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© Operational Excellence Consulting. All rights reserved.
MANAGING
AN ISO
CERTIFICATION
AUDIT
© Operational Excellence Consulting. All rights reserved.
© Operational Excellence Consulting. All rights reserved. 2
© Operational Excellence Consulting. All rights reserved. 2
Learning Objectives
Acquire basic
knowledge of
ISO
Gain an
overview of the
ISO certification
process
Describe the ISO
certification
audit approach
Learn how to
prepare and
handle an ISO
certification
audit
NOTE: This is a PARTIAL PREVIEW. To
download the complete presentation, please
visit: https://www.oeconsulting.com.sg
© Operational Excellence Consulting. All rights reserved. 3
Contents
2
3
4
The ISO Certification Process
The ISO Certification Audit Approach
Preparing for an ISO Certification Audit
1 ISO In Brief
5 Handling an ISO Certification Audit Session
© Operational Excellence Consulting. All rights reserved. 4
ISO in Brief
§ Non-governmental organization (NGO) established in 1947, based
in Geneva, Switzerland
§ Has a membership of over 160 national standards institutes from
countries in all regions of the world
§ The world’s largest developer of voluntary International Standards,
based on global and market relevance
© Operational Excellence Consulting. All rights reserved. 5
ISO Does Not Certify
§ ISO does not carry out
management system certification,
e.g. ISO 9001:2015 (QMS)
§ ISO does not issue certificates
§ ISO does not accredit, approve or
control certification bodies
§ ISO develops standards and
guidelines to encourage good
practice in accreditation and
certification
© Operational Excellence Consulting. All rights reserved. 6
Accreditation & Certification Bodies
Accreditation Body
Certification Body
Company or Organization
requiring certification
e.g. UKAS
e.g. BSI, DNV,
TUV SUD, etc.
© Operational Excellence Consulting. All rights reserved. 7
Becoming ISO Certified: Example of ISO
9001:2015 (QMS) Certification
§ The certification body examines
the Quality Management System
(QMS) for conformity to the ISO
9001:2015 standard
§ The QMS audit is a compliance
audit
§ Certification means the
organization has a documented
QMS that is fully implemented
and meets ISO 9001:2015
requirements
© Operational Excellence Consulting. All rights reserved. 8
Example of ISO 9001:2015 (QMS) Certification
Process
Implementation of
QMS
Conduct Internal
Audit and Review
Result by Top
Management
Selection of a
Certification Body
Stage 1 Audit
Stage 2 Audit
Confirmation of
Registration
Continual
Improvement and
Surveillance Audits
© Operational Excellence Consulting. All rights reserved. 9
Types of Audits
2nd Party
Audit
External provider
audit
Other external
interested party
audit
3rd Party
Audit
Certification
and/or
accreditation
audit
Statutory,
regulatory and
similar audit
1st Party
Audit
Internal audit
© Operational Excellence Consulting. All rights reserved. 10
Internal Audit
§ To ensure the whole management
system (e.g. QMS) is audited to check:
• The system is being followed
• The system meets ISO requirements, such
as ISO 9001:2015
• The system is effectively implemented and
maintained
© Operational Excellence Consulting. All rights reserved. 11
Principles of Auditing
Source: Based on ISO 19011:2018 Auditing Management Systems
© Operational Excellence Consulting. All rights reserved. 12
ISO Certification Audit Focus
Effectiveness of the ISO Management System
in achieving the organization’s objectives
and in providing products and services that
conform to customer and applicable
regulatory requirements.
© Operational Excellence Consulting. All rights reserved. 13
Audit Approach
§ Focuses on employees’ understanding of the organization’s
processes and verifies that these processes are:
• complied with
• under control
• achieving the desired results
Provide evidence, e.g. records, meeting
minutes, reports, data and emails.
