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distributors (general)

  1. Sidney Vianna

    Informational UTC ASQR Rev.11 has a mistake; certification of distributors to IATF 16949

    United Technologies has recently released a new revision of it's Supplier Quality System Requirements document. In paragraph 4.1.2, it requires: As people in the automotive supply chain knows, distributors cannot be certified to the IATF16949 standard; only manufacturing sites. I tried...
  2. A

    API Q1 9th ed Addendum 2 - Vendor Assessment for critical products

    Hi everyone, I have a question and wish to get advice from you Section 5.6.1.2, API Q1 9th edition, Addendum 2 specified that: For purchase of critical products, components or activities, the initial evaluation of suppliers by the organization shall be site-specific for each supplier and shall...
  3. Q

    Control of outsourced processes - drop shipped products

    Hello I am a ISO consultant. One of my customers had a major non conformance on their transition audit for (from 9008 to 2015)this (then called me for help). They are a distributor. They sometimes have products delivered directly from their supplier to their customer. I have not come across this...
  4. Q

    AS9120B Clause 8.4.1.1 External Providers Scope of Approval

    We just went through our AS9120B upgrade audit and got a non-conformance on Clause 8.4.1.1 The organization has not fully maintained a register of external providers that includes the scope of approval. We had our approved external providers listed as Supplier (distributors), Vendor (repair...
  5. D

    Customer Specific Requirements / Distributors (IATF 16949)

    Hello All! I haven't posted here in a while but we're preparing for our ITAF 16949 certification and I have a question regarding customer specific requirements or CSRs and how they relate to distributors. We have a dozen or more direct automotive customers but we also sell quite a few...
  6. C

    Approval of raw material suppliers which do not manufacture the material

    Hi all, In case of raw material suppliers, how far back do we need to go throughout the supply chain? Is it enough to approve the supplier of a raw material, which does not manufacture the material? Should I also approve the manufacturer of the raw material or is it the responsibility of the...
  7. E

    Participation required in OASIS and IAQG?

    Must a distributor of aluminum and steel sold to aerospace manufacturers become a member of the IAQG and contribute information to OASIS? Can anyone explain the relationship between these entities? Thanks for any help you can give.
  8. supadrai

    Countries where you should (absolutely?) avoid appointing a distributor ...

    ... as your regulatory liaison (for lack of a better general term). So far, I'm finding the below: 1. Brazil (Brasilian Holder of Registration) 2. Saudi Arabia (Authorized Representative) 3. Costa Rica 4. U.S.A. (U.S. Agent, but multiple initial importers) 5. Canada (Regulatory...
  9. J

    Distribution and PPAPs for products they do not manufacture

    New to this forum so I apologize if this is a repeat. What is the risk assumed when a distributor completes a PPAP for products they do not manufacture? Some of our suppliers will not or cannot complete a PPAP and with customer requirements we must submit one. With no control over the...
  10. Z

    Do we need a Risk Register for ISO 9001:2015

    It appears that a "risk register" is not required for ISO 9001:2015. We always post issues, situations, risks, concerns and potential problems on a large dry erase board so that the issues do not get forgotten. Would it also be necessary to draft a register to house these risks and resolutions...
  11. V

    Inspection of Initial Importer/ Distributor Products and Materials

    Hello, I work for a dental medical device company who is currently going for ISO13485 and CE certifications. I have a question regarding the Receiving, Inspection and release of products from initial importers/distributors. Are there any suggestions in the receiving and inspection process...
  12. M

    What level of control should be exercised on distributors?

    Question for discussion: What level of control/requirements do you exercise on distributors? Do you treat them as suppliers (providing distribution service) or customers (they issue an order, you fill it, no additional control necessary). If the former, what qualification requirements do...
  13. P

    IVD device distribution, what to do?

    Question 1: Our company designs and manufactures reagents and software for tissue typing. I am investigating the requirements to distribute these products in Japan as in-vitro diagnostic (IVD) for diagnostic purposes. According to information the medical device regulatory approval process...
  14. F

    Distributors Audit guide

    Hi all, As I've seen some information regarding distributors, I guess here's the place to ask if any of you has a Distributor Audit Guide. What to look for when auditing a distributor, what questions to ask, which details to focus on, and so on. Main focus of the audit will be this points...
  15. O

    Distributors and ISO 13485 - DHF and DMR Responsibilities

    If my company is going to distribute a device that we are having co-manufactured (our name on the product), and we are ISO 13485 certified, but the company manufacturing our product is not, what requirements as far as ISO 13485 is concerned are there? Can the manufacturer hold the DHF and DMR...
  16. G

    AS9120 Purchase Department Performance Requirements

    Hi, Our Company doing Trading and Distribution of Aerospace and Military spares and Materials. We would like to fix and measure Purchase department performance for our AS9120 Certificate objective purpose. Please advise anyone can help me for this requirement. Best regards Ganesan
  17. E

    Regulations/ Restrictions to send Product Labeling (brochures, etc)

    Hello everyone, I wanted to inquire if there are any regulations/restrictions in sending product labeling (brochures, surgical procedure techniques) to distributors in countries where our products have not been registered. We are planning to enter certain markets and would like to send our...
  18. T

    Certificate of Conformance - Meaning and Definition of - Medical Device Manufacturers

    Morning, One of our distributors in the US has requested that we include a "Certificate of Conformance" with each shipment which should 1) state conformance with the referenced (?) national and international standards. 2)That the items shipped were tested according to referenced drawings...
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