critical suppliers

  1. H

    Critical Supplier Agreement acc. to NBOG 2010-1 Annex II

    We had an surveillance audit for CE certication according to Medical Device Directive 93/42/EEC. One of the non-conformities is as following: "Contracts with critical suppliers do not meet all the requirements of NBOG 2010-1 ANNEX-II. For example: The content of the contract does not include...
  2. S

    Critical supplier - Obligated to have an ISO-certified QMS?

    Hi everyone, As a critical supplier (contract manufacturer), are they obligated to have an ISO-certified QMS? Or any kind of QMS? Thanks!
  3. A

    Critical Supplier/Quality Agreement Procedure

    Does anyone have an example of a procedure for determining a critical supplier and an example of a Quality Agreement that would be used for different types of Critical Suppliers. I would think a Quality Agreement for a component supplier would be different than a supplier of services or for an...
  4. C

    Partial Design Validation and changes to a critical supplier

    We are a manufacture of a class II medical device and we changed our LED supplier for a device that treats wrinkles. Can I get away with a partial design validation to confirm the LED requirements for the specified application have been met? Or would I also need to do a partial verification?
  5. S

    Financial status of critical vendor

    Is there any forum or report that provides financial stability of critical vendors like broadband providers (Airtel, Aircel and TATA etc.) Aircel recent bankrupt came so suddenly and have affected business continuity, a advance warning system will help.
  6. Pmarszal

    Supplier Auditing Services (Audit Needed?)

    We have a supplier that is on the other side of the world and were looking at different options to verify that the supplier’s controls are sufficient. We initially though that we could have a virtual audit of the supplier but after a bit of research, many do not recommend this approach for...
  7. S

    Supplier Classifications - Please give me a good definition of the following terms

    Hi everyone, Can somebody give me a good definition of the following terms? 1- Critical Supplier 2- Moderately-Critical Supplier 3- Non-critical supplier My group is trying to decide whether we should cut out the second category and define suppliers as either Critical or...
  8. Q

    Is a Domain Registrar a Critical Supplier?

    Good afternoon, Working through a bit of a mess of an AVL that I inherited from a former employee (I am the "replacement"). They listed our domain registrar as a critical supplier because customers interact with our stand alone software medical device through our website. So in theory, if the...
  9. M

    Notified Body (NB) Audits of Sub-Contractors and Critical Suppliers

    Wondering if anyone can share experiences with respect to the likelihood that critical suppliers/sub-contractors may be audited by Notified Bodies. I'm looking at an article from LNE-GMED, which raises some concerns... The article states: "Per the NBOG’s Best Practice Guide 2010-1; a critical...
  10. Q

    Critical Supplier's Senior Management Changes

    Hi all, We have been informed by one of our critical suppliers that their CEO has changed. This supplier is responsible for manufacturing, packing and sterilisation of our product. As this is one of the key parts for our business, should we do anything to confirm that he company is going to...
  11. A

    Critical Suppliers which will not allow us to audit them

    Hello again :bigwave: I am in the process out developing the supplier audit schedule for 2015, however some suppliers that we deem critical are un willing in terms of allowing us to audit them. I believe they allowed a representative to visit them whilst in the new supplier development stage...
  12. J

    API Q1-9 Critical Supppliers and Risk Assessment

    Question about and risk assessment. We have 4 or 5 suppliers that we would classify at Critical - There is little substitute available if they were to have a dis for whatever reason: 1. They either sell specialized material and stock for us, 2. The products we buy are...
  13. S

    Is it acceptable to have an ASL for Critical suppliers alone?

    I have a question around the Approved Supplier List (ASL) in an ISO 13485 and a medical device world. During one of the supplier audits, I found that they track only their Critical suppliers in the ASL and do not cover the non critical suppliers. Is this acceptable from FDA and ISO 13485...
  14. U

    Must We Audit Critical Suppliers? How often?

    Hello, everyone. We had MDD audit this year and NB auditor said clearly "you must audit your foreign factory (making class II devices) at least ONCE A YEAR. NB must audit them according to ZLG3.9 B17 if you fail to show clear evidence of good controlling. " My question is, 1. Is this...
  15. G

    How to manage a problem Overseas Tooling Supplier

    Dear Forum users, We have a oversea supplier who supplies us critical tooling. In the recent years, it has been given us a lot a grief, e.g. supply not in time, incorrectly machined parts. But in general their performance is not so bad. We have no intention to move to another supplier...
  16. E

    Changing Critical Supplier: What are the requirements

    Hi, I'm looking to change a critical supplier. The design verification, validation and process validation has been completed using the original vendor. What is required to qualify a new supplier. Should verification testing be repeated in full? Would we need to sterilize and Accelerate age as...
  17. M

    What determines a Critical Subcontractor?

    I've been reviewing some opinions as to the definition of a "critical" subcontractor, but am still a bit fuzzy here. One person suggested that it is only "critical" if it's the only company that can supply the item/service? Or, more often used is the phrase "anything that would affect product...
  18. W

    What Type of Service Suppliers should be on our Approved Service Suppliers List

    During a recent 3rd party surveillance audit, an Opportunity for Improvement resulted involving the assurance that outsourced service suppliers are included in the supplier evaluation process. On our crtitical suppliers list we already include suppliers of calibration services. WHAT OTHER TYPES...
  19. J

    What to expect when a Critical Supplier moves?

    I was just informed from one of our suppliers that they will be moving their operations into a facility that is owned by their parent company. This supplier provides a critical cobalt-chrome porous coating for several of our medical devices. This process was part of our 510(k) submission for...
  20. G

    Choosing Supplier Evaluation Methods - Determining what a Critical Supplier is

    Over the many years that I have been in the quality field, I have seen the term "Critical Supplier" used many times. In all of that time I have yet to see a good definition of that term. Most people tell me that "you know one when you see one". Well that hasn't done me any good. The use of...
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