17025 and PAR 4.2.2

Douglas E. Purdy

Quite Involved in Discussions
#1
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!
 
Last edited:
Elsmar Forum Sponsor
J

Jimmy Olson

#2
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
Super Moderator
#3
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
#4
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
Super Moderator
#5
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

#6
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

#7
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
Super Moderator
#9
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.
 
Thread starter Similar threads Forum Replies Date
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
R Who is the customer in the ISO/IEC 17025:2017? ISO 17025 related Discussions 1
C Compliance with ISO 17025 requirement 8.4.2 - Controls - Records recovery ISO 17025 related Discussions 4
G ISO 17025-2017 Management Review reporting items - Inputs ISO 17025 related Discussions 1
S High voltage testing - ISO 17025 - 7.2.2 Validation of methods and 7.3 Sampling ISO 17025 related Discussions 3
S Internal calibrations - Part of an ISO 17025 accredited testing laboratory (Automotive) ISO 17025 related Discussions 3
I Approved Suppliers ISO/IEC 17025:2017 and used test equipment ISO 17025 related Discussions 6
W Issuing reports under ISO 17025:2017 ISO 17025 related Discussions 2
S The (E) in ISO/IEC 17025:2017(E) ISO 17025 related Discussions 3
T ISO 17025:2017 Clause 4.2.2 - The difference between "be notified" and "be informed" ISO 17025 related Discussions 4
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
DuncanGibbons Who are ISO/IEC 17065 and 17025 applicable to? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
V IS/ISO/IEC 17025:2017 Clause 7, sub clause 7.11 Control of data and information management ISO 17025 related Discussions 1
V IS/ISO/IEC 17025:2017 Clause 4.1 Impartiality ISO 17025 related Discussions 3
F ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold ISO 17025 related Discussions 9
A ISO 17025 Requirement 6.2 - Department Manager Testing Qualifications ISO 17025 related Discussions 1
F ISO 17025 8.6.2 Customer Feedback Analysis ISO 17025 related Discussions 5
F ISO 17025 8.8 Internal Audits in a segmented company ISO 17025 related Discussions 5
F Faulty Equipment and ISO 17025 General Measurement Device and Calibration Topics 1
F Online courses - Metrology, standardization, calibration and ISO 17025 Training - Internal, External, Online and Distance Learning 3
F Proficiency Testing for ISO 17025: AC Current Ranges ISO 17025 related Discussions 1
F ISO 17025:2017 Format for Procedure and Records Document Control Systems, Procedures, Forms and Templates 3
F ISO 17025:2017 Clause 7.4.1 - Requirements for Procedures ISO 17025 related Discussions 4
F Complying with ISO 17025 by UNIDO ISO 17025 related Discussions 0
F Measurement Audit and ILC for ISO 17025 Clause 7.7.2 - Comparison with results of other laboratories ISO 17025 related Discussions 0
F ISO 17025:2017 mandatory documentation requirements ISO 17025 related Discussions 1
F Linking an ISO 31000 Risk management SOP to ISO 17025 ISO 17025 related Discussions 2
K ISO 17025:2017 clause 7.6.2 - Performing calibration of its own equipment shall evaluate the measurement uncertainty ISO 17025 related Discussions 6
C ISO 17025 2017, Requirement 6.6.3 - Communicate requirements to external providers ISO 17025 related Discussions 4
D Risk Assessment Procedure in accordance with ISO 17025:2017 ISO 17025 related Discussions 5
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
J ISO 17025 - Please share a sample procedure for monitoring the validity of results ISO 17025 related Discussions 1
J ISO 17025 Documented Procedure for 6.2.5 - Determining competency ISO 17025 related Discussions 4
G ISO 17025:2017 7.1.2 - Should I produce a document for the customer? ISO 17025 related Discussions 8
G ISO 9001 and ISO 17025 - Measuring tools not in calibration system General Measurement Device and Calibration Topics 3
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab ISO 17025 related Discussions 0
D USFDA vs NRTL/IEC 17025 Differences - Compliance testing lab US Food and Drug Administration (FDA) 6
E Discussion between co-worker on tolerance and uncertainty and how to apply it. Thoughts? 17025 ISO 17025 related Discussions 1
S Can anybody share a sample risk assessment prepared based on ISO 17025:2017? ISO 17025 related Discussions 15
U ISO 17025:2017 Clause 7.7 Ensuring the Validity of Calibration Results ISO 17025 related Discussions 6
G From an ISO 17025 auditor perspective must micrometer calibration check anvil flatness? General Measurement Device and Calibration Topics 4
S ISO 17025 Requirements for Mobile On-site Calibration ISO 17025 related Discussions 2
C Must your reference standard provider be ISO17034 certified to meet your testing lab's ISO 17025 certification requirements? Other ISO and International Standards and European Regulations 2
S The procedure for replicate check in calibration lab as per ISO 17025 General Measurement Device and Calibration Topics 2
B ISO 17025 8.5 Actions to address risks and opportunities ISO 17025 related Discussions 7
G ISO 17025 - Requirement to Monitor Environment ISO 17025 related Discussions 10
D Laboratory Manual ISO/IEC 17025 Example wanted ISO 17025 related Discussions 2
Douglas E. Purdy ISO/IEC 17025:2017 3rd Ed. Changes from 2nd Ed. ISO 17025 related Discussions 6
Douglas E. Purdy ISO/IEC 17025:2017 Clause 8 & Annex B ISO 17025 related Discussions 9
B Supervision of personnel ISO 17025 Cl. 6.2.5(d)?? ISO 17025 related Discussions 1

Similar threads

Top Bottom