Preparing A Quality Manual: Guide

NABL 160
NABL
NATIONAL ACCREDITATION
BOARD FOR TESTING AND
CALIBRATION LABORATORIES
GUIDE
for PREPARING
A QUALITY MANUAL
ISSUE NO. : 05 AMENDMENT NO : 00

ISSUE DATE: 27.06.2012 AMENDMENT DATE: --
Amendment Sheet
Sl Page Clause Date of Amendment made Reasons Signature Signature

No. No. Amendment QO Director
1
10
National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 160 Guide for Preparing a Quality Manual
Issue No: 05 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 1/ 59
Contents
Sl. Contents Page No.
Amendment sheet 1
Contents 2
1. Introduction 3
2. Process for preparing a Quality Manual 4
3. Structure and format of Quality Manual 7
4. Management Requirements 18
4.1 Organisation 18
4.2 Management system 21
4.3 Document control 24
4.4 Review of requests, tenders and contracts 26
4.5 Subcontracting of tests and calibrations 27
4.6 Purchasing, services and supplies 28
4.7 Service to the customer 29
4.8 Complaints 30
4.9 Control of nonconforming testing and/ or calibration work 31
4.10 Improvements 32
4.11 Corrective action 33
4.12 Preventive action 34
4.13 Control of records 35
4.14 Internal audit 36
4.15 Management review 38
5. Technical Requirements 40
5.1 General 40
5.2 Personnel 41
5.3 Accommodation and environmental conditions 43
5.4 Test and calibration methods and method validation 45
5.5 Equipment 49
5.6 Measurement traceability and calibration 51
5.7 Sampling 54
5.8 Handling of calibration and test items 55
5.9 Assuring the quality of test and calibration results 56
5.10 Reporting the results 58

1. Introduction
Testing and Calibration laboratories are required to comply with the

requirements of ISO/IEC 17025:2005 ‘General Requirements for the
Competence of Testing and Calibration Laboratories’ and Medical Testing
laboratories have to comply with the requirements of ISO 15189:2007
‘Medical laboratories – Particular requirements for quality and
competence’.
One of the pre-requisite for seeking NABL Accreditation is that applicant

laboratory shall submit its Quality Manual, describing its policies, the
structure of management system documentation and compliance to
ISO/IEC 17025 or ISO 15189, as applicable & relevant NABL Specific
Criteria.
In preparing the Quality Manual, it should not be restricted to the contents

of this guide. However, all elements of ISO/IEC 17025 or ISO 15189 as
applicable must be addressed in the intended Quality Manual. As an
illustration this document provides guidance to Testing and Calibration
laboratories for addressing the requirements of ISO/IEC 17025 in their
Quality Manual. Similarly, the requirements of ISO 15189 can be
addressed by Medical Testing laboratories in their Quality Manual.
The amount of details to be provided in the manual will vary depending

upon the size, field of activities, and nature of testing / calibration
performed by the laboratory. The Quality Manual shall include or make
reference to other documents such operational procedures, work
instructions, forms etc.
For preparing the Quality Manual, the laboratory may also get its technical
personnel trained in NABL’s training program on management system for
laboratory personnel. A calendar of such training courses is regularly
published in the NABL News/ web-site.

2. Process of preparing a Quality Manual
The management should nominate individuals from one or more functional

area/ section of the laboratory and a Quality Manager, having a
background of Management Systems. This group should get fully
acquainted with all NABL documents and understand the assessment
procedure & methodology of making an application. Relevant requirements
for NABL accreditation should be discussed amongst concerned staff of
the laboratory. The team should collectively make the effort to prepare the
Quality Manual with the guidance of the Quality Manager.
Laboratory needs to ascertain the status of its existing management

system and its competence. For that all existing policies, objectives,
procedures, work instruction whether documented or otherwise are
required to be listed and compared with the requirements of ISO/IEC
17025 or ISO 15189 as applicable, relevant NABL Specific criteria and
other requirements.
The laboratory should examine that the existing management system is

appropriate or it needs modification or it needs to be built from scratch.
The laboratory will be able to decide. However, it is advisable that the
laboratory writes the manual afresh, as the elements of ISO/ IEC 17025 or
ISO 15189 are quite different from other Quality Management System
standards, even though the system elements are similar.
It must be remembered that Quality Manual is a policy document, which

has to be supplemented by a set of other documents like procedure
manuals, work instructions, forms, reports etc. to align the management
system in accordance with ISO/IEC 17025 or ISO 15189, as applicable
and relevant NABL specific criteria. Therefore, the management system of
the laboratory needs to be structured.

The management system of the laboratory can be structured in many
ways. A typical structure of management system document hierarchy,
generally followed, is given below:
Quality
Manual
(Level A)
Management system
Procedures
(Level B)
Other quality documents

(W ork instructions, forms, reports, etc.)
(Level C)
The order of development of a hierarchy for an individual laboratory

usually starts with the development of the laboratory’s Quality Policy &
objectives followed by the implementation plan of the various elements of
ISO/IEC 17025 or ISO 15189 as applicable in brief. This is the apex
document or Level A document termed as the ‘Quality Manual’.
The Quality Manual has to be supplemented by a set of management

system procedures, Level B documents, which describe the detailed
procedures of the activities of individual function units needed to
implement the management system. All procedures are cross referred in
the Quality Manual.
Management system procedures may further be supplemented with

detailed work instructions, forms, reports etc. termed as Level C
documents. In some hierarchy systems, forms and reports may be grouped
as Level D documents.

The quantity of documented procedures, work instructions, forms, reports
etc. and the nature of their format and presentation are to be determined
by the individual functional units. However, it is preferred that each of
these set of documents are arranged in the same structure and format so
that the users become familiar with the consistent approach applied to
each requirement and to improve the likelihood of systematic compliance
with ISO/IEC 17025 or ISO 15189 as applicable.

3. Structure and Format of Quality Manual
There is no required structure or format for a Quality Manual. However,

any Quality Manual should convey accurately, completely and concisely
the Quality Policy, objectives, address or reference to the next level of
documentation and management responsibilities of the laboratory. One of
the methods of assuring that the subject matter is adequately addressed
and located would be to align the sections of the Quality Manual to the
elements of the ISO/IEC 17025 or ISO 15189 as applicable. Other
approaches, such as structuring the manual to reflect the nature of the
laboratory or nature of work carried out by the laboratory are equally
acceptable.
This guide is not intended to define a unique structure, format, content or

method of presentation for the Quality Manual, which can be applied to all
(or even some) laboratories. It is unique to each laboratory. However, it is
recommended that the first few pages of the Quality Manual should
address to the sections of general information like title, authority under
which it is issued, scope of the Quality Manual, amendment record of the
manual, contents of the manual, references to other documents,
definitions and abbreviations used, distribution record, brief description of
the laboratory and the management system.
After these pages, should place the section on ‘Quality Policy and
Objectives’ of the laboratory. The Quality Policy is required to be stated
under clause 4.2 of management requirements. It is preferred that it is
placed after the introductory pages, since this is the basic objective, the
laboratory’s management system is designed to meet. The remaining
sections of the Quality Manual should describe all applicable elements of
the ISO/IEC 17025 or ISO 15189. The description of these sections of the
Quality Manual should be in a sequence similar to that of ISO/IEC 17025
or ISO 15189, as applicable. Other sequencing or cross-referencing, as
appropriate to the laboratory, is acceptable.

