Quality System Manual

Quality System Manual

INDEX

4.1 Organization

4.2 Management System

4.3 Document Control

4.4 Review of requests, tenders and contracts

4.5 Subcontracting of tests and calibrations

4.6 Purchasing services and supplies

4.7 Service to the customer

4.8 Complaints

4.9 Control of nonconforming calibration work

4.10 Continual Improvement

4.11 Corrective Action

4.12 Preventive action

4.13 Control of records

4.14 Internal audits

4.15 Management reviews

4.16 Customer-supplied product

4.17 Product Identification and traceability

4.18 Inspection and Testing

4.19 Inspection and test status

4.20 Servicing

4.21 Statistical Techniques

5.1 General Technical requirements

5.2 Personnel

5.3 Accommodation and environmental conditions

5.4 Calibration methods and method validations

5.5 Equipment

5.6 Measurement Traceability

5.7 Sampling

5.8 Handling of calibration Items

5.9 Assuring the quality of Calibration results

5.10 Reporting the results

 5.11 Customer Satisfaction

4.0 Management requirements

4.1 Organization and management

4.1.1 JM test Systems Inc. is privately owned and was incorporated inLouisianain 1982. All facilities operate under the Quality
System. The legal entity of the laboratories:

JM Test Systems, Inc.

Calibration Lab Division

7323 Tom Drive

Baton Rouge,Louisiana70806

Branch Laboratory

JM Test Systems, Inc.

1600 Watterberg Way

Alexandria,Louisiana71303

Branch Laboratory

JM Test Systems, Inc.

1020 N. Texas Ave

Odessa,Texas 79761

Branch Laboratory

JM Test Systems, Inc.

738 SouthMain

Clute,Texas 77531

JM Test Systems mobile calibration trailers that serve as an extension of the facility they are assigned.

4.1.2 Scope

It is JM Test Systems responsibility and policy to perform calibration and testing activities in accordance with ISO 17025
“General requirements for the competence of testing and calibration laboratories” and ISO 9001 “Quality Management
Systems-Requirements”, as well as all customer requirements and regulatory laws.

This Quality Manual is designed and written to address and meet the requirements of the following standards within our limited
scope of calibration;

ISO 17025

ISO 9001

NIST Handbook 150

ANSI/NCSL Z540-1

ASME 3800

10 CFR Part 21

10 CFR Part 50 Appendix B

Vocabulary and definitions used will be based on the ISO 9000 standard whenever possible.

4.1.3 JM Test Systems management system covers all work performed in its permanent facilities, at sites away from its permanent
 facilities, and mobile facilities.

4.1.4 JM Test Systems is not part of a parent organization. It is a provider of equipment calibration and repair services only. There
are no potential conflicts of interest with any conflicting activity.

4.1.5 JM Test Systems:

a) Have management and technical personnel with the authority, responsibility, and resources needed to carry out their duties
including the implementation, maintenance and improvement of the management system, and to identify the occurrence of
departures from the quality system/ procedures for performing calibrations, and to initiate actions to prevent or minimize such
departures;

b) Has arrangements to ensure that management and personnel are free from any undue internal and external commercial,
financial and other pressures and influences that may adversely affect the quality of their work;

c) Has policies and procedure QP10 “Protecting confidentiality and proprietary rights” to ensure the protection of its customer’s
confidential information and proprietary rights including for protecting the electronic storage and transmission of results;

d) Has procedures and the following policies to avoid employee and company involvement in activities that would diminish
confidence in its competence, impartiality, judgement or operational integrity:

Lab Technicians are not compensated based on the number of instruments calibrated,
Lab Technicians do not have a quota of instruments to be calibrated in any specific timeframe
Lab Technicians are not permitted to process any instruments from their previous place of employment for a
period of at least one year
Lab Technicians are subject to random drug and alcohol testing per company Human Resource Department
requirements.
Lab Technicians are not permitted to compete (race) one another regarding the number of items processed.
Lab Technicians are given Decision Rule (QP 27) training by Lab Management to help eliminate bias and report
consistent calibration data.
Lab Technicians have a management advisory staff of Metrology Engineers and Metrologists who are
independent of lab management to ask questions and consult with regarding technical and measurement issues.
Lab Technicians calibration work is subject to independent QA inspection to ensure high quality calibrations.

e) Has defined the organization and management structure in an Organizational Chart in Quality Procedure QP 6. The
relationships between Quality Management, Technical and Laboratory Operations and Support Services;

f) Has specified in QP 6 the responsibility, authority and interrelationships of all personnel who manage, perform or verify the
quality of calibrations;

g) Provides adequate supervision of calibration staff, including trainees, by persons familiar with methods and procedures and
purpose of each calibration;

h) Has a Technical Manager with the overall responsibility for the technical operations and the provision of the resources
needed to ensure the required quality of laboratory operations;

i) Has a Quality Manager who, irrespective of other duties and responsibilities, has defined responsibility and authority for
ensuring that the quality system is implemented and followed at all times; The Quality Manager has direct access to the
highest level of management at which decisions are made on laboratory policy or resources; i.e., reports directly to the
President of the company. The Quality Manager is responsible for promoting communication of customer requirements.

j) Appoints deputies for key managerial personnel;

Quality Manager: J. Kraus Deputy Quality Manager: Y. Cain

Technical Manager: Y. Cain Deputy Tech Manager: S. Brady

Lab Manager: H. Seguin Deputy Lab Manager: T. Blouin

k) Ensures that personnel are aware of the relevance and importance of their activities and how they contribute to the
achievement of the objectives of the management system.

4.1.6 The Quality Manager, Technical Manager and Lab Managers are responsible for ensuring that appropriate communication
processes are established within the laboratory and that communication takes place regarding the effectiveness of the management
system.

4.1.7 Process Identification

Section Process Governing document Recorded on

Quality Management Plan quality QP 25 None

Quality Management Control documentation and data QP 12 QF 122

Quality Management Protection of electronic data WI-4 None

Quality Management Control of records QP 7 Records matrix

Quality Management Control of electronic data QP 23 None

Management Responsibility Mgt responsibility and authority QP 6 None

Management Responsibility QS Management review QP 20 QF 101

Resource Management Training and qualification QP 8 & 30 QF 140

Resource Management Environmental controls WI-6 None

Product Realization Purchasing QP 13 Purchase Order

Product Realization Subcontractor controls QP 3 QF 131&133

Product Realization Measurement uncertainty QP 21 None

Product Realization Project review QP 9 QF 100

Product Realization Contract review QP 31 QF 25

Product Realization Inspection and test QP 26 QF 261

Product Realization Identification and status QP 22 Work Order

Product Realization Handling and storage QP 1

Product Realization ESD controls WI-7 Validation label

Product Realization Packaging WI-1 None

Product Realization Customer complaints QP 18 QF 105

Product Realization Calibration of equipment WI-3 Work Order

Product Realization Processing of standards QP 17 QF 43/QF 83

Product Realization Adjustment of intervals WI-10 QF 553

Product Realization Reverse traceability WI-9 & WI-25 QF 43

Measurement/analysis Proficiency Testing QP 11 Computer

Measurement/analysis Technician fails WI-16 Computer

Measurement/analysis Internal audit QP 19 QF 106

Measurement/analysis QA of documentation and product QP 2 QF 103

Measurement/analysis Corrective/Preventive action QP 24 QF 105

Measurement/analysis Nonconforming calibrations QP 29 QF 105

4.1.8 Process Sequence

1. CONTRACTS REVIEWED PER QP 31

2. INCOMING EQUIPMENT
3. EQUIPMENT TAGGED PER QP 1
4. EQUIPMENT RECEIVED PER WI-2
5. EQUIPMENT IDENTIFIED PER QP 22
6. WORKORDER GENERATED PER QP 1
7. PROJECT REVIEW PER QP 9
8. EQUIPMENT CALIBRATED PER WI-3
9. EQUIPMENT INSPECTED PER QP 2
10. EQUIPMENT PACKAGED PER WI-1
11. STORED RECORDS PER QP 7

