES
INSTRUCTIONS, METHODS,
STANDARDS AND SPECIFICATIONS
Dormant
FORMS Documents
Which becomes records

KEEP THE FOLLOWING 6 BASIC QUESTIONS

(THE SIX WISE MEN) IN MIND
• What is the policy / procedure?

• Why is it done?
• How will it be implemented (instruction / methods /
standard specifications / ...etc)?
• Where will it be performed / recorded / kept (forms /
records)?
• Who will be responsible (performing operator /
authoriser...etc)?
• When will it be done?

KEY REQUIREMENTS

KEY REQUIREMENTS CONTENTS A B C D E F G H I J K 52
SOME OF THE KEY REQUIREMENTS THAT YOU

NEED TO UNDERSTAND
• PRINCIPLES OF IMPARTIALITY
• SAFEGUARDING AND MANAGEMENT OF IMPARTIALITY
• ESTABLISHED UNDER NATIONAL LAW AND HAVE
LEGAL PERSONALITY
• COMPETENT PERSONNEL
• MONITORING
• EQUIPMENT
• OUTSOURCING (SUBCONTRACTING)
• CONFIDENTIALITY

PRINCIPLES OF IMPARTIALITY
It is essential that a CAB’s decisions results are based on

objective evidence of conformity (or nonconformity) and
that its decisions are not influenced by other interests or by
other parties.

MANAGEMENT OF IMPARTIALITY
• All personnel have to formally commit themselves to the adherence of

confidentiality as well as independence from commercial and other
interests or relationships, arising from any existing or prior association with
customers, that may result in a conflict of interest.
• A CAB shall ensure that activities of their subsidiaries or subcontractors do
not affect the confidentiality, objectivity and impartiality of its conformity
assessment activities.
• The impartiality of the CAB’s top level management and assessment
personnel shall be guaranteed.
• The remuneration of the CAB’s top level management and assessment
personnel shall not depend on the number of audits carried out or on the This only applies to certification bodies.
results of such audits.

ESTABLISHED AS A LEGAL ENTITY
• A body shall be established under national law and have

legal personality.
• The body shall be a legal entity or a defined part of a legal
entity such that it can be held legally responsible for all its
activities and so that it can bear rights and obligations.

THE IMPORTANCE OF COMPETENCE AND

SKILLS
Qualifications, training and on-going competence

monitoring of staff of the conformity assessment body is
important. The technical competency of the staff has to be
relevant in terms of experience and sector expertise. The
following elements are important:
• The staff’s relevant educational levels and study specialisation;

• The staff’s relevant work experience in the business sectors related to the
scope;
• Staff is able to understand the characteristics of the relevant processes and
products and applicable regulatory requirements; and
• The staffs ability to demonstrate knowledge and skills acquired through
audit activities, as a complement or an alternative to direct work
experience.

COMPETENT PERSONNEL
The CAB shall have at its disposal the necessary personnel

with technical knowledge and sufficient and appropriate
experience to perform the conformity assessment tasks.
The personnel responsible for carrying out the conformity
assessment activities shall have the following:
• Sound technical and vocational training covering all the conformity

assessment activities of the relevant scope;
• Satisfactory knowledge of the requirements of the assessments they carry
out and adequate authority to carry out such operations;
• Appropriate knowledge and understanding of the requirements,
• The ability required to draw up the certificates, records and reports to
demonstrate that the assessments have been carried out, and
• Knowledge of the management system/quality manual.

MONITORING
• The CAB shall ensure the satisfactory performance of the conformity

assessment activities including the review and attestation process by
establishing, implementing and maintaining procedures for monitoring the
performance and competence of the personnel involved.
• The body shall review the performance and competence of its personnel in
order to identify training needs.
• Even if the standard does not mention monitoring it is often part of the
internal mechanisms used by the CAB to supervise its activities and
persons involved.
• The CAB shall conduct monitoring e.g. by on-site observations, or by using
other techniques such as review of conformity assessment reports and
feedback from customers to evaluate performance of conformity
assessment personnel and to recommend appropriate follow-up actions to
improve performance.
• The CAB shall maintain evidence that its personnel is continuing to
perform competently.

EQUIPMENT
• The CAB shall have shall have access to all necessary This is not applicable to certification bodies.
equipment or facilities.
• The equipment outside the permanent control of the
CAB; they may use such equipment, provided that access
to the equipment is assured, the equipment is fit for
purpose and adequately calibrated and maintained.