Thereafter the list of documents, records and forms maintained by the
laboratory should be placed. Any supportive data, to be provided should
be annexed at the last.
A brief explanation of these sections has been given below. These

sections, should preferably be sequenced in the manner as given below:
Title
The title of the Quality Manual should clearly indicate the name of the
laboratory to which the manual belongs. It should also indicate the issue
number, issue date, holders name and the copy number. A typical ‘title
page’ is shown at page 11.
Release Authorisation
The section on ‘release authorisation’ should indicate the authority under

which the Quality Manual has been released. The management
responsible for the implementation of Quality Manual, normally the Head
of the laboratory should authorise its release for usage. Each copy should
bear evidence of this release. A typical ‘release authorisation’ is shown at
page 12.
Table of contents
The table of contents of a Quality Manual should show the titles of the
sections within it and how they can be located. The numbering system of
sections, subsections, pages, figures, exhibits, diagrams, tables, etc.,
should be clear and logical. A typical ‘table of contents’ is shown at
page 14.

Scope and field of application
This section of the Quality Manual should clearly mention the compliance
to the applicable standard(s) and NABL documents. It should also define
the field(s)/ discipline(s)/ area(s) and the section(s)/ division(s)
department(s) of the laboratory, to which the Quality Manual is applicable.
To ensure clarity and avoid confusion, the use of disclaimers (eg. what is
not covered by the Quality Manual and situations where it should not be
applied) may also be mentioned.
Use of references
Wherever appropriate, and to avoid unnecessary document volume,

reference to existing recognised standards or documents available with
the Quality Manual user should be incorporated.
Definitions
Although it is recommended, when practical, to use standard definitions

and terms which are referenced in recognised quality terminology
documents or in general dictionary usage, this section of the Quality
Manual should contain the definitions of terms and concepts that are
uniquely used within the Quality Manual.
The use of references to existing concepts, terminology, definitions and

standards (eg. ISO 8402) is highly recommended.
Abbreviations
Whenever the abbreviations are used, its expanded form should be

defined in this section.

Distribution of the manual
The method of distribution of the authorised manual should provide

assurance that all users have appropriate access. Proper distribution and
control can be aided, for example, by serialisation of copies for recipients.
Management should ensure that individuals are familiar with those
contents of the manual appropriate to each user within the laboratory. A
typical ‘distribution record’ is shown at page 15.
Introduction
The introductory pages of a Quality Manual should provide general

information about the laboratory concerned and the Quality Manual itself.
The minimum information about the laboratory should be its name, site,
location and means of communication. Additional information about the
laboratory, such as its line of business, a brief description of its
background, history or size, may also be included.
The information about the Quality Manual itself should include:

a The current issue number, date of issue and identification of
amended contents
b A brief description of how the Quality Manual is revised and

maintained, who reviews its content and how often, who is authorised
to change the Quality Manual, and who is authorised to approve it,
this information may also be give under the system element
concerned; a method for determining the history of any change in
procedure may be included, if appropriate
c A brief description of the documented procedures used to identify the

status and to control the distribution of the Quality Manual, whether
or not is contains confidential information, whether it is used only for
the laboratory’s internal purposes, or whether it can be made
available externally

d Evidence of approval by those responsible for authorisation of the
contents of the Quality Manual.
Quality Policy and Objectives
This section of a Quality Manual should state the laboratory’s Quality

Policy and objectives, which should be in line with the requirements of
clause 4.2 of ISO/IEC 17025 or ISO 15189, as applicable. This is where
the laboratory commitment to quality is presented and where the
laboratory’s objectives for quality are outlines. This section should also
describe how the Quality Policy is made known to, and understood by, all
employees and how it is implemented and maintained at all levels.
Elements of the Management system
The subsequent sections of the Quality Manual should describe all the
elements of the ISO/IEC 17025 or ISO 15189 as applicable.
The format or method of presentation for the description of management

system elements, which can be applied, is unique to each laboratory.
However it is recommended that the description of the elements of the
management system be in a sequence similar to that of ISO/IEC 17025 or
ISO 15189, as applicable.
Further the description of each element should be divided into logical

sub-sections revealing a well-coordinated management system. This may
be done by inclusion of policy and objectives with respect to the element
or reference to the policy, scope, person(s)/ position responsible for
executing that policy, documented management system procedures and
reference to records for each element.
The management system procedure of each element of Quality Manual,

wherever applicable, should be briefly outlined, covering the major aspects
of respective clause of ISO/IEC 17025 or ISO 15189. The actual process/
procedure may be covered in separate procedure document and cross
referred in the Quality Manual.

List of documents, records and forms
All documents which are maintained by the laboratory and the records &
forms, which are used by the laboratory should be listed in these sections.
These must find reference in the Quality Manual or the associated
document.
Annexure for supportive information
Whenever it appears in this document, that supportive data has to be

provided, it should be attached as an annexure at the end.
Page Footer
It is recommended that to facilitate ease of handling and updating of the

Quality Manual, each page within the manual should have a page footer,
similar to the given on the typical pages shown in the next few pages.
Page footer shows the Issue status, amendment status, page no. etc. As
and when the manual is amended, the relevant pages where amendment
takes place are replaced by new pages and is cross referred in the
amendment record. A typical ‘amendment record’ is shown at page 13. It
also gives the copy number. As and when each holder is issued a Quality
Manual, a copy no. is allotted to him/ her and this is indicated in the
distribution record, page 15. The signatures of the persons/ position who
have prepared, approved and issued the Quality Manual are also placed in
the page footer.

TITLE PAGE
The title page of the Quality Manual should normally contain the following:
QUALITY MANUAL
of
(Name & Address of Laboratory)
Issue No. :
Issue Date :
Copy No. :
Holder’s Name :

QUALITY MANUAL RELEASE AUTHORISATION
Immediately after the title page, this page should be placed. A typical authorization
should normally contain the following:
RELEASE AUTHORISATION
This Quality Manual is released under the authority of
(name and designation of the Head of the laboratory)
and is the property of
(name of the laboratory with address).
(Signature, Name & Designation)
Name of Laboratory:
Document No.: Document Name: Quality Manual
Issue No.: Issue Date: Copy No.: Section No. Page No.:
Amend No.: Amend Date Prepared by: Approved by: Issued by:

AMENDMENT PAGE
An amendment page should be inserted immediately after the title page. Specific
instructions to each holder of the Quality Manual as to the amendment procedure to
be followed to maintain each copy upto date should be included. To ensure that
each copy of the Quality Manual contains a complete record of amendments, this
amendment page should be updated and issued with each set of amended/ new
pages of the Quality Manual.
A typical amendment page should normally contain the following:
AMENDMENT RECORD
Sl Page Section/ Clause/ Date of Amendment made Reasons of Signature of

