ISO 9001: 2008 Proposed Changes Albert Fessey
ISO 9001 – 2008 Proposed Changes Final Draft International Standard IS 0/FDIS 9001 • Drafted by ISO/TC 176/SC 2 • Voting began on 7 th August 2008 • Voting terminated on 7 th 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 General requirements 4. 2. 1 General (Documentation requirements) 7. 5. 2 Validation of processes for production and service provision 7. 5. 4 Customer property 7. 5. 5 Preservation of product 7. 6 c Identification of calibration status 8. 1 a Measurement to demonstrate conformity to product requirements 8. 2. 2 Internal audit 8. 2. 4 Authorising release of product 8. 3 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?
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