nabl 001 quality manul

NABL 001

NABL

NATIONAL ACCREDITATION BOARD FOR TESTING AND CALIBRATION LABORATORIES

Quality Manual

ISSUE NO : 09 ISSUE DATE: 01.09.2008

AMENDMENT NO : 00 AMENDMENT DATE: --

AMENDMENT SHEET Sl no

Page No.

Clause No.

Date of Amendment

Amendment made

Reasons

Signature QM

Signature Director

1 2 3 4 5 6 7 8 9 10

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PREAMBLE Conformity Assessment is defined in ISO/IEC 17000:2004, Conformity assessment -Vocabulary and general principles, as: "Demonstration that specified requirements relating to a product, process, system, person or body are fulfilled."

Conformity assessment procedures provide a means of ensuring that the products, services, or systems produced or operated have the required characteristics, and that these characteristics are consistent from product to product, service to service, or system to system. Conformity assessment provides benefits for manufacturers and service providers, consumers and government regulators, as well as for international trade in general.

Testing is one of the most common forms of conformity assessment and is also one of the most essential ones. Testing if used as a generic term includes activities like Sampling, Testing, Measurement and Calibration.

The liberalization of trade and industry policies of the Government of India has created quality consciousness in domestic trade and provided greater thrust for export. As a consequence testing centres and laboratories have to demonstrably operate at an internationally acceptable level of competence. The general requirements for laboratories or other organizations, to be considered competent to carry out sampling, testing (other than medical) and calibration are specified in the International Standard ISO/IEC 17025:2005.

Another very important area under testing, which plays a vital role in human health and safety, is medical / clinical diagnostic testing. The general requirements for laboratories to be considered competent to carry out sampling and testing in medical field are specified in the International Standard ISO 15189:2007. Accreditation bodies for laboratories thus play a pivotal role in formal recognition of technical competence of laboratories by providing accreditation to this international standard. National Accreditation Board for Testing and Calibration Laboratories (NABL) has been established to provide accreditation services to laboratories in an impartial and nondiscriminatory manner.

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For the accreditation process to be effective and internationally recognised, the accreditation bodies are required to design and operate their systems and processes in line with requirements of ISO/IEC 17011:2004 “Conformity Assessment – General requirement for accreditation bodies accrediting conformity assessment bodies”.

The Quality Manual provides information on management system established for NABL. The management system is based on requirements of ISO/IEC 17011:2004.

The NABL Quality

Manual is a dynamic document in the sense that it will undergo amendments in response to requirements of continuous improvement based on feedback received from any of the interested parties (stake holders).

Dr B. Hari Gopal Director, NABL

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CONTENTS Sl.

Page No.

Title Amendment Sheet

1

Preamble

2

Contents

4

Distribution list

6

Quality Policy

7

1

Scope

8

2

Normative references

9

3

Terms and Definitions

11

4

Accreditation Body

4.1

Legal Responsibility

12

4.2

Structure

12

4.3

Impartiality

16

4.4

Confidentiality

19

4.5

Liability and financing

19

4.6

Accreditation activity

20

5

Management

5.1

General

22

5.2

Management system

22

5.3

Document control

24

5.4

Records

25

5.5

Non-conformities and corrective actions

26

5.6

Preventive actions

26

5.7

Internal audits

26

5.8

Management reviews

27

5.9

Complaints

28

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Sl.

Title

Page No.

6

Human resources

6.1

Personnel associated with the accreditation body

29

6.2

Personnel involved in the accreditation process

30

6.3

Monitoring

32

6.4

Personnel records

34

7

Accreditation process

7.1

Accreditation criteria and information

35

7.2

Application for accreditation

36

7.3

Resource review

37

7.4

Subcontracting the assessment

37

7.5

Preparation for assessment

37

7.6

Document and record review

39

7.7

On-site assessment

40

7.8

Analysis of findings and assessment report

40

7.9

Decision-making and granting accreditation

41

7.10

Appeals

42

7.11

Reassessment and surveillance

43

7.12

Extending accreditation

44

7.13

Suspending, withdrawing or reducing accreditation

44

7.14

Records on CABs

44

7.15

Proficiency testing and other comparisons for laboratories

45

8

Responsibilities of the accreditation body and the CAB

8.1

Obligations of the CAB

46

8.2

Obligations of the accreditation body

46

8.3

Reference to accreditation and use of symbols

48

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DISTRIBUTION LIST The Quality Manual is available on NABL LAN to all NABL officers and support staff. A hard copy of the Quality Manual is maintained with the Quality Officer.

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QUALITY POLICY National Accreditation Board for Testing and Calibration Laboratories (NABL) is committed to promote, coordinate, guide, implement and maintain an accreditation system for testing, calibration and medical laboratories suitable for India in accordance with the relevant national and international standards and guides.

NABL maintains a management system in accordance with ISO/IEC 17011:2004 and that its accredited testing and calibration laboratories implements ISO/IEC 17025:2005 and medical laboratories implements ISO 15189:2007.

NABL complies with the requirements of International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Laboratory Accreditation Cooperation (APLAC) for maintaining obligations as a signatory to Mutual Recognition Arrangements (MRAs). NABL shall also maintain strong linkages with ILAC & APLAC to keep pace with the latest developments and implement them.

NABL ensures that the policies are documented, communicated, implemented and are effective at all levels.

This policy and the management system carry the endorsement and full support of the Governing Body of NABL.

Dr. T. Ramsami Chairman, NABL & Secretary Department of Science and Technology

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1

SCOPE

National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to the Testing and Calibration laboratories operating their management system as per ISO/IEC 17025:2005 and to Medical laboratories as per ISO 15189:2007, for the disciplines / fields listed in NABL-100. NABL operates its management system based on ISO/IEC 17011:2004 ‘Conformity assessment – General requirement for accreditation bodies accrediting conforming assessment bodies’. This document addresses requirements contained in ISO/IEC 17011:2004, as relevant to the fields of testing, calibration and medical.

This document includes the relevant requirements of APLAC MR001 ‘Establishing and Maintaining Mutual Recognition Arrangements between accreditation bodies’ and other mandatory documents of APLAC and ILAC, essential for the peer evaluation process and to maintain Mutual Recognition Arrangements (MRAs).

A list of normative references is given in the next page. In this document, the clause numbers as in ISO/IEC 17011:2004 are maintained.

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2

NORMATIVE REFERENCES In the policies described in this Quality Manual and the procedures and work instructions given in the related Procedure Manual and Assessors’ Guide, due consideration has been given to the following international standards and guides : •

ISO/IEC 17011:2004 – Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies

•

ISO/IEC 17025:2005 – General requirements for the competence of testing and

•

calibration laboratories ISO 15189:2007 ‘Medical laboratories – Particular requirement for quality and competence’

•

ISO/IEC Guide 43-1:1997 – Proficiency Testing by Interlaboratory comparisons Part 1: Development and operation of Proficiency Testing schemes

•

ISO/IEC Guide 43-2:1997 – Proficiency Testing by Interlaboratory comparisons Part 2: Selection and use of Proficiency Testing schemes by laboratory accreditation bodies

•

ISO 19011:2002 – Guidelines for quality and/or environmental management systems auditing

•

ISO/IEC 17000:2004 Conformity assessment - Vocabulary and General principles

•

ISO 9000:2000 Quality management systems - Fundamentals and vocabulary

•

VIM:1993 International vocabulary of basic and general terms in metrology, issued

by BIPM, IEC, IFCC, ISO, IUPAC, IUPAP and OIML

•

APLAC MR001 – Establishing and Maintaining Mutual Recognition Arrangements between accreditation bodies

•

APLAC MR002 – Asia Pacific Laboratory Accreditation Cooperation Mutual Recognition Arrangement (MRA) text

•

APLAC TR001 – Guidelines on Training Course for Assessors’

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•

IAF/ILAC A2:05/2007 – IAF/ILAC MRAs: Requirements for Evaluation of a Single Accreditation Body

•

ILAC G3:1994 – Guidelines for Training Courses for Assessors used by Laboratory Accreditation Schemes’

•

ILAC G21::2002 – Cross Frontier Accreditation – Principles for Avoiding Duplication

•

ILAC P1:2007 – ILAC Mutual Recognition Arrangement: Requirements for Evaluation of Accreditation Bodies by ILAC-recognized Regional Cooperations

•

ILAC P8:2006 – ILAC Mutual Recognition Arrangement: Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for claims of Accreditation Status by Accredited Laboratories

•

ILAC P9:2005 – ILAC Policy for Participation in National and International Proficiency Testing Activities

•

ILAC P10:2002 – ILAC Policy on Traceability of Measurement Results

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3

TERMS AND DEFINITIONS For the purposes of this quality manual, the terms and definitions given in ISO/IEC 17000 will apply. Where the terms and definitions are neither included in ISO/IEC 17011 nor in ISO/IEC 17000, the terms and definitions of ISO 9000 or VIM apply.

If different definitions for specific metrological terms are given, the definitions of VIM will be preferred.

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4

ACCREDITATION BODY

4.1

Legal Responsibility NABL is a registered society under the Societies Act thus having its own legal identity. It operates as an autonomous body under the aegis of in the Department of Science and Technology (DST), Ministry of Science and Technology, Government of India.

4.2

Structure A schematic diagram of organizational structure of NABL is given below. The organisation structure of NABL has been appropriately designed to meet the requirements of operating a laboratory accreditation system, which can generate confidence in its activities.

Governing Body / Chairman NABL

Technical Committees

Director NABL Accreditation Comm - Testing Training Committee Accreditation Comm - Calibration

Technical Operations Manager CPAIC Committee

Accreditation Comm - Medical

Appeals Committee

Registrar (Fin. & Admn)

Quality Officer

Group I Chem+Mech Testing

PT Officers

Group II Chem+Bio & Forensic Testing

Certificate Co-ord Officer

Group III Mechanical Testing & Calibration

Complaints & Appeals Officer

Group IV Elect+Electronics Testing & Calibration

Group V Medical Testing

Training Officers

Assessors

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4.2.1

The apex body in NABL organization is the NABL Governing Body. In keeping with Rules & Regulations and orders of NABL, the Governing Body has the responsibility for providing policy guidelines and direction; overall administration, management and controls for the operations of NABL. Since its inception in 1998, Chairman of NABL Governing Body has been the Secretary of the Department of Science and Technology (DST), the parent organization for NABL. Financial Adviser of DST and Director of NABL are ex-officio members of the Governing Body. Remaining members are drawn from the National Metrological Institutes, National Standards bodies, major laboratory groups, important regulatory agencies, Industry Associations, Private Bodies, etc, as applicable.

The Governing Body is appointed by the Parent organization in the Government in accordance with the Memorandum of Association of NABL. NABL has documented its management system in accordance with the requirements of ISO/IEC 17011:2004.

NABL Secretariat comprises of Director, Technical Operations Manager, Quality Officer, PT Officer, Training Officer, Complaints & Appeals Officer, Accreditation Officers and support staff. The Director, NABL is responsible for administering and managing the NABL Secretariat and reports to the Chairman, NABL Governing Body. The responsibility for day to day operations of NABL rests with Technical Operations Manager, NABL who reports to Director, NABL. All the officers and support staff are full time employees of NABL. The officers have requisite academic qualifications, knowledge and experience in laboratory operations as well as in accreditation processes. The Finance & Administrative functions are supported by Registrar (F&A).

NABL operates its accreditation process through empanelled Lead Assessors and Technical Assessors covering all fields as specified in the scope of NABL. All Lead Assessor and Technical Assessors are personnel having considerable experience in laboratory activities. They are trained by NABL as per the relevant international criteria and subsequently empanelled as Lead Assessors / Technical assessors through contractual agreements.

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Recommendations of Accreditation Committees form the basis for accreditation decisions. Membership of accreditation committees is drawn from divisional heads of NMI’s, Standard Bodies, the experienced assessors (including those from accredited laboratories), academic institutions, important professional bodies, regulatory agencies / bodies etc. The members of the Accreditation Committees are selected on the basis of their technical knowledge and familiarity with accreditation process. However care is taken while selecting composition of an Accreditation Committee that expertise in all areas covered under the committee is available and no single group or organization predominates the committee.

The field specific technical inputs for formulation of specific guidelines and other similar tasks, is derived from various ad-hoc / permanent technical committees set up for the purpose. Composition of Technical committee is mainly driven by the purpose for which the committee is set up. For multi-disciplinary fields or in areas where two or more fields overlap, care is taken to include members from relevant fields so that a balanced view emerges. Committee members are drawn from different organizations that form the spectrum of interested parties.

4.2.2

The Governing Body of NABL has the overall authority and responsibility for decisions relating to accreditation, including the granting, maintaining, extending, reducing, suspending and withdrawing of accreditation. Chairman, NABL on behalf of the Governing Body is responsible for certain functions like taking decisions on accreditation and certain other functions defined from time to time. Director, NABL acts as the member secretary for the Governing Body.

4.2.3

NABL is a society, registered under the Societies Registration Act. It operates as an autonomous body under the aegis of in the Department of Science and Technology (DST), Ministry of Science and Technology, Government of India.

4.2.4

NABL Governing Body, vested with the necessary authority, constitutes the top management. The Director NABL is responsible for administering and managing the NABL Secretariat.

The responsibility for day to day operations of NABL rests with

Technical Operations Manager, NABL. The duties, responsibilities and authorities of top management is documented in NABL 004 ‘Rules and Regulations of NABL’; for NABL staff it is documented in NABL 015; for Accreditation Committee members it is documented in NABL 011; for Assessors it is documented in NABL 210.

4.2.5

The overall authority and responsibility of major functionaries of NABL are: a.

Development of policies relating to the

Governing Body / Chairman,

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b. c. d.

operation of the accreditation body

NABL

Supervision of the implementation of the

Director NABL and Technical

policies and procedures

Operations Manager, NABL

Supervision of the finances of the

Director, NABL and

accreditation body

Registrar, NABL

Decisions on accreditation

Chairman, NABL on behalf of the Governing Body

e.

Contractual arrangements

Director NABL or an officer authorised by Governing Body

f.

4.2.6

Delegation of authority to committees or

Governing Body / Chairman,

individuals, as required, to undertake defined

NABL on behalf of Governing

activities on behalf of top management

Body

NABL has access to expertise for advising on matters related to accreditation through the following committees: 

Accreditation Committees: These are standing Committees, responsible for the evaluation of the initial assessment and re-assessment reports and make necessary recommendations regarding accreditation. Accreditation Committees may make policy recommendations on issues related to accreditation for the consideration of NABL Governing Body and if required provide advice on matters related to complaints and appeals.



Technical Committees: These are ad-hoc / permanent committees, constituted to assist in interpretation and/or formulation of specific criteria and general guideline documents.

The Technical Committee shall also be constituted to

advise NABL for evolving new programs. 

Appeals Committee: It is a committee set up specifically for dealing with appeals against the decisions of NABL.

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4.2.7

NABL has documented procedures for appointment of the above committees, which also include details about terms of reference and operation of these Committees. For Accreditation Committees these are addressed in NABL 011, for technical committees these are addressed in NABL 003.

4.2.8

The Organisation structure of NABL showing lines of authority and responsibility is defined in 4.2.1 of this document.

4.3

Impartiality

4.3.1

NABL has formulated its policy and procedures in a manner to safe guard the objectivity and impartiality of its activities, at all levels. All personnel involved in the accreditation process are required to sign a statement of impartiality. The formats for these statements are covered in Form 74 for Assessors, Form 75 for NABL officers and staff and Form 76 for Committee members.

4.3.2

NABL Committees comprise of members selected on the basis of their necessary technical competence, knowledge of principles and processes of accreditation, in a manner so as to maximise the uniformity of interpretation and impartiality of judgment and to maintain the balance of interest. Various committees of NABL have members from National Metrological Institute, National Standards bodies, Regulatory bodies, Government departments, accredited laboratories, users of laboratories, individuals who are technical experts in their own field, etc. The committees have been constituted in such a way that no single group dominates the decision making process.

4.3.3

As the sole national body for laboratory accreditation in India, NABL renders accreditation services in a non-discriminatory manner. These services are accessible to all applicant laboratories, irrespective of their size, legal status, ownership and degree of independence, membership of any association / group or the number of laboratories already accredited in a particular field.

On receipt of completed application, the accreditation process is initiated for all the laboratories whose scopes of operation fall under the disciplines covered by NABL. A uniform fee structure is maintained for all laboratories and the charges are maintained at a reasonable level so that laboratories are not denied participation in the accreditation process.

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4.3.4

All NABL officers and staff are governed by established professional ethical norms ensuring their impartiality in the discharge of assigned duties. They are required to sign a statement of impartiality in Form 75.