No. Para/ line Amendment Amendment person
(a s a p p l ic a bl e ) authorising
Amendment
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
Name of Laboratory:

CONTENT PAGE
For the ease of reference, the manual should contain a table of contents listing the
major sections, sub-sections and their page numbers. A list of the Annexures should
also be included.
A typical table of contents should normally contain the following:
CONTENTS
Section Contents Page

Quality Manual release authorisation
Amendment sheet
Contents
Scope
References (if any)
Definitions (if any)
Abbreviations (if any)
Distribution List
Introduction ( B ri ef de scripti on of the Laboratory & management s yste m )
Quality Policy and Objectives
Management Requirements
Organisation
Management system
Document Control
Technical Requirements
General
Personnel
List of all documents maintained by the laboratory

List of all records
List of all forms
Annexures (if any)
Name of Laboratory:

DISTRIBUTION LIST
The distribution record should list the holders of the controlled copies of Quality
Manual with their allotted copy numbers. Copies of Quality Manual distributed as
uncontrolled copies, should not be listed.
A typical distribution list should normally contain the following:
DISTRIBUTION LIST
The following are the authorised holders of the controlled copy of Quality Manual.
Controlled copy No. Name/ Designation of the holder of controlled copy
Name of Laboratory:

4. Management Requirements
4.1 Organisation
4.1.1 Give the name, address, type of corporate structure and whether or not an
affiliate of a larger organisation and any other information required to
identify the laboratory, including its legal status, such as Government, a
registered society or under company’s act. The date of incorporation may
also be mentioned.
4.1.2 The laboratory shall make a compliance statement that it carries out its
testing/ calibration activities in accordance with the requirements of
ISO/IEC 17025:2005, the needs of its customer, the regulatory authorities
or the organisations providing recognition, at all times. The names and
details of the regulatory bodies and the organisations providing recognition
may also be mentioned.
4.1.3 Describe the laboratory and its operations to convey a true picture of the
organisation such as location, size, whether permanent/ part of
permanent/ independent site/ mobile, branches, type of services offered,
major fields of activity etc.
4.1.4 If the laboratory is a part of larger organisation which also performs other
activities, other than testing and/ or calibration, the responsibility of the
key personnel in the organisation that have an involvement or influence on
the testing and/ or calibration activities such as production, commercial,
marketing or finance shall be clearly defined in order to identify the
potential conflict of interest with the laboratory personnel, which might
adversely effect the judgement & integrity of staff and quality of work.

4.1.5 a A statement that the laboratory has adequate number of staff both
managerial and technical, appropriate to the scope of work being
carried out.
Define the duties/ responsibilities of the managerial and technical

personnel to carry out their duties and to identify the occurrence of
departures from management system or procedures.
b Describe the procedure that is followed to ensure that the

laboratory’s management and personnel are free from any undue
internal and external commercial, financial and other pressures which
might influence their technical judgement.
c Describe the procedure which the laboratory uses to protect the

proprietary right and confidential information of the customer.
Under no circumstances the results of test and/ or calibration be made known to
any third party without the written consent of the customer. No reports should be
send by fax without customers prior permission.
d State policy and describe procedure that the laboratory is not

engaged in any activity that may diminish its trust in its independence
of judgement, competence, impartiality and integrity in relation to its
testing and/ or calibration.
e Describe the organisation and management structure of the

laboratory with the help of a chart showing Quality Management,
Technical Management and other support services alongwith their
linkages. The relationship with its parent organisation (if any) should
be stated.
f Describe the arrangement whereby written instructions and

information are given to members of staff to ensure that every
employee is aware of the extent and limitations of his areas of
responsibility and authority. Provide an organisation chart to show
the interrelationship of the laboratory staff.
Copies of job descriptions be issued to all personnel to ensure that they are aware
of both their responsibility and authority.

g State the laboratory’s arrangement for providing supervision to
laboratory staff.
The supervision has to be provided by persons familiar with methods and
procedures, purpose of each test and/ or calibration and assessment of the test
and/ or calibration results.
h Include a statement that the Technical Manager (however named)

has an overall responsibility of technical operations of the laboratory
as a whole or its sub-section their off and provision of resources to
ensure the required quality.
i Include a statement that the Quality Manager (however named) is

responsible for ensuring that the management system related to
quality is implemented and followed, at all times.
Also include a statement that the Quality Manager has direct access
to the highest level of management at which decisions are made for
laboratory policy and resources, commensurate with the organisation
chart.
j Describe arrangements in the event of absence of key laboratory

staff, including Quality Manager and Technical Manager.
k Describe arrangements to ensure that laboratory personnel are aware

of the relevance and importance of their activities and how they
contribute to the achievements of the objectives of the management
system.
4.1.6 Describe the arrangement whereby top management ensures that

appropriate communication process are established within the laboratory
and that communication takes place regarding the effectiveness of the
management system.

4.2 Management System
4.2.1 General
Describe the documentation, implementation and maintenance of the

management system of the laboratory. Include a statement that the
management system is appropriate to the scope of its activities and in
accordance with ISO/IEC 17025:2005 and NABL documents.
A statement also to be made that the management system documentation

of the laboratory is communicated to, understood by, available with and
implemented by those personnel who are responsible for maintaining the
quality of test and/ or calibration results.
The Quality Manual of a laboratory is the basic document to describe its management
system. Associated documents like operating procedures, work instructions, forms,
report etc. also form a part of the management system. The management system of the
laboratory need not be complex. Much will depend on the size of the laboratory and the
scope of testing/ calibration requiring accreditation.
4.2.2 Quality Policy
The laboratory must define its management system policies related to

quality, including Quality Policy statement and objectives, preferably in the
beginning of the Quality Manual. The quality policy statement shall be
signed by the Chief Executive or any person of the top management who
takes decisions on the laboratory’s policy and resources. The statement
must include atleast the following:
a commitment of the laboratory management in relation to quality of its
testing and calibration services and to provide its customers at all
times with a service complying with recognised standards of practice
b standard of services given to its customers
c the purpose of the management system related to Quality

d all staff shall familiarise themselves with the content of the Quality
Manual and comply with the Policies and Procedures laid down in the
Manual and associated documentation, at all times
e commitment to compliance with ISO/IEC 17025:2005 and to

continually improve the effectiveness the management.
The quality policy statement should be concise and may include the requirement that
tests and/ or calibrations shall always be carried out in accordance with stated methods
and customers requirements. It may also include that the laboratory gives emphasis in
producing reliable and accurate tests and/ or calibration results. When test and/ or
calibration laboratory is part of a larger organisation, some quality policy elements may
be in other documents.
4.2.3 Describe arrangements that top management provides evidence of

commitment to the development and implementation of the management
system and continually improving its effectiveness.
4.2.4 Describe arrangements that top management communicates to the

organisation the importance of meeting customer as well as statutory and
regulatory requirements.
4.2.5 Documentation Structure
Describe the structure of documentation used in the management system.

It shall include or make reference to the supporting procedures, including
technical procedures, i.e., reference to supporting documents such as
operating procedures etc. Pyramid structure for documentation may also
be described here or referred. It shall include or make references to the
supporting documents such as operating procedures, work instructions,
forms, reports etc. This may also be described by a pyramid structure of
management system document hierarchy.

