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.
Monday, December 15, 2008
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.
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).
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.
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.
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.
ISO9001 Ceritfication Bodies in Malaysia
There are more than 10 certification bodies issuing ISO9001:2000 certificates to companies and organisation implementing the ISO9001:2000.
Each certification body would have its own ISO9001 certification logo. I have included the logos for all us to know.
ISO website is good place to seek out authorised and relevant resources on various ISO standards including ISO9001:2000.
Two most popular ISO standards are the ISO9001:2000 and ISO14001:2004.
The following article elaborates on the similarities and differences of the ISO9000 series and ISO14000 series of standards.
ISO 9000 and ISO 14000
This section provides a concise overview of ISO's best known management system standards and their impact on the world.
In brief
The ISO 9000 and ISO 14000 families are among ISO's best known standards ever. ISO 9001:2000 and ISO 14001 (1996 and 2004 versions) are implemented by over a million organizations in 161 countries.
The ISO 9000 family addresses "quality management". This means what the organization does to fulfill:
* the customer's quality requirements, and
* applicable regulatory requirements, while aiming to
enhance customer satisfaction, and
* achieve continual improvement of its performance in pursuit of these objectives.
The ISO 14000 family addresses "environmental management". This means what the organization does to:
* minimize harmful effects on the environment caused by its activities, and to
* achieve continual improvement of its environmental performance.
The ISO 9000 and ISO 14000 families are among ISO's best known standards ever. ISO 9001:2000 and ISO 14001 (1996 and 2004 versions) are implemented by over a million organizations in 161 countries.
The ISO 9000 family addresses "quality management". This means what the organization does to fulfill:
* the customer's quality requirements, and
* applicable regulatory requirements, while aiming to
enhance customer satisfaction, and
* achieve continual improvement of its performance in pursuit of these objectives.
The ISO 14000 family addresses "environmental management". This means what the organization does to:
* minimize harmful effects on the environment caused by its activities, and to
* achieve continual improvement of its environmental performance.
P.S. I love to acknowledge the source for the sake of demonstrating the CREDIBILITY of the short elaboration.
What is ISO9001?
What is ISO 9001?
ISO 9001 is an international standard for quality management systems, superceding BS 5750.
ISO 9001 requires that you have a system for managing your business, and the goods or services it produces and that you follow your system. ISO 9001 combines the following to achieve the objective of ‘continual improvement of the quality management system’:
* management responsibility
* resource management
* product realisation
* measurement, analysis, improvement
Who does ISO 9001 apply to?
The standard is applicable to all industries whatever their size if their business is design, development, production, delivery or supply.
What benefit does ISO 9001 bring you?
Because you have ISO 9001 certification, it demonstrates to your customers that your quality system has been examined and found acceptable by an independent and internationally recognised body. Your ISO 9001 certification shows that you always put the customer first and focus your business on meeting your client's needs.
ISO 9001 is an international standard for quality management systems, superceding BS 5750.
ISO 9001 requires that you have a system for managing your business, and the goods or services it produces and that you follow your system. ISO 9001 combines the following to achieve the objective of ‘continual improvement of the quality management system’:
* management responsibility
* resource management
* product realisation
* measurement, analysis, improvement
Who does ISO 9001 apply to?
The standard is applicable to all industries whatever their size if their business is design, development, production, delivery or supply.
What benefit does ISO 9001 bring you?
Because you have ISO 9001 certification, it demonstrates to your customers that your quality system has been examined and found acceptable by an independent and internationally recognised body. Your ISO 9001 certification shows that you always put the customer first and focus your business on meeting your client's needs.
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