ISOM QUALITY INTERNAL AUDIT GUIDE

A GUIDE TO THE INTERNAL AUDITING

OF
ISO 9001:2000 QUALITY MANAGEMENT
SYSTEMS

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 ISOM QUALITY INTERNAL AUDIT GUIDE

First edition March 2002

 Copyright 2002 Isom Ltd.

This document may be reproduced by the purchaser for the sole

purpose of implementing the purchaser's own quality system.
Requests for reproduction for other purposes should be sent to Isom
Ltd at the address below.

Isom Ltd
9 Patford Street
Calne
Wiltshire
Tel: 01249 812343
Fax: 01249 816963
www.isom.co.uk
e-mail: info@Isom.co.uk

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 ISOM QUALITY INTERNAL AUDIT GUIDE

CONTENTS

Page No

CONTENTS 3

SECTION 1 INTRODUCTION 4
1.1 Purpose of the Guide 4
1.2 Aim of Internal Audit 4
1.3 Requirements for Internal Audit 5
1.4 Terminology 6

SECTION 2 DEVELOPING INTERNAL AUDIT PROCEDURES 7

2.1 General 7
2.2 Responsibilities 8
2.3 Planning and Preparing Internal Audit Procedures 8
2.4 Documenting Internal Audit Procedures 12

SECTION 3 PREPARING FOR AND CARRYING OUT

INTERNAL AUDITS 16
3.1 Pre-Audit Preparation 16
3.2 Opening Meeting 17
3.3 Carrying Out the Internal Audit 18
3.4 Closing Meeting 20

SECTION 4 POST AUDIT ACTIVITIES 21

4.1 Reporting to Quality Manager 21
4.2 Follow-up Action 21
4.3 Reporting to Top Management 22

APPENDIX 1 Example Audit Check/Record Form 23

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 ISOM QUALITY INTERNAL AUDIT GUIDE

SECTION 1

INTRODUCTION

1.1 Purpose of the Guide

Organizations operating Quality Management Systems (QMS)

approved to ISO 9000 standards are required to carry out periodic
Internal Audits of those systems. These audits are also known as First
Party Audits. Note that although references within this guide are
primarily to the ISO 9001:2000 standard, the guidance is also
applicable to internal audits for QMS to earlier versions of the standard
(ISO 9001, 9002 and 9003 of 1994).

The purpose of this guide is to provide information and assistance to

enable an internal audit system to be set up with the minimum of
expenditure. The guide is also intended to provide guidance to an
organization’s appointed internal auditors in the preparation for and
carrying out of those audits.

The information provided is based upon our experience as a small

technical writing company awarded registration to BS 5750 (the British
standard for quality systems at that time) on first assessment. Isom
achieved the award by using its professional technical writing skills to
prepare all the necessary QMS documentation for registration in-house,
seeking assistance from a consultant only when necessary. In taking
this course of action, the outlay in gaining registration was considerably
reduced. Subsequently, Isom’s QMS, including our Internal Audit
procedures, has been successfully updated in-house to meet the
requirements of ISO 9001:1994 and, more recently, ISO 9001:2000.

1.2 Aim of Internal Audit

The Internal Audit should ascertain the level of control that the
organization has over its quality systems and the effectiveness of those
systems. Ideally (and hopefully), you are confirming that your

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 ISOM QUALITY INTERNAL AUDIT GUIDE

organization is operating according to its documented QMS procedures

and that the organization is in control of the QMS, its implementation,
maintenance and improvement.

1.3 Requirements for Internal Audit

The mandatory requirements for Internal Audits are defined in clause

8.2.2 of the ISO 9001:2000 standard.

In summary, the organization is required to conduct Internal Audits at

planned intervals to determine whether its QMS:
• conforms to the requirements of the standard;
• conforms to the organization’s planning for product realization;
• conforms to the QMS requirements previously established by the
organization;
• is being implemented and maintained effectively.

Planning of an internal audit programme should take into account the

status and importance of the processes or activities to be audited and
should also consider the results of previous audits.

The standard requires the audit to be an objective and independent

examination of the quality activities - auditors should not have been
involved in the process or activities being audited.

The ISO 9001:2000 standard is usually issued as a set complete with

the following related standards:

• ISO 9000:2000: Quality management systems - Fundamentals and

vocabulary. This standard includes definitions of the terminology
used throughout the series of standards (see 1.4 Terminology
below).
• ISO 9004:2000: Quality management systems - Guidlines for
performance improvement. This standard includes guidelines for
g1improving a QMS beyond the requirements of ISO 9001:2000.
Guidelines relevant to internal audit are found in clause 8.2.1.3.

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1.4 Terminology

Generally, terminology within this guide is the same as used with the
ISO 9001:2000 standard (and defined within the ISO 9000:2000
standard). For example, ‘organization’ is used to denote a company,
corporation, firm, enterprise, business, etc.

Of particular importance for internal audits, ‘nonconformity’ is defined

as:
‘non-fulfillment of a requirement’

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 ISOM QUALITY INTERNAL AUDIT GUIDE

SECTION 2

DEVELOPING INTERNAL AUDIT

PROCEDURES

2.1 General

ISO 9000:2000 defines an audit as a:

‘systematic, independent and documented process for obtaining
audit evidence and evaluating it objectively to determine the
extent to which audit criteria are fulfilled’

In the context of a QMS, systematic means that:

• audits are carried out according to a plan;
• the whole QMS is audited within a pre-determined period;
• the audits are carried out according to documented procedures;
• the audit findings are formally reported and recorded;
• effective post-audit action is taken where required.

The complexity of your Internal Audit procedures will depend to a large

extent on the size and complexity of your organization and of your
QMS. Due to the size of our organization and the nature of our
business, Isom is fortunate in that our Internal Audits are conducted by
one auditor carrying out one documented procedure. A large, multi-
department, organization may need to develop several different Internal
Audit procedures, each one tailored to the needs of a particular
department, or even a particular process area. In each case, however,
the aim of the audit is the same and the procedures should all follow
the same principles.

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2.2 Responsibilities

Overall responsibility for planning and conducting Internal Audits,

reporting results and maintaining records lies with top management. In
all but the smallest organizations these responsibilities will be delegated
to a Quality Manager. The Quality Manager may head a separate
Quality Department, which includes designated auditors, or may
operate without their own staff, relying on auditors co-opted from other
parts of the organization on an as-needed basis.

Managers of departments or areas audited are responsible for ensuring

that follow-up actions, particularly regarding any detected
nonconformities and their causes, are carried out without undue delay.
Where necessary, the follow-up actions should be verified and the
verification recorded.

2.3 Planning and Preparing Internal Audit Procedures

When planning an Internal Audit System, you need to make the

following decisions:
• how many individual internal audit procedures are required;
• how often should the internal audits be carried out;
• what should be included in the procedure for each internal audit;
• who should carry out the internal audits;
• what are the responsibilities of auditors.

Requirements for individual internal audits

The first stage in planning procedures is to determine how many

individual internal audits will be required. It is possible to audit small
organizations with one procedure and in one operation. Larger
organizations will require individual audits for separate departments,
e.g. Finance, Stores, Drawing Office, etc., or even for separate work
areas, e.g. Calibration Control of measuring/checking instruments.
There are no hard and fast rules, you should be guided by your
experience, knowledge of the organization and common sense - each

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audit should be capable of a being carried out by a single auditor in a

reasonable time frame.

When planning audits for individual departments arrange for them to

cross bridges between related departments/work areas - e.g. between
Stores and Receipt and Despatch, or between Stores and Goods
Inward. Do not leave gaps that may remain un-audited and
consequently hide potential problems.

Frequency of audits

The ISO 9001:2000 standard requires only that internal audits are
conducted at ‘planned intervals’ - there is no guidance as to what those
intervals should be.

