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iso 9001 - quality management systems

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    ISO 9001 - Actions Taken When Measuring Equipment is Found to be Unfit for Use

    At the end of section Measurement traceability in ISO 9001:2015 there is a note that states: "The organization shall determine if the validity of previous measurement results has been adversely affected when measuring equipment is found to be unfit for its intended purpose, and shall...
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    PPAP Documentation Control

    Hello, After an in depth PPAP review which lasted days, we have been hit with a rejection on the final step. 7.5.3 - Documentation Control. The customer has demanded we meet the following criteria before the PSW be signed: Full contents page which every document listed Every page to be...
  3. Q

    ISO 9001 Clause 9.1 - Monitoring measurement analysis and evaluation

    Hello everyone Could you share something in this point? I have experienced that most of users and auditors, in this clause are satisfied with little data to take actions, complaints, rejects, supplier evaluation, kpis, and that's all. The standard asks more actions, identify what to measure...
  4. Q

    Write down same nonconformity in several processes?

    Hi all Please share your opinion in this issue. Auditing a 9001 system. When auditing the responsible of the Management system (Coordinator) in the process management system, it was found that for Some documents, the responsible didn´t follow what the procedure stated. The procedure states...
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    ISO 9001 8.4.1 - Determining controls applied to externally provided processes

    My company uses our supplier's datasheet to verify part dimensions. The supplier does not notify us when dimensions change so we only find out when we have an issue. At that point the paperwork gets updated and the old rev is discarded. Some parts, however, are catalog so I have transferred...
  6. Sidney Vianna

    ISO 9001 News Improving the Brand Integrity of ISO 9001 - Task Group of ISO TC 176

    The ISO TC 176 created a Task Group to tackle the "brand integrity" of ISO 9001. So far, in the working space designated for the TG, there are no publicly available documents. A recent article in the CQI Quality World magazine triggered a discussion in LinkedIn and I joined in, despite the...
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    ISO 9001:2015 standard documentation

    Hi All, I am currently working on growing my knowledge of ISO 9001 but I have been largely doing so without the documentation. I'm at a point where I feel like having the actual standards documentation to just pull up and read would be really beneficial. I'm not a quality manager or anyone...
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    Comparison matrix between IATF 16949:2016 to ISO 12207, ISO 9001 and Automotive SPICE

    Hello, I try to make a comparison matrix between IATF16949:2016 to ISO12207, ISO9001 and Automotive SPICE According to my undestanding, IATF16949 is quite general, and ISO12207 is very software development oriented. Is that kind of comparison matrix available somewhere? Thanks
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    Records required for ISO 9001 clause - Fitness for purpose of the monitoring and measurement resources

    In Clause No. : "The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources." Which records shall me maintained to demonstrate this requirement as we are in to machining activity ? Please help. Thanks...
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    Can subsidiaries use the holding company's ISO 9001 QMS and be classified as ISO 9001 certified?

    Hello; I just jumped into the world of researching ISO 9001 to be implemented in our companies. We have come to that point of time that our customers require us to have an ISO 9001 certification. So let me just point out that our area of expertise is very wide; we deal with everything from...
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    Infrastructure and Environment for the operation of processes (ISO 9001 7.1.3 & 7.1.4)

    I'm looking for advise on what CB auditors would be looking for to evidence 7.1.3 and 7.1.4 of ISO 9001:2015. I'm very familiar with CB auditors verifying the inspection dates of fire extinguishers as a way of evidencing compliance with legal requirements and provision of infrastructure but I...
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    Can we integrate both ISO 9001:2015 and API Q1 Management System Standards

    Can we integrate for both Standard ISO 9001 :2015 and API Q1
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    ISO 9001:2015 - "Resources" - handled by leadership team?

    It makes sense to me that Resources in ISO-9001:2015 are the responsibility of the leadership team unless they've specifically delegated the Quality Manager. Has anyone else determined a different business function to act as the Process Owner for Resources?
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    Complying with ISO 9001:2015 - 9.1.1 b - Monitoring, measuring, analyzing and evaluation

    Hi fellows. (Methods for the monitoring,measuring, analazing and evaluation) To comply to standard, 9001 2015, in this clause, what specifically the standard ask us to do? How is this done? E.g. for processes performance, to explain that every month indicators, are collected, then are included...
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    Is consultant prohibited in ISO9001 audit?

    Hi, Anyone knows if consultant attending audit is prohibited by any accreditation or certification body rules? I know that for IATF16949 it states clearly this prohibition. How about ISO9001 audit?
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    IATF 16949 manufacturing cell in ISO 9001 factory?

    I've been tasked with conducting a gap analysis on our current facility. We are ISO9001 and are currently negotiating a new 5 years contract worth millions with a new customer. However, the new customer wants us to be IATF accredited, I'd just like press you for some guidance on this. The new...
  17. I

    ISO 9001 and VWAD (Verified-Accredited Wholesale Distributors certification)

    I am assisting a pharmaceutical company with their QMS documentation for ISO 9001 certification. They are also applying to VAWD (Verified-Accredited Wholesale Distributors certification) Based on ISO 9001 I am creating SOPs and processes and integrating VAWD criteria into those documents. The...
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    ISO9001:2015 6.3 - Planning of Changes - OFI from auditor

    All, Good day! I received OFI from auditor ~ (The Change Control Procedure could be est to outline control with regards to sudden changes with regards to internal/external aspect, such people, amendment in customer requirements, legal/regulatory requirements, technology, environment and QMS...
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    Reasons to change certification body and typical costs

    Two questions so I'll start with the last one. What's a typical fee for an auditor to certify to iso 9001: 2015? Based on size, number of sites and complexity in sure. But say 50 employees, one site and low to average level of complexity for an automotive manufacturer (2nd/3rd tier). Is there...
  20. Q

    ISO 9001:2015 Clause 8.3 - Is it possible to exclude one product but include it in other?

    Hi everybody Please help to clarify this situation. I have a manufacturing company toward the certification in 9001. Mainly sells two products, but only in one is applied 8.3. Is it possible to declare somewhere that one product doesn't apply 8.3, while the other does it? Both product in...
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