The Assessors are trained in the Assessor training course to act objectively and be impartial in conducting the assessments. They are required to enter in to an agreement with NABL by inking their signatures in NABL 230 ‘Contract between NABL and Asessors’, which includes a commitment to abide by terms and conditions of NABL and for maintaining impartiality. The Assessors are also required to sign a statement of impartiality and confidentiality in form 74 for each assessment undertaken by them.

Due care is taken while constituting the Accreditation Committees, to avoid situations of undue commercial, financial or other pressures on the members which would compromise impartiality. As a confirmation of their commitment, all Committee members are required to sign a declaration of impartiality and confidentiality in Form 76, while accepting the membership of the Committee. While doing so they are also required to declare any interest in any testing and/or calibration laboratory in any capacity e.g. shareholder, director, consultant, ex-employee etc. If a member of a committee is in any way connected with the laboratory under consideration, he/she is not involved in discussions and recommendation related to that laboratory.

4.3.5

The recommendations by the accreditation committee form the basis for accreditation decision by the Chairman, NABL. The members of the Accreditation Committee are selected on the basis of their necessary technical competence, knowledge of principles and processes of accreditation past performance as Assessors or Committee members.

If a member had been an assessor to a laboratory under consideration, he/she is required to inform the Chairman of the Committee and not participate in the decision making of that laboratory.

4.3.6

NABL neither has a laboratory nor offer any consultancy services for Laboratory Accreditation. Also, NABL does not recommend any person or consultant to its clients for accreditation services.

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4.3.7

All the government departments; laboratories, scientific institutions and training institutions operating under the aegis of various government departments, ministries, etc, could be considered as related bodies to NABL. However none of them have same top management as NABL for performing activities given under clause 4.2.5 of ISO/IEC 17011:2004. They also have distinctly different names and logos. Hence there is no likelihood of potential conflict of interest situations.

Relationships with related bodies who are involved in some of the policy making functions of NABL through membership on NABL governing body, etc, are given below, which clearly establish the absence of potential conflict of interest situations.

The National Metrological Institutes namely National Physical Laboratory (NPL-India) and Bhabha Atomic Research Centre are governmental entities like NABL. However they belong to different government departments distinct from the government department which is the parent body for NABL. The Indian NMIs are not accredited by NABL. NPL in collaboration with NABL offers training programs and proficiency testing programs to calibration laboratories (accredited and applicant). NPL does not undertake these activities on commercial basis. These are complementary activities without any potential for conflict of interest. NPL also provides calibration services to laboratories.

These services are mostly geared towards providing traceability to the national NMI. Though NPL levies charges for this service, these are not at commercial rates and Bhabha Atomic Research Centre is primarily a research organization that provides traceability for radiological measurements.

The Standards Bodies, the Bureau of Indian Standards (BIS) under the Ministry of Consumer Affairs & Public Distribution and Standardization Testing and Quality Certification (STQC) under the Ministry of Information Technology have distinctly different top managements and belong to different ministries of the Government. Both BIS and STQC operate testing / calibration laboratories that are accredited by NABL. Members of the NABL Governing Body drawn from these organizations are not directly involved in day-to-day operations of the laboratories operated by the standards bodies and accredited by NABL. Members of NABL Accreditation Committees drawn from these organizations are experts in their fields and they do not participate in accreditation decision making related to laboratories of their parent organization.

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Quality Council of India (QCI) is a separate legal identity.

QCI functions under a

separate Ministry i.e. Department of Industrial Policy and Promotion, Ministry of Commerce. Both NABL and QCI have different Governing Bodies.

QCI provides accreditation to Certification Bodies, Hospital Accreditation and other accreditation activities. There is no overlap with NABL activities. There are few NABL Assessors which are used by QCI for Hospital Accreditation, which is based on National Standards. To maintain the confidentiality, impartiality and to avoid the situation of potential conflict of interest, the NABL Assessors sign a statement.

4.4

Confidentiality NABL management system is documented and implemented in a manner to ensure confidentiality of information related to accreditation activities, at all levels. All documents, correspondence related to the accreditation matters are kept confidential.

All physical records are kept in safe custody and computer records are accessible to NABL Secretariat only and are password protected.

The Assessors, the Accreditation Committee members and NABL officers & support staff are bound by a commitment to maintain confidentiality, through signed statements (in Form 74, 76 and 75 respectively).

As a matter of policy, the information about any laboratory acquired during the course accreditation process is not disclosed to any one by NABL without the written consent of the laboratory except when required by the APLAC / ILAC Evaluators, Government or Law.

4.5

Liability and financing

4.5.1

The liabilities of NABL may arise due to legal proceedings initiated by accredited laboratories, users of accredited laboratories, consumer associations or through contractual liabilities. In all such cases NABL seeks advice from appropriate and competent legal consultants. NABL has obtained an insurance liability policy to cover the financial liability arising out of legal proceedings.

4.5.2

The financial requirements of NABL are met from the following sources: i

Financial support provided by Department of Science & Technology, Government of India. The description is given in the DST’s annual grant-in-aid publication.

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ii

The earning from the Accreditation services in terms of application fees, annual

accreditation fees etc The specific heads under which NABL’s income is received is given in NABL’s Annual Report.

4.6

Accreditation activity

4.6.1

NABL provides laboratory accreditation services to testing and calibration laboratories operating their Management systems in accordance with ISO/IEC 17025:2005 ‘General requirements of competence of testing and calibration laboratories’. NABL also provides accreditation to medical laboratories operating their Management systems in accordance with ISO 15189:2007 ‘Medical Laboratory – Particular requirements for Quality and Competence‘. The sub-fields and major groups under these accreditation are also listed in NABL 100. For providing these accreditation services to laboratories, NABL operates its management system in accordance with the requirements of ISO/IEC 17011:2004. The relevant requirements of

APLAC MR001 ‘Establishing and

Maintaining Mutual Recognition Arrangements between accreditation bodies’ essential for the peer evaluation process for mutual recognition arrangements (MRA) between accreditation bodies” have also been incorporated suitably in the management system of NABL. As a necessary supplement to the accreditation criteria documents ISO/IEC 17025:2005 and ISO 15189:2007, NABL has published field /discipline specific criteria and other guidance documents for various fields /disciplines of testing, calibration and medical for which accreditation is provided by NABL. These contain additional requirements for specific fields of testing and provide explanation of the clauses of ISO/IEC 17025 or ISO 15189 wherever relevant, for avoiding differing interpretations of the same by users. The laboratories applying under specific field(s) / discipline(s) are also required to comply with the requirements of the Specific Criteria document of relevant field(s) / discipline(s).

4.6.2

The Specific Criteria / guidance documents are drafted by the technical committee(s) which are constituted field / discipline wise and experts of the major groups of a field are represented in the committee. The members of the committee are selected on the basis of their necessary technical competence in the specific field under review and knowledge of accreditation process, with appropriate participation of interested parties.

NABL also makes use of application and guidance documents published by International bodies like, ILAC, APLAC, EURACHEM, EA, etc, where appropriate, by adopting the same or using them as a basis for formulating its own documents.

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4.6.3

NABL has a policy of constantly endeavoring to extend its activities and field /disciplines of testing, calibration and medical. The work of extension is taken up after consideration of requests from interested parties including regulatory and other Government bodies or as a part of planned expansion of its activities in other emerging fields /disciplines of testing, calibration and medical. The detailed procedure is covered in NABL 021.

NABL also provides accreditation services to laboratories, outside India and follow ILAC G21:2002 ‘Cross Frontier Accreditation – Principles for Avoiding Duplication’.

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5

MANAGEMENT

5.1

General

5.1.1

NABL has established, implemented and maintains a management system suitable for laboratory accreditation system in conformity with ISO/IEC 17011:2004 and the same is detailed in the Quality Manual and its supporting documents. Inputs received from monthly review meetings, internal audits and management reviews and internal and external feedbacks are utilized for continually improving effectiveness of the management system.

5.1.2

NABL has documented, implemented and maintained the management system conforming to the requirements of ISO/IEC 17011:2004. The documented system comprises of : 

A Quality Manual, which defines NABL’s policies with respect to various requirements of ISO/IEC 17011:2004. It also includes brief description about all the clauses and where relevant makes suitable references to the specific procedures.



The Procedures / Procedure Manuals describe how an activity is actually performed. These documents support the Quality Manual in implementation and maintenance of the management system. They also contain or refer to relevant record formats.



Documents on Specific Criteria for accreditation, guidance documents which provide the interpretation and other documents, as referred in this Quality Manual.

