ISO 13485:2016 Quality Policy Requirements

Fat Larry

Registered
Our company is currently in the process of MDSAP certification and on review of our current Quality Policy I've noticed that it talks about the QMS intending to comply with relevant ISO and international regulatory requirements and specifically lists these. For example ISO 13485, 93/42/EEC, US FDA QSR 21 CFR 820 etc. However, the ISO 13485 standard does not appear to specifically require this. Under section 5.3 Quality Policy the standard states: "b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system;". In order to comply with this clause does anyone know if companies need to list the standards and regualtions it complies with in order to meet Section 5.3 of the standard? Does the "requirements" part of this clause mean that standards and regulations should be identified?
 
There is no requirement that the quality policy specifically list applicable standards. I have never listed standards, but you could if you wanted to. However, you should list the regulations and standards in your quality manual because this clarifies the scope of your quality system.
 

myusoffice

First Time Right...
The scope of your quality management system should include and specifically state all applicable regulatory requirements and quality system management standard being applied. This is normally documented in Quality Manual.

Quality Policy doesn't require to state applicable regulatory requirements. Hope this helps
 

John Broomfield

Leader
Super Moderator
Don’t make your quality policy document too specific. It should be reasonably timeless except when changing your chief executive.
 

Manto

Starting to get Involved
I am trying to understand ISO 13485 Section 4.1.1 ROLES UNDERTAKEN BY THE ORGAIZATION UNDER APPLICABLE REGULATORY REQUIREMENTS.
Can someone put this in layman terms for me and share an example.
 

Manto

Starting to get Involved
I have several list of documents needed and some state 4.1.1 and other don't. Does anyone have a GOOD list of document I need to create?
 
The documents you need will depend on your organization's need and the type of organization.

As for examples for complying with 4.1.1, usually this information is located in the quality manual in a section about the company or in a scope statement:

Example quality manual sections:

Company Information
Blastomed is a medical device manufacturer located in Someplace, California, USA.

Scope:
Blastomed is a medical device manufacturer located in blah blah. Blastomed maintains a quality system compliant with the following standards and regulations...

Alternatively, you could have a separate scope document for the organization. This may make sense if the organization has multiple roles, like if they manufacture one type of device but only distribute another.
 

Manto

Starting to get Involved
Our company has several different brands under one roof. The Brand and part that I am trying to have certified for ISO 13485 is MEDICAL BLAH BLAH and our Purchase orders state BRAND X. How do I justify this??? Do I need to make the Medical Blah Blah a stand alone entity? Do I need to make all my documents state Medical Blah Blah or is there a rationale? I knew this was not going to be an easy task but this is throwing me for a loop
 

Jim Wynne

Leader
Admin
Our company has several different brands under one roof. The Brand and part that I am trying to have certified for ISO 13485 is MEDICAL BLAH BLAH and our Purchase orders state BRAND X. How do I justify this??? Do I need to make the Medical Blah Blah a stand alone entity? Do I need to make all my documents state Medical Blah Blah or is there a rationale? I knew this was not going to be an easy task but this is throwing me for a loop
You can't have 13485 registration for a product; the registration is for the quality system that produces the product. You need to be a little more clear on the description of "BLAH BLAH" and "BRAND X" to get better responses.
 

Manto

Starting to get Involved
Sorry Jim this is very confusing to me but I will try to clarify.
I am creating a QMS for Medical Blah Blah LLC in hopes of being certified to ISO 13485.
The Medical Blah Blah LLC manufactures and sells the product. Brand X has several different products lines and different lets say divisions under one production facility. The parts to manufacture Medical Blah Blah are bought under the Brand X name, all the purchase orders state Brand X and are brought in house for assembly of medical Blah Blah
SO our purchase orders all state brand X. so I do not have a connection to parts used to make Medical Blah blah under Medical Blah Blah LLC
This is making it difficult for me to try to create procedures
Don't know if that helped but I will think on it tonight to see if I can come up with a better explanation
 
Top Bottom