Audit boundaries - Is a Registrar permitted to audit a company's QMS by visiting their suppliers?

L

lorenambrose

Quality Assurance Manager
#1
#1
A quick question........

Is a Registrar permitted to audit a company's QMS by visiting their suppliers? Is there an actual prohibition regarding this?
 
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Al Rosen

Al Rosen

Leader
Super Moderator
#4
#4
8.4.3 l addresses this.

The organization shall ensure the adequacy of requirements prior to their communication to the external provider.
The organization shall communicate to external providers its requirements for:

l. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;
 
Sidney Vianna

Sidney Vianna

Post Responsibly
Leader
Admin
#6
#6
Al Rosen said:
l. the right of access by the organization, their customer, and regulatory authorities to the applicable areas of facilities and to applicable documented information, at any level of the supply chain;
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The right of access does not include the customer’s CB, though. No CB should be visiting suppliers without the registrants awareness and approval.

In the regulated medical device sector, critical suppliers, e.g. sterilization service providers can be audited in unannounced audits. But that’s not the normal practice.
 
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