OUTSOURCING (SUBCONTRACTING)
• Where the CAB subcontracts specific technical tasks connected with the assessment of
conformity or has recourse to a subsidiary, it shall ensure that the subcontractor is
competent to carry out the subcontracted work or the subsidiary meets the
requirements as described above.
• The CAB shall take full responsibility for the work performed by subcontractors.
• The CAB shall keep at the disposal of the assessors the relevant documents concerning
the evaluation assessment of the qualifications of the subcontractor or subsidiary for
the work carried out by them.
• The CAB may not under any circumstances subcontract evaluation of results and
decision on conformity, as that would make the evaluation meaningless.
• For example, a CAB may subcontract tests while continuing to assess the results of the
tests and in particular to validate the test report in order to evaluate whether the
requirements of the relevant legislation are met.
• The CAB shall ensure that their subcontractors maintain the necessary competence.
• Subcontracting shall be part of contact review with the customer, carried out under be a
contract.

CONFIDENTIALITY
• The personnel of the CAB shall be bound to observe

professional secrecy with regard to all information gained
in carrying out their tasks.
• Proprietary rights shall be protected.
• The confidentiality arrangements shall ensure that no
results or other proprietary information are disclosed to
any other party than the manufacturer or its authorised
representative.
• Information about the client obtained from sources other
than the client (e.g. complainant, regulators) shall be
treated as confidential.

OPERATIONAL
REQUIREMENTS

OPERATIONAL REQUIREMENTS CONTENTS A B C D E F G H I J K 63
APPEALS AND COMPLAINTS PROCESSES
A CAB needs to be able to demonstrate that:
• It has formal, robust and documented process(es) to receive analyse,

manage and take independent decisions in relation to appeals against it.
• It communicates receipt of appeal, and the details of the formal process,
appeals panel, status and progress of the appeal, and its outcome to the
relevant client.
• It takes responsibility for all decisions at all levels of the appeals process.
• It ensures the process, outcome and consequences are non discriminatory.
• The people handling the appeal are independent of the relevant
conformity assessment activity and engagement.
• It has a description of the appeals process that is publically available.
• It implements preventive and corrective actions and decisions.
• It has a similar process for handling complaints in relation to its conformity
assessment activities, which in addition to the elements above also
includes safeguarding the confidentiality of the complainant and what the
complaint is about.

OPERATIONAL REQUIREMENTS CONTENTS A B C D E F G H I J K 64
INFORM THE ACCREDITATION BODY

IMMEDIATELY OF CHANGES
Inform the Accreditation Body immediately of changes in Note! An important SANAS document to take
into account is F147. This is available on
any aspect of its status or operations that affects its: www.sanas.co.za.
• Legal, commercial or organisational status;

• Organisation and management, in particular key managerial staff;
• Policies or procedures, where relevant;
• Premises;
• Personnel, equipment, facilities, working environment or other resources,
• where significant; and
• Other matters that may affect the accredited Body’s capability, or scope of
accredited activities, or conformance with the accreditation requirements,
• or any other relevant criteria of competence specified by the Regulator or
• the Accreditation Body.

TECHNICAL REQUIREMENTS
Applicable to laboratories, inspection bodies and
verification bodies

TECHNICAL REQUIREMENTS CONTENTS A B C D E F G H I J K 66
ANOTHER WAY TO PREPARE FOR

ACCREDITATION?
You may want to follow a bottom up

• The bottom up approach where you approach i.e. to look at what you are already
doing in your laboratory.
start with Technical Requirements If this approach is followed it must be
emphasised that this should be looked upon
• The Technical Requirements are: as an exercise to determine what you have or

have not got in place (gap analysis) and from
there management should set out their
policies and necessary Management
Requirements to give direction on the way
forward with the system.

ARE YOU A LABORATORY THAT NEEDS TO

PREPARE FOR ACCREDITATION?
You may want to follow a bottom up approach i.e. to look at

what you are already doing in your laboratory.
Ask yourself and your staff the following questions:
• What are you doing with your equipment?

• Which methods or work instructions are you using for your technical
activities, e.g. testing/calibration/inspection?
• How do you calculate your uncertainty of measurement?
• How do you handle test, calibration, inspection/verification items?
• How do you manage the laboratory environment?
• What are the qualifications, experience and competence of your laboratory
personnel?
• The next slides look at the above questions in more detail.

WHAT ARE YOU DOING WITH YOUR

EQUIPMENT? YOU NEED TO CONSIDER THE
FOLLOWING:
• How do you handle for transport, store, use and maintain your measuring
equipment?
• How often do you check your equipment and what informs the intervals?
• Do you calibrate or verify you equipment, what are the intervals and what
informs the intervals?
• Do you have equipment instructions, what are they and where are they
available?
• Do you maintain your equipment, when and how and where are the
records?
• Do you calibrate your equipment after repairs/ maintenance, where are the
records and is the calibration status reflected on the equipment?
• Do you make sure that only authorised personnel use the equipment? How
do you do it?
• How do you make sure that defective equipment is not used?
• How do you make sure that equipment is not adjusted without
authorisation?
• How do you make sure that corrective factors are applied after calibration?

