nabl 160 -guide preparing a quality manual.pdf

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NABL 160

NABL NATIONAL ACCREDITATIONBOARD FOR TESTING ANDCALIBRATION LA BORATORIES

GUIDE

r PREPARING

A QUALITY MANUAL

ISSUE NO. : 05 AMEN DM ENT NO : 00

ISSUE DATE: 27.06.2012 AMEN DM ENT DATE: --


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National Accreditation Board for Testing and Calibration LaboratoriesDoc. 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

Amendment Sheet

Sl PageNo.

ClauseNo.

Date of Amendment

Amendment made Reasons SignatureQO

SignatureDirector

1

2

3

4

5

6

7

8

9

10


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Contents

Sl. Content s Page No.

Amendment sheet 1Contents 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 244.4 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. Techn ic al Requi rements 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


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1. Introduct ion

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.


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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.


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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:

QualityManual

(Level A)

Management systemProcedures

(Level B)

Other quality documents(Work 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.


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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.


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3. Struct ure 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 .

Af te r these pages, shou ld place the sect ion on ‘Qua li ty Po li cy 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.


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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 br ie f explanation of these sect ions has been given be low. These

sections, should preferably be sequenced in the manner as given below:

Tit le

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 Authori sat ion

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 c ontents

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.


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Scope and f i e ld of appl icat ion

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 situati ons 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.

Defin i t ions

Al though it is recommended, when prac tica l, to use standard defin it ions

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 .

Abbrev iat ions

Whenever the abbreviations are used, its expanded form should be

defined in this section.


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Issue No: 05 Issue Date: 27.06.2012 Amend No: 00 Amend Date: -- Page No: 10 / 59

Distr ibut ion 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.

In t roduct ion

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 Manua l 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


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d Evidence of approval by those responsible for authorisation of the

contents of the Quality Manual.

Quali t y Pol icy and Object ives

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 th e 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.


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List of docu ments, record s and form s

Al l documents which are main ta ined 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 associateddocument.

Annex ure for support i ve informat ion

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

provided, it should be attached as an annexure at the end.

Page Foot er

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.


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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 :


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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 labor atory)

and is the property of

(name of the laboratory with address).

(Signature, Name & Designation)

Name of Laboratory:

Document No.: Document Name: Q u a l i t y M a n u a l

Issue No.: Issue Date: Copy No.: Section No. Page No.:

Amend No.: Amend Date Prepared by: Approved by: Issued by:


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AMENDMENT PAGE

An amendment page shou ld be inserted immed iate ly af ter the tit le page. Spec if ic

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 typica l amendment page should normal ly conta in the fo llowing:

AMENDMENT RECORD

Sl Page

No.

Section/ Clause/

Para/ line(as applicable)

Date of

Amendment

Amendment made Reasons of

Amendment

Signature of

person

authorising

Amendment

1.

2.

3.

4.

5.

6.

7.

8.

9.

10 .

Name of Laboratory:

Document No.: Document Name: Quality Manual




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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 typica l table of conten ts shou ld normally contain the fo llowing :

CONTENTS

Section Contents Page

Quality Manual release authorisation

Amendment sheet

Contents

Scope

References (if any)

Definitions (if any)

Abbreviations (if any)

Distribution List

Introduction (Brief description of the Laboratory & management system )

Quality Policy and Objectives

Management Requirements

Organisation

Management systemDocument 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:





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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 typica l dis tr ibution list shou ld norma lly contain the fo llowing:

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:





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4. Management Requirements

4.1 Organisat ion

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.


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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 responsibil ity and authority.


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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 Qual it y 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 ar rangements in the event of absence of key labora tory

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.


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4.2 Management Syst em

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 documenta tion

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 Quali t y Pol icy

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


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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 Documentat ion 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.


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4.2.6 Responsibi l i ty

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 responsibil it ies of key personnel are defined in Quality Manual and others

having different responsibil it ies 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.


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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 l ist 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 l ist or e quivalent document control procedure, which identif ies the

revision status and distribution.

Al l documents ge ne ra ted by th e la bo ra to ry shall be un iq ue ly ide nt if ied , wh ic h sh al l

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.

Responsibi l i ty

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.


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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.

Responsib i l i ty

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.


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4.4 Review of requests, tenders and c ontr acts

Policy

State the laboratory’s policy for the review of requests, tenders and

contracts including subcontracted work.

Responsibi l i ty

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 separatelyin 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 customeretc., during the execution of contract and during the amendment to the contract shall bemaintained.


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4.5 Subcontract ing of tests and cal ibrat ions

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.

Responsibi l i ty

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.


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4.6 Purchasing, services and sup pl ies

Policy

State the laboratory’s policy for purchasing, services and supplies which

affect the quality of test and/ or calibration.

Responsibi l i ty

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 br ie fly 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

identif ication, 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 verif ied for adequate quality).

Records


The records of evaluation of supplies of crit ical 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.


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4.7 Service to th e 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).

Responsibi l i ty

The person(s)/ position responsible for author ising the customers for theseservices, 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.


