ISO 9001:2000

Auditing a Quality Management System

Section 2

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 ISO 9001:2000

Objectives
At the end of this section every participant will be able to
 knowledge the quality system audit processes and
established requirements for being assigned as an
auditor for carrying out assessment based on quality
systems standards.

 Understand the activities of audit and the audit report

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 ISO 9001:2000

Section contents

 QMS audit definition

 Types of audit
 Party definition
 Audit objectives and responsibilities
 Auditee Responsibility
 Audit scope
 Audit stages
 Audit Preparation
 Audit Execution
 Subsequent Action

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 ISO 9001:2000

QMS audit definition

 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.
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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Audit
Audit
Programme Auditee

Audit
Scope Audit client

Audit Audit Team

Audit Criteria
Auditor
Evidence

Tech
Audit Audit Expert
Finding Conclusions Qualifications

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 ISO 9001:2000

Objective Evidence

 Data supporting the

existence or verity of
somthing

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 ISO 9001:2000

Nonconformity

 Non-fulfilment of a
requirement

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 ISO 9001:2000

Party definition
 First party – The organisation
 Second Party – The Purchaser, customer,
Client, Supplier, ….etc
 Third Party – An Independent Organisation
carrying out an audit on behalf of a client or an
Accredited Certification Body

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 ISO 9001:2000

Reasons for conducting Audits

To determine the conformity or non-
conformity of the quality system
elements with specified requirements.
To determine the effectiveness of the
implemented QMS.

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 ISO 9001:2000

Audit scope
 The customer or interested parties make the
final decisions on which QMS elements,
physical locations and organizational
activities are to be audited within a specified
time frame.
 This should be done with the assistance of
the lead auditor.
 If appropriate, the audited should be
contacted when determining the scope of the
audit .
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 ISO 9001:2000

Audit Procedure
 The method for planning, initiating and
conducting audits and follow up activities
including corrective actions

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 ISO 9001:2000

Review

QMS audit definition

Types of audit
Party definition
 Audit objectives and responsibilities
Auditee Responsibility
Audit scope

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 ISO 9001:2000

Audit stages

1- Preparation

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation a. Initial planning

b. Preliminary visit
c. Detail planning

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages
a. The opening meeting
1- Preparation b. The actual audit
c. Report preparation
d. the closing meeting

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation

2- The Audit

a. Issue the audit report

b. Closing out agreed corrective action 3- Subsequent Action
c. Planning surveillance, periodic
review or re-audit
d. Compiling record

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 ISO 9001:2000

Audit stages

1- Preparation  Initial Planning

 Decide who shall carry out the audit
2- The Audit  Identify Requirement
 Notify the Auditee

3- Subsequent Action  Agree Date

 Preliminary visit
 Gather information

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 ISO 9001:2000

Audit stages

1- Preparation  Preliminary visit

 Meet the Management & Staff
2- The Audit  Determine the Standard requirement
 Inform the auditee of the purpose of

3- Subsequent Action audit

 Gain knowledge of the products &
facilities
 Decide on the audit structure, team &
duration

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 ISO 9001:2000

Audit stages

1- Preparation  Preliminary visit

 Check for any special security & safety
2- The Audit arrangement
 Answer all auditee questions - so as to
clam their fears
3- Subsequent Action
 Obtain copies of auditee’s Quality
manual, procedures, and flowcharts
 Site layout

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 ISO 9001:2000

Audit stages

1- Preparation  Detail planning

 The audit plan should be approved.
2- The Audit
 The audit plan should be designed to

3- Subsequent Action be flexible in order to permit changes.

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 ISO 9001:2000

Audit stages

1- Preparation  Detail planning

 The audit objectives and scope.
2- The Audit
 Identification of the individuals
3- Subsequent Action having significant direct
responsibilities regarding the
objectives and scope.
 Identification
of reference
documents).

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 ISO 9001:2000

Audit stages

1- Preparation  Detail planning

2- The Audit
3- Subsequent Action
 Identification of audit team members.
 The language of the audit.
 The date and place where the audit is
to be conducted.
 Identification of the organizational units
to be audited.

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 ISO 9001:2000

Audit stages

1- Preparation  Detail planning

2- The Audit
3- Subsequent Action
 The expected time and duration
for each major audit activity.
 The schedule of meetings to be
held with audited management.
 Confidentiality requirements.
 Audit report distribution and the
expected date of issue.