WHAT ARE YOU DOING WITH YOUR

EQUIPMENT? AFTER CONSIDERING THE
QUESTIONS IN THE PREVIOUS SLIDE YOU
SHOULD MAKE SURE THAT THE FOLLOWING IS
IN PLACE OR PUT IT IN PLACE :
• A procedure for the handling of transportation, storage,

usage and maintenance of your measuring equipment.
• A procedure for the performance of intermediate check
on the equipment.
• A justifiable calibration programme.
• Equipment instructions that is readily available.
• Records for the laboratory equipment including historical
performance so that trends can be identified.
• Measurement traceability of equipment calibration.

WHICH METHODS OR WORK INSTRUCTIONS

ARE YOU USING? YOU NEED TO CONSIDER THE
FOLLOWING:
• Which test/calibration methods, standards or laboratory methods are you

using?
• Why do you use and how do you justify these methods?
• Why is the method fit for the intended purpose (validation)? Is the method
capable for its intended use?
• Is the method repeatable and reproducible? Has the method
demonstrated correct performance in terms of accuracy, precision,
detection limits and robustness?
• When you perform a test how does it progress from start to finish? How do
you ensure the method’s continued capability?
• How do you determine the performance of the method?
• How do you make sure that the results of the test/calibration are valid?

WHICH METHODS OR WORK INSTRUCTIONS

ARE YOU USING?
• After considering the questions in the previous slide you should make sure
that the following is in place or put in place:
• The published international, regional or national or other recognised
method that contains enough information on how to perform the test/
calibration used by the operating staff.
• If the above method is unclear a rewritten or supplement internal method
can be used by the operating staff.
• Documentation for optional steps in the method or additional information.
• Contract reviews or training records that demonstrate the ability of the
laboratory to select the appropriate method.
• Validation evidence i.e. calibration using reference standards or reference
materials, comparisons results with other methods, inter-laboratory
comparisons, systematic assessment of the factors influencing results and
or assessments of uncertainty of measurements.

HOW DO YOU CALCULATE YOUR UNCERTAINTY

OF MEASUREMENT? YOU NEED TO CONSIDER
THE FOLLOWING:
• Do you perform your own calibrations?

• Do you identify components that contribute to the overall combined
uncertainty of measurement e.g. mass, volume, temperature, inter-
analysts, etc.?
• Do you decided on the approach for estimating each component’s
contribution to the overall uncertainty of measurement e.g. Empirical
approach or Guide to Compression of Measurement Uncertainty (GUM)?

HOW DO YOU CALCULATE YOUR

UNCERTAINTY OF MEASUREMENT?
• After considering the questions in the previous slide you should make sure
that the following is in place or put it in place:
• A procedure for calculating the best measurement capabilities/uncertainty.
• Uncertainty budgets for all calibrations.
• Records of how uncertainty of measurement was estimated.

HOW DO YOU HANDLE TEST OR CALIBRATATION

ITEMS? YOU NEED TO CONSIDER THE
FOLLOWING
• How do you transport, receipt, handle, store, retain or dispose of items?

• How do you identify items?
• How do you inspect items condition on receipt?
• How do you protect the items form lost or deterioration?
• How do you store you items?
• How do control access to items?
• What is the on-shelf stability of items prior and after analysis?
• Does the items identification protocol protect client details?

HOW DO YOU HANDLE TEST OR

CALIBRATION SAMPLES?
After considering the questions in the previous slide you

should make sure that the following is in place or put it in
place:
• A procedure for the transport, receipt, handle, store, retain or dispose of

items.
• A documented chain of custody for receiving to disposal of items.
• An item procedure and plan.
• Records of all data influencing the quality of the results.
• Records of item delivery/waybill handover, item condition on receipt which
should include seal intactness and evidence that packaging was not
tempered with.
• Records of who received items and means of tracing back signatures e.g.
signature specimen.

HOW DO YOU MANAGE THE CAB’S

ACCOMMODATION AND ENVIRONMENT?
You need to consider the following:
• Are the accommodation and environmental conditions conducive for

laboratory work?
• Do the environmental conditions ensure valid results?
• Do you monitor and control the environmental conditions?
• Do you stop work if the environmental conditions may jeopardise the
results?
• Do you manage access to the laboratory?
• Do you make sure that incompatible areas are effectively separated?
• Do you ensure good housekeeping?
• Do you identify critical conditions (e.g. humidity, temperature, vibrations)
that could affect your results and do you keep control over the measures?
• Do you establish tolerance limits for the above critical conditions and how
do you handle outliers?