Quality System Matrix

Organization 4.1 QP 6 Management responsibilities and authority

QP 10 Protecting confidentiality/proprietary rights

QP 14 Onsite operations

Quality system 4.2 QP 25 Quality plan

Document control 4.3 QP 12 QS document and data control

QP 23 Control of electronic calibration data

Review of requests, tenders and contracts 4.4 QP 9 Project review

QP 5 Accredited Calibration process

QP 31 Contract review

Subcontracting of tests and calibrations 4.5 QP 3 Subcontractor and vendor qualification

WI-11 To Factory

Purchasing services and supplies 4.6 QP 3 Subcontractor and vendor qualification

QP 13 Purchasing

QP 26 Inspection and test

Service to the client 4.7 QP 13 Purchasing

WI-13 Changing need-by dates

Complaints 4.8 QP 18 Customer complaints

Control of nonconforming calibration work 4.9 QP 29 Control of nonconforming calibration work

WI-16 Technician failures

Corrective action 4.10 QP 24 Corrective and Preventive Actions

Preventive action 4.11 QP 24 Corrective and Preventive Actions

Control of records 4.12 QP 7 Quality records

WI-4 Protection and backup of electronic records

Internal audits 4.13 QP 19 Quality system audit

Management reviews 4.14 QP 20 Quality system management review

General Technical requirement 5.1 WI-3 Technician guide

Personnel 5.2 QP 8 Training

QP 30 Technician Qualification

Accommodation and environmental conditions 5.3 WI-6 Environmental controls

WI-7 ESD controls

WI-8 Preventive maintenance

Test and calibration methods and validation 5.4 QP 2 QA of documentation

QP 22 Identification of measuring and test equipment

WI-23 Validation of calibration methods

Equipment 5.5 WI-9 Reverse traceability searches

QP 17 Management of Lab standards

WI-7 ESD Controls

WI-5 Standards-due processing

WI-2 Receiving

WI-8 Preventive maintenance

Measurement traceability 5.6 QP 17 Management of Lab standards

QP 5 Accredited calibration

WI-10 Calibration intervals

WI-9 Reverse traceability searches

WI-5 Standards due processing

Sampling 5.7 QP 21 Determining measurement uncertainty

Handling of test and calibration items 5.8 QP 1 Receiving/handling of test equipment

WI-1 Shipping

WI-2 Receiving

Assuring the quality of calibration results 5.9 QP 2 QA of documentation

QP 11 Proficiency testing plan

Report results 5.10 WI-29 Amending certificates & reports

4.2 Management System

4.2.1 JM Test Systems has established, implemented and maintained a quality system appropriate to the repair, calibration and
certification of measuring and test equipment. It documents its policies, systems, programs, procedures and instructions to the extent
necessary to assure the quality of calibration results. JM Test Systems has defined and documented how the requirements for quality
are met. JM Test Systems uses a generic Quality Plan contained in a procedure. This quality plan references other documented
procedures that form an integral part of the quality system. JM Test Systems Quality System Documentation is communicated to,
understood by, available to, and implemented by all appropriate personnel.

4.2.2 JM Test Systems’ management system policies are defined in this Quality Manual. Management objectives including quality
objectives are established and reviewed at formal management review meetings. Laboratory personnel are trained to familiarize
themselves with quality documentation and implement the policies and procedures. These overall objectives have been documented
in the following quality policy statement issued under the authority of the President:

QUALITY POLICY

JM Test Systems, Inc. will return to the customer an instrument that is repaired calibrated and/or certified along with reliable and
accurate test data. If necessary, the instrument will be restored to a “like new” appearance. We will continually strive to improve the
quality of our services through personnel training, membership in the National Conference of Standards Laboratories, maintaining ISO
17025 Lab Accreditation and conformance to ISO 9001 requirements along with the use and development of state-of-the-art
measurement equipment and techniques.

4.2.3 JM Test Systems top management provides evidence of commitment to the development and implementation of its
management system and to continually improving its effectiveness.

4.2.4 Management communicates to its employees the importance of meeting customer requirements, statutory and regulatory
requirements.

4.2.5 The quality manual includes supporting procedures including a Documentation matrix & cross reference.doc of applicable
procedures. The following is the structure of the quality system documentation:

Level I Quality Manual (QM) Policy

Level II Quality Procedures (QP) Procedures

Level III Work Instructions/Calibration Procedures Work Instructions

Level IV Quality Forms (QF) Forms

 4.2.6 The roles and responsibilities of the Technical Manager and Quality Manager, including their responsibility for ensuring
compliance with this International Standard, are defined in the Quality Manual and in Quality Procedure QP 6 “Management
responsibility and authority”.

4.2.7 Top management ensures that the integrity of the management system is maintained when changes to the management
system are planned and implemented.

4.2.8 Quality planning

JM Test Systems has defined and documented how the requirement for quality is met. A generic quality plan contained in QP
25 “Quality Plan” that references other documented procedures that form an integral part of the quality system.

Quality planning is consistent with other requirements of the quality system and is documented in a format to suit the
company’s method of operation. Consideration is made to the following activities;

A) Preparation of quality plans (See Quality Procedure QP 25)

B) Identification and acquisition of controls, processes, calibration equipment and standards

C) Training for the skills required to achieve required quality

D) Updating inspection, test and quality control techniques

E) Clarification of standards of acceptability for requirements

F) The identification and preparation of quality records.

4.3 Document Control

4.3.1 General

JM Test Systems establishes and maintains Quality Procedure QP 12 “Quality System Document and Data Control” to control the
following documents;

Level I Quality Manual (QM) Policy

Level II Quality Procedures (QP) Procedures

Level III Work Instructions How to Work Instructions

Level IV Quality Forms (QF) Forms

Quality Procedure QP 16 “Technical document and data control” governs internally generated calibration procedures and
external sources, such as standards, external calibration methods, software, specifications and manuals. Documents and data
can be in the form of any type of media, such as hard copy or electronic media;

ASTM

ANSI

Technical Orders (Air Force)

NAVAIR and NAVSHIP

Industry standards

JM Calibration procedures

4.3.2 Document approval and issue

4.3.2.1 JM Test Systems procedure ensures that:

a) authorized documents are available on the WIKI computer network to all employees where operations essential to the
effective functioning of JM Test Systems are performed;

b) documents are reviewed and revised to ensure continuing adequacy, suitability and compliance with applicable
requirements;

c) invalid or obsolete documents are promptly removed from all points of issue or use, or otherwise assured against
unintended use’

d) Obsolete quality system documents retained for either legal or knowledge preservation purposes are suitable marked.

4.3.2.2 All quality system documents generated by JM Test Systems are uniquely identified with a revision number, the date of
issue and/or revision, title, page number, and the issuing authority.

4.3.2.3 All quality system documents generated by JM Test Systems are reviewed at least every two (2) years. Proof of review
is evidenced by either an updated release date or the use of the documentation Review form.
 4.3.3 Document changes

4.3.3.1 Changes to documents are reviewed and approved by the same function that performed the original review unless
specifically designated otherwise. The designated personnel have access to pertinent background information upon which to
base their review and approval.

