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Mark Kaganov's Articles

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  • Is your ISO 9001 Quality Manual Complete? Checklist Will Tell
    Some people call it "senior moments", some people call it "spaced it out", simply speaking, we all sometimes forget something - human nature.
  • ISO 13485:2003 - Managing Forms
    Auditing numerous companies of different sizes in medical device manufacturing industries, I found that control of forms is one of the notorious issues with maintenance of ISO 13485:2003 QMS. Various companies, by odd reasons, 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"
  • What is a Quality Manual for ISO 13485?
    Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 13485 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your organization in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 13485:2003 QMS should be:
  • ISO 9001 Documentation
    A guideline for Developing Quality Manuals, ISO 10013 Standard, suggests a documentation structure for ISO 9001 QMS. This model in the standard proposes use of a three-level arrangement. Most companies I worked with utilize four-level structures instead to include records, A typical four-level documentation structure consists of:
  • ISO 9001 Quality Manual
    A quality manual is the top-level definition of a quality management system of your company. It is similar to an expanded mission or vision statement. Quality manual establishes the policy level position of your management in the area of quality management system (QMS). There are two definitions of what a quality manual for an ISO 9001 QMS should be:
  • Quality Manual for ISO 9001:2000 Standard
    Well, formally there are a number of definitions of what a quality manual is. These definitions are in ISO 10013, ISO 9001 and other standards. In fact, a quality manual is a top-level document defining your quality management system. A quality manual establishes the policy level position of your management in the area of quality management system. There are two principal definitions of what a quality manual for an ISO 9001:2000 QMS should be:
  • ISO 9001 Controlling forms
    One of the controversial issues with interpretation of ISO 9001:2000 Standard and others is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001:2000, element 4.2.3, "Documents required by the quality management system shall be controlled." Let's see if a form qualifies to be a "document" that shall be controlled.
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