5.2

Management system

5.2.1

NABL’s Top management has defined and documented the Quality Policy which is included in the beginning of this document.

The overall quality objectives of NABL have been defined as given below, which also take care of the needs of interested parties and are consistent with NABL policies. These objectives form the basis for defining measurable quality objectives during the management review and are subject to periodic review and monitoring. These also become the tool and the basis for continually improving the effectiveness of the management system.

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The objectives that are consistent with the policies of NABL are listed below: i.

To promote implement and maintain an accreditation system for laboratories in accordance with the relevant national and international standards, suitable for the country and responsive to changing needs,

ii.

To provide timely accreditation services to accredited and applicant laboratories.

iii.

To organize awareness programs on all aspects of laboratory accreditation by various means including seminars, workshops, laboratory-industry-accreditation body meets etc.

iv.

To prepare and maintain database of assessors and experts in different disciplines of calibration and testing and undertake regular monitoring of assessors.

v.

To undertake appropriate training programs in support of laboratory accreditation and related activities and for their improvement, like training of assessors, accreditation officers, etc.

vi.

To develop and operate mechanisms to deal with complaints as well as appeals against NABL decisions on accreditation

vii.

To establish and maintain linkages with international and regional bodies such as International Laboratory Accreditation Cooperation (ILAC), Asia Pacific Laboratory Accreditation Cooperation, etc, through active participation in various meetings and activities of such bodies

viii.

To undertake all the activities that shall promote bilateral / multilateral (mutual) Recognition Arrangements between NABL and accreditation bodies in other countries for wider acceptance of test results of NABL accredited laboratories

The policies and objectives in respect of various requirements of ISO/IEC 17011:2004 are covered in the respective sections of the Quality Manual. These Policies are defined in such a manner that they provide commitment to quality and comply with ISO/IEC 17011:2004.

The quality policy and objectives are made available to NABL secretariat. The Policy aims and objectives are informed and made understood, to all persons in NABL for implementation and continued compliance.

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NABL ensures that effective communication takes place for the needs of the interested parties by :  providing information on its website and through newsletter  answering queries on time  conducting training programs, seminars, awareness campaign, etc.  reviewing and monitoring of quality objectives based on feedbacks 5.2.2

NABL operates a management system meeting the requirements of ISO/IEC 17011 for laboratory accreditation covering fields/disciplines as given in NABL 100.

NABL has adequate resources to cater to the volume of work as detailed in 6.1.1 of this document.

The requirements of ISO/IEC 17011 are addressed in the NABL 001 ‘Quality Manual’, and associated NABL documents, as provided in NABL 200 ‘Master List of documents’.

All NABL documents are available on NABL LAN system, accessible to all NABL officers for implementation in their areas of work. During the internal review meetings the work progress and effectiveness of implementation of NABL processes is monitored.

5.2.3

The Chairman NABL, on behalf of the NABL Governing Body, appoints a member of NABL management, as Technical Operations Manager. The Technical Operations Manager, irrespective of his/her other responsibilities, has the responsibility and authority that includes : a) establishment of procedures needed for the management system. b) reporting to the Chairman, Governing Body on the performance of management system and any need for improvement.

5.3

Document control NABL has a system of controlling all internal and external documents that relates to its accreditation activity. The control system includes the following: i)

All internally generated documents that form part of NABL Quality Management System are reviewed for adequacy and approved by authorized personnel before release. For external origin documents the controls pertain to their updation and controlled release.

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ii) Documents are periodically reviewed and when necessary updated/revised to ensure continuing suitability and compliance of the system. iii) Changes to document are reviewed and approved by the same function that performs the original review, unless specifically designated. iv) The Master list of all controlled documents is used to identify the current revision status of documents to preclude the use of invalid and /or obsolete document. v) It is ensured that relevant editions of documents are available at the point of use (accreditation officers, assessors, laboratories, etc) for effective functioning. For NABL secretariat, the documents are available in LAN and for others the documents are available at NABL web site <www.nabl-india.org>. vi) All documents forming part of management system are kept in legible condition and are uniquely identified. vii) Controls are maintained by providing limited / restricted accessibility to safeguard the confidentiality of documents.

The detailed procedure of document control has been documented vide NABL 012.

5.4

Records

5.4.1

NABL has a system of maintaining the records, wherever these records are required to be maintained in compliance with the requirements of ISO/IEC 17011 and also where they are required as an objective evidence of compliance to a procedure. The procedure for identification, collection, indexing, accessing, filing, storage, maintenance, and disposal of records has been documented vide NABL 012.

5.4.2

Retention period of different types of records is defined in NABL 012. These records are stored in safe custody at appropriate places and accessible to authorised staff of NABL. The obsolete records are disposed of by shredding or tearing. The access to the computer records on LAN is password protected.

The detailed procedure for Control of records has been documented in NABL 012.

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5.5

Non-conformities and corrective actions NABL has established procedures for the identification and management of nonconformities in the operation of laboratory accreditation system. These could be identified through internal / external audits, feedbacks from laboratories, user of laboratories, assessors, accreditation committee members, regulators, complaint investigations etc. The procedure ensures that the non-conforming work is corrected and the cause of nonconformity is determined. To eliminate the causes of non-conformities and to prevent recurrence, appropriate corrective actions are taken, in a timely manner. If required, the effectiveness of the corrective action taken is reviewed. A record of all non-conformities and corrective action taken is maintained.

The trends in non-conformities and the status of corrective actions are reported in the management review meetings. The detailed procedure is addressed in NABL 012.

5.6

Preventive actions NABL has established procedure to identify opportunities for improvement and to take preventive actions to eliminate the causes of potential non-conformities. The procedure includes the sources for identification of areas for implementing preventing action, collection and analysis of data, trend / risk analysis based on which an action plan is drawn for implementation. The information sources for preventive action could include, but not restricted to: the feedbacks from laboratories, assessors, accreditation committee members, users of laboratories, staff of NABL, APLAC, ILAC and other accreditation bodies.

A record of preventive action taken is maintained. The effectiveness of the preventive action taken is reviewed. The status of preventive action taken is reported in the management review meetings. The procedure is addressed in NABL 012.

5.7

Internal audits

5.7.1

NABL has system of conducting periodic internal audits to verify that its management systems and the accreditation activities conform to the requirements of ISO/IEC 17011:2004, APLAC MR001, ILAC P1, ILAC P9, IAF/ILAC A2 and NABL 001 that the management system is implemented & maintained. The procedure is detailed in NABL 012.

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5.7.2

The internal audits are normally conducted once in a year covering all the elements of the Standard ISO/IEC 17011:2004. An audit program is planned taking into consideration the importance of the processes and areas to be audited. The effectiveness of the corrective actions on the non-conformities of the previous audits is also reviewed. The Quality Officer is responsible for the internal audit process.

5.7.3

NABL Internal audit procedures and planning ensure that audits are conducted by qualified personnel different from those who perform the activity to be audited and are knowledgeable in accreditation processes, audit techniques and requirements of ISO/IEC 17011:2004.

The outcome of the audit is formally informed to all concerned personnel responsible for the area audited vide the audit report for their timely and appropriate action. The audit report also includes information on opportunities for improvement, if identified.

The progress of the corrective actions taken is reviewed by the Quality Officer, NABL. The analysis of results of internal audit, trends, major corrective actions, etc are reported to the Technical Operations Manager.

5.8

Management Reviews

5.8.1

NABL has a procedure for review of NABL management system at a periodicity of at least once a year, to ensure its continued adequacy and effectiveness in satisfying the requirements of the Standard ISO/IEC 17011, APLAC MR001, ILAC P1, ILAC P9, IAF/ILAC A2 and NABL 001. The detailed procedure is documented in NABL 012.

5.8.2

As per the procedure Chairman, NABL conducts the management review of the NABL management system covering all the input elements as described in ISO/IEC 17011. The review includes current performance and improvement opportunity, where available, for the review elements identified.

5.8.3

The resolutions / actions for implementation arising out of management review shall include: a) improvement of the management system and its processes / services, b) accreditation processes in conformity with relevant accreditation standards and expectations of interested parties, c) defining or re-defining or the policies, goals and objective,

d) requirement of additional resources.

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5.9

Complaints NABL is open to receiving complaints for any of the activities performed by its officials, assessors and the accredited laboratories. The laboratory and the assessors are informed about this policy. All complaints are acknowledged and after investigations, the complainant is informed about the outcome of the complaint.

