ISO 13485 Quality Policy that concisely meets standard

[Sam Lazzara]

I have developed quality systems for numerous clients, and here I am again.
With regard to the Quality Policy, I went back and read the standard and guidance info, and reflected back on how I like to manage objectives. Thought I would share what I have come up with...for the sake of getting feedback from the group.

What follows are the relevant ISO 13485 requirements and ISO 14969 guidance, and at the bottom is the Quality Policy I am planning to propose to the new client.

ISO 13485, 5.3 Quality policy
Top management shall ensure that the quality policy
(a) is appropriate to the purpose of the organization,
(b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system,
(c) provides a framework for establishing and reviewing quality objectives,

NOTE: ISO 9001:2008 has same requirements except (b) says:
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system

GUIDANCE - ISO 14969
The quality policy establishes
— a commitment to quality and the continuing effectiveness of the quality management system to meet customer and regulatory requirements,
— the context for quality objectives, and
— the relationship of the organization’s objectives to the customers’ requirements.
It is important that the organization’s quality policy be considered when preparing the overall organization policies related to its business operations (e.g., marketing, sales, finance) in order to ensure that all organization policies are consistent and supportive of each other.
The quality policy should communicate the organization’s commitment to quality and its overall vision of what quality means to the organization’s business and customers.
In order to demonstrate that the organization is committed to implementing its quality policy, it will need to identify clear, overall quality goals for the business that are directly relevant to the organization and its customers.

________________________________________________________________
ACME MEDICAL QUALITY POLICY

Our quality system exists to deliver "innovative life-enhancing products" that meet customer and regulatory requirements.

We maintain the effectiveness of our quality system by continually pursuing measurable objectives related to:
1. Product development and improvement.
2. Quality system planning and improvement.
3. Supplier quality assurance.
4. Personnel training and competence.
5. Regulatory compliance and internal/external audits.
6. Customer focus and process effectiveness/efficiency.
______________________________________________________________

The "innovative, life-saving products" part can be replaced by whatever the client wishes that is "appropriate for the purpose of the organization"; it could (but need not) mention the type of device or medical specialty.

I have typical organized the ongoing quality objectives under the 6 headings shown in the Quality Policy above. In other words, those headings establish the "framework" for quality objectives. The specific measurable (SMART) objectives vary and are updated periodically (with accomplishments), but the headings should work for any type of organization.

Thoughts? Other ideas?

Thank you
Sam

 

[somashekar]

It is good to keep the objectives out of the policy.
The elements in 5.3 a) b) c) can be stitched into the policy and the d) e) are the communication and review part which can be demonstrated.
Example:
We, at ACME MEDICAL are committed to comply with the requirements and meet the customer needs in providing "innovative life-enhancing products" through continual improvement in our process approach.
This will be done by maintaining the effectiveness of the Quality management system and by periodic review of our objectives.
We shall operate within the framework of all applicable regulatory requirements.

 

[John Broomfield]

I have developed quality systems for numerous clients, and here I am again.
With regard to the Quality Policy, I went back and read the standard and guidance info, and reflected back on how I like to manage objectives. Thought I would share what I have come up with...for the sake of getting feedback from the group.

What follows are the relevant ISO 13485 requirements and ISO 14969 guidance, and at the bottom is the Quality Policy I am planning to propose to the new client.

ISO 13485, 5.3 Quality policy
Top management shall ensure that the quality policy
(a) is appropriate to the purpose of the organization,
(b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system,
(c) provides a framework for establishing and reviewing quality objectives,

NOTE: ISO 9001:2008 has same requirements except (b) says:
b) includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system

GUIDANCE - ISO 14969
The quality policy establishes
— a commitment to quality and the continuing effectiveness of the quality management system to meet customer and regulatory requirements,
— the context for quality objectives, and
— the relationship of the organization’s objectives to the customers’ requirements.
It is important that the organization’s quality policy be considered when preparing the overall organization policies related to its business operations (e.g., marketing, sales, finance) in order to ensure that all organization policies are consistent and supportive of each other.
The quality policy should communicate the organization’s commitment to quality and its overall vision of what quality means to the organization’s business and customers.
In order to demonstrate that the organization is committed to implementing its quality policy, it will need to identify clear, overall quality goals for the business that are directly relevant to the organization and its customers.

________________________________________________________________
ACME MEDICAL QUALITY POLICY

Our quality system exists to deliver "innovative life-enhancing products" that meet customer and regulatory requirements.

We maintain the effectiveness of our quality system by continually pursuing measurable objectives related to:
1. Product development and improvement.
2. Quality system planning and improvement.
3. Supplier quality assurance.
4. Personnel training and competence.
5. Regulatory compliance and internal/external audits.
6. Customer focus and process effectiveness/efficiency.
______________________________________________________________

The "innovative, life-saving products" part can be replaced by whatever the client wishes that is "appropriate for the purpose of the organization"; it could (but need not) mention the type of device or medical specialty.

I have typical organized the ongoing quality objectives under the 6 headings shown in the Quality Policy above. In other words, those headings establish the "framework" for quality objectives. The specific measurable (SMART) objectives vary and are updated periodically (with accomplishments), but the headings should work for any type of organization.

Thoughts? Other ideas?

Thank you
Sam

Sam,

I see no evidence of top management commitment to:

1. comply with requirements
2. maintain the effectiveness of the management system

One could argue that a system is not effective until it has fulfilled its objectives (look at the definition of effectiveness).

This is okay with the continual improvement requirement in ISO 9001 but not with ISO 13485 that, unusually, requires to system to be effective at all times.

So your "continually pursuing measurable objectives" would not conform with the requirements of ISO 13485 unless, perhaps, you can show the objectives stretch the system beyond effectiveness.

ISO 13485 is not interested in any excuses for not meeting requirements including the oft used excuse of continual improvement.

John

 

[MRWardell]

I might also suggest a reference to risk management per 14971. Our auditor found fault with our risk management procedure last audit, which we updated. In reviewing 14971 it seemed that our policy should also state our commitment to assessing and controlling risk throughout product design and production. We made this change and our auditor "approved" of this change. It also brought the idea risk management more in focus for senior management.

 

[Marcelo]

Agree with somashekar.

Policy is only intentions and directions. Objectives are the real deal, and the system has to be constructed to fulfill the objectives (which MUST reflect the quality policy but not be the same).

 

[Sam Lazzara]

Just to clarify my intention with those 6 points. They are NOT the objectives. They are the framework (headings) for specific objectives to fall under. They are intended to provide a framework for establishing objectives - which is one of the requirements of a quality policy per 13485.

 

[arios]

I like the policy the way you wrote it

 

[somashekar]

Just to clarify my intention with those 6 points. They are NOT the objectives. They are the framework (headings) for specific objectives to fall under. They are intended to provide a framework for establishing objectives - which is one of the requirements of a quality policy per 13485.

Hi Sam.
Why make a meaning out of the word 'framework' as headings and create some framework and then the objectives.
By mentioning about 'Establishing quality objectives' within the policy in itself is providing a framework.
~~~ Simplicity is the best policy ~~~

 

[Jim Wynne]

I think it's OK as written, but does anyone else see a problem with a company that needs a consultant to establish its quality policy?

 

[arios]

I think it's OK as written, but does anyone else see a problem with a company that needs a consultant to establish its quality policy?

The governement?