4.2.6 Responsibility
The person(s)/ position responsible for implementing and monitoring

programs and policies to achieve laboratory’s quality objectives shall be
identified. The role and responsibility of the Technical Management and
the Quality Manager for ensuring compliance to ISO/IEC 17025:2005,
should be clearly defined.
Generally the responsibilities of key personnel are defined in Quality Manual and others
having different responsibilities within the management system at appropriate position,
in the second/ third level of documentation.
4.2.7 Describe arrangements that top management ensures that the integrity of
the management system is maintained when changes to the management
system are planned and implemented.

4.3 Document Control
4.3.1 General
Describe the system to uniquely identify all documents generated by the

laboratory and the procedure to control these documents
The laboratory must list all documents that form part of its management system, both
internally generated or from external source such as policy statements, procedures,
specification, calibration tables, charts, text books, posters, notices, memoranda,
software, drawings, plans, regulations, standards and other normative documents etc.
and maintain a master list or equivalent document control procedure, which identifies the
revision status and distribution.
All documents generated by the laboratory shall be uniquely identified, which shall
include document number, issue number, date of issue, amendment/ revision number,
date of amendment/ revision, page numbering, total number of pages, approving
authority and issuing authority.
4.3.2 Document approval and issue
Procedure
Describe the document approval and issue procedure. It shall atleast

include the following information:
a availability of authorised edition of appropriate documents at all
locations
b periodic review of documents
c removal of obsolete documents from all locations
d retention of a copy of obsolete document.
Responsibility
The person(s)/ position responsible for review and approval of documents

shall be identified for all level of documentation.
The laboratory shall ensure that all documents are reviewed and approved by authorised
personnel prior to issue.

4.3.3 Document changes
Procedure
The laboratory shall state the procedure to identify the altered or new text,
in the amended document.
Where documentation control system allows the amendments of

documents by hand pending re-issue, the procedure and authority for such
amendment shall be defined.
Where the laboratory maintains the amendments to documents in a

computerised system, procedures to describe the changes and its control
shall be defined.
Policy with respect to all above may be given in Quality Manual and the actual process
may be covered in a separate procedure referred in the Quality Manual.
Responsibility
The person(s)/ position authorised to review and approve changes/

amendments shall be identified.
It should be preferably be the same person who performed the original review.

4.4 Review of requests, tenders and contracts
Policy
State the laboratory’s policy for the review of requests, tenders and
contracts including subcontracted work.
Responsibility
The person(s)/ position responsible for review of request/ indent of new,

repetitive/ routine, special work, tenders and contracts may be identified.
Procedure
Briefly outline the procedure for review of requests and tenders which
shall include:
a defining, documenting and understanding customer requirements
before commencing work
b assessment of laboratory’s capability and resources
c appropriate method selection
d work that is subcontracted by the laboratory.
The details of how the review is actually done, may be covered separately
in a procedure cross referred herein.
Records
Make a reference to the document, where the records are maintained.

The records of reviews, any significant changes, pertinent discussions with the customer
etc., during the execution of contract and during the amendment to the contract shall be
maintained.

4.5 Subcontracting of tests and calibrations
Policy
State the laboratory’s policy for subcontracting of test and/ or calibration

work.
The NABL policy for subcontracting by the laboratories is that the work shall be placed
with an accredited laboratory.
Responsibility
The person(s)/ position responsible for subcontracting the works may be

identified.
Procedure
Briefly outline the procedure for subcontracting, which should include

advising customer of such arrangements in writing, seeking customers’
approval and accepting the responsibility for the subcontracted work. The
actual process may be covered in a separate procedure cross referred in
the Quality Manual.
Records

Records of all subcontractors that are used and record of evidence of compliance with
ISO/IEC 17025:2005 for the work in question, shall be maintained.

4.6 Purchasing, services and supplies
Policy
State the laboratory’s policy for purchasing, services and supplies which
affect the quality of test and/ or calibration.
Responsibility
The person(s)/ position responsible for authorising purchases may be

identified.
Procedure
Briefly outline the procedure for the selection and purchase of services
and supplies, evaluation of suppliers of critical items, receipt and storage
of reagents/ consumables, inspection & verification.
Also briefly outline the procedure for review and approval of purchase
documents for technical contents. The actual process may be covered in
separate procedure cross referred in the Quality Manual.
The description in the purchase document may include types, class, grade, precise
identification, specification, drawings, inspection instructions, other technical data
including approval of test results, the quality required and the management system
standard under which they were made.
Where assurance of quality of outside support services or supplies is unavailable, the

laboratory’s policy of using the items may be stated (i.e. whether they should be
inspected or otherwise verified for adequate quality).
Records

The records of evaluation of supplies of critical consumables & services and the list of
those approved shall be maintained. The records of action taken to check the
compliance of supplies/ services used with specified requirements shall also be
maintained. The records like purchasing documents may also be maintained.

4.7 Service to the customer
Policy
State the laboratory’s policy for service to the customer. The policy may
address to the following:
a maintenance of good communication
b to clarify their request
c monitor the laboratory’s performance in relation to the work
performed
d provide reasonable access to relevant areas of the laboratory for the
witnessing of test(s)/ calibration(s) performed for the customer
e preparation, packaging and despatch of test(s)/ calibration(s) items
f advice and guidance in technical matters
g opinion and interpretation based on results
h to maintain confidentiality to other customers during the monitoring
i delays or major deviations in the performance of test(s)/
calibration(s).
Responsibility
The person(s)/ position responsible for authorising the customers for these
services, if required shall be identified.
Procedure
Briefly outline the procedure for implementation. It may also include the
procedure for obtaining feedback from the customers on laboratory’s
quality of services. The actual process may be documented separately and
cross referred in the Quality Manual.
Records

The records of the customer feedback, both positive and negative from the customers
shall be maintained.

4.8 Complaints
Policy
State the laboratory’s policy on resolution of complaints to improve the

quality of services provided.
Responsibility
The person(s)/ position responsible for resolution of complaints shall be

identified.
Procedure
Briefly outline the procedure for resolution of complaints received from

customers or other parties. The procedure shall have a provision of
promptly auditing those aspects, which are indicated by the complainant
and conveying it for management review. The actual process may be
documented separately and cross referred in the Quality Manual.
Records

The records of all complaints written or verbal shall be maintained. The records shall
also, include the complainant’s name/ organisation, the investigations carried out and
the corrective action taken by the laboratory, shall be maintained.

4.9 Control of nonconforming testing and/ or calibration work
Policy
State the laboratory’s policy on control of nonconforming work, when any

work and results do not confirm to its own procedures or the agreed
requirements of the customers.
Responsibility
The person(s)/ position responsible for management of nonconforming

work and actions such as halting of work, withholding of test reports/
calibration certificates & resumption of work shall be identified.
Procedure
Briefly outline the procedure for control of nonconforming work, which

shall include:
a authority for halt of work, if necessary
b an evaluation of the significance of the non-conforming work
c Corrections and decision about the acceptability of nonconforming
work to be taken
d notification to the customer and work recall, if necessary
e authorising the resumption of work
f action taken to prevent future occurrence.
The actual process may be covered in a separate procedure cross referred

in the Quality Manual.
Records

Records of all non-conformities and action taken for correcting the non-conformities shall
be maintained.