All complaints and the action taken are recorded. The procedures for dealing with complaints has been documented vide NABL 132. The procedure includes system of establishing validity of the complaint, taking appropriate actions and assessing their effectiveness, suitable correspondence with all the parties involved including the complainant.

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6

HUMAN RESOURCES

6.1

Personnel associated with the accreditation body

6.1.1

NABL Secretariat, comprising of Director, Technical Operations Manager, Quality Officer, PT Officer, Training Officer, Complaints & Appeals Officer, Registrar (Finance & Administration), Accreditation Officers and support staff, are involved in the accreditation activities of NABL. All the officers and support staff are full time employees of NABL. The Officers have requisite academic qualifications, knowledge and experience in laboratory operations as well as in accreditation procedures. The Director, NABL is responsible for administering and managing the NABL Secretariat and reports to the Secretary, Department of Science and Technology, Government of India, who is also the Chairman of NABL. A job profile of all NABL officers and support staff is available in the personnel records.

6.1.2

NABL has empanelled Lead Assessors and Technical Assessors for all fields / disciplines covered in the scope of NABL. All Lead Assessor and Technical Assessors have vast experience in the Laboratory or any related activity and are empanelled through a contractual agreement. In case of new and emerging areas, NABL has access to other experts from laboratories or industry or related organizations, both national and international.

6.1.3

The duties and responsibilities of: i NABL Staff are documented in NABL 015 ii Assessors are documented in NABL 210 iii Accreditation committee members are documented in NABL 011 The authorities are documented at relevant places alongwith the activity.

6.1.4

All NABL employees are required to sign a statement for maintaining confidentiality and impartiality which includes independence from commercial and other interest or any association with laboratories, etc. at the time of their appointment.

All Accreditation Committee members are required to sign a statement of confidentiality and impartiality at the time of their nomination.

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All Lead Assessors and Technical Assessors are required to sign a contract with NABL in document NABL 230, which specifies the terms and conditions of their empanelment.

The contract contains a declaration in respect of independence and impartiality, as well as a confidentiality statement.

Also all assessors are required to sign form 74, a statement on confidentiality, impartiality and integrity for every assessment carried out by them. The technical experts and observers also sign form 74 for each assessment.

6.2

Personnel involved in the accreditation process

6.2.1

NABL selects its Employees, Assessors and Accreditation Committee members for the operation of its accreditation system based on their qualification, experience and competence. The details are given below: NABL Staff The selection of NABL Accreditation Staff is made based on the requirement. The minimum entry level for officers is Trainee Accreditation Officer/ Program Associate. The qualification required is masterâ&#x20AC;&#x2122;s degree in science or bachelorâ&#x20AC;&#x2122;s degree in engineering or technology with minimum two years of relevant work experience in a laboratory / industry. The next level is Accreditation Officer. The qualification will remain same and the experience will be 5 years.

The newly appointed Accreditation Officers / Trainee Accreditation Officers / Program Associates work under the guidance of experienced Accreditation Officer for 1 year and within this period he/she is required to qualify the Assessor training course organised by NABL. After 1 year they work independently. Senior officers appointed are given orientation by the Technical Operations Manager before the responsibility is assigned to them.

Further all Accreditation Officers are required to qualify refresher courses when the laboratory standard is revised. Training programs are organized by NABL for its accreditation officers in specific fields based on requirements. The Officers are also encouraged to attend training courses conducted by reputed national and international organisations.

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NABL Assessors The minimum qualification requirements for assessors is a Bachelor’s degree in Engineering or a Master’s degree in science and a minimum of five years working experience in the relevant field of testing / calibration, at supervisory level and above.

The Assessors for medical laboratories are required to be postgraduate in medical fields or Ph.D. in scientific fields.

Further the potential Assessors are required to qualify the NABL Assessor Training Course. The course material is based on APLAC & ILAC guidelines. Subsequently the Assessors are required to attend refresher courses as and when the laboratory standard is revised. When required assessors are provided training to upgrade their technical skills. Details are given in NABL 013.

Accreditation Committee members The desired qualification requirements for the members of Accreditation Committee are a minimum of Bachelor’s degree in Engineering or a Master’s degree in science and a minimum of fifteen years working experience in the relevant field of testing / calibration in a senior position. For members of the medical laboratory Accreditation Committee the desired qualification requirements are post graduation in medical fields or Ph.D. in relevant scientific fields with ten years or more work experience in a senior position.

The members are selected based on their necessary technical competence, knowledge of principles and processes of accreditation, past performance as Assessors or Committee members.

The accreditation

committee members are given short

orientation

regarding

accreditation process, NABL policies and procedures, NABL expectations from the accreditation committee and obligations of committee members, during the first meeting of the newly constituted / reconstituted Accreditation Committee. Those who are not able to attend the first meeting are provided with NABL 011 – Procedures and Terms for Accreditation Committee.

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6.2.2

Guided by requirements in specific fields, NABL continuously endeavors to expand its pool of trained assessors from all appropriate sources. In order to be empanelled, potential Assessors are required to qualify the NABL Assessor Training Course. NABL organises Assessor Training courses for ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 assessor training courses for medical laboratories.

The course material is based on APLAC TR001 ‘Guidelines on Training Course for Assessors’ and ILAC G3 ‘Guidelines for Training Courses for Assessors used by Laboratory Accreditation Schemes’. A procedure for selection, training and formally approving Assessors and Experts used in the assessment process has been documented vide NABL 013.

6.2.3

The specific areas / fields of expertise of assessors and experts used for assessment are identified on the basis of their educational background and subsequent work profile.

This information is available in individual assessor files maintained by the Training Officer and this is updated periodically. A database of Assessors and experts is maintained to include updated areas / fields of competence / expertise.

6.2.4

The training program for NABL assessors ensures that the participants acquire knowledge about accreditation procedures, accreditation criteria & requirements and assessment techniques. Further they are also evaluated for their personal attributes like analytical and communication skills etc., as laid down in ISO 19011:2002 ‘Guidelines for Quality and/or Environmental Management System Auditing’.

The procedure for

assessor training is covered in NABL 013. The qualified assessors are empanelled to the NABL Assessor list. They are allotted an Assessor ID number, which is used in the data base and correspondence with the Assessor 6.3

Monitoring

6.3.1

For ensuring satisfactory performance of the assessment and the accreditation decision making process, NABL has a system of monitoring the performance of NABL Staff, assessors and the Accreditation Committee members.

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The performance of each NABL staff member is monitored through annual performance appraisal. The appraisal forms are suited to the task performed by the concerned individual. Completed annual appraisal forms are evaluated and vetted by designated officers. Outcome of performance appraisals is one of the parameters while deciding on the future assignments and training needs.

The performance of Accreditation Officers is also monitored by the Chairman Accreditation Committee. The procedure is documented in NABL 017.

The Accreditation Committee members are appointed for a period of 2 years and their performance is monitored based on annual self appraisal in Form 77 that is evaluated by the Director NABL using Form 78. While reconstituting Accreditation committees, past performance of a member who has previously served on the committee is duly considered.

Normally no member serves more than two consecutive terms as an

Accreditation Committee member. If Director, NABL is either a Chairman or member of an Accreditation Committee, his/her performance related to accreditation committee is 6.3.2

evaluated collectively by other members of the committee.

NABL has a system of monitoring the performance of the Lead Assessors, Technical Assessors and Experts. This monitoring is conducted using any of the following direct or indirect means : a. b.

Feedback from NABL officers during on-site assessment

c.

Feedback from Peer Assessors during assessment

d.

Feedback from the laboratories on their assessment.

e.

Performance of the Assessors in the Assessors’ conclaves.

f.

Tutors’ feedback after NABL Assessors’ training and refresher training.

g.

Complaint against assessors from any source.

Feedback from Accreditation Committee members on the assessment reports presented during the meetings.

The feedbacks received are evaluated and appropriate follow up action is taken to improve the Assessors performance. The procedure for monitoring the performance of Assessors is covered in NABL 013.

NABL may organise assessor’s conclaves in order to minimise the perceptional differences amongst the assessors and to bring uniformity in assessment process. The details are given in NABL 013.

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6.4

Personnel records

6.4.1

NABL maintains up to date records of qualifications, training, experience and the areas/fields of expertise of each member of its staff and the Accreditation Committee members.

6.4.2

A computerised database is maintained at the NABL Secretariat containing relevant up to date information about each Lead Assessor, Assessor and Technical expert, which covers the following : a.

name and address,

b.

the position held in their own organization,

c.

education qualifications and professional status,

d. e.

work experience, training in management systems, assessment and conformity assessment

f.

activities, competence for specific assessment tasks,

g.

experience in assessment and results of their regular monitoring.