Certainly, the internal audits should be carried out no less than once
per year. More meaningful results will be obtained if they are carried
out more often. Obviously, the higher the frequency of the internal
audits, the greater need for auditing resources and the greater the
interruption to day-to-day operation of the organization. In Isom’s case,
we considered every six months to be a reasonable compromise. It
should also be noted that it is perfectly acceptable to audit some
activities at a higher frequency than others

Where a number of individual audits are required an audit schedule

should be prepared. This schedule should show which department,
work area, etc. is audited and when. It should also show which, if any,
activities are audited more often than others and that the complete
QMS is audited within the pre-determined period.

Content of Internal Audit procedure

What to include in a procedure for Internal Audit will to a large extent

depend upon your own QMS. However, there are some fundamental
questions to be answered which will provide a basis for your audits,
these are:
• has the nature of the product and/or process changed since last
audited, i.e. do the QMS procedures, work instructions, etc. reflect
current practice and are they still relevant?

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• are staff aware of the organization’s quality policy and are the
quality procedures and objectives relevant to their work?
• does the quality of the organization’s product(s) reflect that staff
are adequately and appropriately trained, skilled and competent?
• are the relevant documented procedures being followed?
• are appropriate records being kept?

The procedure should be structured to provide answers to the above

questions as applied to your QMS. Further information on this subject
is given in 2.4 Documenting Internal Audit Procedures.

Assigning personnel for auditing

Depending on the structure of your organization, the required auditors

may be part of a dedicated Quality department or may be temporarily
seconded from other activities.

The standard does not include specific requirements for the source of
internal auditors. However, it does state that the selection of auditors
should ‘ensure objectivity and impartiality of the audit process’ (ISO
9001:2000 clause 8.2.2). Neither does the standard include a
requirement for specially trained internal auditors, although it does
include a general requirement that staff performing specific tasks
affecting quality should be assigned on the basis of appropriate
education, training, experience and competency (ISO 9001:2000 clause
6.2.1). These points should be considered when selecting and
assigning auditors.

It is suggested that a good auditor will have most of the following

personal qualities:
• be objective and analytical with reasoned judgement;
• be mature and self-motivated;
• be a good communicator (both written and oral);
• be tenacious;
• be tactful, diplomatic and patient;

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• be open minded and flexible.

Quite a tall order and obviously very much the ideal auditor.

Responsibilities of individual auditors

Generally organizations will utilize an audit team comprising several

auditors under the control of a lead auditor. The audit team being
under the overall control of the Quality Manager.

Overall, an audit team are responsible for:

• complying with the requirements of the audit;
• communicating and clarifying the requirements of the audit to
other management and personnel;
• carrying out the audit in accordance with the documented Internal
Audit procedures;
• recording the audit results and safeguarding audit documents;
• verifying that corrective actions are carried out effectively;
• ensuring that confidential and ‘privileged’ information is treated
with due respect and discretion;
• bringing audit observations and recommendations to the attention
of management.

Principal responsibilities of a lead auditor are:

• assisting with selection of auditors;
• control and representation of the audit team;
• control of the complete audit;
• final decisions on:
conduct of the audit;
the audit report, observations and recommendations.

Individual auditors are responsible for:

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• supporting and co-operating with the Lead Auditor:

• planning and carrying out assigned audit tasks;
• documenting observations during the audit;
• reporting audit results to the Lead Auditor;
• assisting the Lead Auditor to compile the audit report.

Obviously, if only one auditor is used, their responsibilities will be a

combination of all the above.

2.4 Documenting Internal Audit Procedures

The procedures for Internal Audit must be documented and can be

included in the organization’s Quality Manual or in a separate Quality
Procedures Manual or even as separate stand-alone procedures.
There is no set down format within the ISO standard; it is a matter of
choice. Isom chose to present these in a separate Quality Procedures
Manual, mainly to keep the Quality Manual from seeming ‘cluttered’.
Choose what best suits your organization. However, if the procedures
are not included in the Quality Manual there must be references to
them within that manual.