HOW DO YOU MANAGE THE LABORATORY

ENVIRONMENT?

should make sure that the following is in place or put in
place:
• Records of the environmental conditions that are controlled and

monitored and how and when it was checked.
• A plan that indicates what actions will be taken when environmental
conditions are outside the acceptable range (control charts).
• Access limitations posted clearly to prevent unauthorised access.
• Documentation on specific contamination or housekeeping controls.
• For housekeeping purposes keep the laboratory clean i.e. look under,
behind, on top of equipment to keep it clean.

HOW DO YOU ENSURE THAT YOUR

PERSONNEL ARE COMPETENT?
You need to consider the following:
• Do you know what the requirements are for your personnel in terms of
competency?
• Do you ensure that the relevant expert personnel have sufficient
understanding of the relevant subjects and a realistic appreciation of limits
of their own knowledge in the content of the opinions and interpretations
reported?
• Can all the personnel demonstrate their competence to perform the task
expected from them?
• Do you know what the training needs are?
• Do you supervise trainees and contracted personnel?

HOW DO YOU ENSURE THAT YOUR

PERSONNEL ARE COMPETENT?

should make sure that the following is in place or put in
place:
• Job descriptions for managerial, technical and key support staff.

• Personnel records for education, training, technical knowledge and
experience with evidence that they are qualified as per the requirements of
the job descriptions.
• Policy and procedure to identify training needs.
• A training matrix for each position or area in the company and
documented training.
• Signed training records.
• Evidence of successful outside training.
• Evidence of competency declaration on technical operations.
• A competency declaration mechanism appropriate for your technical
objectives.
• A procedure for confirming continued competence of staff.
• Competency and authorisation records.

80
C O N TAC T D E TA I L S
Main Switchboard Number:
+27 (0) 12 394-3760
General Fax Number:

+27 (0) 12 394-0526
the dti Campus

77 Meintjies Street
Sunnyside
Pretoria, 0002
South Africa
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ACCREDITATION

for conformity assessment bodies

SANAS 2013 ©. All rights reserved.

ACCREDITATION TOOLKIT SANAS 2013 ©. All rights reserved.

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION TOOLKIT ©SANAS

HAVE YOU BEEN ASKED TO GET SANAS

Do you want to know what accreditation is?

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION FIELDS ACCREDITATION STANDARD USED

services. Verification laboratories

WHAT’S THE DIFFERENCE BETWEEN

• Accreditation and Certification are regularly wrongfully used

Note! Not only certification bodies are accredited.

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION TOOLKIT ©SANAS

THE TERMINOLOGY USED IN THE WORLD OF

“A Standard” is a document that provides requirements,

“Assessment” means a process undertaken by SANAS to

“Accreditation Requirements” means any and all

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION TOOLKIT ©SANAS

• SANAS is the South African National Accreditation

ACCREDITATION TOOLKIT ©SANAS

WHO DOES SANAS ACCREDIT?

ACCREDITATION TOOLKIT ©SANAS

WHAT IS SANAS’ RESPONSIBILITY?

SANAS assess factors relevant to a CAB’s ability to produce precise,

• Technical competency of staff;

ACCREDITATION TOOLKIT ©SANAS

WHAT SANAS ACCREDITATION IS NOT?

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION TOOLKIT ©SANAS

WHAT ARE THE BENEFITS OF SANAS

Successful accreditation can reap many benefits for the

• Improved management policies • Improved documentation

ACCREDITATION TOOLKIT ©SANAS

WHAT ARE THE BENEFITS OF SANAS

Government bodies and regulators are constantly called

• Protecting the health and welfare of consumers and the public;

ACCREDITATION TOOLKIT ©SANAS

BENEFITS FOR GOVERNMENT BODIES AND

• In order to make informed decisions, Government bodies and regulators

ACCREDITATION TOOLKIT ©SANAS

BENEFITS FOR CUSTOMERS IN THE PRIVATE

Private sector are constantly called upon to comply with

• Government regulations to protecting the health and welfare of

ACCREDITATION TOOLKIT ©SANAS

BENEFITS FOR CUSTOMERS IN THE PRIVATE

The use of accredited conformity It also helps to identify best

ACCREDITATION TOOLKIT ©SANAS

ACCREDITATION TOOLKIT ©SANAS

WHAT ARE THE REQUIREMENTS FOR

• The requirements for accreditation is set out in:

ACCREDITATION TOOLKIT ©SANAS

SOME EXAMPLES OF ACCREDITATION

ACCREDITATION TOOLKIT ©SANAS

WHERE DO I GET THE STANDARDS?

These ISO/IEC and SANS standards can be bought at the