ISO 9001 - Expert Advice Community

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  • Interested parties - Decision

    "Actually, I'm establishing a quality manual. I just wanted to know that, should we include certification bodies as an interested party, and if yes, then what will be their requirements and what will be the mechanism for their review and monitoring?”
  • Certificates of products bought

    "Is it mandatory to pursue the certificate of the product bought from an external provider?”
  • Environmental conditions and operations

    "Regarding temperature monitoring in the warehouse, does that fall under clause 8.5.1 or 7.1.4?"
  • Traceability of calibration

    My doubt is on calibration certificate . When we send an equipment for calibration, we need to obtain calibration certificate for the equipment to be calibrated. But does the standard mandate to get calibration certificate of the master equipment used to calibrate our equipment.
  • Preparing for a surveillance audit

    "I am newly appointed in sugar industry as compliance officer. We are ISO 9001 2015 certified with certification body. Now I am preparing for surveillance up-grade audit may kindly advise for preparation of up-grade and their requirements. Advise for documents required in the audit.”
  • What are quality management procedures?

    "What are quality management procedures?”
  • Use of certification logo

    "Would like to clarify and confirm the 3-yr validity of the ISO 9001 Certificate issued by a Certifying body/registrar. Example, if a certificate was originally issued on July 2016 and was re-certified on July 2017 which expired on July 2018, can we still use it or at least the logo for communication and marketing purposes?”
  • Authority to approve documents

    “I need clarification for the ISO 9001:2015 Procedure. Top Management Signature required for all Standard Operation Procedure (SOP) ? My current practice of company is : Top Management needed upon the document request example like HR Procedure. Please advise me on this.”
  • Risks and opportunities - an approach

    Address risk and opportunities regarding ISO 9001:2015 - I am very confused regarding implementation this topic. Because my understandings regarding this new approach, differs a lot from all implementations and guidance of reputable experts. a lot of them go to risk assessment against each activity using FMEA!! and others transform it to strategic business risk without touching the opportunities any more. Please, I need reasonable discussion regarding this wonderful approach which considered now to me as a nightmare.”
  • Required documentation

    "What is the quality management requirement for documentation?”