The audit documentation usually consists of a combination of text

describing internal audit policy and management responsibilities (which
will be included in the Quality Manual and/or associated Quality
Procedures Manual) and separate working procedures for the auditors.
These working procedures are most usefully presented in the form of
check lists with ‘tick’ boxes (or YES/NO boxes) for ease of completion.
Points to consider when compiling these procedures/check lists are:
• decide audit objective(s) linked to specific requirements of the
standard;
• identify aspects of the QMS documented procedures which are
relevant to the department/work area being audited;
• identify relevant process inputs, outputs, interfaces (e.g. with other
processes), inspection points, hold points and any feedback
loops;

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• follow a logical sequence to avoid unnecessary return visits to

areas or personnel already audited.

Taking Isom’s documentation as an example, text in the Quality Manual

combines a statement of the organization’s responsibilities with a broad
outline of the procedure and is as follows:

Internal Audit
(ISO 9001:2000, Clause 8.2.2)

To ensure that the organization’s QMS is being operated correctly and

effectively, the Quality Manager shall organise a system of internal audits.

At least one audit must be carried out in every six month period. Any higher
frequency of audits is at the discretion of the Quality Manager. The Quality
Manager may assign any suitably trained personnel to carry out the audit but
must ensure that the personnel assigned has not been involved in the
activities being audited.

The results of audits will be analysed in Management Review (refer to

SECTION 2).

Internal Audits shall be carried out using QMS Form 6. Procedures for
Internal Audits are described in 1.3 INTERNAL AUDIT in SECTION 1 of the
organization’s Quality Procedures Manual.

As can be seen, this text refers to the more detailed procedures

included in the associated Quality Procedures Manual as follows:

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1.3 INTERNAL AUDIT

(ISO 9001:2000, Clause 8.2.2)

In compliance with SECTION 5 of the Quality Manual, the Quality Manager

shall organise a system of internal quality audits.

At least one audit shall be carried out on a six-monthly basis. Any higher
frequency of audits is at the discretion of the Quality Manager.

The Quality Manager may assign any suitably trained personnel to carry out
the audit but must ensure that the personnel assigned have not been involved
in the activities being audited.

The audits shall be carried out by using QMS Form 6 (refer to Appendix F)
and are designed to ensure the following:
(1) That quality system documentation adequately defines the needs of
the organization.
(2) That the documented procedures are practical, understood and
followed.
(3) That training is adequate.
(4) That customer satisfaction can be measured and monitored (refer to
SECTION 5 of the Quality Manual and Appendix L of this manual).

The results of the audit shall be recorded on QMS Form 6 (refer to Appendix
F) and shall indicate the following:
(1) The deficiencies found.
(2) The corrective action required.
(3) The time agreed for corrective action to be carried out.
(4) The person responsible for carrying out the corrective action.
(5) The recommendations for improvements as necessary.

QMS Forms 6 shall be filed with other Quality Records by the Quality Manager
and shall be made available when Management Reviews are carried out.

This text defines the responsibility for organizing the audits, their
planned frequency and the criteria for assigning auditors. The text also
gives a summary of what the audit should achieve and what should be
included in its record - in Isom’s case this also refers to our QMS Form

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6 which is used to carry out and record the actual Internal Audit (refer to
text below).

Note that the Isom text refers to ‘... suitably trained personnel ...’ (see
2.3 Planning and Preparing Internal Audit Procedures).

The auditors’ procedures/check lists should enable them to:

• ensure that the appropriate QMS procedures are being followed
correctly;
• ensure that process/product inspections are being carried out
correctly;
• ensure that any required documentation (e.g. forms) has been
completed correctly;
• ensure that the required QMS records have been completed and
filed;
• identify nonconformities with the organizations QMS.

Isom’s Internal Audits are carried out using the QMS form mentioned
above. This is an integral part of the procedure and is used as an
enhanced check list. A copy of the form is reproduced as Appendix 1
to this guide. Notes on the use of the form are included as italic text in
grey boxes.

