NABL 161

NATIONAL ACCREDITATION

NABL BOARD FOR TESTING AND

CALIBRATION LABORATORIES

GUIDE
for INTERNAL AUDIT AND
MANAGEMENT REVIEW
FOR LABORATORIES

ISSUE NO : 03 AMENDMENT NO : 00
ISSUE DATE: 25.03.2008 AMENDMENT DATE: --
 AMENDMENT SHEET

Sl. Page Clause Date of Amendment made Reasons Signature Signature

No. No. No. Amendment QM Director
1

10

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
Issue No: 03 Issue Date: 25.03.2008 Last Amend No: 00 Amend Date: -- Page No: i
 CONTENTS

Sl. Title Page

Amendment Sheet i
Contents ii
Introduction 1
Terminology 2-3

Section A: Internal Audit

1. Objectives of Internal Audit 4

2. Organisation of Internal Audit 5
3. Planning of Audit 6
4. Implementation of Internal Audit 7-8
5. Follow up of Corrective Actions 9
6. Records and Reports of Internal Audit 10
7. Additional Unscheduled Audits 11
8. Formats for Internal Audit 12-13

Section B: Management Review

1. Objectives of Management Reviews 14

2. Organisation of Management Review 15
3. Planning of Management Reviews 16
4. Implementation of Management Reviews 17
5. Records of Management Reviews 18

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
Issue No: 03 Issue Date: 25.03.2008 Last Amend No: 00 Amend Date: -- Page No: ii
INTRODUCTION

General Requirements for the Competence of Testing and Calibration Laboratories,

ISO/ IEC 17025: 2005 clause 4.14 & 4.15 requires that a laboratory shall periodically,
and in accordance with a predetermined schedule and procedure, conduct:
a. Internal audits of its activities to verify that its operations continue to comply with
the requirements of the management system and ISO/ IEC 17025: 2005, and
b. Management reviews of its management system and its activities to ensure their
continuing suitability and effectiveness, and to introduce any necessary changes or
improvements.

It is assumed that the laboratories have implemented a management system that meets
the requirement of ISO/ IEC 17025: 2005. This document has been prepared to give
laboratories guidance on how to establish a programme for internal audit and
management review. The document consists of two sections: Section A – Internal Audit
and Section B – Management Review.

The guidelines given in this document are general in nature. The actual accomplishment
of an internal audit or a management review depends on the size, scope and
organisation structure of the laboratory and, for the smaller laboratory, many of the items
described in this document can be carried out in a simplified manner.

An internal audit and a management review must have been conducted preferably
before the assessment team visits the laboratory for the assessment/ surveillance/ re-
assessment.

NABL, at any time, may call for the internal audit and/ or management review reports.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
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TERMINOLOGY

Management System
The organisational structure, responsibilities procedures, processes and resources
needed to implement quality management.

Quality Management
That aspect of the overall management function that determines and implements the
quality policy.

Quality Assurance
All those planned and systematic actions necessary to provide adequate confidence that
a product or service will satisfy given requirements of quality.

Quality Audit
A systematic and independent examination to determine whether quality activities and
related results comply with planned arrangements and whether these arrangements are
implemented effectively and are suitable to achieve objectives.
Note: In this document, the term ‘internal audit’ is used to emphasise that the audit is
done by the laboratory itself.

Management Review
A formal evaluation by top management of the status and adequacy of quality system in
relation to quality policy and objectives.

Quality Manager
A member of staff with defined responsibility and authority for ensuring that the
management system is implemented and followed at all times and shall have direct
access to the highest level of management at which decisions are made on laboratory
policy or resources [ISO/ IEC 17025, clause 4.1.5 (i)].

National Accreditation Board for Testing and Calibration Laboratories

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Quality Auditor
A person qualified to perform quality audits.
Note: In this document the term ‘auditor’ is used.

Auditee
An organisation to be audited.
Note: In this document the term ‘Auditee’ refers to the individuals working in the
laboratory.

Observation
A statement of fact made during an audit and substantiated by objective evidence.

Objective Evidence
Qualitative or quantitative information, records or statements of fact pertaining to the
quality of an item or service or to the existence and implementation of a quality system
element, which is based on observation, measurement or test and which can be verified.

Non-Conformity
The non-fulfillment of specified requirements.

