NABL 161
National Accreditation Board for Testing
           and Calibration Laboratories (NABL)
 Guide for Internal Audit and Management Review
for Conformity Assessment Bodies (Laboratories /
                     PTP / RMP)
ISSUE NO.: 06                     AMENDMENT NO.: --
ISSUE DATE: 05-Feb-2020           AMENDMENT DATE: --
                                               AMENDMENT SHEET
   S.      Page Clause Date of                      Amendment                   Reasons           Signature Signature
   No.      No.  No. Amendment                                                                    QA Team     CEO
   1
   10
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                                                      CONTENTS
  S. No.     Title                                                                                     Page No.
             Amendment Sheet                                                                                    1
             Contents                                                                                           2
             Introduction                                                                                       3
             Terminology                                                                                        4
             Section A: Internal Audit
  1.         Objectives of Internal Audit                                                                      7
  2.         Organisation of Internal Audit                                                                    8
  3.         Planning of Audit                                                                                 10
  4.         Implementation of Internal Audit                                                                  12
  5.         Follow up of Corrective Actions                                                                   14
  6.         Records and Reports of Internal Audit                                                             15
  7.         Additional Unscheduled Audits                                                                     16
  8.         Formats for Internal Audit                                                                        17
             Section B: Management Review
  1.         Objectives of Management Reviews                                                                  20
  2.         Organisation of Management Review                                                                 21
  3.         Planning of Management Reviews                                                                    22
  4.         Implementation of Management Reviews                                                              23
  5.         Records of Management Reviews                                                                     24
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                                                  INTRODUCTION
  General Requirements for the Competence of Testing and Calibration Laboratories, ISO/ IEC 17025:2017
  clause 8.8 and 8.9 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 17025:2017, 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.
  Similar requirements are stated in ISO 15189:2012, ISO/IEC 17043:2010 and ISO 17034:2016 in various
  clauses for Internal Audit and Management Review.
  It is assumed that the CABs have implemented a management system that meets the requirement of
  ISO/IEC 17025:2017 or ISO 15189:2012, ISO/IEC 17043:2010 and ISO 17034:2016. This document has
  been prepared to give CABs guidance on how to establish a program 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 CAB and, for
  the smaller CAB, many of the items described in this document can be carried out in a simplified manner.
  NABL, at any time, may call for the internal audit and/ or management review reports from the CABs.
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                                                  TERMINOLOGY
  Management System
  The quality, administrative and technical systems that govern the operations of a CAB.
  Internal 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.
  The term internal audit refers to an audit done by CAB to establish the extent of conformity to the
  documented requirements or standards as per the laid down procedure.
  Note: In this document, the term ‘internal audit’ is used to emphasise that the audit is done by the CAB
  (wherever resources permit).
  Management Review
  A formal evaluation by top management of the status and adequacy of Management system in relation to
  quality policy and objectives.
  Person responsible for Management System
  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 CAB policy or resources.
  Auditor
  A person who is trained, qualified and harboring the audit skills to perform audits.
  Auditee
  Any individual being audited
  Note: In this document the term ‘Auditee’ refers to the individuals working in the CAB.
  Observation
  A statement of fact made during an audit and substantiated by objective evidence.
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  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
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  1.    Objectives of Internal Audit
        1.1    The CAB should conduct internal audits of its activities to verify that the operations continue
               to comply with the requirements of defined management system.
        1.2    The internal audits should also ensure that the defined management system fulfils the
               requirements of ISO/ IEC 17025:2017 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO
               17034:2016.
        1.3    The audit should also ensure whether or not the requirements of the CAB’s Management
               System Document / Quality Manual and related documents are applied at all levels of work.
        1.4    The non-conformities found during the internal audit should give valuable information for the
               improvement of the CAB’s management system and technical competence, which is to be
               used as an input to management review.
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  2.    Organisation of Internal Audit
        2.1     The internal audits should be carried out periodically according to predetermined schedule
                and procedure to verify that the CAB operations are continually complying with the defined
                requirements of the management system.
