Scribd
Upload
34 views1 page

Key Requirements in ISO 13485

ISO 13485:2016 outlines key requirements for incoming inspection, including the need for organizations to verify that materials meet specified criteria before use. Verification can involve inspection, testing, or supplier certifications, and documentation is essential for compliance. Best practices include maintaining inspection records, defining acceptance criteria, and using approved supplier lists.

Uploaded by

Lokesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
34 views1 page

Key Requirements in ISO 13485

ISO 13485:2016 outlines key requirements for incoming inspection, including the need for organizations to verify that materials meet specified criteria before use. Verification can involve inspection, testing, or supplier certifications, and documentation is essential for compliance. Best practices include maintaining inspection records, defining acceptance criteria, and using approved supplier lists.

Uploaded by

Lokesh
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 1

Key Requirements in ISO 13485:2016 Related to Incoming

Inspection:
1.Clause 7.4.3 - Verification of Purchased Product:
 The organization must establish criteria and processes
for verifying that incoming materials meet specified
requirements before use in production.
 The verification process may include inspection, testing,
or supplier certifications .
2️. Clause 8.2.4 - Monitoring and Measurement of Product:
 The organization must ensure that materials conform to
requirements before being accepted for further
processing.
 If verification is not performed at the time of receipt ,
there must be a justification and alternative control
measures in place.
3️. Clause 7.5.1 - Control of Production and Service
Provision:
 Ensures that documented procedures are in place to
manage and track the acceptance of incoming
materials.

Does This Mean an Incoming Inspection Report is


Mandatory?
🔹 Yes, if your process requires inspection or testing to verify
material conformity, you must maintain a record (e.g., an
incoming inspection report ).
🔹 No, if you rely on supplier certifications or other
verification methods, but you must document and justify your
approach.
Best Practice for Compliance:
✅ Maintain an Incoming Inspection Record for traceability.
✅ Define acceptance criteria for materials in purchase
specifications.
✅ Use approved supplier lists and require supplier quality
documents.
✅ Establish inspection sampling plans based on risk assess

You might also like