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EN 9100 vs ISO 9001
"What is the fundamental difference between the EN9100 and the ISO9001 standards?” -
Terminology of ISO 9001 - shall word
"In the ISO 9001 standard, the expression "shall consider" is used extensively. I was wondering what implication it had in actual audits. i.e. if we "shall consider what needs to be obtained from external providers" (clause 7.1.1), in what kind of question from the auditor might this translates into? Are we required to have any proof that we did indeed consider it? I have a similar question for the following "shall" clauses: shall ensure and shall understand?” -
Quality Manual and IMS Manual
"Is the scope of IMS Manual fulfill the requirement of QMS, or I need to develop other document.” -
Determining causes in internal audits
"We are a multi-site organisation with ISO 9001 systems and a team of internal quality auditors. The internal auditors obviously check implementation against the system and raise NCRs where there are shortfalls. This is done using a Corrective Action Request (CAR) and the form specifies what requirement hasn’t been complied with. The auditee is then asked to identify the root cause and corrective actions. We have had a comment that the internal auditor should identify the root cause / corrective action. I struggle with this because the detail of why it wasn't complied with is only truly understood by the auditee. Q. Is it correct to place the responsibility onto the manager to find root cause etc OR should it be done by the internal auditor do this OR both?” -
Form identification
"Can we use a dynamic form for testing record that may have slightly different information for each product family but is basically the same. Do we need to change the rev or have different forms? Seems to many forms would be bad as would one form that does not have all the information. Having the basic "frame" be controlled but the specific information fluid makes more sense.” -
Documenting risks and opportunities
“How can we documented risks to fulfill requirements of ISO 9001:2015?” -
Certification costs
“I would like to know if doing the audits to obtain ISO certificates is free for companies, such as hospitals.” -
Internal audit is different from gap analysis
“Do we have to do an internal audit this year, if we carried out a full gap analysis against each clause, in preparation for our transition? If you do, would you have a sample template?” -
Documenting Quality Policy & Quality Objectives
"The mandatory documents Quality Policy & Quality Objectives have to be 2 stand-alone documents, or can they be contained within a Quality Manual?” -
Lack of information in non-conformance description
"What action to be taken when non-conformance given during surveillance audit due to internal audit not cover few clauses?”