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 SECTION A

INTERNAL AUDIT
1. Objectives of Internal Audit

1.1 The laboratory should conduct internal audits of its activities to verify that the
operations continue to comply with the requirements of management system.
1.2 The internal audits should ensure that the management system fulfils the
requirements of ISO/ IEC 17025, NABL relevant specific criteria document
and regulatory bodies.
1.3 The audit should also ensure whether or not the requirements of the
laboratory quality manual and related documents are applied at all levels of
work.
1.4 The non-conformities found during the internal audit give valuable information
for the improvement of the laboratory’s management system and technical
competence, which is to be used as a input to management reviews.

National Accreditation Board for Testing and Calibration Laboratories

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2. Organisation of Internal Audit

2.1 The internal audits should be carried out according to a written procedure as
described in the quality manual.
2.2 The audit should be programmed such that each element of the
management system is checked at least once a year. In large laboratories it
may be advantageous to establish a plan whereby the different element of
management system or different sections of the laboratory are audited
throughout the year.
2.3 The quality manager is responsible for the conduct of the audit and he/ she
should ensure that the audits are carried out in accordance with the schedule
plan.
2.4 The audits shall be carried out by qualified personnel who understand the
technical requirements they are auditing and who are trained specifically in
auditing techniques and processes.
2.5 The quality manager may delegate the task of performing audits provided the
person is familiar with the laboratory’s management system and NABL
accreditation requirements.
2.6 In large laboratories carrying out calibration and/ or testing in a wide range of
technical disciplines, it may be necessary for audits to be carried out by team
of individuals. One of the auditors may act as a lead auditor, however the
responsibility of the conduct of audit lies with the quality manager.
2.7 In small laboratories, the quality manager may carry out the audit, but the
management should ensure that the activities of the quality manager are
audited by another person.
2.8 The auditor shall be independent of the activity to be audited and personnel
shall not audit their own activities.
2.9 Where a laboratory has accreditation for calibration and/ or testing at the
clients’ site, or for sampling, these activities must be included in the audit
programme.
2.10 Audits carried out by the other parties, such as customers or NABL, cannot
be considered to substitute for or override the laboratory’s own internal audit
responsibilities.

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3. Planning of Audit

3.1 An audit plan needs to be established by quality manager and should include
the audit scope, the audit criteria, the audit schedule, reference documents
(such as the laboratory’s quality manual and audit procedure) and audit team
members.
3.2 The audit programme may include horizontal audit / vertical audit so that all
the sections/ departments are audited for every aspect/ clause of the
management system and ISO/ IEC 17025.
3.3 Each auditor should be assigned specific management system elements or
functional departments to audit. Such assignments should be made by the
quality manager or the lead auditor in consultation with the auditors
concerned. The auditors should have adequate technical knowledge of the
activities they are to audit.
3.4 Working documents required to facilitate the auditor’s investigations and to
document and report results, may include:
- ISO/ IEC 17025 and any specific criteria document
- Laboratory’s quality manuals and associated documents such as system
procedures, test methods, work instructions, records etc.
- Checklist used for evaluating management system elements (normally
prepared by the auditor assigned to audit that specific element).
- Forms for reporting audit observations, such as non-conformity form or
corrective action form. These forms should include nature of non-
conformity, agreed corrective action, time required for corrective actions
and confirmation that the corrective action has been taken and is effective.
3.5 An audit timetable should be developed by each auditor in conjunction with
their auditee to ensure the smooth and systematic progress of the audit.
3.6 Prior to the actual audit, a review of documents, manuals, previous audit
reports and records should occur to check for compliance with the system
criteria and to develop a checklist of key issues to be audited.

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4. Implementation of Internal Audit

4.1 The implementation of the audit consists of investigation and analysis.

4.2 The opening meeting would introduce the audit team, confirm the audit
criteria, review the audit scope, explain the audit procedure, clarify any
relevant details, and confirm the timetable including the time or date and
attendees for the closing meeting.
4.3 The investigation process for gathering objective evidence will involve asking
questions, observing activities, examining facilities, and examining records.
The auditor will be examining the conformity of the activities with the quality
system.
4.4 The auditor will use the management system documents as reference
(quality manual, system procedures, test methods, work instructions, records
etc.), and compare what is actually happening with what these quality
system documents state should happen.
4.5 At all times during the audit, the auditor will be seeking objective evidence
that the management system requirements are being fulfilled. Evidence
should be collected as efficiently and effectively as possible and without
prejudice or upset to the auditees.
4.6 Non-conformities should be noted if they seem significant, even where they
are not covered by checklists, and should be investigated further to identify
the underlying problems.
4.7 All audit observations should be recorded. After all activities have been
audited, the audit team should carefully review and analyse all of their
observations to determine which are to be reported as non-conformities and
which can be included as recommendations for improvement.
4.8 The audit team should prepare a clear concise report supported by objective
evidence of non-conformities and recommendation for improvement. The
non-conformities should be identified in terms of specific requirements of
laboratory’s quality manual and related documents against which the audit
has been conducted.
4.9 The audit team should hold a closing meeting with the top management of
the laboratory and those responsible for the functions concerned. The main
purpose of this meeting is to present audit findings and report to top
management in such a manner so as to ensure that they clearly understand
the results of the audit.

