Christel | Passionate About SHEQ Management

ISO9001:2008 - The proposed new changes

• May 15th, 2008

The norm is for the Standards to receive an update every 6 to 7 years. The update for the ISO9001: 2000 version is thus way overdue. However the draft is out with the possible changes highlighted.

The first interesting inclusion is a statement that this update has been influenced by the ISO14001: 2004 version to enable more compatibility between the two standards.

This once again illustrates the move towards integrated systems and streamlining of management systems. A further emphasis is on compliance to statutory requirements compared to only customer and regulatory requirements in the previous version.

The first step in any management system is the compliance to the laws of the country in which the system is being implemented. This confirms the strategic SHEQ development path of an organization:

Further changes include:

4.1 Identify the processes have been replaced by “Determine” the processes. Controls should also now be applied to outsourced processes.

4.2.1 Referral is made to the inclusion of records and not only documents throughout the system

4.2.4 The whole section on control of records has changed.

5.5.2 The management rep should be from the organization.

6.2.2 “Product quality” has bee replaced by “conformity to product requirements”. “Competence” has been included.

6.3 “Information systems” have been added to infrastructure.

6.4 “Work environment” has been broadened to include clean rooms, anti-static pre-cautions and hygiene controls.

7.1 Planning of product realization include monitoring as well.

7.2.1 Statutory and regulatory requirements are stricter controlled with the inclusion of the word “applicable”.

7.5.2 Processes such as welding, sterilization, training, heat treatment, call center service, or emergency response may need validation – Note 2.

7.5.3 The organization shall identify the product status with respect to monitoring and measurement requirements throughout product realization

7.5.4 Customer property can include intellectual property and personal data.

8.2.2 A documented procedure shall be established to define the responsibilities and requirements for planning and conducting audits, establishing records and reporting results as well as records of the audit and its results shall be maintained

8.2.3 When determining suitable methods, the organization should consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the quality management system.

8.2.4 Evidence of conformity with the acceptance criteria shall be maintained.

8.3 A documented procedure shall be established and (d) when nonconforming product is detected after delivery or use has started, by taking action appropriate to the effects, or potential effects, of the nonconformity and records of the nature of nonconformities and any subsequent actions taken, including concessions obtained, shall be maintained (see 4.2.4).

8.5.2 (f) Reviewing the effectiveness of the corrective action taken.

8.5.3 (e) Reviewing the effectiveness of the preventive action taken.

Kindly note that the above have not been approved yet and are still open for comment. This article serves to inform the implementer of the management system of possible changes to pro-actively make a mental note of possible implications for the existing ISO9001 system.

• Contact Christel Fouche |
• Management Systems
• 
  Print This Article

One Response to “ISO9001:2008 - The proposed new changes”

1. Angelo Says:
   November 4th, 2008 at 11:29 am

   Very Informative and striving for continual improvement in Africa