4.10 Improvements
Policy
State the laboratory’s policy on improvement of the effectiveness of its,

management system.
The policy may include use of quality policy, quality objectives, audit
results, analysis of data, corrective and preventive actions and
management reviews.
Responsibility
Designate the management persons(s)/ position responsible for

improvements shall be identified.
Procedure
Briefly outline the procedure of identification, implementation and

monitoring the improvements.

Records

Records of all improvements implemented shall be maintained.

4.11 Corrective action
Policy
State the laboratory’s policy on corrective action when nonconforming

work or departures from policies and procedures in the management
system or technical operations are identified.
Responsibility
The person(s)/ position responsible for planning, implementing and

monitoring appropriate corrective action shall be identified.
Procedure
Briefly outline the procedure for implementing corrective action which shall
include:
a sources of information for identification of problems
b cause analysis
c selection and implementation of corrective actions
d monitoring of corrective actions
e additional audits where non-conformities/ departures cast doubt.

Records

Records of all corrective actions taken shall be maintained.

4.12 Preventive action
Policy
State the laboratory’s policy on preventive actions for needed

improvements and identification of potential sources of non-conformities,
technical as well as concerning the management system.
Responsibility
The person(s)/ position responsible for taking preventive actions shall be
identified.
Procedure
Briefly outline the procedure for preventive action and action plan to
implement & monitor to reduce the likelihood of the occurrence of non-
conformities.
The procedure for preventive action shall include initiation of such actions
and application of controls to ensure they are effective.
The sources for identification of areas for implementing preventive action

may include feedback from staff and customers, internal quality checks,
management review, proficiency testing, results, customer feedback,
analysis of data, trend/ risk analysis, etc. Such feedback serves as
controls and based on these an action plan to identify the potential
sources of non-conformities and required improvement & preventive
measures can be drawn for implementation.

Records
Records of identification of potential sources of non-conformities, investigations carried
out, required improvements and preventive measures taken shall be maintained.

4.13 Control of records
Policy
State the laboratory’s policy to maintain and control record pertaining to

quality and technical activities. Also state policy on confidentiality,
protection and security of records, especially computer records.
Scope
List all quality and technical records maintained by the laboratory and give
a unique identification record number.
Responsibility
State the person(s) responsible for maintaining and controlling each

record.
Procedure
Briefly outline the procedure for identification, collection, indexing, access,

filing, storage, maintenance and disposal of quality and technical records.
The quality records shall include reports of internal audit, management review,
corrective action, preventive action etc. The technical records shall include original
observations, derived data, calibration records, staff records, a copy of each test report
or calibration certificate, personnel responsible for sampling, participation in proficiency
testing etc.
Briefly describe the procedure for control and time period for retention of
records, especially the test and/ or calibration worksheet, raw data and
test report/ calibration certificate.
Briefly describe the procedure for corrections, if mistakes occur.


4.14 Internal Audit
Policy
State the laboratory’s policy in respect to conduct internal audit of all

activities to verify that the operations continue to comply with the
requirements of laboratory’s management system and ISO/IEC
17025:2005.
Scope
State the activities of the management system including testing and/ or

calibration activities, which will be audited to cover all elements of the
laboratory’s management system and ISO/IEC 17025:2005.
Responsibility
State the person/ position responsible for planning, organising internal

audits and coordinating the corrective action.
Normally this activity is the responsibility of the Quality Manager.
Procedure
Briefly outline the procedure for conduct of internal audit. The procedure
shall take account of:
a the frequency of conducting the internal audit at regular intervals
b training and qualification criteria of personnel conducting the internal
audit, that they are independent of the activity to be audited to the
extent possible.
The procedure shall also include the procedure for the corrective action(s)
to be taken and its verification including notifying customers in writing, if
the findings of internal audit cast doubt on the effectiveness of operations
or on the correctness/ validity of test and/ or calibration results. The
detailed process may be covered in a separate procedure cross referred in
the Quality Manual.

Records

The records of the activities covered; the audit findings including the areas audited,
records verified, objective evidence gathered for verifying compliance with the
requirements of ISO/IEC 17025:2005 & the laboratory’s management system and the
gaps/ non conformities observed if any; corrective actions that arise from them,
implementation, its verification and the effectiveness of the corrective action taken shall
be recorded.

4.15 Management review
Policy
State laboratory’s policy for the conduct of Management Review to ensure

the continuing suitability and effectiveness of laboratory’s management
system and its testing and/ or calibration activities and to introduce
necessary changes and improvements.
It is expected that the top management (chief executive) of the laboratory who has the
executive responsibility for running the laboratory, undertakes the management review.
The members of senior management having overall responsibility for design and
implementation of laboratory’s management system for the Technical Management, may
also be involved in the management review.
Scope
State the activities, the Management Review shall take account of,
however they should not be limited to the following:
a the suitability of policies and procedures
b reports from managerial and supervisory personnel
c the outcome of recent internal audits
d corrective and preventive actions
e assessments by external bodies
f the results of inter-laboratory comparisons or proficiency testing
g changes in the volume and type of the work
h customer feedback
i complaints
j recommendations for improvement
k other relevant factors, such as quality control activities, resources
and staff training.
Responsibility
State the person/ position responsible to convene the Management Review

meeting and the person who shall implement the decisions of the meeting.

Procedure
Briefly outline the procedure for conduct of the Management Review

covering all the aspects stated above and the frequency at which it is
conducted.
The procedure shall also include that any action identified during the
review, is implemented within the agreed time limit. The detailed
processes may be covered in a separate procedure cross referred in the
Quality Manual.
Records

Records of all management review, and the actions that arise from them shall be
recorded. Records should also identify the personnel responsible for the actions and
agreed time frame. It should also include report on the actions of previous reviews.

5. Technical Requirements
5.1 General
State the factors that determine the correctness and reliability of the tests/
calibrations performed by the laboratory. These factors should not be
limited to:
a human factors
b accommodation and environmental conditions
c test and calibration methods and method validation
d equipment
e measurement traceability
f sampling
g the handling of test and calibration items.
The laboratory shall take account of the factors in developing the test and/ or 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
Policy
State the laboratory’s policy on ensuring personnel competence and with

regard to training needs, relevant to the present and anticipated tasks of
the laboratory. Formulate and state goals with respect to education,
training and skills of the laboratory personnel.
Job Description
Provide job description of the laboratory staff which shall include atleast
the following:
a name
b qualification
c training attended
d management duties
e expertise
f responsibilities
g further expertise/ training required.
This data may be maintained by the personnel department and be also annexed with the
procedural manual of relevant sections.
Supervision of Personnel
Provide for each technical operating department/ section, information of

the number of supervisory & non-supervisory personnel and the
procedures used to ensure adequacy of supervision.
Include a statement that department/ section laboratory managers ensure

that only staff members who have been assessed and found competent to
perform a test and/ or calibration are allowed to perform only that test and/
or calibration independently.
Other staff members may only assist in performing that test under close supervision of a
competent staff member.

