Metrology and Quality

- The  Guide M-17025       
- Why purchase the Guide M-17025?                          
- Free sample of the Guide M-17025
 

Español  

 Quality Manual ISO IEC 17025 FREE SAMPLE !!

 

THE GUIDE M-17025

GUIDE FOR IMPLEMENTING A QUALITY SYSTEM ISO/IEC 17025

 

 

   

What is the Guide M-17025?

The Guide M-17025 is a set of editable documents in electronic format  in Microsoft Office Word® and Excel®, which lead the user through the implementation of each of the requirements of ISO/IEC 17025:2005, or the equivalent national standard.   

  

 

Why is the Guide M-17025 a useful tool?

The Guide M-17025 makes the implementation of the quality system ISO/IEC 17025 an easy job for the top manager, quality manager, head and technicians of the laboratory, with minimal training, in a simple, orderly, reliable, compact way and in the shortest time possible.

 

What does the Guide M-17025 contain?

The Guide M-17025 contains the following templates*:

- 1 Quality Manual (69 pages).

This provides a guide to implementing the quality management system ISO/IEC 17025:2005 in your laboratory:

1. OBJECTIVE AND SCOPE.

2. DEFINITIONS AND NOTATIONS.

3. REFERENCES.

4.  MANAGEMENT REQUIREMENTS.

4.1 Organization.

4.2 Quality management system.

4.3 Document control.

4.4 Request, tenders and contracts.

4.5 Subcontracting of testing and/or calibrations.

4.6 Acquisition of laboratory key services and supplies.

4.7 Customer service.

4.8 Policy and procedure for complaints.

4.9 Control of nonconforming work.

4.10 Continuous improvement.

4.11 Corrective actions.

4.12 Preventive actions.

4.13 Control of generated records.

4.14 Internal audits.

4.15 Management review.

5. TECHNICAL REQUIREMENTS.

5.1 Factors of influence to take into account.

5.2 Personnel.

5.3 Accommodation and environmental conditions.

5.4 Service methods and procedures.

5.5 Laboratory equipment.

5.6 Traceability of measurements.

5.7 Sampling requirements.

5.8 Ensuring the integrity of items under service.

5.9 Quality assurance of the results generated by the laboratory.

5.10 Results report generated by the laboratory.

6. ANNEXES.

6.1 Procedures of the quality system.

6.2 Forms of the quality system.

- 29 Managerial and technical procedures (201 pages).

These documents conduct the user to satisfy each of the requirements of the standard ISO/IEC 17025:2005:

1.       Procedure to ensure the protection of confidential customer information.

2.       Procedure to avoid intervening in activities that may reduce the confidence of the laboratory.

3.       Procedure for control of documents.

4.       Procedure for review of requests, tenders and contracts.

5.       Procedure for selection and purchase of key services and supplies.

6.       Procedure for complaints and nonconforming work.

7.       Procedure for corrective actions.

8.       Procedure for preventive actions.

9.       Procedure for control of records.

10.     Procedure for internal audits.

11.     Procedure for management reviews.

12.     Procedure to identify personnel training needs and to provide the training.

13.     Procedure for uncertainty estimation.

14.     Procedure for collection, storage, transmission and processing of data in electronic format.

15.     Procedure for ensuring the integrity of laboratory equipment.

16.     Procedure for intermediate checks of laboratory equipment (and/or reference materials).

17.     Procedure for updating correction factors.

18.     Procedure for calibration of laboratory equipment.

19.     Procedure and sampling plan.

20.     Procedure to ensure the integrity of items under service.

21.     Procedure for quality assurance of the results generated by the laboratory.

22.     Procedure for testing.

23.     Procedure for calibration. 

24.     Procedure for method validation of analytical testing. 

25.     Procedure for method validation of physical testing. 

26.     Procedure for method validation of calibration. 

27.     Procedure for method confirmation of analytical testing. 

28.     Procedure for method confirmation of physical testing. 

29.     Procedure for method confirmation of calibration. 

-35 Managerial and technical forms (176 pages).

These forms provide mechanisms to monitor each procedure and generate objective evidence of their operation (records):

1.       Form to ensure the protection of confidential customer information.

2.       Form of ethics code.

3.       Form for master list for control of documents.

4.       Form for review of requests, tenders and contracts.

5.       Form for selection and purchase of key services and supplies.

6.       Form for evaluation of suppliers of key services and supplies.

7.       Form for complaints and nonconforming work (including corrective actions).

8.       Form for preventive actions.

9.       Form for control of records.

10.     Form for internal audits.

11.     Form for management reviews.

12.     Form for customer feedback.

13.     Form to measure the personnel awareness of the quality system.

14.     Form for personnel authorizations.

15.     Form to identify personnel training needs and to provide the training.

16.     Form for uncertainty estimation.

17.     Form for collection, storage, transmission and processing of data in electronic format.

18.     Form for ensuring the integrity of laboratory equipment.

19.     Form for intermediate checks of laboratory equipment (and/or reference materials).

20.     Form for updating correction factors.

21.     Form for calibration of laboratory equipment.

22.     Form for procedure and sampling plan.

23.     Form to ensure the integrity of items under service.

24.     Form for quality assurance of the results generated by the laboratory.

25.     Form for testing report.

26.     Form for calibration report.

27.     Form for report of analytical method validation.

28.     Form for report of method validation of physical testing.

29.     Form for report of method validation of calibration.

30.     Form for report of analytical method confirmation.

31.     Form for report of method confirmation of physical testing.

32.     Form for report of method confirmation of calibration.

33.     Form for report of development of new methods.

34.     Form for inventory of standards and equipment.

35.     Form for traceability chart.

 

-5 Spreadsheets (5 files).

These spreadsheets provide a guide to prepare indicators for monitoring and improvement of the quality system:

1.        Control chart type p for nonconforming work

2.        Control chart type c for nonconforming work.

3.        History of corrective actions.

4.        History of preventive actions.

5.        Control chart type X-MR for customer feedback.

- 1 User manual (13 pages).

This provides instructions for using and modifying documents of the Guide M-17025, and to adapt them to your laboratory.

*These documents can be edited and adapted to any kind of calibration or testing laboratory, independent of its size or activity. They are focused to the implementation of the quality system ISO/IEC 17025 and they do not include specific technical documents regarding the calibration or testing of items, in a particularized way.  

  

     

 Manual      Procedures          Forms 

   

METRyCAL

Barroco 3 Fracc. Mision Mariana, Corregidora, Queretaro, Mexico. C.P. 76903

Phone +52 (442) 1 35 10 50       

info@metrycal.com