ISO 13485 Quality Policy that concisely meets standard

D

DRDDO

#11
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
Hi Sam

concerning ___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.

I prefer to follow ISO 10014 : priciple 1-8, and add 9: concerning product safety

What do you thinks?
 
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T

TamTom

#12
Hello,

I'm on my first steps to discover ISO 13485. We have a quite generic "Corporate Policy" with the header
- Customer satisfaction
- Innovation and Improvement
- Employee satisfaction
- Management
- Environment and safety
and Partnership,

each of these header follows more detailed Policy statements.
I have to admit there is nowhere mentioned to keep the system effective at all time. The commitment to the Quality Management is part of the Organization manual.

I invented the new policy 2008, it was planned to fit for ISO 9001 and ISO 14001, I really don't want to change it now again.

Is the commitment in the Manual OK? Policy is also part of the manual.

Regards,

TamTom
 

somashekar

Staff member
Super Moderator
#13
Hello,

I'm on my first steps to discover ISO 13485. We have a quite generic "Corporate Policy" with the header
- Customer satisfaction
- Innovation and Improvement
- Employee satisfaction
- Management
- Environment and safety
and Partnership,

each of these header follows more detailed Policy statements.
I have to admit there is nowhere mentioned to keep the system effective at all time. The commitment to the Quality Management is part of the Organization manual.

I invented the new policy 2008, it was planned to fit for ISO 9001 and ISO 14001, I really don't want to change it now again.

Is the commitment in the Manual OK? Policy is also part of the manual.

Regards,

TamTom
The QP is the documented statement of commitment by the top management such that your functional objectives can always be so aligned to meet the stated policy. ISO 13485 requires that commitment to comply with requirement is addressed, as it is about QMS requirements for regulatory purpose. It also requires that commitment is made towards maintaining the effectiveness of the QMS as the regulatory keeps getting amended or new regulations gets introduced, and you must address them and respect them.
Now, since focus in 13485 is specific and likewise in ISO 14001, I would suggest that the policy be stated specific to the focus area and keep them short and seperate.
 
Last edited:

Sam Lazzara

Trusted Information Resource
#14
Hi Sam

concerning ___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.

I prefer to follow ISO 10014 : priciple 1-8, and add 9: concerning product safety

What do you thinks?
Your number 9 could also be tied to "risk management" which was mentioned in an earlier post in this thread.

I was not familiar with ISO 10014 until now - interesting. It looks like the 8 principles were taken from ISO 9000:
1. customer focus
2. leadership
3. involvement of people
4. process approach
5. system approach to management
6. continual improvement
7. factual approach to decision making
8. mutually beneficial supplier relationships

I think objectives could fit under some of these headings but I am not comfortable with requiring objectives under each one. To each his own I guess....the important thing for me is to have a framework to follow when establishing objectives.
 
T

TamTom

#15
Hello somashekar,

No way, that would meant I need to go back to 3 different policies. We have 5 different QMS standards to follow, my policy need to cover them all.

Thanks fo the answer, I will see how to handle it.

Greetings

TamTom
 

somashekar

Staff member
Super Moderator
#16
Hello somashekar,

No way, that would meant I need to go back to 3 different policies. We have 5 different QMS standards to follow, my policy need to cover them all.

Thanks fo the answer, I will see how to handle it.

Greetings

TamTom
I can understand your apprehension, however each standard focus on specific areas and would call for a top level documented statement of a quality policy. My feeling is that for ease of communication and understanding and reviewing suitability simple and few lines specific policy is better than one big.
 
D

DRDDO

#17
Your number 9 could also be tied to "risk management" which was mentioned in an earlier post in this thread.

I was not familiar with ISO 10014 until now - interesting. It looks like the 8 principles were taken from ISO 9000:
1. customer focus
2. leadership
3. involvement of people
4. process approach
5. system approach to management
6. continual improvement
7. factual approach to decision making
8. mutually beneficial supplier relationships

I think objectives could fit under some of these headings but I am not comfortable with requiring objectives under each one. To each his own I guess....the important thing for me is to have a framework to follow when establishing objectives.

Try

http://irrigation.rid.go.th/rid5/download/CDNum1-2552 (E)/index.html

Line 600

DRDDO:bigwave:
 
Q

QSMLauren

#18
I am interested in learning from others as to whether you have the actual words "maintain effectivess" (Section 5.3 of 13485) in your Quality Policy, and if not have you gotten any non-conformances for your registrar?

We have the words "Comply with Quality System Requirements" and "Continually Improve". Which by one of the commentors on this thread said continually improve was an excuse / not the same as improving the effectiveness.

This has passed 13485 complaince audits; but the Quality Manager prior to me had marked it an internal non-conformance. I would very much like to keep as is!

Thanks,
Lauren
 

John Broomfield

Staff member
Super Moderator
#19
I am interested in learning from others as to whether you have the actual words "maintain effectivess" (Section 5.3 of 13485) in your Quality Policy, and if not have you gotten any non-conformances for your registrar?

We have the words "Comply with Quality System Requirements" and "Continually Improve". Which by one of the commentors on this thread said continually improve was an excuse / not the same as improving the effectiveness.

This has passed 13485 complaince audits; but the Quality Manager prior to me had marked it an internal non-conformance. I would very much like to keep as is!

Thanks,
Lauren

Lauren,

Yes, medical devices are meant only to come from fully effective management systems (according to ISO 13485)! Therefore, if you imply that your management is less than fully effective this is a nonconformity.

The policy statement, however, is meant to come from the hearts and minds of the leaders not the standard. It has to be true not made up from the words of the standard.

I am sure the leaders of a management system responsible for medical devices would ensure their system is fully effective in delivering safe devices and services for ensuring those devices are used safely.

In other words, you could limit the meaning of effective to the safety of the product (device and services). But you are bound to continually improve your products, the processes for making these improved products and the management system to nurture these improved processes.

Leaders of a sustainable business will seek to maintain a balance between effective controls for existing products and innovation for new products.

John
 
#20
My feeling is that for ease of communication and understanding and reviewing suitability simple and few lines specific policy is better than one big.
Also, with the ISO 13485 requirement that personnel on all levels know and understand how the QP affects them, wouldn't one be courting danger by introducing objectives, or a "framework" thereof, within the QP? 5.4.1 notes that Quality objectives "are established at relevant functions and levels within the organization"; why let them encroach into the QP, where their specific framework does not belong?
 
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