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SECTION 3

PREPARING FOR AND CARRYING OUT

INTERNAL AUDITS

3.1 Pre-audit Preparation

Depending upon the organization's structure, size and its QMS, some
or all of the following preparatory actions may need to be carried out by
the audit team, or auditor, prior to the audit:
• review the scope and size of the audit, determine size of audit
team;
• obtain audit check lists (procedures) and ensure they are up to
date and complete;
• obtain details (work carried out, personnel, management
structure) of the department(s) or process area being audited;
• obtain copies of relevant work process flow charts or work
instructions;
• prepare audit programme and agree programme with auditees;
• obtain details of any restrictions that may apply to the audit (e.g.
restricted access to certain areas on security or safety grounds);
• arrange for departmental guide(s) or escort(s) for the auditor(s),
these guides should:
have a good knowledge of the activities carried out by the
department or work area being audited;
know the names, titles, etc. of department personnel;
be capable of understanding audit observations.

The mutually agreed audit programme formalizes the audit and should:
• inform those involved (the auditees) about what will happen during
the audit;

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• enable the audit to be carried out efficiently;

• enable the audit to be carried out with the minimum of disruption
to the auditees’ work;
• ensure that a complete audit will be carried out.

The lead auditor should assign specific tasks to each team auditor
before the opening meeting.

3.2 Opening Meeting

The internal audit should start with an 'Opening Meeting' with the head
of the department/work area being audited. The objectives of the
opening meeting are:
• to confirm arrangements for the audit; to introduce the audit team;
• to meet key participants in the audit;
• to confirm specific details (of the department/work area);
• to brief the departmental management/work area supervisors and
to answer any questions raised;
• to gain information about the working of the department/work
area;
• to verify that nothing has changed since pre-audit contact;
• to allow clarification of any aspect of the audit.

The audit team should arrive together and at the agreed time. The
meeting should be controlled by the lead auditor who should endeavour
to maintain the initiative at all times. Other auditors within the team
should contribute to the meeting when invited to do so. The meeting
should be kept as short as possible; time wasting should be avoided.

If considered necessary, a brief familiarization tour of the department/

work area being audited may follow the opening meeting.

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3.3 Carrying Out the Internal Audit

The precise actions of an auditor during an internal audit will, of course,

depend upon the documented procedure/check list. There are,
however, definite right and wrong ways to conduct an audit. The
following are generally considered to be good auditing practice:

Behaviour of auditors
• the auditor should show a friendly but formal approach to
auditees;
• the auditor should be observant and understanding;
• the auditor should strive to achieve good communication and
recording during the audit;
• the auditor should be aware of their ‘body language’, e.g. do not
display aggression, do not point fingers at auditees, etc.

Interviewing auditees
• use the procedures/check lists as guides, do not be inhibited by
them;
• wherever possible, ask only open-ended questions’, e.g. ‘How do
you monitor the ...?’ not ‘Do you monitor the ... by ...?’;
• allow the auditee time to answer your question fully, do not lead
their answers;
• do not let the departmental guide or escort answer for the auditee;
• observe the auditee’s body language, are they:
looking uncomfortable;
looking too comfortable/acting too confidently;
passing ‘secret messages’ (by means of gestures, facial
expressions, etc.) to other auditees;
• wherever possible use the ‘feedback loop’ method of checking,
i.e.:
ask questions (open-ended) to provide information;
observe what is happening;

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check the relevant documented instructions provided,

records generated and interfaces for compliance;
record positive or negative ‘objective’ evidence.
• do not criticise auditees at the work place (see also ‘When
nonconformities are discovered’ below).

When nonconformitiess are discovered

• DO NOT:
criticise the employee;
tell them that you are going to raise a nonconformity;
write out the nonconformity notes at the auditee’s workplace.
• DO:
thank the auditee for their time and attention;
discuss the nonconformity in private with the auditee’s
manager or supervisor.

Grading nonconformitiess in a QMS

Any nonconformitiess found should be graded as follows:

Critical - This is a nonconformity that is likely to result in an unsafe
product or in unsafe conditions for people using that product. The
required corrective action should be given the highest priority and
completed as soon as possible.
Major - Although not critical, this grade may result in failure of, or
seriously reduce the use, of a product. A failure to meet a
requirement of the standard, or a nonconformity having a significant
effect on efficiency or cost should also be graded as Major.
Minor - Any nonconformity that, although not desirable, will not
seriously affect the use of the product should be graded as Minor.
Correction of items in this grade will result mainly in improvements to
the QMS.

