Is a Quality Policy Statement a Requirement? (ISO 13485)

SGquality

Quite Involved in Discussions
#1
In an ISO 13485 supplier audit, they have a Quality Vision statement that says that they are committed to their customers and together they will create value by providing products with innovation and expertise.

They do not have a Quality Policy statement but are using the above Quality Vision as a Quality Policy. Is this acceptable or a separate Quality Policy statement required?
 
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GStough

Staff member
Super Moderator
#2
Bump....

FWIW, ISO 13485:2016 states in 4.2.1(a) "The quality management system documentation (see 4.2.4) shall include: a) documented statements of a quality policy and quality objectives..."

If I saw this in one of my supplier audits and they were using the "Quality Vision statement" as their quality policy, I would accept it. In the audit report, I would make a comment that their "Quality Vision statement" is their quality policy.

Perhaps others have differing opinions.....?
 

howste

Thaumaturge
Super Moderator
#4
In an ISO 13485 supplier audit, they have a Quality Vision statement that says that they are committed to their customers and together they will create value by providing products with innovation and expertise.

They do not have a Quality Policy statement but are using the above Quality Vision as a Quality Policy. Is this acceptable or a separate Quality Policy statement required?
Like Gidget implied, the requirement to have Quality Policy statement doesn't mean they have to call it a Quality Policy statement. I see this as no problem. In auditing a supplier to see if they're acceptable I would think this is one of the lower priorities in the scope of your audit.
 

Coury Ferguson

Moderator here to help
Staff member
Super Moderator
#5
In an ISO 13485 supplier audit, they have a Quality Vision statement that says that they are committed to their customers and together they will create value by providing products with innovation and expertise.

They do not have a Quality Policy statement but are using the above Quality Vision as a Quality Policy. Is this acceptable or a separate Quality Policy statement required?
I am in agreement with Steve and Gidget on this. To me, Quality Vision is Quality Policy at least in my opinion.
 

SGquality

Quite Involved in Discussions
#6
Bump....

FWIW, ISO 13485:2016 states in 4.2.1(a) "The quality management system documentation (see 4.2.4) shall include: a) documented statements of a quality policy and quality objectives..."

If I saw this in one of my supplier audits and they were using the "Quality Vision statement" as their quality policy, I would accept it. In the audit report, I would make a comment that their "Quality Vision statement" is their quality policy.

Perhaps others have differing opinions.....?
Yes, I agree but the statement does not meet the ISO 13485 requirements like, "includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system". Would that be acceptable? I am asking this cos in one of our internal certification audits, the ISO auditor gave us a finding over not having "maintain the effectiveness" in our quality policy !

Is the supplier required to have a QMS certified to 13485? Is having a quality policy a requirement you impose on the supplier?
Having a quality policy is not forced upon but having an ISO 13485 certificate is
 

Marcelo

Inactive Registered Visitor
#7
Vision is a desired future state, what the company wants to be in the future (which differs from mission, where mission usually includes what the company is now).

A policy is a guide to action.

So, the examples mentioned by the OP are really policies, not vision.

If there's anything wrong, it's that.

And mixing the concepts really means that they do not understand them.
 
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