ISO 9001:2008 Proposed Changes

Albert Fessey

ISO 9001 2008 Proposed Changes

Final Draft International Standard IS0/FDIS 9001

Drafted by ISO/TC 176/SC 2 Voting began on 7th August 2008 Voting terminated on 7th October 2008 Predicted to be issued in November 2008

ISO 9001 2008 Proposed Changes

Summary of Changes
Changes are minimal, some are: # Rewording of the text (with no impact) # To provide consistency in terminology # Clarification of approach/application

# Subtle, but could have some implications

ISO 9001 2008 Proposed Changes

Rewording of the text Example 7.5.3 - Identification and traceability Used to be: Where traceability is a requirement, the organization shall control and record the unique identification of the product Now reads: Where traceability is a requirement, the organization shall control the unique identification of the product and maintain records

ISO 9001 2008 Proposed Changes

Rewording of the same text Other Examples:
4.1 4.2.1
7.5.2

General requirements General (Documentation requirements)

Validation of processes for production and service provision

7.5.4
7.5.5 7.6 c 8.1 a 8.2.2

Customer property
Preservation of product Identification of calibration status Measurement to demonstrate conformity to product requirements Internal audit

8.2.4
8.3

Authorising release of product

Control of nonconforming product

ISO 9001 2008 Proposed Changes

To provide consistency in terminology 6.2 Human resources The words product quality are not used, replaced by conformity to product requirements This is now the same as in 6.3 Infrastructure and 6.4 Work environment
7.6 Control of monitoring and measuring equipment No longer uses the term devices, the term now used throughout is equipment This also as been reflected in 7.5.1 d

ISO 9001 2008 Proposed Changes

Clarification of approach/application
Some examples are as follows: 1.1 General (Note 1) - now states what the term product means 4.1 General requirements: - section e) clarifies that an organization monitors and measures processes where applicable - Notes 2 & 3 clarify what an outsourced process is and the types of control that may be required 4.2 Documentation requirements a document might include more than one procedure and a requirement may be covered by more than one procedure (e.g. Corrective Action)

ISO 9001 2008 Proposed Changes

Subtle, but could have some implications 0.1 General - now states the design & implementation of the QMS is influenced by its business environment, changes in that environment, or the risks associated with that environment 6.3 Infrastructure - section c) now includes information systems to supporting services

7.2.1 Determination of requirements related to product - new note added addressing post delivery activities, such as warranty provisions, maintenance services, recycling or final disposition

ISO 9001 2008 Proposed Changes

Subtle, but could have some implications (Continued) 7.5.4 Customer property - the Note now states that Customer property can include intellectual property and personal data 7.6 Control of monitoring and measuring equipment new Note added stating Confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use

ISO 9001 2008 Proposed Changes

What happens next?