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4.8 Complaints

Policy

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

quality of services provided.

Responsibi l i ty

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.


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4.9 Control of nonconfo rming test ing and/ or cal ibrat ion 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.

Responsibi l i ty

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.


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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.

Responsibi l i ty

Designate the management persons(s)/ position responsible forimprovements shall be identified.

Procedure

Briefly outline the procedure of identification, implementation and

monitoring the improvements.



Records


Records of all improvements implemented shall be maintained.


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4.11 Correct ive act io n

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.

Responsibi l i ty

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.


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4.12 Prevent ive act io n

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.

Responsibi l i ty

The person(s)/ position responsible for taking preventive actions shall be

identified.

ProcedureBriefly 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 identif ication of potential sources of non-conformities, investigations carried

out, required improvements and preventive measures taken shall be maintained.


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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.

Responsibi l i ty

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 certif icate, 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.




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4.14 Internal Audi t

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.

Responsibi l i ty

State the person/ position responsible for planning, organising internal

audits and coordinating the corrective action.

Normally this activity is the responsibil ity 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.


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Records


The records of the activit ies covered; the audit f indings including the areas audited,

records verif ied, objective evidence gathered for verifying compliance with therequirements 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 verif ication and the effectiveness of the corrective action taken shall

be recorded.


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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 responsibil ity for running the laboratory, undertakes the management review.

The members of senior management having overall responsibil ity 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 recommendat ions for improvement

k other relevant factors, such as quality control activities, resources

and staff training.

Responsibi l i ty

State the person/ position responsible to convene the Management Review

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


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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

Make a reference to the document, where the records are maintained.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.


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5. Technic al Requi rements

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 samplingg 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 qualif ication of personnel and in the

selection and calibration of the equip ment it uses.


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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 Descr ip t ion

Provide job description of the laboratory staff which shall include atleast

the following:

a nameb 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.

Supervis ion 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 toperform a test and/ or calibration are allowed to perform only that test and/

or calibration independently.

Other staff members may only assist in per forming that test under close supervision of a

competent staff member.


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Train in g and Assessm ent 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 thepersonnel should also be described.

Also describe the evalua tion procedure fo r the ef fect iveness of the tra in ing

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 certif icate, to

give opinion and interpretations and to operate particular types of equipment. Also the

records of their educational & professional qualif ication, training, skil ls and experience

shall be maintained.


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5.3 Accommodat ion an d En vi ronmen tal Co ndi t ions

Policy

State the laboratory’s policy with respect to accommodation and

environments facilitate correct performance of the tests and/ or

calibrations.

Accommodat ion

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 Condit ions

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.


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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.


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5.4 Test and Calib rat ion Methods and method val idat ion

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 identif ication

b scope

c description of the type of item to be tested or calibrated

d parameters or quantit ies and ranges to be determined

e apparatus and equipment, including technical performance requirements


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f reference standards and reference materials required

g environmental condition required and any stabilization period needed

h description of the procedure, including

- affixing of identif ication 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 be fore 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 da ta to be rec ord ed an d me th od of an al ys is an d pre sent ati on

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 Specif i cat ions

State the laboratory’s policy for referring to latest standards as the basisfor test and/ or calibration methods, whenever possible.

List the relevant standard specifications on which the test and/ or

calibration procedures are based.


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Validat ion 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 scientif ic understanding of

the theoretical principals of the method and practical experience

f any other technique.

Est imat ion of Uncerta inty o f 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 certif icate

b method employed

c equipment used with reported uncertainty in the calibration certif icate

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 identifyall 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.


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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.


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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 cal ibrat ion 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.


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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 identif ication, and a serial number or other unique

identif ication

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 certif icates 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.


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5.6 Measurement Traceabi l i t y and Calib rat ion

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 ca li bra ti on ce rt i fi ca te be ar in g an ac cr ed it at ion bod y sy mbol fr om a ca li br at ion

laboratory accredited in accordance with ISO/IEC 17025:2005, for the calibration

concerned is sufficient evidence of traceability of the calibration data reported.

Calibr at ion 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 deta iled procedure for ca librat ion may be given in a separate document

and cross referred in the Quality Manual.


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The overall program of calibration and verif ication 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 bealternatively 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 certif icates in such cases indicate the traceability to National or

International standards of Measurement. The calibration certif icate shall also provide a

statement on the uncertainty of measurement and standards used with their valid

calibration, uncertainty & traceability.

Use of Reference Standard o f Measur ement

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.

Responsibi l i ty

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

calibration program shall be identified.


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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 l ike equipment name, calibration

status, date of the calibration and due date of next calibration.


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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 sa mpling shall be recorded. It shall atleast include sampling

procedure used. identif ication of the sampler, environmental conditions (if relevant),

diagrams to identify the sampling location and if appropriate, statistics principles upon

which the sampling is based.


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5.8 Handl ing o f Cal ibr at ion and Test i tems

Policy

State laboratory’s policy with respect to the handling of test and/ or

calibration items to protect the integr ity 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/ Cal ibr at ion i tem ident i f i cat ion

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