ISO 9001:2015 Outsourced Process

[qcstar]

Hello Members

Require your suggestion on this specific case.

Our organization receives order from customers and outsources the manufacturing process to their subcontractors. The subcontractors manufactures based upon the drawings we provide and the final product is inspected by out QA team to ensure whether it meets the requirement.

As much as we dont have primary responsibility towards manufacturing process, we hold equal responsibility in ensuring finished product meets the requirements since we are the contact point for our customers

Our organization is going fr 9001:2015 certification and following level of documentation is established. These are:

1. Quality Policy
2. Quality Objectives
3. Interested Parties
4. Risks & Opportunities Register
5. Quality Manual
6. Control of documented information
7. Procedure for Internal Audit & MRM
8. Procedure for selection & evaluation of these subcontractors.
9. Inspection checklist

Subcontractor is certified for 9001:2015

Just want your suggestions on whether these should suffice. have I missed anything important which I must consider.

Thank you in advance for your time and help.

 

[somashekar]

Hello Members

Require your suggestion on this specific case.

Our organization receives order from customers and outsources the manufacturing process to their subcontractors. The subcontractors manufactures based upon the drawings we provide and the final product is inspected by out QA team to ensure whether it meets the requirement.

As much as we dont have primary responsibility towards manufacturing process, we hold equal responsibility in ensuring finished product meets the requirements since we are the contact point for our customers

Our organization is going fr 9001:2015 certification and following level of documentation is established. These are:

1. Quality Policy
2. Quality Objectives
3. Interested Parties
4. Risks & Opportunities Register
5. Quality Manual
6. Control of documented information
7. Procedure for Internal Audit & MRM
8. Procedure for selection & evaluation of these subcontractors.
9. Inspection checklist

Subcontractor is certified for 9001:2015

Just want your suggestions on whether these should suffice. have I missed anything important which I must consider.

Thank you in advance for your time and help.

The first point is that you have primary responsibility for the manufacturing process. Its then that you have decided to outsource since you are not able to do the same.

 

[qcstar]

Hi, Thanks for the reply. As prime responsibility, what other related documents should we establish ? what process would be audited by the CB.

 

[Jen Kirley]

Hi, Thanks for the reply. As prime responsibility, what other related documents should we establish ? what process would be audited by the CB.

The CB will be interested in how you made your requirements clear, and how you ensure the subcontractor is performing as you require. If there are site visits to verify their processes are in control, a report of those would be helpful.

ISO certification can (should) provide reassurance, but what are the process requirements? Clean room? Do you have other cleanliness needs? Is specialty equipment required? Storage protections for raw materials and finished goods? Will they be storing any of your property? If so, how will they control it? These are just some of the considerations of things that are not part of the ISO standard, except that they are customer requirements. The customer means you, in this case.