ISO9001 2008 Edition

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.

‘Product’ and ‘Service’ will be used interchangeably as always in ISO 9001.

Paragraph 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.

Paragraph 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)

Paragraph 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)

Paragraph 2

Normative reference - the ISO 9000 now refers to ISO 9000:2005

Paragraph 3

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

Paragraph 4.1

The word "determine” replaced "identify".

Any outsourced process has to be suitably controlled to ensure product conformity and, defined in the Quality Management System.

Paragraph 4.2.1

Slight change of words but no change in meaning from earlier edition.

Note 2 was changed - a single document may include requirements for more than one procedure and requirements of one procedure may appear in more than one document.

Paragraph 4.2.3

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

Paragraph 5.1

The word "statutory" had been added.

Paragraph 5.5.2

An addition for a demand that the management representative would have to be a member of the organization's management.

Paragraph 6.2

Words, "affecting product quality" changed to "affecting conformity to product requirements”

Paragraph 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.

Paragraph 6.3

Sub-clause (c) states that information systems are included as part of Infrastructure.

(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.)

Paragraph 6.4

A new note mentioning that noise, humidity, temperatures are part of a working environment.

Paragraph 7.1

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

Paragraph number 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".)

Paragraph 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.

Paragraph 7.3.3

A change of wording. A note had been added clarifying what is included in "preservation of product".

Paragraph 7.5.3

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

Paragraph 7.5.4

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

Paragraph 7.5.5

Change of words; from "conformity of" to "in order to maintain conformity to requirements"

Paragraph 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.

Formula for

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Paragraph 8.2.1

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

Paragraph 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.

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

Paragraph 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.

Paragraph 8.2.4

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

Paragraph number 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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