17025 and PAR 4.2.2

Douglas E. Purdy

Quite Involved in Discussions
I am in the process of re-familiarizing myself with 17025 and ran into a question regarding paragraph 4.2.2 under Quality System. The first sentence establishes the requirement for a Quality Manual, but the next two sentences center on a quality policy statement. The lead-in sentence to the a) thru e) sub-requirements states "It shall include at least the following:." My question is ... What is 'It' refering to, the Manual or the Policy Statement?

Per the note it would seem 'the Quality Policy Statement,' but how can you cover the a) thru e) in a statement and still be useable as a Quality Policy?

Thanks!
 
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J

Jimmy Olson

You are correct in that the 'IT' does apply to the policy. As far as covering everything, it doesn't have to be real specific. As long as everything is basically implied it should be fine.
 

howste

Thaumaturge
Trusted Information Resource
The way I read it, it must all be in the policy statement. Then of course there's a note that it should be concise. :rolleyes:
 

Douglas E. Purdy

Quite Involved in Discussions
Any Examples?

Would someone send me an example that would comply? In the case of the laboratory being a part of an organization that is compliant with ISO-9001:2000, does one have a Quality Policy that complies with 9001 and another for 17025? Any suggestions or recommendations to comply with both standards would be welcome.

Thanks,
Doug
 

howste

Thaumaturge
Trusted Information Resource
Sorry, I don't have an example policy for 17025. I wouldn't recommend having a combined 9001 and laboratory policy though unless all of the people in your organization work in/for the lab. There's way too much required in there that wouldn't apply to most of the organization. I used to have a laboratory scope where I worked for calibrations we performed, and it was completely separate from the quality policy.
 
J

Jimmy Olson

Unfortunately I don't have an example either.

I do agree with Howste about keeping the policies seperate. However, as the note in the standard indicates, if the lab is part of a larger organization some elements of the policy may be located elsewhere. You could review the organizations quality policy established for 9001 and then develope the policy for the lab to fill in the gaps. Or you could just do an entirely seperate one if you want.
 
P

pancho-2007

Out Quality Policy is seperate from the manual. We made and distribute wallet cards for all employee's as well as have copies of the policy on every line on the floor of the plant. Our policy states as follows:

We the management of (Company Name) are commited to provide our customers with quality product, at a competitive price, and to achieve Total Customer Satisfaction.

Managements policy will be realized through participation of ( Company Name) human resources, and implimented by a quality oriented manufacturing system.

I do Hope this helps
 

howste

Thaumaturge
Trusted Information Resource
I emailed someone I know that has a 17025 certified lab for a copy of their policy, and this is what they sent back (I suspect they pulled the whole section of the quality manual):
5.3 QUALITY POLICY

MISSION STATEMENT

Provide the highest standard of laboratory
testing and customer service.
And have fun in the process.

VALUES (Quality Objectives)

1. Integrity - We act with integrity in all that we do.

2. Quality - Each employee is responsible for quality, and we aggressively strive for perfection.

3. Service - We work with our customers internally and around the world to learn their needs and exceed their expectations. We recognize that great customer service and quality are our primary marketing tools.

4. Productivity - We deliver a superior, affordable product by controlling expenses and maximizing efficiency with state-of-the-art technology and facilities.

5. Training - We invest in training each employee to assure that our customers will communicate with industry experts.

6. Employees - We believe that our employees are the best in the industry and our most important asset. We empower them to grow professionally, innovate, and share in the success and growth of the company.

7. Communication - We emphasize rapid and frequent communication. We treat each other and our customers professionally and with respect to facilitate teamwork.

8. Fun - We have fun in the process.

? ? ? ? ? ? ? ? ? ?

XXXX Laboratories' goal is to provide the highest quality laboratory results at a fair price, and to make every effort to provide the results when the customer needs them. We will treat all of our customers as we would like to be treated. We will endeavor not to make unnecessary rules for our customers. We do whatever it takes, without compromising quality, to complete the job on time. We always strive to provide 'knock their socks off' service. Every XXXX employee is a customer service representative.

To accomplish turn-around-time goals and communicate with sponsors, XXXX management:

1. Monitors turn-around-time (TAT) performance

2. Sets turn-around-time goals with employees

3. Maintains lists of TATs on computer

4. Advises customers of estimated TAT upon receipt of samples

5. Flags samples which are needed by the sponsor sooner than normal processing times

To accomplish quality goals, XXXX management:

6. Has a high ratio of Quality Team staff to analysts

7. Requires the Quality Assurance Unit to normally review 100% of XXXX laboratory generated results. A reduced inspection level may be implemented for those tests which have a history of low defects.

8. Confirms the accuracy of each page at the time of final envelope sealing;

9. Performs a wide range of laboratory controls;

10. Maintains a Full-time Training Department to assure that new employees are trained by a master for that function in each area of expertise;

11. Maintains state-of-the-art laboratory facilities;

12. Maintains a sophisticated metrology laboratory with NIST-traceable standards;

13. Provides document accessibility via computer;

14. Analyzes trends of tests and critical systems to ensure continuous improvement

The Quality System is designed to provide a documented framework for providing world class quality service and comply with good laboratory practice (GLP), good manufacturing practice (GMP), good automated laboratory practices (GALP), ISO 9001:2000 quality standard requirements and requirements of ISO/IEC 17025 General Requirements for the Competence of Testing and Calibration Laboratories.

XXXX Laboratories is committed to good professional practice, providing the highest quality service, and striving for continuous improvement. The Quality Policy is reviewed at least annually; and quality goals are set in annual company-wide quality planning meetings, then reviewed approximately monthly in Quality Committee. The Quality Policy is given, in writing, to all new employees, is posted in the laboratory , and employees are trained regularly.
 
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