New Quality Policy - Feedback Wanted

[Bridget]

Hello Everyone:
I would appreciate it if anyone could critique our quality policy to see if it meets the requirements of ISO 13485:2003.

XYX Company is dedicated to total customer satisfaction with an ongoing commitment to excel in providing you with:
 The highest quality materials and products
 Rapid order processing
 Knowledge technical support
 Competitive pricing
 Innovative customer service

XYX maintains the highest standards for our clients, our products and our employees by:
continually improving our knowledge, our abilities and our efficiencies through training, experience and by listening carefully to the needs and expectations of our customers
and by maintaining our quality management system effectiveness and our compliance with all regulatory requirements within our business scope

When I asked top managment to revise it to the new standard they only added the last line (in red). I really don't want to release this, post it, and then have to do it all over again due to a nonconformance (especially since we have waited till the last minute for the transition).
Thanks a bunch,
Bridget

 

[Jim Wynne]

XYX Company is dedicated to total customer satisfaction

Just curious--what is added to the quoted passage by the rest of your policy?

 

[howste]

It seems as though they interpreted this text:

"...includes a commitment to comply with requirements..."

to only include regulatory requirements. What about customer requirements, such as function, performance, delivery etc.?

 

[Wes Bucey]

Seems like a lot of highfalutin' language to me. There are some grammatical errors as it reads currently. I don't know if the error is in the original or just from the transcription.

Personally, I like straightforward language.

"competitive pricing" is advertising, not quality (competing has nothing to do with quality)

"highest quality materials and products" may not be necessary in every situation, nor may customers be willing to pay for them

"our compliance with all regulatory requirements within our business scope"
This is pretty much a given, isn't it? If a company does NOT comply, the regulators put it out of business.

If it were my company, I would choose this wording:
XYX Company is dedicated to total customer satisfaction with an ongoing commitment to continually improving our knowledge, our abilities and our efficiencies through training, experience and by listening carefully to the needs and expectations of our customers.
and omit the rest as superfluous gobbledygook.

 

[Bridget]

Keep it coming

Thanks folks,
That is what I feel like sometimes, the boss is a college grad with a lot of big words. I might not win this battle because over the years the auditors have never written a nonconformance against the policy. I posted it just like it is written but most of our employees, including me, only remember the first line.

JSW -I am sorry I do not understand what you mean, can you explain further?

Wes - it is more of a business pitch than a quality policy?

By the way I can't think of anyone outside of the building that has ever seen it. Our customers don't even ask for the quality manual!

I would still like to have more feedback if anyone else has any to offer. I don't have the #$*%& to show this to the boss but I might discuss it with others who would be able to help me influence him to rewrite it.
Thanks,
Bridget

 

[DannyK]

In my opinion, the quality policy meets the requirements of ISO 13485 since you address the specific requirements of complying with requirements (regulatory) and maintain the effectiveness of your system.

The policy can be improved and simplified.

Danny

 

[Wes Bucey]

Thanks folks,
That is what I feel like sometimes, the boss is a college grad with a lot of big words. I might not win this battle because over the years the auditors have never written a nonconformance against the policy. I posted it just like it is written but most of our employees, including me, only remember the first line.

JSW -I am sorry I do not understand what you mean, can you explain further?

Wes - it is more of a business pitch than a quality policy?

By the way I can't think of anyone outside of the building that has ever seen it. Our customers don't even ask for the quality manual!

I would still like to have more feedback if anyone else has any to offer. I don't have the #$*%& to show this to the boss but I might discuss it with others who would be able to help me influence him to rewrite it.
Thanks,
Bridget

Yes. I believe it is more business pitch than quality policy as it currently reads. Are the grammar errors in the original?
" Knowledge technical support" for example.

In the phrase
"and by listening carefully to the needs and expectations of our customers"
so what? It doesn't indicate anything is done BEYOND listening. How does that convert into action which affects quality? My mind still boggles at the "regulatory" reference in the policy. That's a low level reference that might be in the Procedures.

Even as a business pitch, it is not effective. I can't imagine one executive of the thousands I've met in my career who would be swayed to action by this policy statement. The error is compounded when you write
"By the way I can't think of anyone outside of the building that has ever seen it. Our customers don't even ask for the quality manual!"

If it has no impact, why write it?

• For the auditors? Shame, shame!
• For the employees? Then why the business pitch slant?
• For personal ego [at being able to use polysyllabic words?] Shame, shame!
  

 

[Wes Bucey]

For 13485, the characteristics of a quality policy (citing 13485:Section 5 Management Requirements, specifically 5.3 Quality Policy:
5.3 Define your quality policy.
Make sure that it serves your organization's purpose.
Make sure that it emphasizes the need to meet requirements.
Make sure that it facilitates the development of quality objectives.
Make sure that it makes a commitment to continuous improvement.

Manage your quality policy.
Communicate your policy throughout your organization.
Review your policy to ensure its continued suitability

"Requirements" as a category which encompasses customers, regulators, employees, neighbors, investors, competitors. It specifically talks about communicating policy throughout the organization (not necessarily to customers) - the point being the ones who should know the policy are the ones who will implement it. All the more reason NOT to use high flown language which is difficult to assimilate as a working document which should be part and parcel of every employee's thinking as he goes about his tasks on behalf of the organization.

 

[Sidney Vianna]

Wes, I did not know this Praxium website. Thanks for sharing. But there is a mistake in their information. One of the two basic differences between ISO 9001 and 13485 is the de-emphasis on continual improvement and monitoring of customer satisfaction, due to the heightened regulatory concern over medical devices.
So, while ISO 13485:2003 does not prohibit a written commitment to continual improvement, it is NOT a requirement in paragraph 5.3. as listed in the site you mentioned.
Annex B of ISO 13485 contains a comparison with ISO 9001 and provides for the rationale for the differences between the 2 standards.

 

[Cari Spears]

JSW -I am sorry I do not understand what you mean, can you explain further?

I think he just meant that your policy could just be that first sentence - all the rest of those words don't add anything to it.

Your college educated boss that likes to use big words has created one heck of a run-on sentence. If he doesn't let you change anything else, at least get him to throw in some periods.