National Accreditation Board for Testing and Calibration Laboratories

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 4.10 The quality manager should present observations, taking into account their
perceived significance (both positive and negative aspects), conclusions
regarding the management system’s compliance with the audit criteria. The
non-conformities identified during the audit should be noted and the
appropriate corrective action and time limit for actions should be agreed
upon.

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5. Follow up of Corrective Actions

5.1 The implementation of the agreed corrective action is the responsibility of the
quality manager.
5.2 When a non-conformity that may jeopardize the result of calibration/ test, is
discovered the corresponding activity should be halted until appropriate
corrective action has been taken to lead to satisfactory results. In addition,
results that may have been affected by the non-conforming work should be
investigated and customers informed if the validity of corresponding
certificates/ reports is in doubt.
5.3 The corrective actions procedure may need to be followed to reveal the root
causes of some problems and to implement effective corrective actions.
5.4 The effectiveness of corrective actions should be checked by the quality
manager as soon as possible after the agreed time limit has elapsed and
clear/ close the non-conformity.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
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6. Records and Reports of Internal Audit

6.1 A complete record of the audit should be maintained even if non-conformity

has not been found. These records provide the management with continuous
history of performance. All records must be clearly documented and readily
accessible.
6.2 Each non-conformity identified should be recorded, its nature, possible
cause(s), corrective action required and appropriate time limit for its
clearance.
6.3 The report should include the following information:
a. name(s) of the auditor(s)
b. date of audit
c. details of all areas audited
d. the positive or good aspects of the operations
e. any non-conformity identified along with their document references
f. any recommendations for improvement
g. corrective actions agreed, time period allowed for completion, and
person responsible for carrying out actions.
h. corrective actions taken and date of confirmation of completion of
corrective action.
i. signature of quality manager confirming closure of the non-conformities
and corrective action taken.
6.4 The quality manager should ensure that the report of the audit and, where
appropriate, individual non-conformities, are seen by the laboratory’s top
management. The trends in results of internal audit and the corrective actions
should be analysed by the quality manager and a report prepared for review
by the top management at the management review meeting.
6.5 Audit records may be retained for a minimum period of three years.

National Accreditation Board for Testing and Calibration Laboratories

Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
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7. Additional Unscheduled Audits

7.1 It may be necessary for laboratories to carry out additional unscheduled

audits whenever there is reason to doubt the effectiveness of the
management system. For example, when a non-conforming testing/
calibration work has been detected or the laboratory has received a complaint
which raises a doubt on the tests/ calibrations results etc.
7.2 The additional audit may confine to only that area where the non-conformity
has been detected or the complaint has been received.
7.3 The procedure followed is similar to that of the full audit.

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Doc. No: NABL 161 Guide for Internal Audit and Management Review for Laboratories
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 A TYPICAL FORMAT FOR AUDIT SCHEDULE

Dept./ Section to be audited JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

HV Laboratory X X

Cables and capacitors X X

Lamps & luminaries X

Motors X

Switchgears and control gears X X

Transformers X

Domestic appliances X X

Switches and wiring accessories X

Activity to be audited JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC

Organisation, Management System X

and document control
Review of requests, sub-contracting, X
purchasing, service to customers and
complaints
Control of non-conforming work, X X
improvement, corrective and
preventive action
Records, internal audit and X
management reviews
Personnel, accommodation and X X
environment
Test and/or calibration method and X X
method validation
Equipment and measurement X X
traceability
Sampling and handling of test/ X X
calibration items
Quality of test/ calibration results and X X
reporting of results

Note: These are examples, the schedule may vary according to the size, scope, type and organisational
structure of the laboratory.

