The revision of ISO 9001:2000 to ISO 9001:2008 did not bring in drastic additions. Its changes seek to make clarification in relevant clauses based on the vast application experiences from the various industrial sectors.

Clause 0.1
A statement about whom and where the standard is including any statutory requirements and have the same scale as any customer or regulatory requirements. It also clarified that these requirements are restricted to those applicable to the product.

Clause 0.4
A comment that states that the new standard is made due consideration to ISO 14001:2004.

Quite common for organizations that embarked on ISO 14000 also to have the ISO 9000 certification.

Clause 1
Statutory requirements had been referred in connection with purchased products and product realization. Second note explains that a statutory requirement can be a legal requirement.

Since statutory requirements have the weight of statute behind them. It implied that your suppliers must follow the laws too.

Clause 2
Normative reference – the ISO 9000 now refers to ISO 9000:2005.

Clause 3
Explanation on what is a customer and what is an organization and what is a supplier had been removed.

Clause 4.1
The word “determine” replaced “identify”. The new standard makes it clear that an outsourced process is still part of your QMS. While the responsibility for a process may have been outsourced, your organization is, nevertheless, still responsible for ensuring that it meets all customer, regulatory, and statutory requirements. In essence, the the revised clause requires to you define the type, nature, and extent of controls that are effective in ensuring planned quality levels.

Clause 4.2.1
The new standard has expanded the definition of documentation to include all QMS process records. Part 4.2.1 makes it clear that a single document may contain several procedures or several documents may be used to describe a single procedure. While this has always been an option, the new standard makes this possibility explicit. And the new standard requires you to identify and control the distribution of only those external documents that you need in order to be able to plan and operate your QMS. In other words, only relevant external QMS documents need to be controlled, not all of them.

Clause 4.2.3
It clarified that external documentation are the ones needed for the quality management system.

Clause 5.1
The word “statutory” had been added.

Clause 5.5.2
It is a requirement now that the management representative must be a member of the organization’s own management. Outsiders may no longer perform this important function.

Clause 6.2.1
Words, “affecting product quality” changed to “affecting conformity to product requirements”. All QMS personnel must be competent in any within the QMS which may directly or indirectly affect the organization’s ability or willingness to meet product requirements. Personnel competence must be assured.

Clause 6.2.2
Sub-clause (b) – “provide training or take other actions to satisfy these needs” changed to “where applicable training needs to be provided to achieve the necessary competence”.

Sub-clause (c) – obligation to ensure that the staff attained the expected competence

Clause 6.3
ISO 9001:2008 has now added information systems to the previous list of support services. Both old and new standards expect you to provide the infrastructure (including information systems) that your organization needs in order to ensure that product requirements are being met.

Good to cover information system, process software, design software etc under 6.3c as periodic verification of some design software was audited under 7.6, which is not so correct previously.

Clause 6.4
ISO 9001:2008 says that the term work environment now refers to working conditions. These working conditions include physical and environmental conditions, as well as things like noise, temperature, humidity, lighting, and weather. All of these conditions need to be managed in order to help ensure that product requirements are being met.

Clause 7.1
Sub-clause (c) – measurement had been added to the activities.

Clause 7.2.1
Sub-clause (a) – change of words with no change in the meaning.

Sub-clause (c) – the word “applicable” replaced “related”.

Sub-clause (d) – change of words with no change in the meaning.

A note has been added to explain what is the meaning of “post delivery activities”.

Clause 7.3.1
A note had been added to clarify that design review, verification and validation are separated processes but they can be conducted together.

Clause 7.3.3
Part 7.3.3 of ISO 9001:2000 wants you to make sure that the design and development process generates information (outputs) that your purchasing, production, and service provision processes need to have. ISO 9001:2008 now also says that design and development outputs could include information that explains how products can be preserved during production and service provision.

Clause 7.5.3
A requirement added specifying that product traceability must be included throughout the product realization.

Clause 7.5.4
A change in the note had been amended to highlight that personal data shall be included as customer’s property.

Clause 7.5.5
Change of words; from “conformity of” to “in order to maintain conformity to requirements.

Clause 7.6
Change of words; from “devices” to “equipment” The reference to paragraph 7.2.1 had been removed.

Sub-clause (c) – from “be identified to enable the” to “identification to enable their”

Changes in the notes: Note 1 – the reference to ISO 100012-2 had been removed while Note 3 seeks to explain about situation when configuration of computer must be applied when the computer is identified and used for monitor & measurements processes.

While ISO 9001:2008, Part 7.6, refers to the need to control monitoring and measuring equipment, the old standard talked about controlling devices. Since the term device can refer to almost anything from a literary contrivance to a machine, its meaning wasn’t exactly clear. The new ISO 9001 standard has removed this ambiguity by using the term equipment. Both the old and the new standard wants you to confirm that monitoring and measuring software is capable of doing the job you want it to do. In addition to this requirement, the new standard suggests (in a note) that configuration management and well established verification methods can be used to ensure the ongoing suitability of monitoring and measuring software. However, this is not a requirement, just a statement that explains how the ongoing suitability of software can be maintained.

Clause 8.2.1
A note had been added to throw light on some of the means for conducting customer satisfaction evaluation.

Both old and new standards want you to monitor and measure customer satisfaction (perceptions). A new note to ISO 9001:2008, Part 8.2.1, explains that there are many ways to monitor and measure customer satisfaction. You could use customer satisfaction and opinion surveys. And you could collect product quality data (post delivery), track warranty claims, examine dealer reports, study customer compliments and criticisms, and analyze lost business opportunities.

Clause 8.2.2
Requirements for the audit evidence and results had been added. It is made clearer now that the management is responsible to ensure preventive and corrective action will be taken.

Both old and new standards refer to the need to establish a procedure to define how internal audits should be planned, performed, reported, and recorded (Part 8.2.2). However, the old standard did not explicitly state that audit records must actually be maintained. This oversight has now been corrected. ISO 9001:2008 now explicitly says that you must maintain a record of your internal audit activities and results.

The reference to the ISO 10011 had been updated to ISO 19011.

Clause 8.2.3
Minor change of words i.e. “to ensure conformity of the product” had been removed.

A note had been added to clarify that the organization should determine the type of the monitoring and measuring according to the processes and, how will this affect the quality management system.

Both old and new standards expect you to monitor and measure your QMS processes. A new note to ISO 9001:2008, Part 8.2.3, wants you to consider the impact each process has on the overall effectiveness of your QMS and the impact it has on your ability to meet product requirements, when you’re making decisions about what kinds of process monitoring and measurement methods should be used.

Clause 8.2.4
Change of words: “maintain evidence of conformity with acceptance criteria” had been removed but it is still a perceived requirement.

According to ISO 9001:2000, Part 8.2.4, you must make sure that product monitoring and measuring records indicate who was responsible for authorizing the release of products. However, the old standard did not specify who must be on the receiving end. This has now been clarified. ISO 9001 2008 now makes it clear that records must now indicate who releases products for delivery to customers.

Clause 8.3
An addition sub-clause (d) that specifies how to deal with a nonconforming product that was discovered after delivery.

Nothing new as it had always been addressed under Warranty or After-sales protocol.

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