ISO 15189 Quality Manual

Order Quality Manual

Table of Contents

Introduction 
Quality Policy Statement 
1.0 General
2.0 References 
3.0 Terms and Definitions 
4.0 General Requirements 
    4.1 Impartiality
    4.2 Confidentiality
    4.3 Requirements Regarding Patients
5.0 Structural and Governanace Requirements
    5.1 Legal Entity
    5.2 Laboratory Director 
    5.3 Laboratory Activities
    5.4 Structure and Authority 
    5.5 Objectives and Policies
    5.6 Risk Management

6.0 Resource 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 Externally Provided Products and Services
7.0 Process Requirements
    7.1 General
    7.2 Pre-examination Processes
    7.3 Examination Processes
    7.4 Post-examination Processes
    7.5 Identification and Control of Nonconforming Product/Work
    7.6 Control of Data and Information Management
    7.7 Complaints
    7.8 Continuity and Emergency Preparedness Planning
8.0 Management System Requirements
    8.1 General Requirements and Options
    8.2 Management System Documentation
    8.3 Control of Management System Documents
    8.4 Control of Records
    8.5 Actions to Address Risks and Opportunities for Improvement
    8.6 Continual Improvement
    8.7 Nonconformities and Corrective Actions
    8.8 Evaluations

    8.9 Management Reviews

 
INTRODUCTION

XYZ Laboratory recognizes its responsibility as provider of quality services.  To this end, XYZ Laboratory has developed and documented a management system to better satisfy the needs of its customers and to improve patienet care and management of the laboratory.  The management system complies with the international standard ISO 15189:2022.

This manual has been prepared to define the quality system, establish responsibilities of the personnel affected by the system, and to provide general procedures for all activities comprising the management system. In addition, this manual is utilized for the purpose of informing our customers of the management system, and what specific controls are implemented to assure service quality.

Quality Policy Statement

XYZ Laboratory accepts responsibility for the complete satisfaction of its customers and patients.  We exercise this responsibility through adequate training of our employees, professional and ethical commitment to patient care through quality examinations, meeting and exceeding customer requirements, and maintaining a company culture that fosters continuous improvement.  Our objective is to deliver error free services on time, every time.

The Senior Management and Staff of XYZ Laboratory also undertake to ensure that all activities are conducted in strict accordance with documented procedures and comply with the requirements of the ISO 15189 Standard.

The management team will periodically review the performance of the management system and our quality objectives to ensure their effectiveness, continuing relevance, and suitability.

General Requirements

Organization and Management Responsibility

XYZ Laboratory holds legal responsibility for its operation and is organized to operate in accordance with the requirements of ISO 15189, whether carrying out work in its permanent facilities or on location, at customer sites.

XYZ Laboratory is not part of an organization performing activities other than examinations and testing; therefore, there is no potential conflict of interest amongst its personnel.

The organization of XYZ Laboratory is illustrated below in Figure 1.

Management System

The Quality Manual is the principal document that defines the management system at XYZ Laboratory.

Quality System Procedures are documented to establish and maintain continuity of each activity or function affecting quality.  Quality procedures will be readily available to personnel for reference and implementation. The quality document structure contains this Quality Manual, Quality Procedures, Work Instructions, and Quality Records.

Service Agreements

Agreement review is an integral part of the quality system at XYZ Company. All agreements are reviewed and accepted only if the requirements are clear and understood, and the laboratory has the capability and capacity to assure full customer expectations.

Records of reviews, including any significant changes, are maintained.

Communications are maintained with the client from request/quote through commencement of work. This includes informing the client of any deviation from the agreement.

The process for agreement review is further defined in the Service Agreements Review Procedure.

Identification and Control of Nonconformities

XYZ Company has established and maintains a policy and procedures that are implemented when there are problems with the management system, or with pre-examination, examination, and post examination activities, and the activities do not conform to its own procedures or the agreed requirements of the client.

The policy and procedures shall ensure that nonconforming work or problems that do not conform to requirements are identified and managed, to prevent unintended use or delivery of services. This procedure ensures that non-conforming work or problems are corrected, where applicable, and subject to verification after correction to demonstrate conformity. Where required by the agreement, the proposed rectification of non-conforming work or problems is reported for concession to the customer, the end user, regulatory body, or other applicable authority.

Identification of nonconforming work or problems with the quality system or with testing and activities can occur at various points within the quality system, and technical operations such as customer complaints, quality control, instrument calibration, checking of consumable materials, staff observations or supervision, test report checking, management reviews, and internal or external audits.

Where the evaluation indicates that the nonconforming work could recur or that there is doubt about the compliance of XYZ Laboratory operations with its own policies and procedures, the corrective actions procedure shall be followed to identify the root cause(s) of the problem and to eliminate this (these) cause(s).

The process for nonconforming work is further defined in the Control of Nonconforming Product/Work Procedure.

Validation of methods

All standard and non-standard test methods and procedures are validated to ensure that such methods and procedures are fit for their intended use and are relevant to the requirements of ISO 15189, as well as, the client.

The results of such validation are recorded together with the procedure utilized and any other relevant information. The record states whether the method or procedure is fit for the intended use.

Uncertainty of Examination Results 

XYZ laboratory recognizes that many factors determine the correctness and reliability of the tests performed by a laboratory. These factors include contributions from: human factors, accommodation and environmental conditions, test and calibration methods and method validation, equipment, measurement traceability, and handling of test and calibration items.

The extent to which the factors contribute to the total uncertainty of measurement differs considerably between (types of) tests. XYZ Laboratory takes into account these factors in developing test and calibration methods and procedures, in the training and qualification of personnel, and in the selection and calibration of the equipment it uses.

The Estimation of Estimation of Uncertainty of Measurement Procedure is applied for estimating uncertainty of measurement, except when the test methods preclude such rigorous calculations. In certain cases it is not possible to undertake metrologically and statistically valid estimations of uncertainty of measurement. In these cases the laboratory attempts to identify all the components of uncertainty and make the best possible estimation, and ensure that the form of reporting does not give an exaggerated impression of accuracy. Reasonable estimation is based on knowledge of the performance of the method and on the measurement scope, and makes use of previous experience and validation data.

The degree of rigor needed in an estimation of uncertainty of measurement depends on factors such as:

Requirements of the test method

Requirements of the client

The existence of narrow limits on which decisions on conformance to a specification are based

In cases where a well-recognized test method specifies limits to the values of the major sources of uncertainty of measurement and specifies the form of presentation of calculated results, the laboratory is considered to have satisfied the estimation uncertainty of measurement by following the test method and reporting instructions.

Reporting Results

The results of each test carried out by the laboratory are reported accurately, clearly, unambiguously, and objectively, and in accordance with any specific instructions in the test methods. The results are normally reported in a test report and include all the information requested by the client and necessary for the interpretation of the test results, and all information required by the method used. 

Note:  Paragraph order numbering in the above sample is for illustration purposes only.  The order and numbering in the actual product may differ.

ISO 15189 Sample Procedure

Order Quality Manual


ISO 15189 Quality Manual Information