The New BS EN ISO 9001:2008 Standard
What do the changes mean for you, if you are already registered to BS EN ISO 9001:2000? The fourth and latest edition of the Quality Management Systems - Requirements Standard (BS EN ISO 9001:2008) was published on November 14th 2008. This revision contains minor amendments only. The aim of this revision is to clarify existing requirements and to improve consistency of approach with other management standards, such as ISO 14001:2004.In reality there will be little impact, there are very few changes of any consequence and most organisations will have little problem adapting their system to satisfy these changes.
Following is information to help you to make the required changes.
BS EN ISO 9001:2008 will replace BS EN ISO 9001:2000 but each organisation will be given approximately one year after its publication to make any updates (check with your Certifying Organisation). There should not be any major disruption to your organisation or your registration. Your auditor should be able to guide you through the process. Most changes relate to the reading of the standard and a few (highlighted) relate to changes in your documentation – mainly your Quality Manual. In some cases the changes in the standard will have no effect on your activities or documentation.
Understanding the Requirements of BS EN ISO 9001:2008
Following is general guidance where we have attempted to translate the basics of BS EN ISO 9001:2008 into Plain English. NOTE: Where the term Product is used this should be read as a reference to either Product or Service. The term Supplier means a supplier of Products or Services.
The starting point is the System Requirements section. The pages before this comprise a contents page, foreword and other general information as follows:
1 Scope
1.1 General
1.2 Application
2 Normative References
3 Terms and Definitions
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4 - Quality Management System
4.1 General Requirements
Establish and document your Quality Management System
Implement your Quality Management System Maintain and improve your Quality Management System
4.2 Documentation Requirements
Develop Quality Management System documents including your Quality Policy and measurable Quality Objectives
Prepare your Quality Manual, Procedures and Work Instructions to reflect what you do and how you do it
Control your Quality management System documents
Maintain Quality Management System records |
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Management Responsibility |
