Can anyone tell me or point me in the direction of a good resource on supplier controls for animal tissue suppliers for medical device.
What registrations do they need to have?
What CoCs should we request and so forth.
I have situation in company, where Buyers would like to implement new Supplier to deliver one of the parts to already existing project. The purpose of this change is that the current Supplier does not meet our requirements and presents very poor quality. New Supplier will have to submit...
I just joined this forum and wondering if anyone have experience or expertise developing of medical device component qualification procedure/plan for suppliers.
Can someone tell me how to develop a supplier Component Qualification plan? Thanks.
I have a question and wish to get advice from you
Section 22.214.171.124, 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...
Hi all, first time poster here.
The company I work for has an issue with parts sent to a special process supplier being damaged during process, and supplier being cute about what is causing the damage. Both companies are ISO9001.
We've issued a formal CAR, and either get ignored or blown off...
I'm writing the report for an audit we just did, and I would like some help in understanding exactly what is meant by "its" in 8.4.2 (a) under Type and Extent of Control in ISO 9001:2015. Does it mean the supplier or their supplier?
Full text reads: "The organization shall...
Hello - I'm currently working on supplier evaluation and qualification for a medical device software company. All supplied products are off-the-shelf and/or available to the general public, such as cloud and web services, PC hardware, etc.
Am I required to monitor such suppliers (e.g. Dell...
Hello everyone :bigwave:,
Could you kindly give me some suggestions on how to plan the monitoring of suppliers?
I think monitoring items includes incoming inspection, delivery time. Correct me if Im wrong.
If, after poorly resolved repeated quality problems (same defect, same cause, same part), you decide to reduce using or quit using a supplier, is it better to tell the supplier or just move the business?
Nothing in the supplier’s possession needs to be returned. We have not decided if some no...
I'm freshmen in my field. Currently we are on the way to deploy APQP process with our supplier for my company automotive project. There are something as below:
1. I'm reviewing a supplier timeline and have a concern as below:
as you know, in PTO we need to get samples from...
There is a problem for me about the scope of the requirements of clause 8.4.1 and 8.4.2.
Based on clause 8.4.1 and 8.4.2, it seems that the scope of the requirement is only for suppliers that provide products that incorporate into the organization's own products or directly sent...
I don’t have a lot of experience with supplier management. I was hired for my experience in other areas.
In the last few months I have three suppliers, all ISO9001, where poor document control was a major cause of nonconforming product (I suspect not the root cause). Each individual supplier...
In an annual evaluation of critical suppliers, what type of questions can we ask?They provide critical parts for the devices we build.
So far, the procedure in our company is a questionnaire. But the questions are very high level like "has the supplier's performance been satisfactory?". What...
When are we required to request a supplier's quality management certificate (ISO, etc)? Is this dependent on the risk of the supplied product? For example, should we request QMS certificates only from critical suppliers?
API Spec Q2 states in the last paragraph of clause 126.96.36.199: Outsourced suppliers that impact the quality of services or service-related product, located at the organization’s facility, shall be included as part of the internal audit of the organization.
So now my question is if this is only...
Good day all,
I would like your assistance with implementing a Supplier Quality System (tips, tools, training courses). Let me explain you my case...
I enetered to the company as an SQE reporting to the corporate director of quality for all suppliers in Mexico. I'm focused only on finished...
Is a supplier score card a requirement under ISO and QSR? If so, does the supplier score card apply to critical suppliers only? When does a score card become necessary? How does this apply to suppliers from whom we make 1 or 2 transactions a year? Thanks.
I'm trying to determine how or if I should score pass-through items on a top-level supplier scorecard. One of our suppliers uses a sub-tier supplier that provides components that are incorporated into top-level assemblies that are then delivered to us.
There are occasions when the...
I would like to have some tip / support regarding how to perform assessments / audits for indirect suppliers or material?
It would also be helpful if someone has the possibility to share a Assessment / Audit / Survey template for indirects suppliers or material.
Best regards/ Tobias