ISO 9001:2008 has recently been released. This covers the differences between the 2000 and 2008 version and how this affects companies certified to ISO 9001:2000.

Your certification body will be aiming to upgrade your certification to ISO 9001:2008 at your next surveillance audit and you should aim to be in a position for your systems to meet the 2008 standard by this time. This must be done during 2009 anyway. SSS systems inherently meet the new standard, but we will contact companies for whom we have provided 9001 systems to reassure them. Certification to 9001:2000 become invalid towards the end of 2010.

Health & Safety, Environmental and QA Services and Systems

Menu



ISO 9001:2008

Clause

Comments on changes

SSS stance

1.1 Scope

“Product” also includes intermediate product.
Now includes statutory, regulatory and legal requirements.

SSS systems normally recognise that intermediate stages are often key to the final product.

4.1
General Requirements

Notes added to explain more about outsourcing.
Types of control that may be applied to outsourced processes.
The relationship of outsourcing to clause 7.4 (Purchasing).
Clarification that outsourced processes is still the responsibility of an organization and must be included in the quality management system (QMS).

Outsourcing is normally covered in all SSS systems as we have always believed that QA must include all the aspects of a company’s operations, not just those in-house.

4.2.1 Documentation

There is clarification that QMS documentation also includes records.
Documents required by the standard may be combined.
ISO 9001 requirements may be covered by more than one documented procedure.

Rather than structure systems in the same way as the standard, SSS normally use a structure suited to the operations of the company.  This has always meant that 9001 requirements are covered by different procedures.

4.2.3
Document control

There is clarification that external documents relevant to the QMS need to be identified and controlled.

This has always been covered by SSS systems.  The standard system is 5.2 prA Document Control.

5.5.2
Management representative

There is clarification that this individual must be a member of the organisation’s own management.

This has always been inherent in SSS systems

6.2.1
Human resources

“Conformity to product requirements” is used instead of “product quality”.

This is a minor editorial change.

6.4 Work environment

Defines what is meant by “work environment.”

7.2.1
Customer related processes

Gives examples of post-delivery activities, including actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal.

7.3.1
Design & development planning

States that design and development review, verification and validation have distinct purposes.

Text is amended but there is no new substance.

7.3.3
Design & development outputs

States that information needed for production and service provision may need to include preservation of the product.

7.5.4
Customer property

Now includes statement that both intellectual property and personal data should be considered as customer property.

7.6
Control of Monitoring and Measuring equipment

Minor wording changes to state that equipment needs to be identified so that its calibration status can be determined.

8.2.1
Customer satisfaction

Note added to explain that monitoring of customer perception may include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, and dealer reports.

This has always been covered within SSS systems by the customer focus procedures and the system within INTACT.

8.2.3
Monitoring /Measurement of process

Minor changes.  There is still the requirement that monitoring should be appropropriate for the process.

8.3
Control of non-conforming product

Minor changes, but the organisation still must have different ways of tackling non-conforming products once the non-conformity is discovered.