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ISO 9000ISO 9001:2015
ISO 9001:2008
Key Requirements
Most important clause
ISO 9001 Misconceptions
Why do more?
Should we drop ISO9000?
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Key Requirements of ISO 9001:2008

ISO 9001:2008 is divided into 8 sections

  1. Scope (What the standards cover and what they applies to)

  2. Normative references (The other standards that form part of the provisions)

  3. Terms and definitions (What the words used in the standards mean)

  4. Quality management system (Basic provisions on establishing a QMS)

  5. Management responsibility (Provisions that apply to the strategic governance of an organization and its management system)

  6. Resource management (Provisions that put in place the physical, financial and human resources to achieve the organization's objectives and manage its processes)

  7. Product realization (Provisions that create, produce and supply the organizations products and services)

  8. Measurement, analysis and improvement (Provisions that measure performance, identify and manage improvements leading to the satisfaction of all interested parties)

The 250 or so requirements of ISO 9001 can be condensed into five linked requirements.

ISO 9001 basically requires the organization to:

  1. Determine the needs and expectations of customers and other interested parties relative to the goods and services it provides;

  2. Establish policies, objectives and a work environment necessary to motivate the organization to satisfy these needs;

  3. Design, resource and manage a system of interconnected processes necessary to implement the policy and attain the objectives;

  4. Measure and analyse the adequacy, efficiency and effectiveness of each process in fulfilling its purpose and objectives and;

  5. Pursue the continual improvement of the system from an objective evaluation of its performance.

The focus is therefore on results and the processes that produce these results.

The old method of documenting what you do and doing what you document will not cause the right things to happen. The old method of auditing for conformity to requirements or procedures will not verify that processes are being managed effectively and therefore both have to change. An auditor that simply tells you that his/her objective is to establish compliance with the requirements of ISO 9001 is missing the point - he/she needs to tell you exactly what that means in plain language. The auditor, if he/she is doing the job properly, will seek to establish that there is a linkage between the needs of the customer and applicable regulations, the organizationís objectives, the processes for achieving these objectives and the results being produced. An effective approach to conducting such audits is explained in our book ISO9000:2008 Auditor Questions

Also the idea that an effective system can be created simply by addressing the requirements of ISO 9001 through documented procedures is flawed. It creates a bolt-on system that sits outside the business whereas to deliver customer satisfaction it requires the processes to be an integral part of the organization.

Follow the links in the panel on the left to learn more or browse our bookshop for more in-depth treatment of the subject.


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