Monday, December 15, 2008

5 Pillars of ISO9001

ISO9001 has five main pillars.

First pillar is Clause 4 Quality Management System. This is the main pillar or Center Pillar. It entails the general requirements, documented QMS, scope and exclusions, control of documents, and control of records.

Second pillar is Management Responsibility. This is the North Pillar, and associated with "Act" in PDCA cycle.

Third pillar is Resource Management. This is the East Pillar which is related to "Plan" in PDCA cycle.

Fourth pillar is Product Realization. This is the South Pillar, the "Do" in PDCA cycle.

Fift pillar is Measurement, Analysis and Improvement. This is the West Pillar, and associated with the "Check" in PDCA cycle.

Wednesday, October 15, 2008

ISO9001:2008 update part 4 (clause 5)

For this part 4, I will elaborate on changes for clause 5 Management Responsibility.

Clause 5.5.2 Management representative
This revised ISO9001:22008 contains Clarification that this must be a member of the organization’s own management .

This is just to strengthen and emphasise that the Management Representative must one of the Company's management team.
In some group of companies, the Management Representative could be from HQ. So the numerous companies within the group could be sharing one Management Representative.

This standard emphasises that the Management Representative must be from the same company, not from a sister company, not from the parent company.

Thursday, October 9, 2008

ISO9001:2008 update part 3 (4.2.3, 4.2.4)

ISO9001:2008 updated standard is scheduled to happen on 31 October 2008. Let us look at clause 4.2.3 Document Control and 4.2.4 Records Control.

Clause 4.2.3 Document control
ISO9001:2008 now contains Clarification that only external documents relevant to the QMS need to be controlled. This makes it clearer.
What happened was that some companies and/or organizations did more than that. Some had misunderstood the concept and ended up controlling all sorts of external documents.
It is good now that the new ISO9001:2008 puts it very clearly that only external documents related to ISO9001 quality management system need to be controlled as per clause 4.2.3

Clause 4.2.4 Records control
There is no signigicant change. ISO9001:2008 only contains Editorial changes only (for better alignment with ISO 14001:2004 standard).

Monday, October 6, 2008

ISO9001:2008 update (part 2)

Yesterday, I explained about changes in ISO9001:2008 as related to clause 4.1 General Requirements. Today, I am going to elaborate about ISO9001:2008 clause 4.2.1 Documentation.

Clause 4.2.1 (Documentation)

ISO9001:2008 contains Clarification that QMS documentation also includes records. This was already in ISO9001:2000....just making it more clearly.

Documents required by the ISO9001:2008 standard may be combined. This provides more flexibility. Example, the same form could be used to meet more than one requirement of ISO9001:2008. Example: we can use a Nonconformance, Corrective and Preventive Action Record to satisfy 3 clauses, i.e. 8.3 Control of Nonconforming Product, 8.5.2 Corrective Action, an 8.5.3 Preventive Action.

ISO 9001 requirements may be covered by more than one documented procedure. This has always been practiced by many companies and/or organizations. This is simply to make it clearer.

Sunday, October 5, 2008

ISO9001:2008 update part 1

I will elaborate slightly on the changes in ISO9001:2008 as compared to ISO9001:2000.

Part 1 is on Clause 4.1 General Requirements.

There are additional Notes added to explain more about outsourcing. I think outsourcing, i.e. outsourced processes, should be clearly outlined in the Quality Manual.

Types of control that may be applied to outsourced processes should be complied to. Type of control over outsourced processes should be elaborated in the Quality Manual.

Outsourcing should apparently be linked to clause 7.4 Purchasing. Outsourcing involves purchasing of services for the outsourcing vendors.

The new Standard contains Clarification that outsourced processes are still responsibility of the organization and must be included in the quality management system. The company/organisation implementing ISO9001:2008 is still responsible for all the internal as well as outsourced processes.

Thursday, May 1, 2008

Part 3: ISO9001:2000 Certification Logos





This is part 3 of ISO9001:2000 certification logos seen in companies operating in Malaysia.


Which ISO9001 certification body would your company want to use? Your choice.

More logos of ISO9001 certification






I have included more ISO9001 certification logos here.