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customer requirements

  1. Q

    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...
  2. M

    Perform a coating weight test within 3 hours of processing the parts

    Bit of help on this just had a new spec from a customer which requires us to perform a coating weight test within 3 hours of processing the parts. Who we use for our testing is about an hour away minimum but they cant guarantee that they can perform at test adhoc when we turn up. Is it a...
  3. A

    MedAccred being flowed down to Suppliers (2018)

    Although part of a number of selection/qualification criteria being used, a number of medical device OEMs are looking for their suppliers to be moving towards MedAccred accreditation. Stryker, GE Healthcare, J & J, Medtronic are all making distinct "noises", that new business awards and re-newed...
  4. P

    GM BIQS level 5 training?

    I am new to this forum and here is my first post. :bigwave: Anyone knows about this training? "How to obtain and maintain BIQS Level 5" from NEXUS QSD: The Supplier Development Institute (SDI). 1. Is this association affiliated with GM? 2. Feedback on this training course? 3. If no one does...
  5. J

    IATF 16949 Cl. d - Customer Requirements - How are people addressing?

    Under quality management system requirements,"d" states a document (matrix) indicating where within the organization's quality management system their customer requirements are addressed. My question is how are people addressing this? Just a reference to customer requirements or a correlation...
  6. D

    IATF 16949 Cl. 4.3.2 - Customer Requirements vs. Customer Specific Requirements

    How can I differentiate between customer requirements and customer-specific requirements? I read the definitions in IATF 16949 but could use some help interpreting. :thanks: David
  7. J

    What does "If required by the customer" mean?

    Hi, I have read some words in IATF16949 of "If required by the customer" so what is its meaning? How can I know in this issue? Is it needed to ask if to the customer?
  8. B

    IATF 16949 Cl. 4.3.2 - Meeting Customer Specific Requirements

    I am looking for some insight as to how some of you are planning to meet this requirement. I was originally going to do a high level matrix but have found that some of our customer requirements documents are quite extensive; for example, one is 80 pages and another is 60. Any insights you would...
  9. J

    IATF 16949:2016 8.4.1 Control of Externally Provided Products

    When reading the new description, I am wondering how far to go with suppliers? We produce metal forgings. I know to include material, heat treat, plating, calibration... But do die lube and tooling suppliers need to be included.
  10. A

    ISO/TS 16949 - Sharing Certification Audit Report (NCR's) with the Customer

    Hi Everybody, I want to learn quality experts opinion for below subject. One of our automotive customer request from us share the nonconformities found by the certification body to use as an evidence of their supplier performance evaluation during their audits. IMO valid ISO/TS...
  11. D

    Compliance with Customer Requirements - TS 16949:2009 Requirements

    Hi all, My organization is currently going through a Surveillance Audit and the auditor is really doing a deep dive into one of our customer's Supplier Requirements Manual. My question is this: Does TS 16949:2009 state anywhere that customer requirements are to be strictly adhered to? I...
  12. N

    Customer wants a PPAP/PSW on some Prototype Parts

    Hi we have a customer thats wants us to make a PPAP/PSW documentation to some prototype parts they have already ordered from us?? We are not TS/QS certified only ISO9001/14000 and we are a company that only makes prototypes. How shall we handle this? - My guess is we cant make...
  13. G

    PPAP 4th edition or VDA - VW Requirements

    Hello, Tell me please when my customer VW requires from me PPAP acc. to VDA but my internal rull is to have PPAP acc to PPAP 4th edition from my suppliers, it is acceptable for the customer. I do not find any information that each tier2, tier 3 etc supplier has to submit PPAP acc to VDA.
  14. T

    Determining Customer Requirements for the US Postal Service (USPS)

    I work for a remanufacturing company that supplies the USPS with reman transmissions. We have our annual audit tomorrow and since I have been here (over a year) I have not seen anything from the USPS regarding customer requirements. I can only guess as with any other customer - they want...
  15. Y

    Attachments of Certificate of Compliance - What to send to the Customer

    Hi all, I am working for aerospace industry. I am wondering that should i send compliance documents (Coc, raw material, fai etc...) of my subcontract to my customer or is my coc enough for my customer? Part design belongs to us. I am newly graduate and i have lot of questions to ask :)...
  16. N

    Do you make exceptions to your process for customers?

    One of our biggest customers, (known around the world), has an issue with providing specifications to us with issues. For example, the specification will outline a type of polymer to use. In the material section of the spec, it states to use the polymer. But in the structure formula...
  17. K

    APQP requirement when a new print or spec is received from a customer - Existing Part

    When a new print or spec is recieved from a customer for an existing part already in production does that kick off a APQP meeting?
  18. 4

    Customer Making Changes to a 510k Device They Purchased

    Hello Forum Members, Does anyone have experience with the following situation? A customer purchases capital equipment (class II) from a manufacturer. The manufacturer provides a maintenance contract if they want it. The customer knows there are design improvements that will reduce maintenance...
  19. J

    Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work

    Is it usual for potential clients to ask for (all / the most recent) FDA EIRs / 483s when evaluating a CRO for future work? Do CROs usually comply with the request?
  20. M

    Opportunity For Improvement - Customer to sign off or approve a new design

    Is it necessary to get a customer to sign off or approve a new design if the design engineer has verified that all of the requirements from customer have been met? :thanx:
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