(Quality) ISO 13485, Readiness Self-assessment

Diagnostic Manufacturing

Partnering with suppliers who understand their role in your ISO 13485-compliant quality management system reduces your risk as well as saves you time and money. Use this assessment tool to determine if your relationship to your suppliers is sufficient to keep your process ISO 13485-compliant.

Question Title

* 1. Which of the following does your supplier management program include procedures for? (select all that apply):

Supplier Selection

Supplier Classification (e.g. high risk, strategic partner, transactional supplier)

Evaluation of incoming raw material quality

Evaluation of third party service providers

Periodic monitoring of raw material and service suppliers

None of the above

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* 2. Does your organization have a robust procedure to identify critical or high risk raw materials?

Yes

Not sure

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* 3. How does your organization determine critical or high risk raw materials? (select all that apply)

Material affects many production lines or IVD assays

Only one known supplier offering what you need

Raw material linked to high-revenue finished good

Financial and/or operational reliability of supplier providing the material

My organization does not have a harmonized procedure

I don’t know how my organization determines criticality or risk

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* 4. What controls do you put in place to secure the supply of critical or high risk raw materials? (check all that apply)

Testing pre-shipment samples

Batch reserves or consignment at your supplier’s facility

Holding inventory at your own facility

Increased incoming QC inspections/testing

Change control notification agreements with your suppliers

Qualifying and securing back-up sources

None of the above

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* 5. What controls do you put in place for critical or high risk suppliers? (check all that apply)

Supplier CAPAs (Corrective Action/Preventive Actions)

Confidentiality and/or master supply agreements

Quality agreements

Audits every 1-5 years

Scheduled (monthly, quarterly, etc.) reviews

Supplier questionnaires

None of the above

I don't know

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* 6. Enter your contact information

First Name

Last Name

Company Name

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* 7. What is your job function?

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* 8. May we contact you to help you increase your ISO 13485 readiness?

Yes

Partnering with suppliers who understand their role in your ISO 13485-compliant quality management system reduces your risk as well as saves you time and money. Use this assessment tool to determine if your relationship to your suppliers is sufficient to keep your process ISO 13485-compliant. OK

Question Title

* 1. Which of the following does your supplier management program include procedures for? (select all that apply):

Question Title

* 2. Does your organization have a robust procedure to identify critical or high risk raw materials?

Question Title

* 3. How does your organization determine critical or high risk raw materials? (select all that apply)

Question Title

* 4. What controls do you put in place to secure the supply of critical or high risk raw materials? (check all that apply)

Question Title

* 5. What controls do you put in place for critical or high risk suppliers? (check all that apply)

Question Title

* 6. Enter your contact information

Question Title

* 7. What is your job function?

Question Title

* 8. May we contact you to help you increase your ISO 13485 readiness?

Partnering with suppliers who understand their role in your ISO 13485-compliant quality management system reduces your risk as well as saves you time and money. Use this assessment tool to determine if your relationship to your suppliers is sufficient to keep your process ISO 13485-compliant.