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 ISO 9001:2000

Audit stages

1- Preparation  Audit Team

 The Audit Team must be supplied
2- The Audit with copies of:
 The specification
 Any applicable Contracts against which
3- Subsequent Action the audit is going to be conducted
 check lists, forms, …. Etc..

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 ISO 9001:2000

Audit stages

1- Preparation  Audit Team

 Team Size & Audit Duration will depend
2- The Audit on:
 The size & complexity of the company
 The specification to be applied
3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Working Documents

 Thedocuments required to facilitate the
2- The Audit auditor’s investigations, and to document
and report results, may include:
 Check-lists
3- Subsequent Action
 Forms

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 ISO 9001:2000

Audit stages

1- Preparation  Check-lists
 Are used by the assessor as an Aide
2- The Audit Memoir
 Ensure that all elements of a
specification are addressed
3- Subsequent Action
 Are an invaluable aid when writing the
assessment report
 What, where, who, when, how,& why
questions
 Close questions not used.

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 ISO 9001:2000

Example
AUDIT CHECKLIST ASSESSMENT No:
SPECIFICATION: LOCATION: DATE:
REQUIREMENT CLUSE OBSERVATION

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 ISO 9001:2000

Example
AUDIT CHECKLIST ASSESSMENT No:
SPECIFICATION: ISO 9001 LOCATION: TOP MGT. DATE: 1/1/2007
REQUIREMENT CLUSE OBSERVATION

-How management 5.6

reviews been carried out

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 ISO 9001:2000

4 Group
Exercise (9) Time:30

 Clause checklists

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 ISO 9001:2000

Audit stages

1- Preparation  Forms
 Nonconforming Report (NCR).
2- The Audit  Audit Report.

3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Nonconforming Report (NCR).

 What is the Problem? describe
2- The Audit clearly, concisely and factually.
 Why is it a noncompliance? i.e.
3- Subsequent Action against what requirement.
 Where did it occur? ( i.e. which
department or activity).
 Who avoid apportioning blame
(i.e. naming individuals).
 Objective Evidence.

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 ISO 9001:2000

Audit stages

1- Preparation  Nonconforming Report (NCR).

2- The Audit
3- Subsequent Action
 Used to report nonconformity audit
findings
 Must be factual.
 Must be understandable and
traceable.
 Allow the auditee to implement
corrective action prior to the
closing meeting.

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 ISO 9001:2000

Audit stages

1- Preparation  Non-compliances Categorisaton

 Major
 A lack of procedures needed to satisfy an
2- The Audit
agreed requirement.
 Non-implemented of documented procedure
3- Subsequent Action and arrangements.
 A series of minor non-compliances in a
particular area or activity which collectively
have an adverse effect on product or service
quality.

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 ISO 9001:2000

Audit stages

1- Preparation  Non-compliances Categorisaton

 Minor
Minor discrepancies or lapses in discipline.
2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages
a. The opening meeting
1- Preparation b. The actual audit
c. Report preparation
d. the closing meeting

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Opening Meeting

2- The Audit
3- Subsequent Action
 Punctuality – arrive on time
 The meeting should be brief and to the point.
 General introduction by the audit team and
management.
 Confirmation of the purpose, scope and
exclusions.

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 ISO 9001:2000

Audit stages

1- Preparation  Opening Meeting

2- The Audit
3- Subsequent Action
 Agree arrangement for the closing
meeting
 Review of the programme.
 Provision of guides.
 Check availability of facilities
 Explain the format which the report will
take.

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 ISO 9001:2000

Audit stages

1- Preparation

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Guides
 Selected by the auditee management to
accompany the auditor.
2- The Audit  May or may not be authorized to agree &
resolve noncompliance.
3- Subsequent Action  Will normally assist the auditor with identifying
procedure, activities, and staff
 Should not answer questions on behalf being
audited.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors’ Code of Conduct

 To strive to increase the competence
2- The Audit and prestige of the auditing profession.
 To assist those in my employ or under
my supervision in developing their
3- Subsequent Action
management, quality and auditing skills.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors’ Code of Conduct

 Not to represent conflicting or competing
2- The Audit interests and to disclose to any client or
employer any relationships that may
influence my judgment.
3- Subsequent Action
 Not to discuss or disclose any
information relating to an audit unless
authorized in writing by the auditee and
the auditing organisation.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors’ Code of Conduct

 Not to accept any inducement,
2- The Audit commission, gift or any other benefit
from auditee organizations, their
employees or any interested party or
3- Subsequent Action knowingly allow colleagues to do so.
 Not intentionally communicate false or
misleading information that may
compromise the integrity of any audit or
the auditor certification process.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors’ Code of Conduct

 Not to act in any way prejudicial to the
2- The Audit reputation or interest of the audit
organisation.
 Not to act in any way prejudicial to the
3- Subsequent Action
reputation or interest or credibility of
IRCA.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors’ Code of Conduct

 To act professionally, accurately and in
2- The Audit an unbiased manner.
 In the event of any alleged breach of this
code, to co-operate fully in any formal
3- Subsequent Action
enquiry procedure.