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 A TYPICAL FORMAT FOR INTERNAL AUDIT NON-CONFORMITY

Audit No. : Date: Auditor:

Department/ Section: Activity Assessed: Auditee:

NC No. : Ref. to lab. documents & ISO / IEC 17025 Clause No.:

DESCRIPTION OF NON-CONFORMITY (NC):

Signature of Auditor & date

CORRECTIVE ACTION PROPOSED:

Signature of Auditee & date

RESPONSIBILITY & TIME REQUIRED FOR CORRECTIVE ACTION:

Signature of Auditee/ HOD/ Quality Manager & date

CORRECTIVE ACTION TAKEN:

Signature of Auditee & date

CORRECTIVE ACTION VERIFIED & COMMENTS, IF ANY

Signature of Auditor & Quality Manager & date

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 SECTION B

MANAGEMENT REVEIW
1. Objectives of Management Reviews

1.1 The top management of the laboratory shall periodically conduct a review of
the laboratory’s management system and testing and/ or calibration activities
to ensure their suitability and effectiveness and to introduce any necessary
changes or improvements.
1.2 Management reviews should be planned to establish what changes, if any,
are necessary to ensure that the management system for the laboratory
continue to meet both the laboratory’s needs and the requirements of ISO/
IEC 17025. Quality policy and objectives should be reviewed and revised if
necessary.
1.3 Management review should also take note of changes that have taken place
(or are expected to take place) in the organisation, facilities, equipment,
procedures and/ or activities of the laboratory and ensure (through quality
manager) that quality management system continues to conform to ISO/ IEC
17025.
1.4 The need for changes to the system may also arise as a result of findings
from internal or external quality audits, inter-laboratory comparisons or
proficiency tests, surveillance or reassessment visits by NABL, regulatory
bodies, complaints from customers or change in policies of NABL or APLAC/
ILAC.

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2. Organisation of Management Review

2.1 The top management of the laboratory should be responsible for conducting
reviews of the management system.
2.2 Those members of top management having overall responsibility for the
design and implementation of the laboratory’s management system, and for
taking decisions resulting from the findings of internal audits, should be
involved in management reviews.
2.3 The quality manager should be responsible for ensuring that all reviews are
conducted in a systematic manner according to an established procedure,
and that the management review are recorded.
2.4 The quality manager should also be responsible for ensuring that any action
identified during a review is implemented within the agreed time limit.

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3. Planning of Management Reviews

3.1 Management reviews should be carried out at least once a year. The review
should be programmed and the meeting should be attended by the top
management, including the person under whose authority the quality manual
has been issued. It is essential that the head of the laboratory, technical
management, the quality manager and the section heads are present.
3.2 It is recognized that in a small laboratory, one person may be fulfilling more
than one of the above functions. Good management reviews can occur even
in single person laboratories.

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4. Implementation of Management Reviews

4.1 The management review should be conducted in a systematic manner using

a formal agenda. This should include atleast the following items:
a. matters arising from the previous management review;
b. reports on surveillance and re-assessment visits carried out by NABL or
any other accreditation body and follow-up actions of the laboratory;
c. reports on audits by customers or other approval bodies and follow-up-
actions;
d. results of internal audits carried out since the last management review
and follow-up-actions.
e. trends analysis of results of in-house quality control checks;
f. trends analysis of complaints received from customers;
g. need for amendment of management system, including the quality
manual;
h. adequacy of current human and equipment resources;
i. further plans and estimates for new work, additional staff, new
equipment, changed methods etc.;
j. training requirements for new staff and for updating of existing staff;
k. review of quality policy and setting of objectives for the coming year
l. plan a programme for preventive action;
m. trends analysis of results of the laboratory’s participation in any
proficiency testing or Inter-laboratory comparison programmes; the
corrective action taken where applicable and the need for such
participation in other areas of calibration and/ or testing;
n. plan for implementation of decided changes to the management system,
including a timetable.
o. reports from managerial & supervisory personnel.
p. plan a program for corrective actions
q. customer feedback
r. recommendations for improvement
4.2 It should be the quality manager’s responsibility to ensure that all actions
arising from review are carried out as required. Actions and their effectiveness
should be monitored at regular (perhaps monthly) management meetings.

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5. Records of Management Reviews

5.1 All management reviews should be documented. The documentation may be

in the form of minutes of review meetings together with clear indications as to
the actions to be taken, by whom and in what time limit.
5.2 It should be the quality manager’s responsibility to ensure that all actions
arising from reviews are recorded and discharged as required.
5.3 The records should be readily accessible and be retained for a minimum
period of three years.

National Accreditation Board for Testing and Calibration Laboratories

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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