The information in the database is accessible to all the NABL staff involved in the accreditation process. The database is updated periodically.

The records of all Assessors are also available as hardcopies in individual files of each Assessor, maintained at NABL secretariat.

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7

ACCREDITATION PROCESS

7.1

Accreditation criteria and information

7.1.1

The general criteria against which the laboratories are accredited by NABL are as follows : i)

ISO/IEC 17025:2005 ‘General requirement for the competence of testing and calibration laboratories’ for Testing and calibration laboratories; and

ii)

ISO 15189:2007 ‘Medical laboratories – Particular requirement for quality and competence’ for medical laboratories.

The laboratories are also required to fulfill the requirements of specific criteria specified

by NABL, relevant to the field / discipline of operation of the laboratory.

7.1.2

General information regarding NABL and the procedures followed for accreditation process and related activities, is made available to public, through NABL 100 ‘General information brochure’ and other related documents. These are updated at regular interval and are readily available on the NABL web-site www.nabl-india.org. The information includes the following : a.

Detailed information about accreditation process including the assessment process. This is addressed in NABL 100 - General Informatin Brochure. The terms and conditions for maintaining accreditation is given in NABL 131. The procedure for granting and extending accreditation is addressed in NABL 002 ‘Procedural Manual for Accreditation Process’. The procedure for reducing, suspending and withdrawing accreditation is addressed in NABL 216 ‘Procedure for dealing with adverse decisions‘.

b.

NABL grants accreditation as per the requirements of ISO/IEC 17025:2005 for testing and calibration laboratories and ISO 15189:2007 for medical laboratories.

The eligibility requirements for accreditation are specified in NABL 100. The technical requirements specific to each field is given in the relevant specific criteria / guidance documents. These are listed in NABL 200 ‘Master list of NABL documents’.

c.

The fee structure for accreditation is detailed in NABL 100 ‘General information brochure’; NABL 151 ‘Application Form for Testing Laboratories’, NABL 152 ‘Application Form for Calibration Laboratories’ and NABL 153 ‘Application Form for Medical Laboratories’.

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d.

The obligations / duties of accredited laboratories are addressed in NABL 131 ‘Terms and Conditions for maintaining NABL accreditation’ and NABL 133 ‘NABL Guidelines to Accredited laboratories for use of NABL Symbol’. The requirements that the applicant laboratories are required to fulfill are addressed in NABL 151, NABL 152 and NABL 153.

The rights of the laboratories are addressed in NABL 100.

e.

NABL web-site www.nabl-india.org provides up to date information on accredited laboratories. The information covers name, address, date of grant & expiry of accreditation, scope and fields/disciplines of accreditation.

f.

NABL procedure for dealing with complaints is given in NABL 132 and procedure for dealing with appeals is given in NABL 134.

g.

The information on the authority under which accreditation program operates is given in NABL 100.

h.

The description of NABL’s rights and duties is given in NABL 100.

i.

The general information about the financial support mechanism is given in NABL 100.

j.

The activities of NABL is given in NABL 100 and there are no limitations under which NABL operates.

k.

The information about the related bodies is given in NABL 100.

7.2

Application for accreditation

7.2.1

The applicant laboratory is required to make an application in the prescribed format, duly signed by an authorised representative. The application form includes information on Name and Address of the laboratory; Legal status; Physical locations to be covered: Human and technical resources; Description of the activities of the laboratory; Scope of accreditation applied for; etc. The applicant is also required to submit signed agreement for terms and conditions of accreditation in NABL 131 ‘Terms & Conditions for Maintaining NABL Accreditation’.

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7.2.2

Further the

applicant laboratory is also required to submit a list of standards,

test/calibration methods, range of testing / calibration along with limit of detection / best measurement capability (BMC), corresponding to scope applied for. The laboratory is also required to submit list of authorised signatories for signing the reports, list of equipment / reference material with calibration and traceability details and participation in proficiency testing and its results, along with required number of copies of Quality Manual and other supporting documents, records.

7.2.3

The preliminary review for the adequacy of the application and quality manual submitted by the laboratory is carried out by NABL Secretariat whereas the detailed review is carried out by Lead Assessor. The procedure for preliminary review for the adequacy is addressed in NABL 002.

7.3

Resource review

7.3.1

NABL has provided for adequate competent manpower, both internal (NABL staff) and external (assessors/experts) for the fields / disciplines against which accreditation is being granted at present. As and when NABL considers extending its activities in response to requests from others or as a part of planned expansion of its activities within existing accreditation fields / disciplines or for additional fields / disciplines, the same is undertaken after extensive review and provision of additional resources, if considered necessary.

The procedure is addressed in NABL 021 â&#x20AC;&#x2DC;Procedure for

Extending Accreditation Activitiesâ&#x20AC;&#x2122;.

7.3.2

At present NABL has the capability to complete the initial assessments for the fields / disciplines already covered, in a timely manner.

7.4

Subcontracting the assessment As a matter of policy NABL does not subcontract any part of the assessment activity.

7.5

Preparation for assessment

7.5.1

NABL has a system of conducting a pre-assessment visit of the laboratory before the initial assessment. This is carried out by the appointed lead assessor after the completion of adequacy audit of quality manual and subsequent corrective actions on inadequacies identified, if any. The primary purpose of pre-assessment of the laboratory is to assess the degree of preparedness of the laboratory for the assessment and to estimate the time frame, and number of assessors required for assessment. Detailed procedure for pre-assessment is documented in NABL 002.

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NABL has clear policy of not being involved in any form of consultancy to the laboratories. The assessors are clearly instructed during the training not to be involved in any type consultancy during the assessment process. They are also required to sign a declaration to this effect vide Form 74.

7.5.2

The procedure for appointment of assessment teams as well as for preparation and conduct of assessments is documented in NABL 002. Adequate care is taken while selecting the assessment teams for ensuring that the expertise brought to each assignment is appropriate.

7.5.3

NABL ensures that the team members act in an impartial and non-discriminatory manner. As already stated each Lead Assessor and Technical Assessor is required to sign an agreement with NABL, which specifies the terms and conditions of his/her empanelment. The agreement contains a declaration of independence and impartiality, as well as a confidentiality statement. Further for every assessment undertaken, the assessors are also required to sign a declaration of Impartiality and confidentiality for avoiding conflict of interest situations and to act in a non-discriminatory manner during assessment.

7.5.4

The laboratory is informed about the members of the assessment team sufficiently in advance to allow the laboratory to object to the appointment of any particular assessor or expert. The procedure for dealing with such objections is covered in NABL 002. Once the assessment team has been finalised, NABL confirms to the laboratory in writing.

7.5.5

While the laboratory is informed about the assessment team a copy of this communication along with required documents is send to all the members of the assessment team. The task to be undertaken by each member of the assessment team is detailed in the communication.

7.5.6

At present NABL offers laboratory accreditation services in Testing, Calibration and Medical. If any Laboratory is engaged in more than one of these areas, it is NABLâ&#x20AC;&#x2122;s policy to cover all the areas during every assessment carried out for such laboratories.

Within the individual areas as stated above NABL has established a procedure for sampling to ensure that the assessment team witnesses a representative number of tests/ calibrations out of the applied scope of accreditation, to ensure proper evaluation of competence of the laboratory, as addressed in NABL 023 â&#x20AC;&#x2DC;Procedure for Sampling of Scope of Accreditationâ&#x20AC;&#x2122;.

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7.5.7

For initial assessment, all premises of the laboratory where key activities are performed are assessed. However, if there are other premises where other than key activities are carried out, the same are covered by the sampling plan as described in NABL 023.

7.5.8

For surveillance and re-assessment, where the laboratory performs key activities from various premises, sampling is done. All premises from where key activities are performed are assessed within two accreditation cycles. A procedure is addressed in NABL 023.

7.5.9

The probable date(s) for the initial assessment are sought from the laboratory and depending upon the availability of assessors the dates are agreed upon between NABL, the laboratory and the Assessors. Dates are confirmed in writing.

After the accreditation is granted, a calendar is planned for conducting surveillance and reassessment and after ascertaining availability of assessors these dates are communicated to the laboratory. The planned date is changed only under exceptional circumstances.