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 ISO 9001:2000

Audit stages

1- Preparation  Auditor Characteristics

 Diplomatic
 Honest
2- The Audit
 Impartial
 Communicative
3- Subsequent Action
 Helpful
 Persistent
 Ethical
 Conscientious

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 ISO 9001:2000

Audit stages

1- Preparation  Auditor Characteristics

 Patient
 Fair minded
2- The Audit
 Articulate
 Analytical
3- Subsequent Action
 Co-operative
 Observant
 Professional

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 ISO 9001:2000

Audit stages

1- Preparation  Audit Technique

 Ask Questions
2- The Audit  Examine Objective Evidence
 Observe Activities

3- Subsequent Action  Listen to Reactions

 Record Finding

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 ISO 9001:2000

Four groups
Exercise (10) Time: 15 min

1- Preparation  Dealing with Problems

 Auditor may not always receive full co-
2- The Audit operation form auditee.
 What are the types of un co-operative auditee
 How to deal with this problem
3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Auditors Six Friends

when asking questions ….
2- The Audit Who?
what?
3- Subsequent Action
where?
when?
why?
how?
and the seventh …. Ok Show Me?

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 ISO 9001:2000

Audit stages

1- Preparation  YES/NO Questions

 Often elicit dead end answer – you gain
2- The Audit nothing.
 Direct questions - will achieve more
detail answer.
3- Subsequent Action
 Explanation questions – useful for
comparing interfaces.

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 ISO 9001:2000

Audit stages

1- Preparation  Objective Evidence

 Try to establish:-
 That authorised documents are in use
2- The Audit
 That superseded drawing have been
removed
3- Subsequent Action  That good housekeeping is practiced
 That facilities are adequate
 That supervision is adequate

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 ISO 9001:2000

Audit stages

1- Preparation  Objective Evidence

 Try to establish:-
 That orderly records are kept
2- The Audit
 That staff are adequately trained

Well prepared checklists will assist when

3- Subsequent Action answering these questions.

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 ISO 9001:2000

Audit stages

1- Preparation  Finding the Root Cause

 Investigate Noncompliance
2- The Audit  Establish the Root Cause
 Recording the results

3- Subsequent Action

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 ISO 9001:2000

Auditee Noncompliance Auditor

Root Cause Finder

Corrective action Acceptor

Execution

Fallow up

Close
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 ISO 9001:2000

Audit stages

1- Preparation  Audit techniques

DESIGN HORIZONTAL
2- The Audit
PURCHASING HORIZONTAL
3- Subsequent Action
VERTICAL
PRODUCTION HORIZONTAL

TRAINING HORIZONTAL

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 ISO 9001:2000

Audit stages

1- Preparation  Conducting The Audit

 Remember the auditor is attempting to
2- The Audit prove the system
 The aim is not to set out to fail the
system.
3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation  Observations
 Sample taken
2- The Audit  Seeking objective evidence
 Both positive & negative observations

3- Subsequent Action are recorded.

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 ‫‪ISO 9001:2000‬‬

‫‪Exercise‬‬ ‫‪Time:75 min‬‬

‫دراسة حالة‬
‫‪ ‬العمل في مجموعات و مناقشة الحاالت القادمة و االتفاق على‬
‫البند و البند الفرعي من المواصفة المطابق للحالة و على كل من‬
‫المتدربين تحديد سبب إختيار البند‬

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 ISO 9001:2000

Audit stages

1- Preparation  Team meeting

 To discus audit findings
2- The Audit  To discus and agree nonconformities
 To categorize nonconformities

3- Subsequent Action  To plan presentation of audit result for

the closing meeting
 Prepare written report

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 ISO 9001:2000

Audit stages

1- Preparation  Assessment report contents

2- The Audit
3- Subsequent Action
 Audit aim, purpose, scope & exclusions
(as appropriate).
 Number of nonconformities & summary
of audit findings.
 Description of good points and any main
concerns
 Statement on agreed corrective actions
including timescales.
 Identify opportunities for improvement.
 Agreed follow – up actions
 Recommendations

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 ISO 9001:2000

Audit stages

1- Preparation  Assessment report attachments

 Opening/Closing meeting attendance
2- The Audit list.
 Copies of nonconformities.