Training and Assessment of Competence
Describe the procedure for identifying the training needs and providing
training of personnel, relevant to the present and anticipated tasks of the
laboratory. A procedure for assessing the competence/ skills of the
personnel should also be described.
Also describe the evaluation procedure for the effectiveness of the training
actions taken.
The details of the training and assessment program of each section may be contained in
the Training Manual of that section. Each sectional laboratory manager may be
responsible to maintain the manual and plan the training schedule of his section to
satisfy these requirements.
Records

The personnel competence requirements with respect to different task undertaken by
laboratory shall be maintained. The laboratory shall also maintain records of persons
who are competent/ authorised including date of authorization, to perform specific tasks
such as sampling, test and/ or calibration, issue of test report & calibration certificate, to
give opinion and interpretations and to operate particular types of equipment. Also the
records of their educational & professional qualification, training, skills and experience
shall be maintained.

5.3 Accommodation and Environmental Conditions
Policy
State the laboratory’s policy with respect to accommodation and

environments facilitate correct performance of the tests and/ or
calibrations.
Accommodation
Briefly describe the building facilities, location, construction features,

energy & water sources and lighting. A layout plan may be included.
Describe measures to control access to any particular area of the

laboratory and procedures to ensure laboratory security. If necessary, give
a table listing the staff that is permitted access to the various areas and
the position of staff responsible for security.
Is there effective separation between neighboring areas in which there are

incompatible activities? What measures have been taken to prevent cross
contamination?
Give instructions for laboratory staff to maintain good house keeping.

Prepare/ document special procedures for specific areas, if necessary.
Environmental Conditions
Give a brief description of the environmental conditions such as

temperature and humidity, in the various sections of the laboratory, as
required by particular category of calibration or tests (giving a list if
necessary).
In addition to temperature and humidity, laboratories performing biological

measurements shall specify biological sterility as environmental factor to
be controlled and electo-technical laboratories shall monitor the mains
voltage.

Give a brief description of how to achieve the control of these
environmental conditions. What if they break down? Briefly outline the
procedure to monitor the environmental conditions.
Records

The records of environmental conditions such as temperature and humidity, wherever
relevant, shall be maintained.

5.4 Test and Calibration Methods and method validation
Policy
State laboratory’s policy with respect to selecting any particular test and/
or calibration method i.e. whether prescribed in national or international
standards, published in reputed journals, text books, equipment
operational manuals or laboratory developed methods etc. to meet the
customer’s requirements.
The methods published in national or international standards with latest valid edition
shall be used. Methods published in journals, text books, equipment manuals and
laboratory developed methods or non-standard methods suggested by the customer,
shall be validated.
Test and Calibration Methods
Briefly describe the procedure and instruction for use of appropriate

methods and procedures for all tests and/ or calibrations within its scope.
This should include sampling, handling, transport, storage and preparation
of items to be tested and/ or calibrated, and where appropriate, an
estimation of measurement uncertainty as well as statistical techniques for
analysis of tests and/ or calibration data.
Describe the general arrangements for issuing, amending, updating,

retrieving, reviewing and approving of test and calibration methods.
Designate the staff responsible for the above task.
Describe the procedure for writing laboratory developed and non-standard

methods. The procedure should include that in-house methods shall be
validated and approved before issue.
Each test or calibration procedure shall contain at least the following information:
a appropriate identification
b scope
c description of the type of item to be tested or calibrated
d parameters or quantities and ranges to be determined
e apparatus and equipment, including technical performance requirements

f reference standards and reference materials required
g environmental condition required and any stabilization period needed
h description of the procedure, including
- affixing of identification marks, handling, transporting, storing and preparation
of items
- checks to be made before the work is started
- checks that the equipment is working properly and, where required, calibration
and adjustment of the equipment before each use
- the method of recording the observations and results
- any safety measures to be observed
i criteria and/ or requirements for approval/ rejection

j data to be recorded and method of analysis and presentation
k the uncertainty or the procedure for estimating uncertainty.
For in-house methods, guidance should be provided for amplifying standard

specifications to make a step-by-step procedure, which is unambiguous to the staff
concerned.
Procedure Manuals
List the various categories of test and/ or calibration methods employed

and make a cross-reference to the Test and/ or Calibration Procedure
Manual(s) in the Quality Manual.
International, Regional or National Standard that contain sufficient and concise

information on how to perform the tests and/ or calibrations do not need to be
supplemented or rewritten as internal procedures if these standards are written in a way
that they can be used as published by the operating staff in the laboratory. It may be
necessary to provide additional documentation for optional steps in the method or
addition details.
Standard Specifications
State the laboratory’s policy for referring to latest standards as the basis
for test and/ or calibration methods, whenever possible.
List the relevant standard specifications on which the test and/ or

calibration procedures are based.

Validation of Methods
Where the laboratory is using the laboratory developed or non-standard

methods, the laboratory shall confirm the techniques used for the
determination of the performance of a method.
One or combination of the following techniques may be used for the determination of
performance of a method.
a calibration using reference standards or reference materials
b comparison of results achieved with other methods
c Inter-laboratory comparisons
d systematic assessment of the factors influencing the result
e assessment of the uncertainty of the results based on scientific understanding of
the theoretical principals of the method and practical experience
f any other technique.
Estimation of Uncertainty of Measurement
The laboratory shall state the procedure applied to estimate the

uncertainty of measurement for all types/ ranges of calibration.
When estimating the uncertainty of measurement, all uncertainty components which are
of importance in the given situation shall be taken into account, which shall include but
not be limiting to:
a reference standards and reference materials with reported uncertainty in the
calibration certificate
b method employed
c equipment used with reported uncertainty in the calibration certificate
d environmental conditions
e properties and condition of the item being tested/ calibrated.
For calibration laboratories and testing laboratories performing their own calibrations
shall estimate the uncertainty of measurement for all calibrations and types/ range of
calibrations.
For testing laboratories availing the services from calibration laboratories, shall identify
all the components of uncertainty and make a reasonable estimation for all test
parameters, and shall ensure that the form of reporting of the result does not give a
wrong impression of the uncertainty. The degree of rigor needed in an estimation of
uncertainty of measurement depends on the requirements of test method, requirements
of customer and the existence of narrow limits on which decisions on conformance to a
specification are based.

Control of Data
Describe the arrangement to ensure that all data transfer are subjected to
appropriate checking by responsible staff.
Describe the procedure to protect the integrity, confidentiality and security

of data, particularly when using computer processing, including software
validation.

5.5 Equipment
Policy
State laboratory’s policy on use of equipment and reference materials for

complying to required specifications and capable of achieving the desired
accuracy.
Procedures for test and calibration equipment
Make a cross reference to the document where a list of major equipment

are maintained and also make a statement to the effect that it has all the
necessary equipment and reference material for meeting the stated policy.
List the range of major test and/ or calibration equipment, reference standards and
materials required by the laboratory.
Describe the procedure for commissioning new equipment including the

criteria for acceptance and safeguarding from adjustments.
The laboratory shall confirm that all equipment under the control of
laboratory requiring calibration are identified and labeled to indicate the
status of calibration, date of last calibration and date of next calibration.
Describe a procedure for intermediate checks to maintain confidence

status of the equipment.
Describe the procedure for safe handling, transport, storage, use and
planned maintenance of measuring equipment to ensure proper
functioning and prevent contamination or deterioration.
Describe the procedure for safeguarding tests and/ or calibration

equipment, including both hardware and software for adjustment
invalidating the results.

