Tag Archives: iso documentation practices

ISO Requirements or Good Documentation Practices?

  Question Are these standard for ISO or just good documentation practices? 1. All entries, except IPQA, should be made with blue ball pen in clear and legible handwriting. 2. IPQA entries shall be done in black ball pen. Answer … Continue reading

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Document Revision Criteria

Question Is there any criteria available for the frequency of document revision in ISO 9001 or ISO 13485?  Some organization don’t revise the documents for a period of more than 2-3 years.  The reason provided by the organization is that … Continue reading

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ISO 9001:2015 Documented Information Requirements

Question I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document? Answer Thank you for the … Continue reading

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ISO 9001 Electronic Records

Q: I have a few questions about employee training records.  My company is certified to ISO 9001:2008 Quality management systems–Requirements, and we are considering transitioning to electronic records. However, we don’t know what the requirements are from an ISO perspective. Specifically, we want to know: … Continue reading

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ISO 9001 Certification to Meet Customer Requirements

Q: My company is a small manufacturer that makes one product that I designed and engineered. We have a contract to produce the part for a much larger company. The larger company wants us to become certified to ISO 9001:2008 … Continue reading

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ISO 9001 & Time to Retrieve Records

Q: I am looking for an interpretation for ISO 9001:2008 Quality management systems–Requirements, clause 4.2.4 Control of records: “Records shall remain legible, readily identifiable and retrievable.” What is considered readily retrievable (i.e., 24 hrs, 48 hrs, 8 hrs, 1 hr)? I … Continue reading

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AS9100 production rough card

Q: According to our customer requirement, our quality inspectors are signing each step in production rough card in the following way: they apply their personal stamp (which includes their first and last name and personal number), add add a manual … Continue reading

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Standard Vs. Specification and Guidance Documents

Q: What is the difference between a standard and a specification? A: There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, … Continue reading

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ISO 9001 SOPs for HR and IT Departments

Q: My company wants to become certified to ISO 9001:2008 Quality management systems–Requirements by the end of this year. We have nearly all of our common standard operating procedures (SOPs) identified and written. But some of our departments—HR and IT … Continue reading

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ISO 9001 Clause 7.5.1 Work Instructions

Q: Within my organization there has been much debate on what a work instruction is. The term work instruction is not defined in the ISO 9001-2008 Quality management systems—Requirements standard (appears in clause 7.5.1). Our question is that if the … Continue reading

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