Looking for ISO 15189 template texts for a quality handbook

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Project Description

We are about to apply for ISO 15189, therefore we need template texts for that particular ISO norm, which we then can edit and integrate into your ISO 15189 documentation system.

The texts need to be especially tailored for the ISO 15189 for medical laboratories.

We are NOT looking for somebody writing these texts for us,

we are looking for a person, lab or organisation who already possesse such texts and is willing to share them with us.

This should include topics such as:

1. Introduction

a. Laboratory Background

b. Purpose of Quality Manual

c. Distribution List

d. Scope of Quality Management System

e. Terms and Definitions

2. Description of the Laboratory

a. Legal Identity

b. Resources

c. Main Duties

d. Laboratory Management

3. Quality Policy

4. Staff Education and Training

5. Quality Assurance

6. Document Control

7. Records, Maintenance, and Archiving

8. Accommodation and Environment

9. Instruments

10. Reagents and Consumable Management

11. Validation of Examination Procedures

12. Safety

13. Environmental Management

a. Transportation

b. Consumables

c. Waste Disposal

d. Equipment

14. Research and Development (if appropriate)

15. List of Examination Procedures

16. Pre-Examination

17. Validation of Results

18. Quality Control (including interlaboratory comparisons)

19. Remedial Actions and Handling of Complaints

20. Communications

21. Internal Audits

22. Laboratory Information System

23. Ethics

Standard Operating Procedures:

Control of nonconformances

Corrective actions

Preventive actions

Contract review

Document control

Control of records



Internal quality audit

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