ISO 15189 Quality Manual

Wednesday, September 27, 2006

The Whole ISO 15189 Standard Summarized

ISO 15189:2003

4. Management requirements

4.1 Organization and Management
Introduces requirements and responsibilities of the laboratory management like compliance to legal requirements, definition of responsibilities and authorities of all personnel, definition and implementation of policies and organizational structure.

4.2 Quality Management System
Indicates the need for the implementation of a Quality System that includes Quality Assurance, Quality Control, Proficiency Testing procedures, Calibration and Maintenance, described in a Quality Manual. Policies and objectives of a Quality System should be defined. People shall be educated about Quality Management System principles. This topic also presents a summary of issues to be addressed in a Quality Manual.

4.3 Document Control
Requirements for documentation control including elaboration, approval and updating of documents, in paper – or not.

4.4 Review of contracts
Analysis of the capability to meet the requirements of the customers and the need of communication of further amendments

4.5 Examination by referral laboratories
Evaluation, selection and monitoring of referral laboratories, including the need for a clear definition of the interpretation of the examination results.

4.6 External services and supply
Selection and use of purchased external services, equipment and consumable supplies, including criteria for inspection, acceptance, rejection and storage of these materials according to pre-defined standards.

4.7 Advisory services
Advising and assistance on examinations

4.8 Resolution of complaints
Procedures and records of customer complaints resolutions. Causes of complaints must be investigated and corrective actions taken in order to solve them.

4.9 Identification and control of nonconformities
Documentation and analysis of process deviations. Causes must be investigated and corrective actions taken. Sources of deviations include complaints, QC results, calibration procedures, audit results, etc.

4.10 Corrective action
Establishment of corrective actions to avoid recurrence of problems. Results must be evaluated in order to check if the actions taken were effective.

4.11 Preventive action
Identification of preventive actions to avoid occurrence of problems. Results must be evaluated in order to check if the actions taken were effective.

4.12 Continual Improvement
Revision of procedures to improve their performance - by using indicators, for instance. The main idea is to identify opportunities for improvement.

4.13 Quality and technical records
Maintenance, safe disposal and retrieval of quality records. A list of potential records is provided.

4.14 Internal audits
Planning, organization and conduction of audits to check compliance of processes to the ISO 15189 standard and also to the internal procedures.

4.15 Management review
Evaluation of the effectiveness of the system implemented and the need for resources. Indicators, nonconformities and audits results are some issues to be addressed in a management review meeting.

5. Technical Requirements

5.1 Technical Requirements
Definition of responsibilities, evaluation of personnel competences * and training requirements. Records – job descriptions, personnel files, training records, competence evaluation results - shall be maintained. Personnel must be able to develop their functions. Responsibilities of the laboratory director and designees are listed in this topic.

5.2 Accommodation and environmental conditions
Adequacy of space and work environment in order not to compromise the quality of the work performed and reduce the risks of injuries and occupational illness. Areas for dangerous materials storage and safe waste disposal must be provided. Environmental conditions must be controlled when they can affect the quality of the analytical process. Good housekeeping shall be ensured. Provisions must be made when the space is found not adequate.

5.3 Laboratory Equipment
Selection and monitoring of equipment, reference materials, consumables, reagents, instruments and analytical systems. This topic includes monitoring of the performance of equipment, calibration and maintenance procedures and also requirements for computer software and automated equipment.

5.4 Pre-examination procedures
Implementation of a process that includes definition of criteria for request forms, collection, identification, handling, transportation and receipt of primary samples. Criteria for accepting and rejecting samples must be defined. Samples collection procedures must be described in a manual.

5.5 Examination procedures
Control of the analytical process: validation, reference and critical intervals and documented procedures. This item addresses a set of information to be included, when applicable, in the documented procedures.

5.6 Assuring quality of examination procedures
Quality Control procedures: use of internal quality control systems and definition of the uncertainty of results, application of methods to calibrate measuring systems, participation in inter-laboratory comparison programs or alternative mechanisms that can assure the quality of analytical procedures.

5.7 Post-examination procedures
Definition of criteria for storage and safe disposal of primary samples, review and release of results.

5.8 Reporting of results
Description of requirements for reports formatting, transmitting and alteration. Definition of criteria for communication of delays and critical values, retention period of results, etc. The laboratory must achieve compliance to national legal requirements, when applicable.

Get the entire standard at:


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