4.3.3.2 Altered or new text is identified in the document or with appropriate attachments.

4.3.3.3 JM Test System’s documentation control system allows for the amendment of documents by hand pending the
re-issue of the documents, the procedures and authorities for such amendments are defined. Amendments are clearly marked,
initialed and dated. A revised document is formally re-issued as soon as practicable. These amendments must be approved by
the Quality Manager.

4.3.3.4 Work Instruction WI-29 “Amending calibration certificates and reports” is established to describe how changes to these
documents are authorized, changed and maintained in Calmapp®.

4.4 Review of requests, tenders and contracts

4.4.1 JM Test Systems has established and maintains procedure QP 31 “Contract Review” for the technical and quality requirements
review of requests, tenders and contracts. The policies and procedure for these reviews leading to a contract for calibration ensures
that:

a) the requirement, including the methods to be used, are adequately defined, documented and understood;

b) JM Test Systems has the capability and resources to meet the requirements;

c) The appropriate calibration method is selected and capable of meeting the customers’ requirements.

Any differences between the request or tender and the contract are resolved before any work commences. Each
contract is acceptable to both JM Test Systems and the customer.

4.4.2 Quality Form 25 “Contract review checklist” is used to record reviews, including any significant changes. Records are also
maintained of pertinent discussions with a customer’s requirements or the results of the work during the period of execution of the
contract.

4.4.3 The review also covers any work that is subcontracted by JM Test Systems.

4.4.4 The customer is informed of any deviation from the contract.

4.4.5 If a contract needs to be amended after work has commenced, the same contract review process is repeated and any
amendments are communicated to the affected personnel.

4.4.6 Quality Procedure QP 5 “Accredited Calibration Process” provides policy and direction for contract review and issuance of
accredited calibrations.

4.4.7 Incoming equipment is reviewed to determine if JM Test Systems has the ability and resources to calibrate and/or repair the
equipment. This process is governed by Quality Procedure QP 9 “Project Review” and is documented on Quality Form QF 100.

4.5 Subcontracting of tests and calibrations

4.5.1 When JM Test Systems subcontracts work whether because of unforeseen reasons (e.g. workload, need for further expertise
or temporary incapacity) or on a continuing basis (e.g. through permanent subcontracting, agency or franchising arrangements), this
work is placed with a competent subcontractor as defined in Quality Procedure QP 3 “Subcontractor and Vendor Qualification”.

4.5.2 JM Test Systems advises the customer of the arrangement verbally or in writing and, when appropriate, gain the approval of
the customer, preferably in writing.

4.5.3 JM Test Systems is responsible to the customer for the subcontractor’ work, except in the case where the customer or a
regulatory authority specifies which subcontractor is to be used.

4.5.4 JM Test Systems maintains an Approved Vendor Listing of all subcontractors that it uses for calibrations and repairs or
provides critical parts and materials and a record of the evidence of compliance with this International Standard for the work in
question.

4.6 Purchasing services and supplies

4.6.1 JM Test Systems has a policy and Quality Procedure QP 13 “Purchasing” for the selection and purchasing of services and
supplies it uses that affect the quality of calibrations. Procedures exist for the purchase, reception, inspection and storage of
laboratory consumable materials relevant for calibrations.

4.6.2 JM Test Systems ensures that purchased supplies and reagents and consumable materials that affect the quality of calibrations
are not used until they have been inspected or otherwise verified as complying with standard specifications or requirements defined
in the methods for the calibrations concerned. These services and supplies used comply with specified requirements. Records of
inspections taken to check compliance are recorded on Quality Form QF 261 and maintained.

4.6.3 Purchasing documents for items affecting the quality of calibrations contains data clearly describing the services and supplies
ordered including but not limited to the type, class, grade, quality system standard to comply to, and other technical requirements.
 These purchasing documents are reviewed and approved for technical content prior to release.

4.6.4 JM Test Systems evaluates suppliers of critical consumables, supplies and services that affect the quality of calibration on the
basis of their ability to meet quality system requirements, and maintains records of these evaluations and an Approved Vendors
Listing of those that are approved.

4.6.5 Outside services (calibration and repairs) and materials (parts) are inspected by the technician before work is certified. The
technician ensures parts and consumable equipment is inspected prior to use, to verify conformance with any specification relevant
to the item. Upon receipt, critical parts and materials are inspected in accordance with QP 26 “Inspection and Testing Procedure”.

4.7 Service to the customer

JM Test Systems affords customers or their representative’s cooperation to clarify the customer’s request and to monitor JM Test System’s
performance in relation to the work performed, provided that JM Test Systems ensures confidentiality to other customers.

4.7.1 Verification at subcontractor’s premises

Where JM Test Systems proposes to verify purchased product at the subcontractor’s premises, JM Test Systems specifies
verification arrangements and the method of product release in the purchasing documents.

4.7.2 Customer verification of subcontracted product

When specified in the contract, the Customer or Customers Representative is afforded the right to verify at JM Test Systems
premises the conformance of product. Verification by the customer does not absolve JM Test Systems the responsibility to
provide acceptable product, nor does it preclude subsequent rejection by the customer.

4.7.3 JM Test Systems seeks customer feedback, both negative and positive. Customer satisfaction survey forms are presented to
customers to be filled out. Surveys are used to analysis customer service trends to improve the management system, testing, and
calibration activities and customer service.

4.7.3 Servicing

The scope of JM Test Systems’ Business and Quality System include servicing. JM Test provides servicing to our customers
at multiple levels-from equipment pick-up to equipment return and subsequent onsite service to customers after sales or rental
of equipment.

4.8 Complaints

JM Test Systems has a policy and Quality Procedure QP18 ”Customer Complaints” procedure for the resolution of complaints
received from customers or other parties. Records are maintained of all complaints via Corrective Action Report Quality Form 105
and of the investigations and corrective actions taken by JM Test Systems. When the investigation of a complaint reveals any
deficiency in the quality system or any deficiency that could affect the quality of calibrations, it is corrected as soon as possible.

4.9 Control of nonconforming calibration work

4.9.1 JM Test Systems has a policy and Quality Procedure QP 29 “Control of nonconforming calibration work” that is implemented
when any aspect of its calibration work, or the results of this work, do not conform to its own procedures or the agreed requirements
of the customer. The policy and Quality Procedure QP 29 ensures that:

a) the responsibilities and authorities for the management of nonconforming work are designated and actions (including halting
of work and withholding of calibration certificates, as necessary) are defined and taken when nonconforming work is identified;

b) an evaluation of the significance of the nonconforming work is made;

c) corrective actions are taken immediately, together with any decision about the acceptability of the nonconforming work;

d) where necessary, the customer is notified and work is recalled;

e) The responsibility for authorizing the resumption of work is defined.

4.9.2 Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of JM Test
System’s operations with its own policies and procedures, the requirements of Quality Procedure QP 24 are promptly followed.

4.10 Continual Improvement

4.10.1 JM Test Systems continually improve the effectiveness of the quality management system through the use of the quality
policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review.

4.10.2 Improvements to business operations are achieved by using the “process approach” when reviewing quality system element
and operations.

4.11 Corrective action

4.11.1 General

JM Test Systems has established a policy and QP 24 Corrective and preventive action procedure and has designated
appropriate authorities for implementing corrective action when nonconforming work or departures from the policies and
procedures in the quality system or technical operations have been identified.
 4.11.2 Cause analysis

The procedure for corrective action starts with an investigation to determine the root cause(s) of the problem.

4.11.3 Selection and implementation of corrective actions

Where corrective action is needed, JM Test Systems identifies potential corrective actions. It selects and implements the
action(s) most likely to eliminate the problem and to prevent recurrence.

Corrective actions are to a degree appropriate to the magnitude and the risk of the problem.

JM Test System documents and implements any required changes resulting from corrective action investigations.

4.11.4 Monitoring of corrective actions

The Quality Manager/Quality Representative monitors the results of corrective actions to ensure that the corrective actions
taken have been effective. The verification of effective corrective actions is annotated on the CAR

4.11.5 Additional audits

Where the identification of nonconformances or departures casts doubts on JM Test System’s compliance with its own policies
and procedures’ or on its compliance with ISO 17025 or other applicable standards, JM Test Systems ensures that the
appropriate areas of activity are audited as soon as possible.

4.12 Preventive action

4.12.1 Needed improvements and potential sources of nonconformances, either technical or concerning the quality system, are
identified. If preventive action is required, action plans are developed, implemented and monitored to reduce the likelihood of the
occurrence of such nonconformances and to take advantage of the opportunities for improvement.

4.12.2 Quality Procedure QP 24 “Corrective and preventive action” for preventive actions include the initiation of such actions and
application of controls to ensure that they are effective.

4.12.3 JM Test Systems monitors certain performance trends. Opportunities for preventive actions are identified by analyzing
selected data. A decision is made what degree of preventive action effort is required to prevent occurrence.

4.13 Control of records

4.13.1 General

4.13.1.1 JM Test Systems has established and maintain Quality Procedure QP 7 “Quality records” procedure for the
identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Quality
records include reports from internal audits and management reviews as well as records of corrective and preventive actions.
Hard paper files are JM Test Systems official records.

4.13.1.2 All records are legible and are stored and retained in such a way that they are readily retrievable in facilities that
provide a suitable environment that prevents damaged or deterioration and prevents loss. Retention times of records have
been established. Where agreed to by contract, records are available for evaluation by the customer or the customer
representative.

4.13.1.3 All records are held secure and in confidence.

4.13.1.4 JM Test Systems protects and back-up records stored electronically and to prevent unauthorized access to or
amendment of these records.

4.13.2 Technical records

4.13.2.1 JM Test Systems retains records of original observations, derived data and sufficient information to establish an audit
trail, calibration records, staff records and a copy of each calibration certificate issued, for a defined period. The records for
each calibration contain sufficient information to facilitate, if possible, identification of factors affecting the uncertainty and to
enable the calibration to be repeated under conditions as close as possible to the original. The records include the identity of
personnel responsible for the sampling, performance of each calibration and checking of results.

4.13.2.2 Observations, data and calculations are recorded at the time they are made and are identifiable to the specific task.

4.13.2.3 When mistakes occur in records, each mistake is crossed out, not erased, made illegible or deleted, and the correct
value entered alongside. All such alterations to records are initialed and dated by the person making the correction. In the case
of records stored electronically, equivalent measures are taken to avoid loss or change of original data.

4.14 Internal audits

4.14.1 JM Test Systems periodically, and in accordance with a predetermined Quality audit schedule and Quality Procedure, QP 19
“Management System Audit” conducts internal audits of its activities to verify that its operations continue to comply with the
requirements of JM Test Systems quality system and both ISO 17025 and ISO 9001. The internal audit program addresses all
elements of the quality system including calibration activities. It is the responsibility of the quality manager to plan and organize audits
as required by the schedule and requested by management. Such audits are carried out by trained and qualified personnel who are,
wherever resources permit, independent of the activity to be audited.
 4.14.2 When audit findings cast doubt on the effectiveness of the operations or on the correctness or validity of JM Test System’s
calibration results, JM Test Systems takes timely corrective action, and notifies customers in writing if investigations show that JM
Test Systems results may have been affected.

4.14.3 The area of activity audited, the audit findings and corrective actions that arise from them are recorded.

4.14.4 Follow-up audit activities verify and record implementation and effectiveness of the corrective action taken.

4.15 Management reviews

4.15.1 In accordance with a predetermined schedule and Quality Procedure QP 20 “Management Review”, JM Test Systems
executive management biannually conducts a review of JM Test System’s quality system and calibration activities to ensure their
continuing suitability and effectiveness, and to introduce necessary changes or improvements. Branch Labs conduct a local
management review at least annually to discuss unique lab activity. These reviews take in account;

the suitability of policies and procedures;

reports from managerial and supervisory personnel;
the outcome of internal audits;
corrective and preventive actions;
assessments by external bodies;
the results of interlaboratory comparisons or proficiency tests;
changes in the volume and type of work;
customer feedback;
complaints;
other relevant factors, such as quality control activities, resources and staff training;
Recommendations for improvements.

4.15.2 Findings from management reviews and the actions that arise from them are recorded as meeting minutes. Management
ensures that those actions are carried out within an appropriate and agreed timescale.

4.16 Customer-supplied product

4.16.1 JM Test Systems considers a limited definition of customer-supplied product. When taken into consideration the nature of
calibration activities at JM Test Systems, customer-supplied product is considered as accessories to calibration activities. Examples
are; Operating manuals, technical materials, software, cables, power supplies, fluids, carrying cases, consumables, supplied parts for
repair, and reference materials.

4.16.2 JM Test Systems, Inc. has established and maintains QP 1 “Receiving, handling and storage of measuring and test
equipment” for the control of verification, storage and maintenance of any customer-supplied product provided for incorporation into
the calibration or repair process.

4.16.3 When equipment arrives it is processed per Quality Procedures QP 1 and QP 26. A Work Order number tag is placed on it
along with any accessories for tracking it.

4.16.4 Any instances where equipment or accessories provided by customers does not meet with requirements, is lost or damaged, it
is recorded and reported to the customer.

4.16.5 The equipment is tagged and segregated pending resolution and the situation is recorded on the Work Order.

4.17 Product identification and traceability

4.17.1 JM Test Systems, Inc. has established and maintains Quality Procedure QP 23 “Identification and test status of measuring
and test equipment” for the control of product identification and traceability. It provides for unique identification and traceability of
customer and company owned product by suitable, traceable and recorded means from pick-up or receipt through all stages of
calibration/repair to delivery.

4.18 Inspection and testing

JM Test Systems has procedures for the inspection and testing activities in order to ensure that the calibration and repair services it
provides meet specified requirements. Required inspection and testing is established in Quality Procedure QP 25 “Quality Plan” and
QP 26 “Inspection and test”.

4.18.1 Receiving inspection and test

4.18.1.1 Incoming product is not used or processed until it is inspected or verified as conforming to specified requirements.
Verification of the requirements are described in Quality Procedure QP 1 Receiving, handling and storage of materials and
equipment” and QP 26 “Inspection and test”.

4.18.1.2 Consideration is given to the amount of control enforced at the supplier’s facility or any recorded historical evidence of
provided conformance when determining the amount and nature of receiving inspections.

4.18.1.3 In the event that equipment is released for urgent purposes, prior to verification, it is positively identified and recorded
in order to permit immediate recall and replacement.

4.18.2 In-process inspection and test

4.18.2.1 Inspection and testing of equipment is accomplished via applicable calibration procedure and the Technicians Guide
 Work Instruction WI-3.

4.18.2.2 Employees are not allowed to use parts and materials until required inspection and tests are complete.

4.18.3 Final inspection and test

4.18.3.1 Final inspection and test is accomplished per QP 2 “QA of documentation” and WI-27 “QA Instruments” requirements.

4.18.3.2 The Quality Plan and inspection procedures require all specified inspections and tests are completed and the results
meet specified requirements.

4.18.3.3 Measuring and test equipment is not released until all activities specified in the quality plan and documented
procedures have been satisfactorily completed.

4.18.4 Inspection and test records

4.18.4.1 JM Test System has an established record system to provide evidence that specified products have been inspected
and tested. Quality Procedure QP 7 “Quality Records” addresses the control of quality records. The records show clearly
whether the product passed or failed the inspections and tests.

4.18.4.2 Inspection records identify the Inspector who passed or failed the product.

4.18.4.3 Nonconforming product is controlled per the corrective action procedure.

4.19 Inspection and test status

4.19.1 Inspection and test status of Measuring and test equipment is identified in Quality Procedure QP 22 “Identification and test
status of Measuring and test equipment”.

4.19.2 The identification of the inspection and test status is maintained throughout the calibration process to ensure that only items
that has passed the specified inspections and tests pass to the next operation.

4.20 Servicing

4.20.1 The scope of JM Test Systems’ Business and Quality System include servicing. JM Test provides servicing to our customers
at multiple levels-from equipment pick-up to equipment return and subsequent onsite service to customers after sales or rental of
equipment.

4.21 Statistical Techniques

4.21.1 Some activities and processes performed by JM Test Systems, Inc., include the use of statistical techniques. JM Test
Systems management determined that statistical techniques are required for establishing, controlling and verifying process capability
and calibration characteristics. JM Test Systems has established and released a quality procedure to implement the policy. JM Test
Systems applies statistical techniques for establishing, controlling and verifying some process capability and calibration
characteristics. In addition, this allows the company to better target improvement opportunities determine customer satisfaction and
improve ways to identify and prevent potential problems. Some activities and processes that include the use of analysis of data;

Statistical techniques using Uncertainty toolbox ® software to determine Uncertainties.

Statistical control charts using Excel spreadsheet software to monitor and control standards accuracy.

Statistical techniques using Excel software to determine Quality Objectives.

5.0 Technical requirements

5.1 General

5.1.1 Many factors determine the correctness and reliability of calibrations performed by JM Test Systems. These factors include
contributions from:

human factors;
accommodation and environmental conditions;
calibration methods and method validation;
equipment;
measurement traceability;
sampling;
handling of calibration items.

5.1.2 The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of)
calibrations. JM Test Systems takes account of these factors in developing calibration methods and procedures, in the training and
qualification of personnel, and in the selection and calibration of the equipment it uses.

5.2 Personnel

5.2.1 JM Test Systems management ensures the competence of all who operate specific equipment, perform calibrations, and
evaluate results, and sign reports and calibration certificates. When using staff that is undergoing training, appropriate supervision is
provided. Personnel performing specific tasks are qualified on the basis of appropriate education, training, experience and/or
demonstrated skills, as required.
 5.2.2 The management of JM Test Systems formulates the goals with respect to the education, training and skills of JM Test
Systems personnel. JM Test Systems has Quality Procedure QP 8 “Training” for identifying training needs and providing training of
personnel. The effectiveness of training is assessed. The training program is relevant to the present and anticipated tasks. The
effectiveness of the training is evaluated by completion of tests and/or feedback from students.

5.2.3 JM Test Systems uses personnel who are employed by JM Test Systems. Where contracted and additional technical and key
support personnel are used, JM Test Systems ensures that such personnel are supervised and competent and that they work in
accordance with JM Test System’s quality system.

5.2.4 JM Test Systems maintains Quality Procedure QP 30 “Technician Qualification” that governs current job descriptions for
managerial, technical and key support personnel involved in calibrations. Job qualifications are categorized using a letter system that
segregates work into letter coded areas. Technicians performing calibrations in an area must have been qualified for the area or be
obtaining “OJT” in the area while under direct supervision of a qualified technician. Technicians assigned to new areas will receive
training in the area until qualified in the area. Training and qualifications are recorded in the technician personal training record. A
technician qualifications list is posted on the work assignment board listing each technicians name, stamp number, initials, and
qualified areas.

5.2.5 The management authorizes specific personnel to perform particular types of calibrations, to issue calibration
reports/certificates, to give opinions and interpretations and to operate particular types of equipment. JM Test Systems maintains
records of the relevant authorizations, competence, educational and professional qualifications, training, skills and experience of all
technical personnel, including contracted personnel. This information is
readily available and includes the date on which authorization and/or competence is confirmed.

5.3 Accommodation and environmental conditions

5.3.1 JM Tests Systems facilities for calibration, including but not limited to energy sources, lighting and environmental conditions,
are such as to facilitate correct performance of calibrations.

JM Test Systems ensures that the environmental conditions do not invalidate the results or adversely affect the required quality of
any measurement. Particular care is taken when calibrations are undertaken at sites other than a permanent laboratory facility. The
technical requirements for accommodation and environmental conditions that can affect the results of calibrations are controlled.
Environmental controls are addressed and governed by Work Instruction WI-6.

5.3.2 JM Test Systems monitors, controls and records environmental conditions as required by the relevant specifications, methods
and procedures or where they influence the quality of the results. Due attention is paid, for example, to biological sterility, ventilation,
dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, and sound and vibration levels, as appropriate
to the technical activities concerned. Calibration activities are stopped when the environmental conditions jeopardize the results of
calibrations. Laboratory Manager’s makes the decision when to proceed with calibration operations based on equipment type and
adjustments.

5.3.3 There is effective separation between neighboring areas in which there are incompatible activities. Measures are taken to
prevent cross-contamination.

5.3.4 Control access to and the use of areas affecting the quality of calibrations. Lab management determines the extent of control
based on its particular circumstances.

5.3.5 Measures are taken to ensure good housekeeping in JM Test Systems facilities.

Scheduled cleanups are performed at all facilities.

5.4 Calibration methods and method validation

5.4.1 General

JM Test Systems uses appropriate calibration methods (calibration procedures) for all calibrations within its scope. These
include sampling, handling, transport, storage and preparation of items to be calibrated, and, where appropriate, an estimation
of the measurement uncertainty as well as statistical techniques for analysis of calibration data.

JM Test Systems has instructions on the use and operation of all relevant equipment, and on the handling and preparation of
items for calibration where the absence of such instructions could jeopardize the results of calibrations. All instructions,
standards, manuals and reference data relevant to the work of JM Test Systems is kept up to date and is made readily
available to personnel in the technical library. Deviation from calibration methods occur only if the deviation has been
documented, technically justified, and authorized.

5.4.2 Selection of methods

JM Test Systems uses calibration methods which meet the needs of the customer and which are appropriate for the
calibrations it undertakes. JM Test Systems uses Calibration Procedures for all calibrations performed. Documented calibration
procedures are essential to ensure consistency and to reduce reliance on the technician’s memory. Calibration procedures will
provide instructions to enable technicians to adequately calibrate each test characteristic or measurement parameter of
interest. Calibration procedures are available from these sources:

A. Equipment manufacturer technical/operation manuals

B. JM Test Systems developed Calibration Procedures (CP)

 C. Government Industry Data Exchange Program (GIDEP)

D. U.S. Military and Government procedures and standards

E. Procedures from recognized organizations

When the customer does not specify the method to be used, JM Test Systems selects appropriate methods from the above
sources. JM Test Systems-developed calibration procedures may also be used if they are appropriate for the intended use.
The customer is informed if any different calibration method other than the above four sources is chosen. JM Test Systems
informs the customer when the method proposed by the customer is considered to be inappropriate or out of date.

5.4.3 JM Test Systems-developed calibration methods

The introduction of Calibration Procedures developed by JM Test Systems for its own use is a planned activity and is assigned
to Metrology Engineers who are qualified and who are equipped with adequate resources.

Calibration procedures are updated as development proceeds and effective communication amongst all personnel involved is
ensured.

5.4.4 Non-standard methods

When it is necessary to use methods not covered by the above four sources, these are subject to agreement with the customer
and include a clear specification of the customer’s requirements and the purpose of the calibration. The method developed is
validated appropriately before use.

5.4.5 Validation of methods

5.4.5.1 Validation is the confirmation by examination and the provision of objective evidence that the particular requirements
for a specific intended use are fulfilled.

5.4.5.2 JM Test Systems validates non-standard methods, internally-developed methods, standards methods used outside
their intended scope, and amplifications and modifications of standard methods to confirm that the methods are fit for the
intended use. Work Instruction WI-23 “Validation of calibration methods” provides policy and instructions regarding validation.
The validation is as extensive as is necessary to meet the needs of the given application or field of application. JM Test
Systems records the results obtained, the procedure used for the validation, and a statement as to whether method is fit for the
intended use.

5.4.5.3 The range and accuracy of the values obtainable from validated methods (e.g. the uncertainty of the results, detection
limit, selectivity of the method, linearity, limit of repeatability and/or reproducibility, robustness against external influences
and/or cross-sensitivity against interference from the matrix of the sample/test object), as assessed for the intended use, is
relevant to the customers’ needs.

5.4.6 Estimation of uncertainty of measurement

5.4.6.1 JM Test Systems has and applies Quality Procedure QP 21 “Determining measurement uncertainty” for determining
measurement uncertainty, calibration adequacy, and analysis of calibration data for all calibrations and types of calibrations.

5.4.6.2 JM Test Systems applies a procedure for estimating uncertainty of measurement. In certain cases, the nature of the
test method may preclude rigorous, metrologically and statistically valid, calculation of uncertainty of measurement. In these
cases, JM Test Systems attempts to identify all the components of uncertainty and make a reasonable estimation, and ensures
that the form of reporting of the result does not give a wrong impression of the uncertainty. Reasonable estimation is based on
knowledge of the performance of the method and on the measurement scope and makes use of, for example, previous
experience and validation data.

5.4.6.3 When estimating the uncertainty of measurement, all uncertainty components that are of importance in the given
situation are taken into account using appropriate methods of analysis.

5.4.7 Control of data

Calculations and data transfers are subject to quality assurance checks in a systematic manner.

5.4.7.1 When computers or automated equipment are used for the acquisition, processing, recording, reporting, storage or
retrieval of calibration data, JM Test Systems ensures that:

a) Computer software developed by the user is documented in sufficient detail and is suitably validated as being
adequate for use;

b) Quality Procedure QP 23 “Control of electronic calibration data” is established and implemented for protecting the
data; this procedure includes, but is not limited to, integrity and confidentiality of data entry or collection data storage,
data transmission and data processing;

c) Computers and automated equipment are maintained to ensure proper functioning and are provided with the
environmental and operating conditions necessary to maintain the integrity of calibration data.

5.4.8 Original data integrity

All calibration data that is collected or gathered on paper then transposed into a computer is considered original data and must
 be maintained by the Lab. All original data is attached to the Work Order and maintained in the customer files.

5.4.8.1 Changes to non-computer generated data

When changes are made to paper documents, the changes are written in and deletions are lined out, initialed, and
dated-all in black or red ink. No pencil marks are allowed.

5.4.8.2 Changes to computer held data

Any change(s) to computer-held data is to be performed by the Lab Manager only. If a revision or correction needs to be
made to the original computer-held data, the original document will be considered voided. A new document will be
created to include the corrected data. The new document will indicate “Revision”. The original voided document will be
kept for future record. Refer to Work Instruction WI-29 :Amending calibration certificates and reports”.

5.5 Equipment

5.5.1 JM Test Systems is furnished with all items of sampling, measurement and test equipment required for the correct performance
of the calibrations (including sampling, preparation of calibration item, processing and analysis of calibration data). In those cases
where JM Test Systems needs to use equipment outside its permanent control, it ensures that the requirements of ISO 17025 are
met.

5.5.2 Equipment and its software used for calibration are capable of achieving the accuracy required and conformance with
specifications relevant to the calibrations concerned. Calibration programs are established for key quantities or values of the
instruments where these properties have a significant effect on the results. Before being placed into service, equipment is calibrated
or checked to establish that it meets JM Test System’s specification requirements and complies with the relevant standard
specifications. It is checked and/or calibrated before use.

5.5.3 Equipment is operated by authorized personnel. Up-to-date instructions on the use and maintenance of equipment (including
any relevant manuals provided by the manufacturer of the equipment) are readily available for use by the appropriate laboratory
personnel.

5.5.4 Each item of equipment and its software used for calibration and significant to the result is, uniquely identified.

5.5.5 Records are maintained of each item of equipment and its software significant to the calibrations performed. The records
include at least the following:

a) the identity of the item of equipment and its software;

b) the manufacturer’s name, type identification, and serial number or other unique identification;

c) checks that equipment complies with the specification;

d) the current location, where appropriate;

e) the manufacturer’s instructions, if available, or reference to their location;

f) dates, results and copies of reports and certificates of all calibrations, adjustments, acceptance criteria, and the due date of
next calibration;

g) the maintenance plan, where appropriate, and maintenance carried out to date;

h) any damage, malfunction, modification or repair to the equipment.

5.5.6 JM Test Systems has a procedure for the safe handling, transport, storage, use and planned maintenance of measuring
equipment to ensure proper functioning and in order to prevent contamination or deterioration.

5.5.7 Equipment that has been subjected to overloading or mishandling, gives suspect results, or has been shown to be defective or
outside specified limits, is taken out of service. It is isolated to prevent its use or clearly labeled “Do not use” until it has been repaired
and calibrated and is performing correctly. Management may institute QP 24 Corrective and Preventive action procedure to
document any nonconforming work. JM Test Systems examines the effect of the defect or departure from specified limits on previous
calibrations using Work Instruction WI-9 “Reverse traceability searches”.

5.5.8 All equipment under the control of JM Test Systems and requiring calibration is labeled and identified to indicate the status of
calibration, including the date when last calibrated and the date recalibration is due.

5.5.9 When, for whatever reason, equipment goes outside the direct control of JM Test Systems, JM Test Systems ensures that the
function and calibration status of the equipment are checked and shown to be satisfactory before the equipment is returned to
service.

5.5.10 When intermediate checks are needed to maintain confidence in the calibration status of the equipment, these checks are
carried out according to the manufacturer’s manual or procedure.

5.5.11 Where calibrations give rise to a set of correction factors, JM Test Systems will provide a procedure to ensure that copies (e.g.
in computer software) are correctly updated.

5.5.12 Test and calibration equipment, including both hardware and software, are safeguarded from adjustments that would
invalidate the calibration results. Tamper-resistant seals are affixed to operator accessible controls or adjustments on calibration
 items which, if moved, will invalidate the calibration. If JM Test Systems equipment is found with a broken seal the equipment is
removed from service and the Lab Manager investigates the condition of the equipment before returning it to service.

5.6 Measurement traceability

5.6.1 General

All equipment used for calibrations, including equipment for subsidiary measurements (e.g. for environmental conditions)
having a significant effect on the accuracy or validity of the result of the calibration or sampling are calibrated before being put
into service. JM Test Systems has established programs and Quality Procedure QP 17 “Management of Laboratory
Standards” for the calibration of its equipment.

5.6.2 JM Test Systems measurement traceability policy and specific requirements.

JM Test System policy requires that:

5.6.2.1 All calibrations and verifications of measuring and test equipment and reference standard’s must be conducted by:

A calibration laboratory accredited to ISO/IEC 17025 by a mutually recognized Accreditation Body; or a recognized
National Metrology Institute (NMI).
A Lab that produces an accredited test report containing appropriate statements of measurement results,
measurement uncertainty, and traceability can be considered to satisfy traceability requirements; or
A laboratory accredited by A2LA to ISO/IEC 17025 and found to meet the T9 requirements of the A2LA Traceability
requirement document for their in-house calibrations

5.6.2.2 When possible, all reference materials shall be obtained from:

A reference material producer accredited to ISO Guide 34 in combination with ISO/IEC17025 by a recognized Asia
Pacific Laboratory Accreditation Cooperation (APLAC) signatory recognized for accrediting reference material
producers; or a recognized National Metrology Institute (NMI).

5.6.2.3 Measurement Traceability

To maintain conformance to A2LA Traceability (T) requirements, JM Test Systems requires:

External calibrations and verifications, must be recorded in a calibration certificate or report endorsed by the
recognized Accreditation Body’s symbol (or otherwise makes reference to accredited status by a specific, recognized
accreditation body) with an indication of the type of entity that is accredited (e.g., via an accreditation certificate
number, inclusion of “calibration laboratory” with the symbol, etc.) or endorsed by the National Metrology Institute
(NMI). (T2)
Internal calibrations and verifications, those requirements outlined in requirement T9 of A2LA Measurement
Traceability policy document apply. For reference materials, these must be recorded in a certificate meeting the
requirements of ISO Guide 31 endorsed by the recognized Accreditation Body’s symbol (or otherwise makes
reference to accredited status by a specific, recognized accreditation body) with an indication of the type of entity that
is accredited or endorsed by the recognized NMI.
Its policy for achieving measurement traceability is placed in this section of the Quality Manual and also for achieving
traceability for reference materials, if applicable. (T3)
Its calculations of measurement uncertainty be in accordance with the ISO “Guide to the Expression of Uncertainty in
Measurement.” These uncertainties, when reported, shall be reported as the expanded uncertainty with a defined
coverage factor, k (typically k = 2) and the confidence interval (typically to approximate the 95% confidence level). (T4)
That if a calibration certificate or test report contains a statement of the measurement result and the associated
uncertainty, then the uncertainty statement shall be accompanied by an explanation of the meaning of the uncertainty
statement. (For example, “This uncertainty represents an expanded uncertainty expressed at approximately the 95%
confidence level using a coverage factor of k=2.) (T5)
Its TURs shall be calculated using the expanded uncertainty of the measurement, not the “collective uncertainty of the
measurement standards”. (T6)
Implicit uncertainty statements be accompanied by words to the effect that the uncertainty ratio was calculated using
the expanded measurement uncertainty. In addition the coverage factor and confidence level must be stated. (T7)
Calibration reports and certificates issued by A2LA-accredited calibration laboratories contain a traceability statement.
(T8)
All in-house calibrations shall be supported by the following minimal set of elements (T9):

a) The in-house laboratory shall maintain documented procedures for the in-house calibrations and the in-house
calibrations shall be evidenced by a calibration report, certificate, or sticker, or other suitable method, and
calibration records shall be retained for an appropriate, prescribed time;

b) The in-house laboratory shall maintain training records for calibration personnel and these records shall
demonstrate the technical competence of the personnel performing the calibrations;

c) The in-house laboratory shall be able to demonstrate traceability to national or international standards of
measurement by procuring calibration services from appropriately accredited calibration labs or an NMI and/or
purchasing reference materials from appropriately accredited reference material producers or an NMI;

d) The in-house laboratory shall have and apply procedures for evaluating measurement uncertainty.
Measurement uncertainty shall be calculated for each type of calibration and records of these calculations shall be
 maintained. Measurement uncertainty shall be taken into account when statements of compliance with
specifications are made;

e) Reference standards shall be recalibrated at appropriate intervals to ensure that the reference value is reliable.
Policy and procedures for establishing and changing calibration intervals shall be based on the historical behavior
of the reference standard.

There are certain calibrations that currently cannot be strictly made in SI units. In these cases calibration shall provide
confidence in measurements by establishing traceability to appropriate measurement standards such as:

the use of certified reference materials provided by a competent supplier to give a reliable physical or chemical
characterization of a material;
the use of specified methods and/or consensus standards that are clearly described and agreed by all parties
concerned.
participation in a suitable program of Proficiency Testing or interlaboratory comparisons.

5.6.2.1 Calibration

The program for calibration of equipment is designed and operated so as to ensure that calibrations and
measurements made by JM Test Systems are traceable to the International System of Units (SI).

JM Test Systems has established traceability of its own measurement standards and measuring instruments to the SI by
means of an unbroken chain of calibrations or comparisons linking them to relevant primary standards of the SI units of
measurement. The link to SI units may be achieved by reference to national measurement standards. National measurement
standards my be primary standards, which are primary realizations of the SI units or agreed representations of SI units based
on fundamental physical constants, or they may be secondary standards which are standards calibrated by another national
metrology institute, When using external calibration services, traceability of measurement is assured by the use of calibration
services from laboratories that can demonstrate competence, measurement capability and traceability. The calibration
certificates issued by theses laboratories contain the measurement results, including the measurement uncertainty and/or a
statement of compliance with an identified metrological specification.

5.6.3 Reference standards and reference materials

5.6.3.1 Reference standards

JM Test Systems has a program and Quality Procedure QP 17 “Management of Laboratory Standards” for calibration of
laboratory standards and reference standards. Reference standards are calibrated by a body that can provide
traceability to NIST. Such reference standards of measurement held by JM Test Systems are used for calibration only
and for no other purpose. Reference standards are calibrated before and after any adjustment.

5.6.3.2 Reference materials

Reference materials are, where possible, traceable to SI units of measurement, or to certified reference materials.
Internal reference materials are checked as far as is technically and economically practicable.

5.6.3.3 Intermediate checks

Checks needed to maintain confidence in the calibration status of reference, primary, transfer or working standards and
reference materials are carried out according to Quality Procedure QP 15 “Intermediate checks” and Work Instruction
WI-24 “Intermediate checks for electronics”.

5.6.3.4 Transport and storage

JM Test Systems has procedures for safe handling, transport, storage and use of reference standards and reference
materials in order to prevent contamination or deterioration and in order to protect their integrity.

5.7 Sampling

5.7.1 JM Test Systems does not perform sampling activities.

5.8 Handling of calibration items

5.8.1 JM Test Systems has Quality Procedure QP 1 “Receiving, handling and storage of materials and equipment” for the
transportation, receipt, handling, protection, storage, retention and/or disposal of calibration items, including all Customer-supplied
product and provisions necessary to protect the integrity of the calibration item, and to protect the interests of JM Test Systems and
the customer.

5.8.2 JM Test Systems has a Work Order (WO) computer system for identifying calibration items. The identification is retained
throughout the life of the item at JM Test Systems laboratories. The system is designed and operated so as to ensure that items
cannot be confused physically or when referred to in records or other documents.

5.8.3 Upon receipt of the test or calibration item, abnormalities or departures from normal or specified conditions, as described in the
calibration method, are recorded. When there is doubt as to the suitability of an item for calibration, or when an item does not
conform to the description provided, or the calibration required is not specified in sufficient detail, JM Test Systems consults the
customer for further instructions before proceeding and records the discussion on the Work Order document.

5.8.4 JM Test Systems has Quality Procedure QP 1 for the receiving and handling of measuring and test equipment and appropriate
 facilities for avoiding deterioration, loss or damage to calibration items during storage, handling and preparation. Handling
instructions that are provided with the item must be followed. When items have to be stored or conditioned under specified
environmental conditions these conditions are maintained, monitored and recorded.

Where a test or calibration item or a portion of an item is to be held secure, JM Test Systems has arrangements for storage
and security that protect the condition and integrity of the secured items or portions concerned. JM Test Systems controls the
packaging, packing, and marking process (including materials used) to the extent necessary to ensure conformity to specified
requirements.

5.8.5 The inspection and test status of measuring and test equipment is delineated in Quality Procedure QP 22 “Identification and
test status of measuring and test equipment”. The identification of the measuring and test equipment status is maintained throughout
the calibration process to ensure that only product that has passed the specified inspections and tests is released.

5.8.6 JM Test Systems has arrangements to protect the quality of its products after final inspection and test. Where specified by
contract, this protection is extended to include delivery to destination.

5.9 Assuring the quality of calibration results

5.9.1 JM Test Systems has quality control procedures for monitoring the validity of calibrations undertaken. The resulting data is
recorded in such a way that trends are detectable and, where practicable, statistical techniques are applied to the reviewing of the
results. This monitoring is planned and reviewed and may include, but not be limited to, the following:

a) regular use of certified reference materials and/or internal quality control using secondary reference materials;

b) participation in interlaboratory comparison or proficiency-testing programs as delineated in Quality Procedure QP 11

“Proficiency Testing Plan”.

c) replicate calibrations using the same or different methods;

d) recalibration of retained items;

e) correlation of results for different characteristics of an item.

5.9.2 Quality control data is analyzed and if found to be outside the pre-defined criteria, planned action is taken to correct the
problem and to prevent incorrect results from being reported.

5.10 Reporting calibration results

5.10.1 General

The results of each calibration or series of calibrations carried out by JM Test Systems is reported accurately, clearly,
unambiguously and objectively, and in accordance with specific instructions in the calibration procedures.

The results are reported in a calibration certificate and data sheet that includes all the information requested by the customer
and necessary for the interpretation of the calibration results and all information required by the calibration procedure used.

5.10.2 Calibration certificates

Each Calibration Certificate and associated data sheet includes at least the following information:

a) a title “Certificate of Calibrations”;

b) the name and address of JM Test Systems, and the location where the calibrations were carried out;

c) Certificate/traceability number of the calibration certificate and on each page an identification in order to ensure that the
page is recognized as a part of the calibration certificate, and a clear identification of the end of the calibration certificate;

d) the name and address of the customer;

e) identification of the calibration procedure used;

f) a description of the item and the condition of the item calibrated;

g) the date of receipt of calibration item and the date of performance of the calibration;

h) reference to the sampling plan and procedure used by JM Test Systems or other bodies where these are relevant to the
validity or application of the results;

i) the calibration results with the units of measurement;

j) the name, function and signature identification of person authorizing the calibration certificate;

k) A statement to the effect that the results relate only to the items calibrated.

l) A statement that the certificate and data sheet will not be reproduced except in full, without the written approval of JM Test
Systems.

5.10.3 Test Reports

 5.10.3.1 In addition to the requirements listed in 5.10.2, test reports, where necessary for the interpretation of the test results,
include the following:

a) deviations from, additions to, or exclusions from the calibration procedure, and information on specific test conditions,
such as environmental conditions;

b) where relevant, a statement of compliance/non-compliance with requirements and/or specifications;

c) A statement on the estimated uncertainty of measurement; information on uncertainty is needed in test reports when it
is relevant to the validity or application of the test results, when a customer’s instruction so requires, or when the
uncertainty affects compliance to a specification limit;

d) where appropriate and needed, opinions and interpretation;

e) additional information which may be required by specific methods, customers or groups of customers.

5.10.3.2 Test reports containing the results of sampling are included in the following, where necessary for the interpretation of
test results:

a) the date of sampling;

b) unambiguous identification of the substance, material or product sampled (including the name of the manufacturer,
the model or type of designation and serial numbers as appropriate);

c) the location of sampling, including any diagrams, sketches or photographs;

d) a reference to the sampling plan and procedures used;

e) details of any environmental conditions during sampling that may affect the interpretation of the test results;

f) any standard or other specification for the sampling method or procedure, and deviations, additions to or exclusions
from the specification concerned.

5.10.4 Calibration certificate

5.10.4.1 Calibration certificates include the following, where necessary for the interpretation of calibration results:

a) the environmental conditions under which the calibrations were made that have an influence on the measurement
results;

b) the uncertainty of measurement and/or a statement of compliance with an identified metrological specification or
clauses thereof;

c) measurements are traceable to National Institute of Standards and Technology (NIST).

5.10.4.2 The calibration certificate relates only to quantities and the results of functional tests. If a statement of compliance with
a specification is made, this identifies which clauses of the specification are met or not met.

When a statement of compliance with a specification is made omitting the measurement results and associated
uncertainties, JM Test Systems records those results and maintains them for possible future reference.

When statements of compliance are made, the uncertainty of measurement is taken into account.

5.10.4.3 When an instrument for calibration has been adjusted or repaired, the calibration results before and after adjustment
or repair, if available, are reported.

5.10.4.4 A calibration certificate or calibration label does not contain any recommendation on the calibration interval except
where this has been agreed with the customer.

5.10.5 Opinions and interpretations

When opinions and interpretations are included, JM Test Systems documents the basis upon which the opinions and
interpretations have been made. Opinions and interpretations are clearly marked as such.

5.10.6 Calibration results obtained from subcontractors

When calibration reports contain results of tests performed by subcontractors, these results are clearly identified. When a
calibration has been subcontracted, the subcontracted laboratory performing the work issues the calibration certificate to JM
Test Systems.

5.10.7 Electronic transmission of results

In the case of transmission of calibration results by telephone, telex, facsimile or other electronic or electromagnetic means,
the requirements of this International Standard are met.

5.10.8 Format of reports and certificates

The format is designed to accommodate each type of calibration carried out and to minimize the possibility of
misunderstanding or misuse.
 5.10.9 Amendments to calibration certificates and data sheets

Material amendments to a calibration certificate or data sheet after issue is made only in the form of a further document, or
data transfer, which includes the statement: “Supplement to Calibration Certificate, number”, or an equivalent form of wording.

Such amendments meet all the requirements of ISO 17025.

When it is necessary to issue a complete calibration certificate, it is uniquely identified and contains a reference to the original
that it replaces.

Work Instruction WI-29 “Amending certificates and reports” provides policy and instructions regarding amendments.

5.11 Customer Satisfaction

JM Test Systems monitors information relating to its customer perception to determine if customer requirements were met. Methods
used to measure customer satisfaction include the monitoring of;

5.11.1 Customer complaints

5.11.2 Questionnaire Surveys

5.11.3 Customer Service Surveys

5.11.4 Warranty returns

5.11.5 Point-of-contact feedback with Sales personal

Approved by: Cliff Morrison - VP Administration

QP 9 | 1.6 | 9/3/15

Reviewers for this document Editors for this document Approver of this document
Brenna Himel 22 Sep 2015 Jerry Kraus 21 Sep 2015 Cliff Morrison 22 Sep 2015

Revision Table

Revision Date Change Description

1.19a 9/21/2015 Amended.