Please select user.Assign
There are no topics yet.
Define - Top Management in section 5 of AS9100D
Design and Develooment Outputs:
Clause 8.3.5.d - Does the organization ensure that design and development outputs: specifies the characteristics of products and services that are essential for their intended purpose and their safe and proper provision.
Can you explain what this means please?
Is it mandatory to record all applicable clauses requirements in the internal audit report.Example (purchase process internal audit)we need to cover all clauses of purchase process as per AS9100 std and record the evidence in the audit report....if not record whether will it be a NC during in CB audit.. But we have internal audit Non conformity and action plan report....
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.
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?
What is the meaning of AS in AS9100? Ican't fint anywere an explenation about.
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.
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."
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.
Is it Ok to consider FAI as a subsitute of Design Validation?