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  • Control of External Providers

    A part of our business is Design & Development although we do not currently have a contract to do this work nor had one since our AS9100 certification last year. So, at this time, I would say this activity is more like freelance prototyping. To create the design specimen, we use several external providers. I believe, since we have not sold our design nor sold any products to customers yet, I would not have to go through the rigor of controlling external providers under the standard. My fear is, an external auditor may feel differently. Your thoughts and comments are greatly appreciated.

  • Business continuity plan

    a)Which clause number of ISO 9001 - covers this requirements. Or this requirements covered in different standard.
    b)During AS9100 audit ,whether the auditors can ask Question regarding Business continuity plan ? So far no auditors asked directly this question during AS9100D audit..Is there any reason.

    c)what is the difference between Contingency plan and Business continuity plan?

  • AS9100 meaning

    Dear friends,
    What is the meaning of AS in AS9100? Ican't fint anywere an explenation about.

  • Documentation Requirements, Corrective Action and Nonconforming Product

    Revision D. We had an auditor tell us that "the standard requires us to document" items like counterfeit parts within the Nonconforming product process specifically (even though we already have it in another process) and human factors documented in the Corrective Actions process specifically. Both of which actually don't state that they need to be documented in the process, but instead need to be determined or ensured coverage (which would be seen in the completion of the process in its own inherently). I don't believe the auditor is accurate in his statement based on how the standard is written. Wanting to get another person's perspective on this.

  • AS9100D, Section 8.4.1

    I'm having trouble to decide the best way to meet this requirement:

    "The organization shall identify and manage the risks associated with the external provision of processes, products, and services."

    Any hints?

  • AS9100D Sections 9 and 10


    I am working in a company that design and produce electromechanical systems. We are trying to define our processes. My question is about identifying/choosing process. Especially it is about AS9100 sections 9 and 10. Based on the process approach, does it make sense to define measurement improvement studies (meaning that AS9100 sections 9 and10) as a process? Why?

    Thanks in advance.

  • FAI vs Design Validation?

    Is it Ok to consider FAI as a subsitute of Design Validation?

  • Machine vs process validation

    I need to know the difference between machine validation and process validation. What kind of document do we need to maintain for the same?

  • Audit scope

    Stage 1 audit complete - is it possible to slim down the scope before stage 2 in order to simplify the process

  • Acceptance media

    I am wondering if a person can use more than one acceptance media for two differentiating jobs. i.e. Having a Tech stamp and a QC stamp for the same person trained in both roles. I am currently amending the controls of acceptance media and I cannot find an answer to this in any of the standard. Thanks in advance

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