Steve Hill Associates LLP

ISO 9001:2008 Changes

ISO 9001:2008 Changes

ISO 9001:2008 implementation plan

Clause	Title	Change summary
0.2	Process approach	Wording changed to emphasise the importance of processes being capable of achieving desired outputs
1.1	Scope	Clarification that “product” can also be “intermediate product” and an explanation that statutory and regulatory requirements can be expressed as legal requirements
4.1	General requirements	Note added that clarifies requirements regarding outsourcing and the types of control that may be applied to such processes
4.2.1	General documentation requirements	Clarification that documentation can also include records and that mandatory procedures may be combined in one document or that the requirements of one procedure may be covered in more than one document
4.2.3	Document control	Clarification that only documents of external origin that affect the quality management system have to be controlled
5.5.2	Management representative	Clarification that this person must be a member of the organisation’s own management
6.2.2	Competence, training and awareness	Requires organizations to ensure necessary competencies have been achieved for staff who indirectly and directly affect product conformity
6.3	Infrastructure	Clarifies that information systems are included
6.4	Work environment	Clarifies the circumstances covered by this requirement
7.2.1	Determination of requirements related to the product	Clarifies what may be covered by post delivery activities e.g. contractual obligations such as warranty, servicing and maintenance
7.3.1	Design and development planning	Clarifies that review, verification and validation have distinct purposes but may be conducted and recorded separately or in any combination as appropriate to product and the organisation
7.3.3	Design and development outputs	Clarifies that product preservation may be included for production and service provision
7.5.4	Customer property	Clarifies that intellectual property and personal data are covered by this requirement
7.6	Control of monitoring and measuring devices	Retitled. The term “devices” has been replaced by “equipment”. Note added relating to checking the conformity of software used for monitoring and measuring purposes
8.2.1	Customer satisfaction	Note added giving examples of how customer satisfaction data may be gathered
8.2.3	Monitoring and measurement of processes	Note added to clarify that consideration be given to product conformity and quality management system effectiveness when deciding methods for monitoring and measuring processes
8.2.4	Monitoring and measurement of product	Clarifies that product release relates to customer delivery
8.3	Control of nonconforming product	Wording changed to make controlling non conforming product more appropriate to service organisations
8.5.2 & 8.5.3	Corrective & preventive action	Wording changed to include reviewing the effectiveness of action taken whilst reviewing corrective and preventive actions
Various	Various paragraphs	Throughout ISO 9001:2008 the word "statutory" has been replaced with "statutory and regulatory" requirements.  A note explaining the differences has been added