Does the scope of ISO 9001:2015 applies to tenders, pricing and sales department of a medical devices distributor?

[medwise]

Hi All,

Does the ISO 9001:2015 applies to all departments within an organisation e.g. tenders & pricing? Clauses within the ISO 9001:2015 standard do not explicitly mention them. I need some guidance on which clauses may be applicable even if they are not explicit.

Thank you.

 

[John Broomfield]

The scope of your management system should defined to the extent that it is effective. Omitting tendering from a system that has evolved its tendering process out of necessity would result in an ineffective organization, let alone its management system.

The scope you decide you want stated on your certificate is more of a marketing decision. For example, you may design your services to gain competitive advantage. So, having servicized your offerings you may want to highlight the fact that you design the services that improve customer satisfaction of their relationship with your company.

Always make sure the scope of your management system is at least as wide as the scope stated on your certificate.

 

[Sidney Vianna]

I need some guidance on which clauses may be applicable even if they are not explicit.

Mainly in 8.2 with focus on 8.2.3

 

[Guest]

Does the ISO 9001:2015 applies to all departments within an organisation e.g. tenders & pricing?

Only the ones which don't get paid for by sales revenue from understanding and meeting customer requirements.