3- Subsequent Action  Lead Auditor signature and date.

 Distribution agreed at meeting.

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 ISO 9001:2000

Audit stages
 Purpose of closing Meeting
1- Preparation
 Advise auditee of findings and
conclusions reached based on
2- The Audit nonconformities found during the audit.
 Recommend:
3- Subsequent Action  ACCEPTABLE
 CONDITIONAL
 UNACCEPTABLE

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 ISO 9001:2000

Audit stages
 Closing meeting
1- Preparation
 Thank management for help.
 Explain that sample taken has
2- The Audit
determined conclusion reached.
 Ask management to defer questions until
3- Subsequent Action
end of summary presentation to
appreciate full picture (unless for
clarification).
 Present summary report
 Quantify noncompliance's
 Conclusion
 Recommendations

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 ISO 9001:2000

Audit stages
 Closing meeting
1- Preparation
 Each team member to present
noncompliance details.
2- The Audit
 Invite questions – for clarification only.
 Agree follow up actions required and ask
3- Subsequent Action
for date by which action will have been
completed.
 Agree distribution of final report.
 Make statement of confidentiality.

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 ISO 9001:2000

Exercise Time:20 min

1- Preparation  Opening & Close Meeting

2- The Audit

3- Subsequent Action

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 ISO 9001:2000

Review

1- Preparation  The opening meeting

 The actual audit
2- The Audit  Report preparation
 the closing meeting
3- Subsequent Action

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 ISO 9001:2000

Audit stages

1- Preparation

2- The Audit a. Issue the audit report

b. Closing out agreed corrective action
c. Planning surveillance, periodic
3- Subsequent Action review or re-audit
d. Compiling record

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 ISO 9001:2000

Audit stages

1- Preparation  Monitoring Corrective Actions:

 To ensure actions raised are being
2- The Audit implemented by auditee
 The agreed timescales are achieved
 Corrective actions are effective
3- Subsequent Action

 Noncompliance's should be closed out at

each visit.

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 ISO 9001:2000

Corrective Actions Responsibilities

Nonconformity

NCR Sign Agreement Category Report of

AR AE AR Closing meeting AR

Accept/Reject Implement
Propose CA
Proposed CA CA
AE
AR AE

Monitor effective Complete action Review action

Action taken Taken
AE AE AR

Reject Action taken or close NCR

AR

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 ISO 9001:2000

Audit stages

1- Preparation  surveillance
 Purpose
 To ensure the quality system remain in
2- The Audit
compliance.
 Carried out by
3- Subsequent Action  Certification organization
 Client or customer
 Frequency
 Six monthly with most certification bodies
 As specified in each contract
 May be pre-planned or unannounced

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 ISO 9001:2000

Auditor’s responsibilities
 Auditors are responsible for:
Verifying the effectiveness of corrective
actions taken as a result of the audit (if
requested by the client).
Retaining and safeguarding documents
pertaining to the audit:
 Submitting such documents as required.
 Ensuring such documents remain confidential.
 Treating privileged information with discretion.
 Cooperating with and supporting the lead auditor.
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 ISO 9001:2000

Lead auditor’s responsibilities

 The lead auditor is ultimately responsible

for all phases of the audit.

 The lead auditor should have management

capabilities and experience and should be
given authority to make final decisions
regarding the conduct of the audit and any
audit observations.
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 ISO 9001:2000

Lead auditor’s responsibilities

 The lead auditor’s responsibilities also cover:
Assisting members with the selection of
other audit team.
Preparation of the audit plan.
Representing management the audit team
with the audited' s
Submitting the audit report.
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 ISO 9001:2000

Independence of the auditor

 Auditors should be free from bias and

influences which could affect objectivity.

 All persons and organizations involved with

an audit should respect and support the

independence and integrity of the auditors.

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 ISO 9001:2000

Auditee Responsibility
 Co-operate with the auditor in the planning
and conducting of the audit
 Provide access for the audit team
 Attend the Opening & Closing Meeting
 address and implement corrective action

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 ISO 9001:2000

Review
QMS audit definition
Types of audit
Party definition
 Audit objectives and responsibilities
Auditee Responsibility
Audit scope
Audit stages
 Audit Preparation
 Audit Execution
 Subsequent Action
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ISO 9001:2008