Describe the procedure for equipment subjected to overloading or
mishandling, giving suspected results or the equipment is declared
defective or when equipment goes outside the direct control of laboratory
and a procedure when it is repaired and brought back/ returned to service.
Describe the procedure to ensure that copies (eg. in computer software)

are correctly updated, where calibrations give rise to set of correction
factors.
Equipment Records

The laboratory shall maintain records of all major test and/ or calibration equipment.
For each equipment atleast the following data should be included:

a the identity of the item of equipment and its software
b the manufacturer’s name, type identification, and a serial number or other unique
identification
c checks that equipment complies with the specification
d 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.
The records for authorization of the technical staff for handling/ operating the
equipments shall also be maintained.
The laboratory shall also maintain records of all test and/ or calibration equipment,
reference standards and reference materials requiring calibration which shall atleast
include equipment name, calibration status, date of the calibration and due date of next
calibration.
For chemical reference materials, the expiry date should be indicated. A record of their
usage should be included.

5.6 Measurement Traceability and Calibration
Policy
The laboratory shall make a commitment to implement NABL policy on

measurement traceability and calibration, given in NABL 142.
The laboratory shall also make a commitment to use the services of

accredited laboratories for external calibrations, to provide traceability to
national/ international standards.
Where traceability to national/ international standards is not practicable,

how does the laboratory provide the satisfactory evidence about the
reliability of the measurement of result.
A calibration certificate bearing an accreditation body symbol from a calibration

laboratory accredited in accordance with ISO/IEC 17025:2005, for the calibration
concerned is sufficient evidence of traceability of the calibration data reported.
Calibration program
Describe the calibration program operative in the laboratory which

includes the scheduling & fixing of calibration due dates and fulfills the
requirements of NABL 142. The program shall cover all measuring
instrument/ equipment, reference standards and reference materials.
For internal calibration, describe calibration procedure including

estimation of uncertainties of measurement and traceability to national/
international standards and acceptance criteria.
A detailed procedure for calibration may be given in a separate document

and cross referred in the Quality Manual.

The overall program of calibration and verification and validation of an equipment shall
be so designed and operated to ensure that measurements made by the laboratory are
directly traceable to National and International standard of measurement, where
applicable. Alternatively the measurement should be traceable to National Standards
through an unbroken chain of NABL Accredited laboratories. The measurements may be
alternatively traceable to the calibration laboratories accredited by APLAC/ ILAC MRA
partners. NABL will recognize the traceability of calibration to international metrology
institutes such as NIST, PTB etc. NABL accredited laboratories are required to ensure
that the calibration certificates in such cases indicate the traceability to National or
International standards of Measurement. The calibration certificate shall also provide a
statement on the uncertainty of measurement and standards used with their valid
calibration, uncertainty & traceability.
Use of Reference Standard of Measurement
Reference materials shall be, where possible, be traceable to SI units or to

Certified Reference Materials. In case the same is not possible, it can
provide traceability as prescribed in ISO/IEC 17025:2005 clause 5.6.2.1
and the same may be described by the laboratory.
The laboratory shall make a statement that reference standards of

measurement held by the laboratory shall be used for calibration only and
for no other purpose. In case the laboratory is using the reference
standard for other purposes, the laboratory shall state the procedure to
demonstrate that its performance as reference standards would not been
invalidated. List of Reference Standard in use shall be maintained along
with the details of its receipt and utilization, if appropriate.
Describe the procedures and schedule for checks needed to maintain

confidence in the calibration status of reference, transfer or working
standards and reference materials.
Responsibility
The person(s)/ position responsible for implementing and monitoring the

calibration program shall be identified.

Records

The laboratory shall maintain records of all established traceability of calibrations
performed on its own measuring instrument/ equipment, reference standard/ material.
This record can be included with the equipment records like equipment name, calibration
status, date of the calibration and due date of next calibration.

5.7 Sampling
Briefly outline the laboratory’s plan and procedures for sampling, when
sampling of substances, materials or products for subsequent testing, is
the responsibilities of the laboratory. The procedure should include the
selection, sampling plan, withdrawal and preparation of a sample to yield
required information.
The actual process may be included in a separate procedure cross

referred in the Quality Manual.
If customer requires deviation for documented sampling procedures, thus two shall be
recorded and included in all documents containing test and/ or calibration results.
No sampling is to be done for calibration as the entire scope/ ranges need to be

demonstrated.
Records

The relevant data related to sampling shall be recorded. It shall atleast include sampling
procedure used. identification of the sampler, environmental conditions (if relevant),
diagrams to identify the sampling location and if appropriate, statistics principles upon
which the sampling is based.

5.8 Handling of Calibration and Test items
Policy
State laboratory’s policy with respect to the handling of test and/ or

calibration items to protect the integrity of test and/ or calibration item.
Procedure
Briefly outline the procedure for safe transportation, receipt, handling,

protection, storage, security, retention and delivery/ disposal for items
received by the laboratory for test and/ or calibration.
Test/ Calibration item identification
Describe the system for identification and recording of test and/ or

calibration item, throughout the life in the laboratory.
The actual process of handling to calibration and/ or test items may be

detailed in a separate procedure cross referred in the Quality Manual.
Records

For each test and/ or calibration item, atleast the following information shall be recorded:
a laboratory identification number
b name of customer
c date of receipt
d sample description
e condition of receipt
f date of test/ measurement completed
g sample disposal date/ date on which sample collected by customer
h identity of assigned analyst.

5.9 Assuring the quality of test and calibration results
Policy
State the laboratory’s policy for assuring the quality of test and calibration
results.
Quality control measures

The laboratory shall describe the quality control procedure for monitoring
the validity of test and/ or calibration and the verification practices for
checking the validity of test and/ or calibration results and for estimating
the components of precision of test and/ or calibration results.
The monitoring shall be planned & reviewed and shall include, but not limited to the
following:
a regular use of certified reference materials and/ or internal quality control using
secondary reference materials
b participation in inter-laboratory comparison or proficiency testing program
c replicate tests or calibrations using the same or different methods
d retesting or recalibration of retained items
e correlation of results for different characteristics of an item.
It is expected that depending upon the nature of test(s) and/ or calibration(s) performed
and volume of work undertaken, one or more of the above measures shall be practiced.
The laboratories shall document a procedure to analyse the quality control

data and where they find that their results/ analysis are outside the pre-
defined criteria, a planned action shall be taken to correct the problem and
to prevent incorrect results from being reputed.
Describe or make cross reference to the document which contains the

schedule and frequency with which such verification practices are carried
out and the procedure for conduct and review of these activities.
Responsibility
Designate the person(s)/ position responsible for coordinating the
verification practices. Specify the management person responsible for
reviewing the results and deciding on the appropriate investigation and
corrective action.

