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Articles by Mark Kaganov

• ISO 13485 - Controlling forms
  Auditing companies in medical device manufacturing industries, I found that control of forms is one of the notorious issues with maintenance of ISO 13485:2003 QMS. Some businesses treat forms in a different way than other instructions, leaving them not controlled. ISO 13485:2003, element 4.2.3, requires: "Documents required by the quality management system shall be controlled." Now let's find out if forms are the same as "documents"
  Published 20Sep2008, viewed 185 times

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