Iso 90001-2008

ISO 9001:2008
Changes to the New Revision vs. ISO 9001:2000 ASQ Nebraska Section 1302 Workshop
Presented by Jon Ridgway
ISO Lead Auditor, CSSBB, CQE, CQA

Overview of ISO 9001:2008
An Amendment, not a revision – mainly
“editorial changes”

Intention:
To remove ambiguity To provide clearer text To improve compatibility with ISO 14001 To improve its ability to be translated Toincorporate TC176 website interpretations

Transition Plan
Published November 15, 2008
Can begin auditing to ISO 9001:2008

Effective November 15, 2009:
ISO 9001:2008 certificates will be issued

Effective November 15, 2010:
ISO 9001:2000 certificates will be invalid Impact: Must transition to ISO 9001:2008 or lose your certification

In General:
Many minor editorial changes:
Referring tostatutory / regulatory requirements:
From “statutory” to “statutory and regulatory”

Rewording sentences without changing meaning From “and / or” to “or” From “cause” to “causes”

Bottomline: No “shalls” removed or added

0.1 General
Split out factors from 1st paragraph into stand-alones Added a new factor:
a) its organizational environment, changes in that environment, and the risksassociated with that environment

0.2 Process Approach
Focus on determining processes, rather than identifying processes – see 4.1 Highlights importance of processes being capable of achieving desired outputs

0.3 Relationship with ISO 9004
Reference to upcoming revision to ISO 9004:2000:
Next ISO 9004 will not have a clause structure similar to ISO 9001:2008 Therefore, no longer a “consistentpair”

0.4 Compatibility with Other Management Systems
Updates the ISO 14001 version:
From ISO 14001:1996 To ISO 14001:2004

1.1 Scope
Clarifies the meaning of “product”
Revised Note 1 to include a product is “any intended output of the process” Added Note 2
Explains that statutory & regulatory requirements can include legal requirements Intended to help non-English speakers understand1.2 Application
Added to 3rd paragraph, “statutory and” to “regulatory requirements” Now reads, “statutory and regulatory requirements”

2.0 Normative References
Updates the ISO 9000 version:
From ISO 9000:2000 To ISO 9000:2005

3.0 Terms and Definitions
Removed supply chain definitions Removed organization and supplier definitions

4.1 General Requirements
Replaced a)“identify…” with “determine…” – see 0.2 Added to e) “as applicable” to measure Outsourcing:
Rewrote last sentence of last paragraph Added Note 2: Explains an “outsourced” process Added Note 3: Must control outsourced processes

4.2 Documentation
4.2.1 General:
Added records to c) and dropped e) records required Clarified: Can be single or more documents to meet a requirement

4.2.3 Control ofDocuments:
Added verbiage to f) Meaning: Not all external documents need to be controlled; only those needed for the planning and operation of the quality management system

4.2 Documentation, Cont.
4.2.4 Control of Records:
From “maintained” (warehousing of records) to “controlled” (regulating the use of records) Broke 1 paragraph into 3 Moved documented procedure requirement up to emphasize it5.5.2 Management Representative
From “member of management” To “member of organization’s management” Meaning: Outsiders cannot be the Mgt Rep

6.2 Human Resources
6.2.1 General:
From “product quality” to “work affecting conformity to product requirements" Added Note on how employees can impact quality, directly and indirectly

6.2.2 Competence, Training & Awareness:
From “product quality”to “work affecting conformity to product requirements"

6.2 Human Resources, Cont.
6.3 Infrastructure:
Added to c), “or information services”

6.4 Work Environment:
Added a Note defining work environment

7.1 Planning of Product Realization
Added to c), “measurement” Now reads: “c) required verification, validation, monitoring, measurement, inspection and test activities...