1. Quality Management Systems
Auditor Training Course
(Three-day Training Course)

2. Participant’s Introduction
 Name
 Organization
 Organization’s Products & Services
 Experience related to QMS
 Is your organization certified ?
 Objective of attending the course / Why
am I here ?

3. Course Facilitators
 Vimal Gandhi

4. Quality Management Systems
Auditor Training Course
To equip:
 participants with the knowledge and skills required
to perform audits to quality management systems
against ISO 9001:2008 in accordance with ISO
19011
Objective

5. Session Norms
Time Keeping / Attendance
Courtesy: No Mobile Phones
House information: Tea Break & Fire
Exit
Respect, Involvement & Interaction.

6. Training Information
 Training will comprise of discussions, role plays,
workshops, presentations & written examination
 Success Criteria
• Continuous Assessment
– Participation in the workshops and role plays
– Time keeping and full attendance in all sessions
– Grading - Excellent, Good, Satisfactory, Fail

7. Training Information
• Examination
Third day – Open Book
Two & half hours (150 minutes)
Four sections – 1. Multiple Choice Questions,
2. Brief Written Answers,
3. Detailed Written Answers,
4. Situations where a CAR might be raised.
Passing Criteria – 70% over all

8. Course Certification
 Certificate of Successful Completion
 Certificate of Attendance

9. Session 1
Introduction to the ISO 9000 series of Standards
 The benefits of a quality management system
 ISO 9000 family of Standards
 The process approach
 The quality management principles

10. ISO 9000 Family
 ISO 9000:2005 -- Quality management systems -
Fundamentals and vocabulary
 ISO 9001:2008 - Quality management systems -
Requirements
 ISO 9004:2009 - Quality management systems -
Guidelines for performance
improvements

11. ISO 9000:2005 Quality management systems -
fundamental and vocabulary
Replaces ISO 8402
Comprises:
2.0 Fundamentals of quality management
systems
3.0 Terms and definitions

12. 2.0 Fundamentals of
quality management systems
 rationale for quality management systems
 process approach
 quality policy and quality objectives
 role of top management
 documentation
 role of statistical techniques

13. 3.0 Terms and definitions
terms having a special meaning
 written definitions
 cross references to other defined terms
 terms may be replaced by its definition in other
definitions

14. Example definition
Specification:
 document (3.7.2) stating requirements (3.1.2)
or by replacing the terms in bold:
 information and its support medium stating need
or expectation that is stated, generally implied or
obligatory

15. Relationship between ISO 9001 & 9004
 Consistent pair for use together or
independently
 ISO 9001 sets out requirements
 ISO 9004
• provides guidance for improvement
• not for implementation of ISO 9001 or
certification/contractual use

16. Consistent with other standards
ISO 14001:2004 Environmental management systems –
Requirements with guidance for use
OHSAS 18001:2007 Occupational health and safety
management systems - Requirements
IS0 27001:2005 Information technology – Security
techniques – Information security
management systems – Requirements

17. ISO 19011
contains information on:
 Terms and definitions
 Principles of auditing
 Managing an audit programme
 Audit activities
 Competence and evaluation of auditors
Guidelines for management systems auditing

18. any activity that takes “inputs”
and converts them to “outputs”
the systematic identification and
management of these activities and the
interactions between activities
Process
Process approach

19. Management
responsibility
Management
responsibility
Resource
management
Resource
management
Measurement
analysis and
improvement
Measurement
analysis and
improvement
Continual improvement of the
quality management system
CustomersCustomers
Product
realisation
Product
realisation
SatisfactionRequirements
Product
Input Output
Process approach

20. Plan-Do-Check-Act cycle & continual
improvement
Act
• How to improve
next time?
Take actions to continually
improve process performance –
effectiveness and efficiency
Plan
• What to do
• How to do it
Establish objectives
necessary to deliver
results in accordance
with customer
requirements
and the organisation's
policies
Check
• Did things happen
according to plan?
Monitor and measure
processes and product
against policies, objectives
and requirements
Do
• Do what was
planned
Implement the
processes

21. Quality Management Principles
 customer focus
 leadership
 involvement of people
 process approach
 system approach to management
 continual improvement
 factual approach to decision-making
 mutually beneficial supplier relationships