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  • Can the same person prepare and review document?

    Good morning, I have a question, could the one who prepares a document be the one who reviews it? How can I justify or prove?

  • Quality Culture and Product Risk Assessment

    I want some help on how to approach quality culture and product risk assessment. 

  • ISO 9001 Quality Inspection Records

    We have some standard quality inspection records.  Basically they are spreadsheets that have a checklist for each product we make where we verify our product meets specifications (for example, height, weight, etc) and then we mark down whether it’s passed or not. Do these inspection records need to be considered as controlled documents?  Do they need to be given a document number, revision level, and approval?  Do they need to be kept on the document control master list?

  • Can a certified company transfer its ISO certificate to another company?

    My question is about ISO certificates. Can a certified company transfer its ISO certificate to another company? While I am saying 'certified company', I don't mean a certification body. It can be a private company. If it is possible to transfer, what is the legal basis for that? Thanks in advance!

  • Documentation requirements for the HR department according to ISO 9001

    What is the documentation requirement for the Human Resources and Controlling departments according to ISO 9001?

  • Does a company need to be ISO certified to present a Quality Manual?

    Hello, I'm trying to put together a quality manual. does the company have to be ISO certified to present a quality manual? Do you all have staff that specialize in pipe, valves, and fittings?

  • Audits and MDR - Internal Audit Requirements

    Hi, my question is the requirements for internal audit. Can we conduct it in house using your internal audit package? Or does the internal auditor have to be a professional/approved auditor. Currently we are using an external consultant but if we can do it ourselves, that would be great. Thank you!

  • ISO 9001:2015 Scope

    I understand "the organization shall consider the products and services" when developing the Scope (4.3) but is it a requirement that all customer facing products and services have to be included in the scope? Thus that product/service would not be included in the Certification.

  • ISO 9001:2015 and the Accounting department

    For ISO 9001-2015 does this standard covers for the whole organization which include accounts department? If yes which all ISO clause we need to use for accounts department?

  • Who should prepare the Quality System documentation?

    I want to know who usually should do the documentation work for a quality system? QC officer or internal auditor?  I want to know the position that prepare these ISO documents.
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