© Operational Excellence Consulting. All rights reserved. 14
Audit Findings
Minor Non-conformity
Observation
Major Non-conformity
© Operational Excellence Consulting. All rights reserved. 15
Planning for an ISO Certification Audit
§ Planning for an ISO certification
audit will take time and effort, but it
will be worth the trouble
§ Taking the time to plan for the audit
will make the audit smoother,
higher quality, less time consuming
and less costly
§ Planning for the audit involves
determining what you want the
auditor to focus on and choosing
an auditor that meets your need
and experience criteria
© Operational Excellence Consulting. All rights reserved. 16
Select a Suitable Audit Firm
§ Auditors specialize in different types of audits and in different
industries
§ There are auditors that specialize in non-profits, government
entities, publicly-traded companies and private, closely held
companies
§ You need to find an auditor that suits your needs and is within your
budget
§ When evaluating firms, make sure that the audit staff has
experience with the type of audit you require, has the appropriate
continuing education and that the firm complies with peer review
requirements
© Operational Excellence Consulting. All rights reserved. 17
Prior to the ISO Certification Audit
§ Designate an audit guide(s) for
your organization to coordinate the
audit activities between the
auditor(s) and the auditees
§ Designate an alternate in case the
audit guide is not available
© Operational Excellence Consulting. All rights reserved. 18
Rights of Auditor
§ Auditors can change the areas to
be audited
§ Auditors can add in more
products, processes and people to
be audited within the audit scope if
they wish to verify something
§ May start the audit session earlier,
or extend the session, if necessary
• Auditees should avoid scheduling
other meetings before or after the
scheduled times
© Operational Excellence Consulting. All rights reserved. 19
How to Handle the Audit Session?
§ Do not panic
§ Ask and clarify
§ Admit obvious non-conformities
§ Offer evidence and explain
patiently
§ Take note of improvement
areas highlighted by the auditor
§ Show internal audit report,
when necessary
© Operational Excellence Consulting. All rights reserved. 20
Auditee’s Conduct
§ Polite
§ Professional
§ Positive / Receptive
§ Sincere
§ Commitment
§ Formal but not overly serious
© Operational Excellence Consulting. All rights reserved. 21
Interacting with Auditors
§ Be honest and open
§ Recognize they may be experts
§ Realize they may not be subject matter
experts
§ Understand the purpose of the meeting and
review related records prior to interviews
§ Turn mobile phones to silent mode
© Operational Excellence Consulting. All rights reserved. 22
Interacting with Auditors
§ Assume auditors are familiar with your
organization’s ISO management system
§ Challenge auditors
§ Show more competence in the ISO
management system standard
§ Argue internally
§ Express unfairness
§ Ask for solution
§ Fix non-conformities on the spot
© Operational Excellence Consulting. All rights reserved.
END OF PREVIEW
To download this presentation,
please visit:
www.oeconsulting.com.sg

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Managing ISO Certification Audits

  • 1. © Operational Excellence Consulting. All rights reserved. MANAGING AN ISO CERTIFICATION AUDIT © Operational Excellence Consulting. All rights reserved.
  • 2. © Operational Excellence Consulting. All rights reserved. 2 © Operational Excellence Consulting. All rights reserved. 2 Learning Objectives Acquire basic knowledge of ISO Gain an overview of the ISO certification process Describe the ISO certification audit approach Learn how to prepare and handle an ISO certification audit NOTE: This is a PARTIAL PREVIEW. To download the complete presentation, please visit: https://www.oeconsulting.com.sg
  • 3. © Operational Excellence Consulting. All rights reserved. 3 Contents 2 3 4 The ISO Certification Process The ISO Certification Audit Approach Preparing for an ISO Certification Audit 1 ISO In Brief 5 Handling an ISO Certification Audit Session
  • 4. © Operational Excellence Consulting. All rights reserved. 4 ISO in Brief § Non-governmental organization (NGO) established in 1947, based in Geneva, Switzerland § Has a membership of over 160 national standards institutes from countries in all regions of the world § The world’s largest developer of voluntary International Standards, based on global and market relevance
  • 5. © Operational Excellence Consulting. All rights reserved. 5 ISO Does Not Certify § ISO does not carry out management system certification, e.g. ISO 9001:2015 (QMS) § ISO does not issue certificates § ISO does not accredit, approve or control certification bodies § ISO develops standards and guidelines to encourage good practice in accreditation and certification
  • 6. © Operational Excellence Consulting. All rights reserved. 6 Accreditation & Certification Bodies Accreditation Body Certification Body Company or Organization requiring certification e.g. UKAS e.g. BSI, DNV, TUV SUD, etc.