7.5.10 Each member of the assessment team is provided with the relevant documents as applicable, to enable them to carry out the assessments in an effective manner. These documents include - ISO/IEC 17025:2005 or ISO 15189:2007; relevant Specific criteria document; NABL 210 ‘NABL Assessors’ Guide’ along with NABL 215 or NABL 217 ‘Assessors checklist’ ; Quality Manual of the laboratory; copy of the application with details of scope of accreditation; relevant portion of previous assessment report and complaint against the laboratory, if any; performance in proficiency testing copy of the pre-assessment report and corrective action (if any) taken by the laboratory and any relevant information pertaining to the laboratory.

7.6

Document and record review

7.6.1

The adequacy of documentation is reviewed by the lead assessor before proceeding for on-site pre-assessment/assessment visit. Further, even during the on-site assessment Lead assessor/Technical Assessors/ Experts are required to review the document to evaluate its conformity with ISO/IEC 17025 or ISO 15189 as applicable and the relevant specific criteria documents and other NABL requirement documents and report the status suitably vide the assessment report.

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7.6.2

If there are gross non-conformities reported by the team member(s), it may be decided not to proceed with the on-site assessment and the non-conformities are reported in writing to the laboratory.

7.7

On-site assessment

7.7.1

Procedure for conducting on-site assessment is detailed in NABL 210, which includes procedure for conducting an opening meeting. During the meeting, where the assessment team and the key personnel of the laboratory are present, the team explains to the laboratory the purpose of assessment, the accreditation criteria, the assessment schedule and the scope of accreditation is confirmed.

7.7.2

The procedure for conducting an on-site assessment is addressed in NABL 210.

7.7.3

The procedure for sampling to identify representative sample for test witness is addressed in NABL 023. This also covers sampling for witnessing the performance of representative number of staff of the laboratory to provide assurance of the competence of the laboratory across the scope of accreditation.

7.8

Analysis of findings and assessment report

7.8.1

The assessment team is required to analyse all relevant information and evidence gathered during the document and record review and the on-site assessment. Based on this the team is required to determine the extent of competence and ascertain whether the work of the laboratory is being performed in accordance with the assessment criteria. The detailed procedure for analysis of information gathered and consolidation of audit findings is given in NABL 210.

The areas of improvement if observed are required to be summarised in NAF 6 and presented by the Assessment team to the laboratory management during the closing meeting, however Assessors are made aware of the fact that the improvements suggested are merely for making the laboratory understand the requirements of the standard and should not be for offering any consultancy.

7.8.2

As per NABL procedures, when the assessment team needs clarification / interpretation on any aspect or if there arises a conflict between assessment team and the laboratory, there exists provision for referring the matter to NABL.

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7.8.3

NABL procedure for conduct of assessment requires that a closing meeting between the assessment team and the laboratory management takes place. During the closing meeting the assessment team briefs the laboratory about the findings of the assessment and provides clarifications on the queries raised by the laboratory. A written report is prepared, consistent with the proceedings of the assessment. The procedure is addressed in NABL 210.

7.8.4

NABL remains responsible for the contents of the assessment report including nonconformities.

7.8.5

NABL procedure ensures that the responses of the laboratory to resolve the nonconformities raised by the assessment team are reviewed to verify their adequacy and effectiveness. If required additional information is called for. The closure of nonconformities is either done based on review of evidence of effective implementation of corrective actions or through a follow-up visit, as appropriate. The detailed procedure is addressed in NABL 002.

7.8.6

The Accreditation Committee is provided with adequate information, to enable them to take a decision regarding recommendation for grant, reduction, extension, maintenance or withdrawal of accreditation. This includes information on, unique identification of the laboratory, dates of the on-site assessment, names of assessors/experts involved in assessment, unique identification of all premises assessed, proposed scope, assessment report, a statement on the adequacy of internal organization, information on the resolution of all non-conformities, summary of results of proficiency testing or Interlaboratory

comparisons

and

any

other

relevant

information.

Based

on

the

recommendation of the accreditation committee, Chairman NABL takes the decision on accreditation. Detailed procedure is covered in NABL 002.

7.9

Decision-making and granting accreditation

7.9.1

The NABL Secretariat analyses the assessment report received from the assessment team; if required, seeks further information and when fully satisfied prepares a summary to include information as stated at clause 7.8.6.

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7.9.2

NABL organises Accreditation Committee meetings at regular intervals. In all cases where the assessment of the laboratory has been conducted and the non-conformities if any, raised by the assessment team are subsequently closed are placed before the Accreditation Committee for a recommendation on decision.

7.9.3

NABL does not have any policy of making use of assessments already performed by another accreditation body for use by its decision taking system.

7.9.4

Decision regarding accreditation is taken by Chairman NABL, based on the recommendation of the Accreditation Committee. An accreditation certificate with unique identification number is then issued to the laboratory. The certificate contains all relevant information, details of which are addressed in NABL 002.

7.9.5

The accreditation certificate is also accompanied by an annexure containing the scope of accreditation. For testing laboratories it includes product category, tests / test method and relevant national / international standard and range of testing / limits of detection.

For calibration laboratories it includes the types of measurement performed, the measurement ranges and the best measurement capability (BMC). The accreditation certificate for medical laboratory defines field of test, items / materials / products tested, specific tests performed, specification/ standard methods or techniques used, range of testing/ limit of detection, wherever applicable and MU/CV%.

7.10

Appeals

7.10.1 NABL has established policy and procedure for dealing with appeals from laboratories against its own decisions. The cases may involve refusal of accreditation or scope reduction for applicant/ renewal laboratories and abeyance, suspension, forced withdrawal or scope reduction for accredited laboratories. The procedure is addressed in NABL 134 â&#x20AC;&#x2DC;Procedure for Dealing with Appeals Against Adverse Decisions Taken by NABLâ&#x20AC;&#x2122;.

7.10.2 The appeals procedure includes appointment of an independent Individual / Appeals Committee, to decide validity of the appeals received. An officer of NABL has been nominated for informing the laboratory of the final decision and to take follow up actions, if required.

The detailed procedure is covered in NABL 134 which also addresses

maintenance of all records.

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7.11

Reassessment and surveillance

7.11.1 Surveillance and reassessment procedures are consistent with initial accreditation procedures. The experience gained during previous assessments is taken into account for future assessments.

7.11.2 NABL grants accreditation to laboratories for a period of 2 years. NABL conducts an annual surveillance and a re-assessment every two years. The first surveillance is conducted on site and subsequent surveillances are desktop surveillances. The desktop surveillance is based on information and data received from laboratories. All reassessment are conducted on-site.

The procedure for the conduct of surveillance and re-assessment is given in NABL 002.

7.11.3 After the grant of accreditation, a plan is prepared for conducting the surveillance and re-assessment of laboratories. The design of the plan is such that it ensures that for each accredited laboratory, the representative samples of the scope of accreditation are assessed during re-assessment. Where the accreditation scope is very large, the plan covers the entire scope over a period of two accreditation cycles. The procedure for sampling of scope of accreditation is detailed in NABL 023.

7.11.4 When the desktop surveillance is conducted requiring the laboratory to submit the documents and if any information/data received cast doubts on the continued compliance to the criteria or on the technical competence of the laboratory, NABL may plan to conduct on-site surveillance visit of the laboratory.

7.11.5 During surveillance or re-assessment, when non-conformities are identified, the laboratory is given a maximum time of two months to take corrective actions and implement them.

7.11.6 After the surveillance, the laboratory is informed by NABL about the decision of continuation of accreditation, in writing. After the re-assessment visit, if the accreditation is renewed, a new certificate bearing the old accreditation number and having new validity period, is issued.

7.11.7 NABL may also conduct special surveillance visit as a result of complaints or changes effecting the laboratory operations. The laboratories have been informed of this provision vide NABL 100.

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7.12

Extending accreditation

7.12

The laboratories at any time during the accreditation cycle can request for extension of scope within already approved field(s) / disciplines or to include new field(s) / disciplines.

NABL has a policy of either conducting special assessment visit or to club it with the forthcoming assessment visit. The procedure to be followed is same as that for the initial assessment except that adequacy audit and pre-assessment are not carried out.

7.13

Suspending, withdrawing or reducing accreditation

7.13.1 NABL has established procedures for suspension, withdrawal or reduction of the scope of accreditation, which are documented in NABL 216. The delegated authority to take adverse decisions is given in chapter 5 of NABL 002.

7.13.2 NABL 216 includes the procedure for dealing with cases where the laboratory fails to meet the requirements of accreditation or the terms and conditions of maintaining accreditation. This procedure also includes cases where the laboratory itself may request for withdrawal of accreditation.

