Organization merger. Should we keep two separate ISO 13485 certificates?

jkc3usc

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#1
Company is a manufacturer and ISO 13485 certified is merging with a distributor who is ISO 13485 certified.

Can they still keep separate ISO certs and separate QMS even if we are now considered one? If not does that mean the QMS of the distributor will need to no fall under the manufacturers requirements?

Keeping 2 separate certs and 2 QMS was easier due to the difference in one manufacturing and one merely distributing.
 
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Sidney Vianna

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#2
Any organization that goes through a merger and/or acquisition will have to, sooner or later, develop business processes that are meaningful and sustainable for the resulting enlarged business. It does not make any business sense to have "separate" quality systems. What it does make sense is to have a well developed quality system that is seamlessly embedded in the organization business processes and, addresses both the manufacturer and the distribution facets of the business. Thinking of quality systems outside the business environment is akin to implement 5G technology using dial up connections.

The best approach is to have ONE single ISO 13485 certificate encompassing both the manufacturing and the distribution scopes of the business.

Good luck.
 

jkc3usc

Involved In Discussions
#3
Any organization that goes through a merger and/or acquisition will have to, sooner or later, develop business processes that are meaningful and sustainable for the resulting enlarged business. It does not make any business sense to have "separate" quality systems. What it does make sense is to have a well developed quality system that is seamlessly embedded in the organization business processes and, addresses both the manufacturer and the distribution facets of the business. Thinking of quality systems outside the business environment is akin to implement 5G technology using dial up connections.

The best approach is to have ONE single ISO 13485 certificate encompassing both the manufacturing and the distribution scopes of the business.

Good luck.
So since the distributer is ISO certified and we were able to have a lot on non applicable clauses does this now open them up to the clauses we have applicable for our manufacturing site?
 

Sidney Vianna

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#4
The applicability of the ISO 13485 Standard requirements for the different processes is always an expectation. As an example, a distributor does not have product design responsibility.
 

jkc3usc

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#5
The applicability of the ISO 13485 Standard requirements for the different processes is always an expectation. As an example, a distributor does not have product design responsibility.
I agree but incorporating them into one QMS and one cert would we just word that into the procedures that this is not applicable?
 

Sidney Vianna

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#6
How many business management systems will the merged organization have?

Hint: If you end up with more than one business management system, your leadership has no idea of what they are doing.
Any functional organization should have a coherent business management system and that includes a quality system that is an integral part of how the business operates. This quality system should be designed to address the risks to product conformity and customer satisfaction in an intelligent manner. Fragmented, multiple quality systems tend to exist in organizations that don't understand the importance of embedding it's quality practices in the day to day operations.

Good luck
 

indubioush

Quite Involved in Discussions
#7
One of your sites should be considered headquarters. Your quality manual will list the section of ISO 13485 that do not apply to your business. It will explain the different sites and their roles. Your specific QMS procedures will have a statement in their scope about which facility/site that procedure is applicable to. For example, scope statement in the design control procedure: This procedure is applicable to the Company Name Location Site only.
 
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