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08 July 2015

Significant Differences between the 2008 and the 2015 versions of ISO 9001

The approach taken in the new revision of the standard is that the certified organisation takes a risk-based approach to it products, services and processes, accompanied by the selected preventive measures to ensure that identified threats are controlled. The key purpose of the quality management system or ISO 9001 approach is to take PREVENTIVE ACTION to perceived threats such as stock-outs, raw material specifications changing, equipment downtime, bottlenecks not identified, inadequate employee training, root causes of defects not identified, data loss, personal data not protected and so forth. 

 

ISO 9001:2008

ISO 9001:2015

Products

Products and services

Exclusions

Term not to be used in the new version

Documentation, Records

Documented Information

Work Environment

Environment for the operation of processes

Purchased product

Externally provided products and services

Supplier

External provider

 

NEWS, NEWS….ISO 9001:2015…NEWS, NEWS….New Version of the standard to be published in Quarter 4 2015. It will be called ISO 9001:2015. There is a 3 year transition period allowed. The transition to the new standard must be completed by September 2018.

The 2015 version of ISO 9001 requires that the context of the organisation is understood (see clause 4.1) and that risks and opportunities that need to be addressed are identified (see clause 6.1).

One of the key purposes of a quality management system is to act as a preventive tool to perceived threats and so the new version does not have a separate clause or sub-clause titled 'Preventive action’. The effective implementation of the requirements of the standard is measured by the extent to which perceived threats are controlled.

The concept of preventive action is expressed through a risk-based approach to formulating quality management system requirements.

There will therefore be greater emphasis in the new version of ISO 9001 on performance based requirements.

Dr. Martin Knox

Dr. Martin Knox

Martin Knox is a PhD Chemist with significant experience in training and development, research, environmental management and water quality management. He is a lead assessor for the following international standards:

  1. ISO 9001
  2. OHSAS 18001
  3. ISO 13485
  4. ISO 14001

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