  • 7. © Operational Excellence Consulting. All rights reserved. 7 Becoming ISO Certified: Example of ISO 9001:2015 (QMS) Certification § The certification body examines the Quality Management System (QMS) for conformity to the ISO 9001:2015 standard § The QMS audit is a compliance audit § Certification means the organization has a documented QMS that is fully implemented and meets ISO 9001:2015 requirements
  • 8. © Operational Excellence Consulting. All rights reserved. 8 Example of ISO 9001:2015 (QMS) Certification Process Implementation of QMS Conduct Internal Audit and Review Result by Top Management Selection of a Certification Body Stage 1 Audit Stage 2 Audit Confirmation of Registration Continual Improvement and Surveillance Audits
  • 9. © Operational Excellence Consulting. All rights reserved. 9 Types of Audits 2nd Party Audit External provider audit Other external interested party audit 3rd Party Audit Certification and/or accreditation audit Statutory, regulatory and similar audit 1st Party Audit Internal audit
  • 10. © Operational Excellence Consulting. All rights reserved. 10 Internal Audit § To ensure the whole management system (e.g. QMS) is audited to check: • The system is being followed • The system meets ISO requirements, such as ISO 9001:2015 • The system is effectively implemented and maintained
  • 11. © Operational Excellence Consulting. All rights reserved. 11 Principles of Auditing Source: Based on ISO 19011:2018 Auditing Management Systems
  • 12. © Operational Excellence Consulting. All rights reserved. 12 ISO Certification Audit Focus Effectiveness of the ISO Management System in achieving the organization’s objectives and in providing products and services that conform to customer and applicable regulatory requirements.
  • 13. © Operational Excellence Consulting. All rights reserved. 13 Audit Approach § Focuses on employees’ understanding of the organization’s processes and verifies that these processes are: • complied with • under control • achieving the desired results Provide evidence, e.g. records, meeting minutes, reports, data and emails.
  • 14. © Operational Excellence Consulting. All rights reserved. 14 Audit Findings Minor Non-conformity Observation Major Non-conformity
  • 15. © Operational Excellence Consulting. All rights reserved. 15 Planning for an ISO Certification Audit § Planning for an ISO certification audit will take time and effort, but it will be worth the trouble § Taking the time to plan for the audit will make the audit smoother, higher quality, less time consuming and less costly § Planning for the audit involves determining what you want the auditor to focus on and choosing an auditor that meets your need and experience criteria
  • 16. © Operational Excellence Consulting. All rights reserved. 16 Select a Suitable Audit Firm § Auditors specialize in different types of audits and in different industries § There are auditors that specialize in non-profits, government entities, publicly-traded companies and private, closely held companies § You need to find an auditor that suits your needs and is within your budget § When evaluating firms, make sure that the audit staff has experience with the type of audit you require, has the appropriate continuing education and that the firm complies with peer review requirements
  • 17. © Operational Excellence Consulting. All rights reserved. 17 Prior to the ISO Certification Audit § Designate an audit guide(s) for your organization to coordinate the audit activities between the auditor(s) and the auditees § Designate an alternate in case the audit guide is not available
  • 18. © Operational Excellence Consulting. All rights reserved. 18 Rights of Auditor § Auditors can change the areas to be audited § Auditors can add in more products, processes and people to be audited within the audit scope if they wish to verify something § May start the audit session earlier, or extend the session, if necessary • Auditees should avoid scheduling other meetings before or after the scheduled times
  • 19. © Operational Excellence Consulting. All rights reserved. 19 How to Handle the Audit Session? § Do not panic § Ask and clarify § Admit obvious non-conformities § Offer evidence and explain patiently § Take note of improvement areas highlighted by the auditor § Show internal audit report, when necessary
  • 20. © Operational Excellence Consulting. All rights reserved. 20 Auditee’s Conduct § Polite § Professional § Positive / Receptive § Sincere § Commitment § Formal but not overly serious
  • 21. © Operational Excellence Consulting. All rights reserved. 21 Interacting with Auditors § Be honest and open § Recognize they may be experts § Realize they may not be subject matter experts § Understand the purpose of the meeting and review related records prior to interviews § Turn mobile phones to silent mode
  • 22. © Operational Excellence Consulting. All rights reserved. 22 Interacting with Auditors § Assume auditors are familiar with your organization’s ISO management system § Challenge auditors § Show more competence in the ISO management system standard § Argue internally § Express unfairness § Ask for solution § Fix non-conformities on the spot
  • 23. © Operational Excellence Consulting. All rights reserved. END OF PREVIEW To download this presentation, please visit: www.oeconsulting.com.sg