        2.2     The audit should be programmed such that each element / activity of the management
                system is checked at least once a year irrespective of the size of the CAB, all the activities,
                all personnel, all procedures, all test methods to be covered in the internal audit. However at
                the time of internal audit, the assessment of technical competence through witnessing the
                test/ calibration may not be necessary.
        2.3     In large CABs it may be advantageous to establish a plan whereby the different element of
                management system or different sections of the CAB are audited throughout the year. If the
                entire management system cannot be audited in one session, then the CAB must ensure
                that all areas are audited throughout the year.
        2.4     The person responsible for management system has the responsibility for planning and
                organizing 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. Wherever resources permit this audit shall be done by CAB personnel only to
                establish the extent of conformity of the CAB to documented requirements or standards.
        2.5     The person responsible for management system may delegate the task of performing audits
                to personnel who are having sufficient technical knowledge with respect to the operations
                of the CAB, trained specifically in audit techniques and process. The auditors shall also
                understand requirements of ISO/IEC 17025:2017 or ISO 15189:2012 or ISO/IEC
                17043:2010 or ISO 17034:2016 (whichever is applicable) and NABL accreditation
                requirements.
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        2.6     In large CABs carrying out a wide range of technical activities, 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 person responsible for
                management system.
        2.7     In small CABs, the person responsible for management system 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 CAB has accreditation for site activities, or for sampling, these activities must be
                included in the audit program.
        2.10    Audits carried out by the other parties, such as customers or NABL, cannot be considered to
                substitute for or override the CAB’s own internal audit responsibilities.
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  3.    Planning of Audit
        3.1    An audit plan needs to be established by the person responsible for management system and
               should include the audit scope, the audit criteria, the audit schedule, reference documents
               (such as the CAB’s Management System Document / Quality Manual and audit procedure)
               and audit team members.
        3.2    The audit program may include horizontal audit / vertical audit + (wherever feasible) so that all
               the sections / departments are audited for every aspect / clause of the management system
               and relevant standard.
               +   Horizontal Audit - This examines one element in a process on more than one item. It is a
               detailed check of a particular aspect of the documentation and implementation of the
               management system.
               Vertical Audit - This examines one sample looking at all of the inputs, operations and
               activities required to produce the output (result). It is a detailed check that all elements
               associated with the activity are implemented.
        3.3    Each auditor should be assigned specific management system elements or functional
               departments to audit. Such assignments should be made by the person responsible for
               management system 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 17025:2017 or ISO 15189:2012 or ISO/IEC 17043:2010 or ISO 17034:2016.
               -     CAB’s Management System Document / Quality Manual 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).
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               -     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 plan and 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 (management system
                document / 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 CAB’s Management System Document /
                Quality Manual and related documents against which the audit has been conducted.
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        4.9     The audit team should hold a closing meeting with the top management of the CAB 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, and take the appropriate corrective action
                based on root cause analysis.
        4.10    The person responsible for management system should present observations, taking into
                account their perceived significance (both positive and negative aspects), and 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 person
               responsible for management system.
        5.2    When a non-conformity that may jeopardize the result of calibration / testing / medical testing
               / PT / RM, 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 cause of some
               problems and to implement effective corrective actions.
        5.4    The effectiveness of corrective actions should be checked by the person responsible for
               management system as soon as possible after the agreed time limit has elapsed and clear /
               close the non-conformity.
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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 and audit plan
               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 person responsible for management system / quality manager confirming
                     closure of the non-conformities and corrective action taken.
        6.4    The person responsible for management system should ensure that the report of the audit
               and, where appropriate, individual non-conformities, are seen by the CAB’s top management.
               The trends in results of internal audit and the corrective actions should be analysed by the
               person responsible for management system 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.
