ISO 9001 Conformance
The Problems
The ability for a company to say "ISO 9001 certified" is a requirement for many industries, and has become important for more and more industries where products include services as well as manufactured products.
The ISO 9001 standard contains the requirements for a quality management system designed to insure that a company's products meet its customer's expectations, however successfully implementing the standard brings challenges.
Do these problems sound familiar?
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I am not ready to pass an ISO 9001 audit.
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I can’t find the correct documentation.
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It is too difficult to develop the right document.
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My document does not meet the requirements of the ISO 9001 standard.
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My company spends too much money on compliance efforts.
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My company is not able to keep up with changes to documents.
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I need to bring my documentation up to the current version of the standard.
The Needs
Organizations seeking registration to ISO 9001 must be able to must successfully execute the following:
- Development of “audit ready” documentation – Solid documentation must include a policy manual, procedures and instructions covering the requirements in the standards with traceability to the stated requirements and objective evidence to support that the documentation is being followed.
- Enforce document control – Successful document control means that you can do the following things well: Revision control, document access, routing, approval and change impact analysis. Besides control, a document must be easy to find and retrieve by the intended user of its contents.