Proficiency Testing
The laboratory shall make a statement that it follows NABL policy on

Inter-laboratory Comparisons and/ or Proficiency Testing, in accordance
with NABL 163.
Proficiency testing is one of the powerful method of checking the validity of the test and/
or calibration results.
All NABL accredited testing and calibration laboratories are required to participate in
Proficiency Testing Programs conducted by NABL or the nodal organizations appointed
by NABL. Laboratories shall also participate (as far as available and practicable) in
international Inter-laboratory Comparison/ Proficiency Testing Programs conducted by
APLAC, EA or equivalent organizations. NABL shall keep the accredited laboratories
informed about all such international programs through NABL newsletter.
NABL is expected to enforce the requirements of APLAC MRA 001 and accordingly it will
be essential for all its accredited laboratories to demonstrate technical competence of its
accredited laboratories by satisfactory participation in International/ Regional/ National
Proficiency Testing Programs, including APLAC in a manner so that each major sub-
areas of major disciplines of a laboratory’s scope of accreditation are covered in a cycle
of 4 years. This will of course not apply to those special areas where Inter-laboratory
Proficiency Testing Programs are not available.
All applicant laboratories are required to successfully participate in at least one

Inter-laboratory Proficiency Testing in accordance with ISO/ IEC Guide-43 (I)- 1996.
Records

The records of all verification practices i.e. internal quality checks and intermediate
checks on reference standards shall be maintained. The records of proficiency testing
and inter-laboratory comparisons shall be maintained. The records shall also include
review of results and investigation/ analysis of deviations if observed and resulting
corrective actions taken and verified.

5.10 Reporting the results
Policy
The laboratory shall state its policy with respect to reporting of results of
each test or calibration carried out by them so that they are reported
accurately, clearly, unambiguously and objectively and in accordance with
any specific instructions in the test or calibration methods.
A standard format may be used by the laboratory, which contains atleast the following
information:
a a title (eg. “Test Report” or “Calibration Certificate”)
b the name and address of the laboratory, and the location where the tests and/ or
calibrations were carried out, if different from the address of the laboratory
c unique identification of the test report or calibration (such as the serial number),
and on each page an identification in order to ensure that the page is recognized
as a part of the test report or calibration certificate, and a clear identification of
the end of the test report or calibration certificate
d the name and address of the customer
e identification of he method used
f a description of, the condition of, and unambiguous identification of the item(s)
tested or calibrated
g the date of receipt of the test or calibration item(s) where this is the validity and
application of the results, and the date(s) of performance of the test or calibration
h reference to the sampling plan and procedures used by the laboratory or other
bodies where these are relevant to the validity or application of the results
i the test or calibration results with, where appropriate, the units of measurement
j the name(s), function(s) and signature(s) or equivalent identification of person(s)
authorizing the test report or calibration certificate
k where relevant, a statement to the effect that the results relate only to the items
tested or calibrated.
In addition to the above any other information as stated in ISO/IEC 17025:2005 clause
5.10.3 and 5.10.4, as relevant may also be contained in the test report/ calibration
certificates.
In case of internal customer or written agreement with the customer, the format may be
made short. However any requirement not reported to customer shall be readily available
in the laboratory.

The laboratory shall explicitly state that:
a the results of test and calibration performed by the subcontractor are
included in the report/ certificate and clearly identified
b the calibration certificates also include environmental conditions,
uncertainty of measurement and the evidence of traceability of
measurement
c wherever required the opinions and interpretations are provided in
the reports/ certificates
d all reports/ certificates bear NABL symbol as per NABL policy
e all reports/ certificates are signed by the authorised signatory.
Describe the procedure for issuing and transmitting of reports/ certificates

to the customers.
Describe the procedure for making amendments to Test Reports and

Calibration Certificates.
State the policy of the laboratory to notify to its customer, of any event
that cast doubt on the validity of issued results. Also the procedure for
issuing the amended or supplementary reports/ certificates shall be stated.

3 rd Floor, NISCAIR
14, Satsang Vihar Marg
New Mehrauli Road
New Delhi – 110 067
Tel.: +91-11-46499999
Fax: +91-11 26529716
Website: www.nabl-india.org

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NABL 160

ISSUE NO. : 05 AMENDMENT NO : 00

Sl Page Clause Date of Amendment made Reasons Signature Signature

National Accreditation Board for Testing and Calibration Laboratories

Sl. Contents Page No.

National Accreditation Board for Testing and Calibration Laboratories

Testing and Calibration laboratories are required to comply with the

One of the pre-requisite for seeking NABL Accreditation is that applicant

In preparing the Quality Manual, it should not be restricted to the contents

The amount of details to be provided in the manual will vary depending

National Accreditation Board for Testing and Calibration Laboratories

The management should nominate individuals from one or more functional

Laboratory needs to ascertain the status of its existing management

The laboratory should examine that the existing management system is

It must be remembered that Quality Manual is a policy document, which

National Accreditation Board for Testing and Calibration Laboratories

Other quality documents

The order of development of a hierarchy for an individual laboratory

The Quality Manual has to be supplemented by a set of management

Management system procedures may further be supplemented with

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories

There is no required structure or format for a Quality Manual. However,

This guide is not intended to define a unique structure, format, content or

National Accreditation Board for Testing and Calibration Laboratories

A brief explanation of these sections has been given below. These

The section on ‘release authorisation’ should indicate the authority under

National Accreditation Board for Testing and Calibration Laboratories

Wherever appropriate, and to avoid unnecessary document volume,

Although it is recommended, when practical, to use standard definitions

The use of references to existing concepts, terminology, definitions and

Whenever the abbreviations are used, its expanded form should be

National Accreditation Board for Testing and Calibration Laboratories

The method of distribution of the authorised manual should provide

The introductory pages of a Quality Manual should provide general

The information about the Quality Manual itself should include:

b A brief description of how the Quality Manual is revised and

c A brief description of the documented procedures used to identify the

National Accreditation Board for Testing and Calibration Laboratories

Quality Policy and Objectives

This section of a Quality Manual should state the laboratory’s Quality

Elements of the Management system

The format or method of presentation for the description of management

Further the description of each element should be divided into logical

The management system procedure of each element of Quality Manual,

National Accreditation Board for Testing and Calibration Laboratories

Annexure for supportive information

Whenever it appears in this document, that supportive data has to be

It is recommended that to facilitate ease of handling and updating of the

National Accreditation Board for Testing and Calibration Laboratories

(Name & Address of Laboratory)

National Accreditation Board for Testing and Calibration Laboratories

This Quality Manual is released under the authority of

(name and designation of the Head of the laboratory)

and is the property of

(name of the laboratory with address).

(Signature, Name & Designation)

National Accreditation Board for Testing and Calibration Laboratories

A typical amendment page should normally contain the following:

Sl Page Section/ Clause/ Date of Amendment made Reasons of Signature of

National Accreditation Board for Testing and Calibration Laboratories

A typical table of contents should normally contain the following:

Section Contents Page