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ISO 9001 - Expert Advice Community

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  • Nonconformance Finding (ISO9001 Audit)

    During ISO 9001 Audit, if Purchase department have no procedure for purchasing, Sale department also have no sale procedure (documented procedure), so it will be considered a nonconformance finding (Major or Minor)? If not, how Auditor assess their compliance with ISO9001 requirement?
  • Manage Risk Effectively

    How to manage risk effectively according to ISO 9001 requirement? For example, Company have 5 teams (HR, Operation, Production, R&D, QA). So each team must manage risk & opportunities in their team. Is that correct? Can you advise me some training course or material in advisera to manage risk?
  • ISO 9000 and ISO 9001

    How ISO 9000 change into ISO 9001?
  • Contract Review and Operational Planning

    What is the relationship between Contract review and operational planning of an implementation?
  • Is a Competitor an Interested party

    Is competitor (not competition) an interested party, and if yes, why?
  • Who to audit during Top Management audition

    Could you please assist us (as new trained Auditors) with advice on how to audit the top management of the organization? The organization has different directors of departments and heads of units who are all referred to as top management according to our organization. Do we have to audit the Director general only or do all directors have to be audited during auditing of top management?
  • Quality plan for service or colective

    I intend to implement the ISO 9001: 2015 standard in my company, which is a service company, so I am stuck in filling in the documents for the production and service delivery procedure. I would like to know if, while filling out the quality plan, should I fill in the quality plan for each service to be provided or should I fill in a single quality plan for the various services?

  • When to Do Internal Documentation Review

    When is the best time to do a company internal ISO 9001:2015 Documentation Review?
  • ISO 9001 Clause 8.2.3.2

    If we are a warehouse and distribution company would this section (Clause 8.2.3.2) be relevant to us? We do not manufacture any products. We provide storage and distribution of our client's products.
  • Lab Software

    I am wondering if you could tell me which standards would be required for a piece of lab software. The software tracks actions include cell culture trees, electronic lab notebook, cell line inventory, collaboration, and gene sequencing capabilities.
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