Key Changes in the 2008 Version of the Standard

There are no additional requirements in the 2008 version. All changes simply provide clarification or place a new emphasis on existing requirements, based on what has been learnt from working with the 2000 version over the last 8 years.

For a complete, detailed list of all changes, refer to “Annex B of ISO 9001:2008”. However, the list below is a summary of key changes. Words in quotation marks are those used in the 2008 version of the Standard.

0.1               General: New emphasis on the organisation needing to consider the “organisational environment” when designing and implementing its quality management system.

4.1          General Requirements: Clarification of what an outsourced process is, i.e. “An outsourced process is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party”.

There is new emphasis on the control of outsourcing with the addition of the notes “Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.”

5.5.2      Management Representative: Emphasis that the management representative must be a member of the “organisation’s management”.

6.2.2      Competence, training and awareness: Additional emphasis on competence, not just training, i.e. that organisations should “provide training or take other actions to achieve the necessary competence”

6.3          Infrastructure: Clarification that the management system infrastructure includes “information systems”.

6.4          Work Environment: Clarification that the work environment “relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather)”

7.2.1      Determination of requirements: Clarification that “post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal”

7.3.1      Design and Development Planning: Clarification that “design and development review, verification and validation have distinct purposes but that they can be conducted and recorded separately or in any combination, as suitable for the product and the organization”

7.5.4      Customer Property: Clarification that customer property can include “personal data”

7.6          Monitoring and Measuring Equipment: Clarification that the confirmation of the ability of software being used for monitoring and measurement would typically include “verification” and “configuration management” (revision management), as opposed to traditional calibration.

8.2.1      Customer Satisfaction: Clarification that the various indicators of customer satisfaction and perception, in addition to typical “customer satisfaction surveys”, could include “customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports”.

8.2.2      Internal Audit: Emphasis that following audit nonconformities being raised, that both “corrections” and “corrective actions” need to be taken, i.e. “Correction” equates to the immediate action to eliminate the detected nonconformity whereas “corrective action” equates to the elimination of the cause of the detected nonconformity (the 2000 version just talked about “actions”).

8.2.3      Monitoring and measurement: Emphasis that organizations should, when  determining suitable monitoring and measuring  methods, “consider the type and extent of monitoring or measurement appropriate to each of its processes” and that these methods are proportionate to their impact.

8.5.2      Corrective action: Emphasis that the “effectiveness of the corrective action” must be reviewed, i.e. not just that the action has been implemented.

8.5.2      Preventive action: Emphasis that the “effectiveness of preventive action” must be reviewed, i.e. not just that the action has been implemented.