This purchasing procedure is updated to the most recent requirements for ISO 13485:2016, Clause 7.4.1 compliance and for compliance with 21 CFR 820.50.
Purchasing Procedure Contents
This purchasing procedure is written with the intent to meet the regulatory requirements for ISO 13485:2016, Clause 7.4.1 and 21 CFR 820.50. The procedure is 5 pages in length. The procedure also references the following forms that are included if you purchase the procedure:
- FRM-007, Inwards Goods Receipt Log (a.k.a., Receiving Log)
- FRM-021, Purchase Order
- FRM-037, Supplier Quality Agreement
- LST-012, Purchase Order Log
Using Purchasing Requisitions
Some companies also prefer to have a purchasing requisition process. Purchasing requisitions are not a regulatory requirement, and we believe that this is just an extra layer of bureaucracy that slows down smaller companies and is only needed by larger companies. Therefore, we highlighted the section related to purchasing requisitions for you to edit or delete as needed.
Buying Our Purchasing SOP
This purchasing procedure is updated to the most recent requirements for ISO 13485:2016, Clause 7.4.1 compliance and for compliance with 21 CFR 820.50. It is a 5-page procedure, and 4 additional forms are included.
Are you planning to buy this procedure?
After your transaction is verified automatically by PayPal, you will receive a subscriber verification email at the email address provided in the shopping cart transaction. The purpose of this is to verify that you would like free email updates when this procedure is updated in the future for continued regulatory compliance. If you do not receive that email, please check your spam folder. Since 50% of these emails are filtered out, we will also send a manual email to you personally to make sure that you receive the content you purchased.
Purchasing Procedure Scope
This procedure covers the purchase for goods and services which form part of your company’s product, its potential impact on its quality or safety, or potential impact on the Quality Management System (QMS).
For purchases from vendors or suppliers providing goods or services which have no impact on the QMS, or on the quality of product, (e.g. office supplies or legal advice), it is not necessary to follow this procedure.
How to write your own purchasing procedure…
Mary Vater, one of our regulatory consultants, wrote a blog about supplier quality and purchasing controls. You can follow her guidance and other articles we have written for writing procedures in general.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: