Pre-course Reading Material

Overview of ISO 9001:2008

Clauses 0.1 to 3 (Pre-course reading material)

Session Plan
Format: Objectives: Pre-course study Understand the origins of the ISO 9000 series of standards Understand the purpose, contents and interrelationships of the ISO 9000 series as well as the supporting standards including ISO 19011 Understand the requirements of ISO 9001:2008 (up to clause 3) and be able to explain and interpret those requirements Be able to use ISO 9000:2005 to enhance the understanding of the ISO 9001:2008 requirements Recognise how the eight management system principles underpin the structure and requirements of ISO 9001:2008

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

Pre-course Reading Material

ISO 9000 family

Annexes A & B for information only

Measurement

ISO ISO 10012 10012 ISO 19011

Quality management systems Fundamentals & vocabulary

ISO 9000: 2005

Audits

Guidelines Managing for the sustained success of an organisation A QMS approach

ISO 9004: 2009

Technical Reports

ISO 9001: 2008

Quality management systems Requirements

as needed (e.g. ISO/TR 10013)

3

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

0.1 General

Adoption of QMS, a strategic decision Many factors can influence the design of QMS Requirements of QMS are complementary to those of products Standard can be used by many parties

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

Pre-course Reading Material

0.2 Process approach

Process approach to quality management encouraged Introduces the process model as conceptual presentation of QMS requirements specified

Controls (e.g.procedure)

Process A Process B

Process C Process D

Input

Process Activities + Resources

Output

Name the parameters needed to identify a process

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

0.2 Process approach

The advantage of this approach is that it permits ongoing

control not only over the individual processes but also their interaction. This approach takes into account the importance of:
understanding and meeting requirements considering processes in terms of added value obtaining results of their performance and effectiveness continually improving them based on objective measurement

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

Pre-course Reading Material

Quality System Model

C U S T O M E R S

Continual Improvement of the Quality Management System Management responsibility

R e q u i r e m e n t s

Resource management

Measurement, analysis, improvement

S a t i s f a c t i o n

Input

Product realisation

Product

C U S T O M E R S

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

0.3 Relationship with ISO 9004 ISO 9001: 2008

Focuses on effectiveness and is certifiable Focuses on customers

ISO 9004: 2009

Focuses on sustained success and is not certifiable Focuses on interested parties

Both focus on quality management approach Both are based on 8 principles

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

Pre-course Reading Material

1.Scope
1.1 General
The standard specifies requirements for a QMS for use to:

a) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. Note: Product = product intended for, or required by, a customer or the product realization processes. This applies to any intended output resulting from product realization processes, including purchasing. Statutory and regulatory requirements can be expressed as legal requirements.
QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

1.Scope
1.2 Application
Requirements are generic Requirement may be excluded if cannot be applied due to the

nature of organisation and its product

Exclusions must:

Not affect ability or responsibility to provide conforming product Be limited to requirements in clause 7 (Cl. 4.2.2: details of & justification for any exclusion to be included in the quality manual)
Conformity to ISO 9001 may not be stated if exclusions go

beyond above

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

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Pre-course Reading Material

2 Normative Reference
For dated references, only the edition cited applies For undated references the latest edition applies ISO 9000 : 2005 Quality Management Systems -

Fundamentals and Vocabulary 3 Terms & Definitions

For terms & definitions, ISO 9000 applies Throughout the standard the term product also

means service

QMS Auditor / Lead Auditor course ( A 17024 ) - Issue July 2013

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