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  7.    Additional Unscheduled Audits
        7.1    It may be necessary for CABs to carry out additional unscheduled audits whenever there is
               reason to doubt the effectiveness of the management system. For example, when a non-
               conforming work has been detected or the CAB has received a complaint which raises a
               doubt on its competence and therefore 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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                                 A TYPICAL FORMAT FOR AUDIT PLAN
        1.   Horizontal audit plan
                 ISO/IEC 17025                DEPARTMENT /      DEPARTMENT /       DEPARTMENT /        DEPARTMENT /
                                              CAB SECTION 1     CAB SECTION 2      CAB SECTION 3       CABSECTION 4
   Cl. 4.1
   Cl. 4.2
   |
   Cl. 6.5
   |
   ||
   Cl 7.4
   |
   Cl 7.8
   ||
   ||
   Cl 8.4
        2.   Vertical audit plan
                 ISO/IEC 17025                DEPARTMENT /      DEPARTMENT /       DEPARTMENT /        DEPARTMENT /
                                              CAB SECTION 1     CAB SECTION 2      CAB SECTION 3       CAB SECTION 4
   Cl. 4.1
   Cl. 4.2
   Cl. 5
   |
   ||
   Cl 6.5
   |
   Cl 7.7
   ||
   ||
   Cl 8.9
  Note: These are examples may vary according to the size, scope, type and organisational structure of
         the CAB.
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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 or ISO 15189 or ISO/IEC
                                            17043 or ISO 17034 Clause No.:
   NON-CONFORMITY (NC) STATEMENT:
                                                                                        Signature of Auditor & date
   CORRECTIVE ACTION PROPOSED:
                                                                                        Signature of Auditee & date
   RESPONSIBILITY & TIME REQUIRED FOR CORRECTIVE ACTION:
                                                                Signature of Auditee/ HOD/ Person responsible for
                                                                                      management system & date
   ROOT CAUSE:
                                                                                        Signature of Auditee & date
   CORRECTIVE ACTION TAKEN:
                                                                                        Signature of Auditee & date
   CORRECTIVE ACTION VERIFIED & COMMENTS, IF ANY
                                                                     Signature of Auditor & Person responsible for
                                                                                       management system & date
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                                                SECTION - B
                     MANAGEMENT REVEIW
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  1.    Objectives of Management Reviews
        1.1    The top management of the CAB shall periodically conduct a review of the CAB’s
               management system and technical 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 CAB continue to meet both the CAB ’s needs
               and the requirements of ISO/ IEC 17025:2017 or ISO 15189:2012 or ISO/IEC 17043:2010 or
               ISO 17034:2016 whichever is applicable. 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
               CAB and ensure (through person responsible for management system) that management
               system continues to conform to the requirements of relevant standard.
        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 APAC/ ILAC.
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  2.    Organisation of Management Review
        2.1    The top management of the CAB should be responsible for conducting reviews of the
               management system.
        2.2    Those members of top management have overall responsibility for the design and
               implementation of the CAB’s management system, and for taking decisions resulting from the
               findings of internal audits, should be involved in management reviews. As a normal practice
               management review shall be organized after the internal audit.
        2.3    The person responsible for management system should be responsible for ensuring that all
               reviews are conducted in a systematic manner according to an established procedure, and
               that the management reviews are recorded.
        2.4    The person responsible for management system should also be ensure 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
               planned and the meeting should be attended by the top management, including the person
               under whose authority the Management System Document / Quality Manual has been issued.
               It is essential that the head of the CAB, technical management, the person responsible for
               management system and the section heads are present.
        3.2    It is recognized that in a small CAB, one person may be fulfilling more than one of the above
               functions. Good management reviews can occur even in single person CABs.
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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.
               The agenda of management review meeting should at least cover the requirements given in
               the corresponding clause of applicable standards e.g. ISO/IEC 17025:2017 or ISO
               15189:2012 or ISO/IEC 17043:2010 or ISO 17034:2016.
               a.
               b.
               c.
               d.
               e.
               f.
               g.
               h.
               i.
               j.
               k.
               l.
               m.
               n.
               o.
               p.
               q.
               r.
        4.2    It should be the responsibility of the person responsible for management system 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 responsibility of the person responsible for management system 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.
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National Accreditation Board for Testing and Calibration Laboratories (NABL)
                                   NABL House
                             Plot No. 45, Sector 44,
                          Gurugram - 122003, Haryana
                       Tel. no.: 91-124-4679700 (30 lines)
                              Fax: 91-124-4679799
                          Website: www.nabl-india.org