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Quality Management Systems Auditor Training Course
(Three-day Training Course)
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 ?
Course Facilitators
Vimal Gandhi
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
Session Norms
Time Keeping / Attendance
Courtesy: No Mobile Phones
House information: Tea Break & Fire Exit
Respect, Involvement & Interaction.
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
Training Information
ExaminationThird day – Open BookTwo & 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
Course Certification
Certificate of Successful Completion
Certificate of Attendance
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
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
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
2.0 Fundamentals ofquality management systems
rationale for quality management systems
process approach
quality policy and quality objectives
role of top management
documentation
role of statistical techniques
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
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
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
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
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
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
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
ProductInput Output
Process approach
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
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