iso 9001:2015

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    ISO 9001:2015 Clause 8.4.3 "Information for External Providers" buying from online retailers.

    I work for a very small manufacturing facility and am working on implementing ISO 9001:2015. In clause 8.4.3, the Standard requires: "The organization shall communicate to external providers its requirements for: a) the processes, products, and services provided b) the approval of products and...
  2. K

    Design and Development Exclusion

    Good day everyone. It's been awhile since I posted here. I'm just basically a lurker here. I want to hear your opinion regarding my dilemma. I'm a newly hired Deputy QMR of a new company. The scope of their QMS is Installation and Distribution of a certain equipment. My question is related to...
  3. A

    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...
  4. I

    Who has had to move from ISO 9001:2015 to ISO 13485 and what were the challenges?

    Apparently there are some possible changes on the horizon which would make hand-held medical devices class 2 instead of class 3 which would allow FDA audits of suppliers for the parts. So if I have to move my company from ISO-9001:2015 compliance to ISO-13485 compliance what are the major...
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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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    ISO-9001:2015 - direction on New Product Development?

    In your experience is there any guidance on new product development and introduction in ISO-9001? Anything that you've found useful besides Design Validation?
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    Necessity of Legal Register to conform to ISO 9001, ISO 14001, IATF 16949

    Hi all - I work for a company who seek compliance with the IATF 16949 standard, as well as 14001 and 45001. We are based in North Wales, UK. I have been asked to compile a register of all legal legislation relevant to health and safety, employment law, energy and environmental. I wondered if...
  8. K

    ISO 9001 Requirements for Raw Material Supplier Assessment and Approval

    I'm new to ISO 9001, but come from an ISO 13485 background. Adjusting to the gray areas in this standard has been a bit challenging. My new company allows the purchaser to assess and approve raw material suppliers with no review or approval from higher up. Is that considered acceptable? Thanks...
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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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    ISO 9001:2015 - Internal Audit Plan Clauses

    Hello, Long-time lurker, first-time poster. I'm planning our repair company's annual internal audit for ISO 9001:2015. In our audit plan, I'd like to list the relevant clauses but I'm having difficulty. Our major processes are: Customer Service, Billing, Training, Purchasing, Contract Review...
  11. Stefan Mundt

    ISO 9001:2015 - 8.5.2 Identification and Traceability

    We are a small organization specialized in Printed Circuit Board assembly. In between production processes, the boards go through various inspection steps. The ISO 9001:2015 standard requires in section 8.5.2 that: "The organization shall identify the status of outputs with respect to...
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    ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance

    I would appreciate some insights regarding the new EU MDR's requirement for a harmonized standard for the quality management system. We currently have an approved product in the EU market and our AR had told us that ISO 9001 compliance was sufficient in regards to addressing the quality system...
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    ISO 9001:2015 8.5.1 f - Scope with customer special process requirements

    Hi all "Where the resulting output can't be verified".... In deciding if it applies or not. I have seen that in most of systems Is not applicable, when applicable, is in what is named "special processes" welding, and some other , But I wonder what are the basis? Maybe it could apply in many...
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    ISO 9001:2015 Supplier Certification Requirements

    Do suppliers to ISO 9000 (2015) companies have to be ISO 9000 approved ? I am reading 8.4 Control of externally provided processes, products and services and as yet do not see a specific mandate ?
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    ISO9001:2015 Clause 9.1 - What the external auditor will look at?

    1) clause9.1.1 (The organization shall evaluate the performance and the effectiveness of the quality management system) ~the question form (internal/external auditor may sound like; -show me how you evaluate the quality performance and the effectiveness of the quality management system? 2)...
  16. Q

    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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    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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    ISO 9001:2015 Clause 10.2.2 - Evidence of all nonconformities and actions

    Hi All, We have a process hole in that we aren't documenting corrections(nonconformities deemed as minor not worthy of a root cause analysis). As a result we're working on creating a process where any one in the org can submit an issue which will go the quality and management team for...
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    Only manufacturing, non applicable - ISO 9001 Clause 8.3

    Hello everyone Just want to be sure my assumption, hope you can help me. In a work shop, fabricating mechanical components, mechanical valves, carbon steel bins, vessels, flanges assemblies,etc. We receive the detailed drawings from the clients, drawings including Bill of materials...
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    ISO9001:2015 9.1.2 - Customer Satisfaction Feedback

    Regarding the requirement for organizations to obtain customer feedback, can this be satisfied by providing the opportunity for customers to provide feedback? I'm wondering of one is considered out of compliance if, for example, only 25% of customers provide feedback through scorecards, etc...
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