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Before leaving the audit site

• find a quiet location to gather your thoughts and organize the
paperwork;
• allocate significance to your findings;
• write up the appropriate section(s) of your report.

3.4 Closing Meeting

For the closing meeting, the audit team should report back to the
people (appropriate managers, supervisors, etc.) that attended the
opening meeting. The following protocol should be observed during
this meeting:
• address comments to the manager or other senior person
present;
• do not criticise any of the auditees;
• confine the discussion to the relevant features of the QMS and
product realization process(es);
• do not try to tell the managers/supervisors how to do their jobs:
• include the positive findings of the audit;
• invite agreement on the audit findings, try not to close the meeting
with disagreements outstanding - it may be better for the audit
team to back-down on some contentious findings;
• reach agreement on nonconformitiess, the associated corrective
action required and the timing of that action;
• invite suggestions for actions:
• answer all queries;
• produce a (hand written) summary of the meeting and get it
signed by the manager/supervisor before closing the meeting.

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SECTION 4

POST AUDIT ACTIVITIES

4.1 Reporting to Quality Manager

Following the closing meeting, the audit report should be finalised and
completed. The report should then be submitted to the Quality
Manager. The Quality Manager should be briefed on any
nonconformitiess found and the associated corrective action(s) and
timing agreed with the auditees. Depending upon your findings, the
Quality manager may decide that a complete re-audit is required; any
such decision should be communicated without delay to the
department.

4.2 Follow-up Action

On completion of the original audit and after discussion with the Quality
Manager (see 4.1. above), the actions detailed below should be carried
out:

• arrange the time and programme for recheck or re-audit, as

appropriate, with the department manager or supervisor;
• on the recheck/re-audit, concentrate on the nonconformities
previously reported or the improvements suggested and agreed.
Ensure that the underlying causes of the nonconformities have
been corrected;
• when all corrective/preventive action is complete, finalise the audit
report and submit it to the Quality Manager for archiving.

Note that any corrective/preventive action to be completed before the

next audit should be clearly identified.

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4.3 Reporting to Top Management

Your organization’s procedures may require that you also report audit
findings to top management. In this case it is likely that the report is
made jointly by the auditor and Quality Manager.

Management are likely to see any recommendations for improvement

as probable costs to the organization and are likely to resist them.
These are probably best presented visually as a cost/benefit impact
matrix in which the cost is shown is shown in relation to the benefits.
As an example, the audit may well have highlighted a particular QA
procedure that is not being carried out well because the associated
documentation (e.g. work instruction) is poorly laid out and not easily
understood. As a result the rejection rate from this part of the process
is unnecessarily high. Revising the documentation to improve its layout
and make it readily understandable will be low in cost but should be
high in benefit due to decreased rejection rates. This is shown on the
example matrix:

High

Cost

Low n
Revise documentation

Low Benefit High

Management will show great enthusiasm for Items in the bottom right of
the matrix; items in the top left hand will be of no interest whatsoever!

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APPENDIX 1 - EXAMPLE AUDIT CHECK/RECORD FORM

Isom has basically one production

process which outputs a product
tailored to suit different clients needs.
The project number identifies the client
and thus the variation.

These questions are asked of the

organization as a whole. The
Deficiencies/Recommendations/
Remarks can refer to the whole
organization or to specific projects.

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These questions refer to specific QMS

processes or to stages in the production
process.

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These questions are intended to

highlight any problems with particular
disciplines or the skills of individuals
and thus pinpoint training and
development needs.

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The initials will be those of the person

responsible for carrying out the
necessary corrective action(s) and are
intended to signify that persons
agreement to taking that action.

The Quality Manager (or other

designated responsible person) will
sign-off the audit and file it in the QMS
records system.

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