7.13.3 NABL 216 also includes procedure for dealing with cases where the appropriate action

by NABL results in reduction in scope of accreditation including cases where laboratory itself asks for reduction in its accredited scope.

7.14

Records on CABs

7.14.1 NABL has a system of maintaining all the records on laboratories, to demonstrate that the requirements for accreditation and competence have been effectively fulfilled. These records are regularly updated by concerned officers.

7.14.2 NABL has a policy and system for maintaining all the records pertaining to laboratories secured to ensure confidentiality. The hard copies of all records related to each laboratory are available in respective laboratory files. Each record is identified by a unique identification number and the number is displayed on the file. The files are stored at appropriate place and properly indexed. These records are kept in safe custody under lock and accessible to authorised staff of NABL. Certain information and databases are also available on NABL LAN for use by authorised staff of NABL. The access to the computers is password protected. The procedure of maintaining records is addressed in NABL 012.

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7.14.3 The records for laboratories include the relevant correspondence, last two assessment reports, minutes of accreditation committee meetings, accreditation decisions and the copies of accreditation certificates issued to the laboratory.

7.15

Proficiency testing and other comparisons for laboratories

7.15.1 The performance of a laboratory in a specific proficiency testing / Inter laboratory comparison is monitored by NABL Proficiency Testing Officer and the concerned Accreditation Officer. Assessors discuss with laboratories, during assessments, regarding their participation in the proficiency testing / Inter laboratory comparisons and the investigations and corrective actions taken by the laboratory for improving its performance, if necessary. The information on participation and performance in the proficiency testing / Inter laboratory comparisons is presented to the Accreditation committee while discussing cases for taking decisions. Procedure for dealing with laboratories for their failure to take appropriate corrective action is detailed in NABL 216.

7.15.2 The proficiency testing / Inter laboratory comparisons are either organised by NABL or some other nodal laboratory as appointed by NABL, based on the guidelines for conduct of Proficiency testing / Inter-laboratory comparisons. NABL has developed these guidelines (NABL 162 and NABL 164) based on ISO/IEC Guide 43. The Proficiency Testing Officer maintains a list of all proficiency testing / inter-laboratory comparisons organised by NABL or other nominated laboratories. The announcements for these are made on NABL website for the information of the laboratories. They may also be informed in writing, 7.15.3 NABL ensures that its accredited laboratories participate in proficiency testing / Inter laboratory comparison programs in accordance with the requirements of APLAC MR001 and ILAC-P9, where available and appropriate. The laboratories are also encouraged to participate in International proficiency testing programs, in cases where national programs are not readily available or planned. Further NABL ensures that corrective actions are carried out when necessary. The policy for minimum participation in proficiency testing / Inter laboratory comparisons has been documented in NABL 163.

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8

RESPONSIBILITIES OF THE ACCREDITATION BODY AND THE CAB

8.1

Obligations of the CAB

8.1.1

Terms and Conditions for maintaining NABL accreditation are defined in NABL 131. By signing the same at the time of applying for NABL accreditation (both initial and renewal) the laboratory commits itself to fulfilling continually the requirements of accreditation, which includes agreement to adapt to changes in the requirements for accreditation.

The Terms and conditions laid down in NABL 131 include the requirements of affording access to all premises where activities of laboratory are performed and affording access to all relevant information, documents and records necessary to assess laboratoryâ&#x20AC;&#x2122;s compliance to the relevant criteria and standards and for maintenance of accreditation.

The laboratory is also required to arrange witnessing of laboratory activities - testing/ calibration/ medical being performed.

As per the requirements of NABL 131 accredited laboratory can claim accreditation only with respect to the scope for which it has been granted accreditation. It is also required that an accredited laboratory does not use its accreditation in a manner as to bring disrepute to NABL. As per the provisions of NABL 131, laboratory is required to make a commitment to pay the necessary fees as determined by NABL.

8.1.2

In accordance with the terms and conditions for maintaining NABL accreditation, the accredited laboratory is required to inform NABL within 15 days of occurrence of any significant changes in respect of its legal, commercial, ownership or organisation status: its organisation, top management, key personnel and authorised signatories; main policies; resources and premises; scope of accreditation or any other matters that may affect the ability of the laboratory to fulfill requirements of accreditation. NABL 131 includes provision for the same.

8.2

Obligations of the accreditation body

8.2.1

As per the requirements of ISO/IEC 17011, NABL has made publicly available information regarding the current status of the accreditation of the NABL accredited laboratories. The information available on NABL website includes names and addresses of accredited laboratories, including contact person and telephone, fax numbers, e-mail, etc; discipline, certificate number, date of issue and expiry of accreditation; scope of accreditation including field / discipline, facility, major group in condensed form.

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The detailed scope of accreditation of a laboratory can also be viewed by clicking on to the certificate number. The website also provides the details like type of service provided by the laboratory – in-house or open to others; type of facility - permanent, mobile or site and region of operation.

The Directory of NABL Accredited Laboratories is also available at NABL website under ‘Publication / Accreditation documents’ which contains name and address of laboratory and contact details; the field(s) / discipline(s) accredited; certificate number; date of issue and expiry of accreditation. This information is updated quarterly.

8.2.2

NABL provides the laboratory with information about suitable ways to obtain traceability of measurement results relevant to the scope for which accreditation is granted, vide NABL-142 (Policy on Calibration and Traceability of Measurements). Further the details of calibration laboratories accredited by NABL can be obtained from Laboratory search option provided on NABL website.

Where traceability to national standards is not available and in the area(s), where no accredited laboratory is available, as a support to accredited laboratories, NABL may approach the identified external calibration provider(s), who can provide the suitable national or international traceability in that area, as the case may be. These external calibration provider(s) will then be evaluated by NABL in that specific area, in accordance with ISO/IEC 17025:2005. The name(s) of such calibration provider, if found competent, will be included in NABL policy document. Also such calibration providers will be encouraged to seek NABL accreditation.

8.2.3

NABL is a signatory to APLAC and ILAC mutual recognition arrangement (MRA) and the latest information in this respect is available at NABL website. On request from the laboratories or their users, a copy of APLAC/ILAC, MRA is provided. NABL provides information about International arrangements through website, NABL-100, awareness programs, training programs etc

8.2.4

NABL communicates any changes to its requirements for accreditation through its website, NABL news, individual letters to accredited laboratories, etc. The precise form and the effective date of changes are decided considering the comments received from interested parties. Subsequent to which implementation of the changed requirements is verified for the accredited labs through verification of submitted documentary evidence, on-site visit, etc.

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8.3

Reference to accreditation and use of symbols

8.3.1

Laboratories accredited by NABL are permitted to use NABL Symbol as a mark of indicating their accreditation status. The NABL policy for protection and use of its symbol is detailed in NABL 133 which has been prepared in line with ILAC P8 â&#x20AC;&#x2DC;ILAC Mutual Recognition Arrangement: Supplementary Requirements and Guidelines for the Use of Accreditation Symbols and for claims of Accreditation Status by Accredited Laboratoriesâ&#x20AC;&#x2122;.

8.3.2

Detailed requirements governing use of NABL Symbol have been stated in NABL 133.

NABL 131 gives the Terms & Conditions for Maintaining NABL Accreditation and the laboratories are required to give their commitment for abiding by the same at the time of grant of accreditation. NABL 131 specifies requirements with respect to claiming accreditation status, when making reference to its accreditation in communication media such as the internet, documents, brochures, or advertising and restricts its use for premises of the laboratory, facility, fields, tests/ calibrations that are specifically included in the accreditation. The accredited laboratory is neither allowed to make misleading or unauthorized statement regarding its accreditation nor the use to imply that a product, process, system or person is approved by the accreditation body. Accredited laboratory is required to take due care to prevent use of its report/certificate or any part thereof in a misleading manner. An accredited laboratory upon expiry, suspension or withdrawal of its accreditation (however determined), is required to discontinue use of all advertising matter that contains any reference to an accredited status.

8.3.3

NABL has policy for taking suitable action to deal with incorrect references to accreditation status or misleading use of accreditation symbols in advertisements, catalogues. The details are addressed in NABL 216.

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National Accreditation Board for Testing and Calibration Laboratories 3rd Floor, NISCAIR 14, Satsang Vihar Marg New Mehrauli Road New Delhi – 110 067 Tel.: 91-11 26529718 – 20, 26526864 Fax: 91-11 26529716 Website: www.nabl-india.org