The purpose of this procedure is to define the requirements for conducting receiving inspection of finished devices, sub-assemblies and components.
Receiving Inspection Procedure (SYS-033) and webinar bundle
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download (including your spam folder).
When is the webinar about the receiving inspection procedure?
This webinar will be live on Monday, February 26, 2024 @ 10:30 am ET. The session will be recorded. You can purchase it on-demand and watch the training as often as you wish.
What will you receive?
This four-page procedure is the primary document meeting the applicable regulatory requirements for conducting receiving inspection as defined in the Quality System Manual (POL-001). The procedure is updated for compliance with ISO 13485:2016 (Clause 7.4.3), 21 CFR 820.80, and Regulation (EU) 2017/745 for CE Marking. The following documents are included with this procedure:
- SYS-033 Receiving Inspection Procedure
- LST-004 Receiving Inspection Log
- FRM-008 Nonconformity Report (NCR)
- Invitation to participate in the live webinar if you purchase this before February 26
- Access to download the recording of the live webinar from our Dropbox folder
- Native slide deck for the webinar
The procedure includes details for inspections performed by your company, as well as inspections performed by your suppliers. The procedure also includes suggestions for a statistical sampling plan. Along with the procedure, you will also receive a template for receiving inspection log. You will need to create an inspection plan or work instructions for specific products if your component drawings and specifications do not include inspection requirements already.
To view all available procedures click here
To review a sample Medical Device Academy procedure click below: