What is the Guide M-15189:2022? 

The Guide M-15189 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 15189:2022, or the equivalent national standard. 

Why is the Guide M-15189 a useful tool?

The Guide M-15189 makes the implementation of the quality system ISO 15189-2022 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-15189 contain?

The Guide M-15189 contains the following templates*:

- 1 Quality Manual (47 pages).

This provides a guide to implementing the quality management system ISO 15189:2022 in your laboratory:

1. OBJECTIVE AND SCOPE.

2. DEFINITIONS AND NOTATIONS.

3. REFERENCES.

4.  GENERAL REQUIREMENTS.

4.1 Impartiality.

4.2 Confidentiality.

4.3 Considerations for patients.

5. STRUCTURAL AND GOVERNANCE REQUIREMENTS.

5.1 Legality of the Laboratory.

5.2 Laboratory director.

5.3 Laboratory activities.

5.4 Organizational structure.

5.5 Objectives and policies.

5.6 Risk management.

6. RESOURCES REQUIREMENTS.

6.1 General.

6.2 Personnel.

6.3 Facilities and environmental conditions.

6.4 Equipment.

6.5 Equipment calibration and metrological traceability

6.6 Reagents and consumables.

6.7 Service agreements.

6.8 External products and services.

7. PROCESS REQUIREMENTS.

7.1 General.

7.2 Pre-examination process.

7.3 Examination process.

7.4 Post-examination process.

7.5 Nonconforming work.

7.6 Information systems management.

7.7 Complaints.

7.8 Plan for emergency situations.

8. MANAGEMENT SYSTEM REQUIREMENTS.

8.1 General requirements.

8.2 Documentation of the management system.

8.3 Document control.

8.4 Control of records.

8.5 Risks and opportunities.

8.6 Improvement.

8.7 Nonconformities and corrective actions.

8.8 Evaluations.

8.9 Management reviews.

9. ANNEXES.

9.1 Procedures of the quality system.

9.2 Forms of the quality system.

- 19 Managerial and technical procedures (248 pages).

These documents conduct the user to satisfy each of the requirements of the standard ISO 15189:2022:

1.       Procedure for patients and laboratory users .

2.       Procedure to establish and review agreements with laboratory users.

3.       Procedure for risks and opportunities.

4.       Procedure for personnel management and competence.

5.       Procedure for equipment management, calibration, verification and recalls.

6.       Procedure for reagents and consumables.

7.       Procedure for purchasing of external products and services.

8.       Procedure for pre-examination and samples management.

9.       Procedure for examination methods.

10.     Procedure for verification of examination methods

11.     Procedure for validation of examination methods.

12.     Procedure for evaluation of measurement uncertainty.

13.     Procedure for monitoring the validity of results (IQC, EQA and Comparability).

14.     Procedure for post-examination and reports management.

15.     Procedure for nonconforming work.

16.     Procedure for information systems management.

17.     Procedure for handling complaints.

18.     Procedure for records management.

19.     Procedure for monitoring quality indicators.

-45 Managerial and technical forms (232 pages).

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

1.       Form for code of ethics.

2.       Form for threats to impartiality.

3.       Form for quotation of examinations.

4.       Form for harm incidents management..

5.       Form for organizational chart.

6.       Form for job descriptions.

7.       Form for master list of documents and software.

8.       Form for policies and objectives.

9.       Form for agreements with laboratory users.

10.     Form for meeting minute.

11.     Form for selection of personnel.

12.     Form for training of personnel

13.     Form for program of personnel supervision.

14.     Form for supervision of personnel.

15.     Form for authorization of personnel.

16.     Form for authorized positions and signatures.

17.     Form for inventory of equipment.

18.     Form for management of equipment.

19.     Form for calibration and verification (check) program of equipment.

20.     Form for identification labels of equipment in operation.

21.     Form for identification labels of equipment out of operation.

22.     Form for metrological traceability chart.

23.     Form for intermediate checks of equipment.

24.     Form for management of reagents and consumables .

25.     Form for inventory of reagents and consumables.

26.     Form for list of external products and services.

27.     Form for evaluation of external providers.

28.     Form for purchase order of external products and services.

29.     Form for examination request.

30.     Form for examination method.

31.     Form for verification of examination methods.

32.     Form for development of methods by the laboratory.

33.     Form for validation of examination methods.

34.     Form for planning the monitoring of the validity of results.

35.     Form for monitoring the validity of results.

36.     Form for proficiency test plan.

37.     Form for results report.

38.     Form for validation of information management systems.

39.     Form for nonconforming work.

40.     Form for complaints

41.     Form for user feedback.

42.     Form for evaluation of dissemination of the management system.

43.     Form for nonconformities and corrective actions.

44.     Form for internal audit program.

45.     Form for management reviews.

-7 Spreadsheets (7 files).

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

1.        Form for scope of the Laboratory.

2.        Form for risks and opportunities.

3.        Form for recording and monitoring of environmental conditions.

4.        Form for statistical control chart of measuring equipment.

5.        Form for estimation of measurement uncertainty.

6.        Form for statistical detection of trends and shifts from monitoring.

7.        Form for monitoring quality indicators.

- 1 User manual (14 pages).

This provides instructions for using and modifying documents of the Guide M-15189, and to adapt them to your laboratory.

*These documents can be edited and adapted to any kind of medical laboratory, independent of its size or activity. They are focused to the implementation of the quality system ISO 15189-2022 and they do not include specific technical documents regarding examinations, in a particularized way.  

 Reduces the time of implementation up to 50 % !!

The Guide M-15189 helps you to significantly reduce the time of implementation of the quality system ISO 15189:2022, up to 50 % or higher, which reduces operating cost of the personnel assigned to this activity and contributes to reaching your company goals on time.

Save resources and reach your goals on time!

Ensure compliance with the requirements!

The Guide M-15189 contains guidelines to ensure full compliance with the requirements of ISO 15189:2022, reducing the possibility of nonconformities which could jeopardize the reliability of the generated results or the accreditation of your laboratory.

Do not risk the accreditation or reliability of your laboratory!

 Makes the personnel´s work  easier!! 

Unlike other similar products, the Guide M-15189 provides suggestions and comments about How to meet every requirement of ISO 15189:2022 and How to generate objective and reliable evidence of compliance.

Simplify your work and avoid inefficient or ineffective quality systems!

Support

The Guide M-15189 includes support via email about the use of the documentation. Do not include metrological or examinations support.  

We are glad to help you!

Low cost!! High added value!!

The low cost of the Guide M-15189 allows it to be accessible to any size and type of laboratory that wishes to get its accreditation in the shortest possible time, with a reliable and efficient quality system ISO 15189:2022.

Get high quality at a low cost!

Fast delivery!

The Guide M-15189  is provided in less than 24 hours (working days). After notification of payment by e-mail, we will send you a web link and a password to download it from our server.

Begin to use it now!