NAME OF LABORATORY QUALITY

MANUAL
Quality Manual: Table of contents
Number Section Page

1.0. General 3
1.1. Index and revision status 3
1.2. Purpose 3

2.0. Background of the laboratory 3

2.1. Activities 3
2.2. History 3

3.0. Definitions and conventions 3

3.1. Definitions and terminology 3
3.2. Abbreviations 4

4.0. General requirements 4

4.1. Impartiality 4
4.2. Confidentiality 4
4.3. Requirements regarding patients 5

5.0. Structural and governance requirements 6

5.1. Legal entity 6
5.2. Laboratory director 6
5.3. Laboratory activities 8
5.4. Structure and authority 9
5.5. Objectives and policies 9
5.6. Risk management 10

6.0. Resource requirements 11

6.1. General 11
6.2. Personnel Management 11
6.3. Facilities and environmental conditions 12
6.4. Equipment 14
6.5. Equipment calibration and metrological tracebility 16
6.6. Reagents and consumables 18
6.7. Service agreements 19
6.8. Externally provided products and services 20

7.0. Process requirements 21

7.1. General 21
7.2. Pre-examination processes 21
7.3. Examination processes 25
7.4. Post-examination processes 32
7.5. Nonconforming work 37
7.6. Control of data and information management 38
7.7. Complaints 39
7.8. Continuity and emergency preparedness planning 40

8.0. Management system requirements 40

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8.1. General requirements 40
8.2. Management system documentation 41
8.3. Control of management system documents 42
8.4. Control of records 42
8.5. Actions to address risks and opportunities for improvement 43
8.6. Improvement 44
8.7. Nonconformities and corrective action 45
8.8. Evaluations 45
8.9. Management reviews 46

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QM 1.0 GENERAL Version 1 03/06/2024

QM 1.1 Index and revision status Version 1 03/06/2024

The numbering of this quality manual corresponds directly to the numbering of ISO 15189:
2022.

This quality manual is only valid if all pages are at the same issue level as shown in
D 84101, index quality manual.

Updates to this manual will be made by re-issuing the relevant section of this manual and
adapting the issue level in the index.

QM 1.2 Purpose Version 1 03/06/2024

This quality manual documents our quality system and demonstrates the laboratory's ability to
execute the indicated tests and to meet regulatory requirements.

This manual establishes compliance with ISO 15189: 2022.

QM 2.0 LABORATORY BACKGROUND Version 1 03/06/2024

QM 2.1 Activities Version 1 03/06/2024

Describe the background, activities, personnel and tests of your laboratory.

Our laboratory's tests / calibrations include:

-- list out the tests performed by your laboratory --

-- Distinguish between the tests which are part of the quality system and those tests which are
not. --

QM 2.2 History Version 1 03/06/2024

Describe the history of your laboratory.

QM 3.0 DEFINITIONS AND CONVENTIONS Version 1 03/06/2024

QM 3.1 Definitions and terminology Version 1 03/06/2024

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The quality manager is responsible for setting up and maintaining a list of definitions and
conventions (D 0001).

Definitions from ISO/IEC, guide 2, edition 1986, "General terms and their definitions
concerning standardization and related activities" are relevant.

The list is added to this quality manual.

QM 3.2 Abbreviations Version 1 03/06/2024

The quality manager is responsible for setting up and maintaining a list of abbreviations used
in the quality manual.

The list is added to the manual (D 0002).

QM 4.0 GENERAL REQUIREMENTS Version 1 03/06/2024

QM 4.1 Impartiality Version 1 03/06/2024

The laboratory operates with a strict commitment to impartiality, ensuring that all activities
are conducted in a structured and managed manner to uphold this principle.

Management is dedicated to maintaining impartiality, as outlined in our Quality Policy (D

80301).

We prohibit any commercial, financial, political, or other influences that may compromise our
impartiality.

To safeguard against potential threats to impartiality, our laboratory continuously identifies

and assesses risks associated with our operations and relationships, including those involving
personnel (see procedure P 401 on Impartiality).

In the event that a risk to impartiality is detected, the laboratory takes decisive action to
eliminate or minimize such risks, demonstrating our commitment to maintaining the integrity
of our results (see procedure P 401 on Impartiality).

QM 4.2 Confidentiality Version 1 03/06/2024

Our laboratory is committed to safeguarding the confidentiality of our clients' sensitive

information and proprietary rights, particularly concerning the electronic storage and
transmission of results.

In accordance with ISO 15189:2022, we are legally accountable for managing all information
generated or obtained during laboratory operations. Prior to disclosing any information to the
public, we will notify our clients about the intended release (see procedure P 701: Review of
contracts). All information, except that which clients choose to make public or as mutually
agreed upon, is treated as proprietary and confidential.
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If legal obligations or contractual agreements necessitate the disclosure of confidential

information, we will inform the affected client of the information shared, unless prohibited by
law.

Information acquired from third-party sources remains confidential between the client and our
laboratory. The identity of these sources is protected and will not be disclosed to clients
unless explicitly agreed upon.

All personnel, including committee members, contractors, and representatives acting on

behalf of the laboratory, are required to maintain the confidentiality of all information
obtained or generated during laboratory activities, except as mandated by law.

QM 4.3 Requirements regarding patients Version 1 03/06/2024

Laboratory management prioritizes the well-being, safety, and rights of patients as

fundamental principles. In alignment with ISO 15189:2022, section 4.3, the laboratory has
established and implemented several key processes:

- Patient and User Feedback: The laboratory actively seeks input from patients and
laboratory users to enhance the selection of examination methods and the interpretation of
results.

- Transparent Information: Patients and users are provided with accessible information
regarding the examination process, including associated costs and expected timelines for
results.

- Examination Review: Regular evaluations of the examinations offered are conducted to

ensure they remain clinically relevant and necessary.

- Incident Disclosure: In cases where incidents may have led to or could potentially lead to
patient harm, the laboratory commits to disclosing such information to patients, users, and
relevant parties, along with documentation of actions taken to mitigate any harm.

- Respectful Treatment: The laboratory ensures that all patients, samples, and remains are
handled with the utmost care and respect.

- Informed Consent: Informed consent is obtained from patients when required, ensuring
they are fully aware of the procedures.

- Sample Integrity: The laboratory guarantees the ongoing availability and integrity of
retained patient samples and records, even in the event of closure, acquisition, or merger.

- Information Accessibility: Relevant information is made available to patients and their

healthcare providers upon request, facilitating informed decision-making.

- Non-Discrimination: The laboratory is committed to upholding the rights of patients to

receive care that is free from discrimination.

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In practice, our laboratory implements these principles through structured protocols, regular
training for staff, and a commitment to continuous improvement, ensuring that all processes
align with the standards set forth in ISO 15189:2022.

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