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ISO 9001 - Expert Advice Community

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  • SWOT analysis and management structure in ISO 9001

    I want to understand the frame/process that is followed in creating an ISO management documentation - are you able to provide a structure. Also I liked that a SWOT analysis is carried out.  Is a SWOT always carried out?
  • Clause 8.5.4 Preservation

    Can you please clarify what this clause means? what is required? how can I demonstrate compliance? 8.5.4 Preservation The organization shall preserve the outputs during production and service provision, to the extent necessary to ensure conformity to requirements. NOTE: Preservation can include identification, handling, contamination control, packaging, storage, transmission or transportation, and protection.
  • Needs and Expectations of Interested Parties

    What are examples of needs and expectations of: - Investors - Regional Offices - Management - Contractors - Consultants - Ministry / Government - Society - Competitors - Media - Suppliers - Regulators - NGO - Employees - Workers - Outsource - Association - MOPH?
  • Internal Audit

    This is my first time doing an internal audit on "sales and marketing". I feel like our company doesn't have a sales and marketing department. How should I go about doing an internal audit for a department that doesn't get used?
  • How to drive opportunity reports by IQA team

    Can you share with me about how to drive opportunity reports by IQA team, how to start?
  • ISO 9001 Surveillance audit

    The company that we were certified through may not be able to do our surveillance audit.  Is a surveillance audit required and if we choose a different company to do our audit, do we have to go through an entirely new certification?
  • Records

    Re: ISO9001:2015 sect. 8.5.1. a) 1) addressing The availability of documented information that defines:  the characteristics of the products to be produced, the services to be performed, or the activities to be performed. and 8.6 Release of product & servcies: The organization shall implement planned arrangements, at appropriate stages , to verify that the product and service requirements have been met. The release .......shall not proceed until the planned arrangements have been satisfactorily completed, ......... My questions are: If this information is contained on a shop traveler that reflects the activities / planned arrangements performed, operator buy-offs and inspection acceptance of outputs to established criteria, does this shop traveler become a record that needs to be maintained?  Can a Certificate Of Conformance alone signed / stamped by inspection suffice as an acceptance of product compliance / Record of Conformity of Product (8.6)?  Can a business elect to not maintain  completed shop travelers reflecting completion of planned activities and not be concerned about a 3rd party auditor wanting to view them, as long as they are able to provide visibility / outline of what the planned activities consisted of and the signed COC?
  • KPI requirements

    Are KPIs also required for the external audit for the sales department?
  • How can I tag an instrument which is not in use as per ISO norms?

    How can I tag an instrument which is not in use as per ISO norms? Some of our company instruments are not in use and are not calibrated. Can I simply mention "Not in use" in a tag and tie on the instrument?
  • ISO 9001 Certification Documentation

    I contact you to ask you some questions regarding the documentation for ISO 9001 certification. We are currently a limited liability company with a single shareholder, I am his partner and I will join the company in January 2022, at the moment for tax issues I do not copy the company but we manage all the effects in two. I specify this thing because one of the doubts we have is related to the presence or not of an organization chart. I see that there may be figures such as CEO, General Manager, Sales, administration manager. We do not have these figures formally to date. Can I appear as General Manager even if I am not in the Chamber of Commerce registration? If you need an engagement letter for certification purposes? The administration is a service that we buy partly from a professional and partly from the accountant which of the cited? do we have to put names or is it enough the role that can then be played by different people? Can we omit the organization chart or make a simplified one? RGQ in our case of coinciding with AD? Are all the chapters and sub-chapters of the manual mandatory? If someone does not belong to us or we have nothing to say, do we put n / a? For example, we do not have offices but we work either digitally from home (especially in the last year and a half) or on-site by the customer. Can we use Teams and Office 365 as a repository? Thank you in advance for your answers
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