Tools, Technologies and Training for Healthcare Laboratories

ISO

ISO-3: The 15189:2003 Standard

This lesson explains how the ISO 15189:2003 standard can be used as the basis for accreditation of quality and competence in Clinical Laboratories and its synergistic relationship with ISO 9001:2000 certification.

See the introduction to this series by Dr. James O. Westgard, Ph.D., FACB

In our last essay, we introduced the ISO 9001:2000 as a Quality Management Standard for the certification of quality systems. In this essay our focus is the ISO 15189:2003 and its utility for clinical laboratories.

Published in 2003, the ISO 15189:2003 - Medical laboratories: particular requirements for quality and competence - quickly became a widely accepted standard to be used for accreditation of clinical laboratory competence. Its main objective is to allow laboratories to organize their operational procedures efficiently, meet the expectations of their clients and improve their service.

The ISO 15189 standard is an important template for assessing the competence of medical laboratories in their technical capacity and the effective quality management of a professional service and its staff - with or without the aim of accreditation. ISO 15189 by itself is not a generic (certification) standard, but a specific one, which means that it is a guideline for orientation, with a more technical approach. It is also very useful for understanding how the requirements of the generic certification standard ISO 9001:2000 – Quality Management - can be applied to clinical laboratory activities. The ISO 15189 standard can be understood as a practical complement to the generic requirements described in the ISO 9001. Even with a technical approach, ISO 15189, like ISO 9001:2000, presents requirements more related to quality management than to operational procedures.

Keep in mind that the standard does not replace national regulations related to health services, but the possible adoption of ISO 15189 by accreditation agencies in the near future – CAP, COLA and JCAHO in the United States, and other national agencies in several other countries all over the World – will make it the basic standard guiding and harmonizing the accreditation process of clinical laboratories.

The ISO 15189 standard is divided in two major parts:

  • Management requirements: generic requirements related to quality management systems
  • Technical requirements: specific requirements related to activities carried out by clinical laboratories

The first part of ISO 15189 is completely based on the ISO 9001: 2000 requirements. A general description of the main ISO 15189 management requirements is provided in table 1 and a comparison between them and related ISO 9001 requirements is provided in table 2.

Table 1: The Management Requirements of ISO 15189:2003

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.

Table 2: Correlation between the ISO 15189 Management Requirements with ISO 9001 Quality main requirements (for details on all ISO 9001 requirements, see also the table in the essay ISO-2)

ISO 15189:2003

ISO 9001:2000

4 Quality management system

4.1.5; 4.2, Quality management system

4.1 General requirements

4.3 Document control; 5.1.2; and 5.4, Pre-examination procedures

4.2 Documentation requirements

4.2.4

4.2.2 Quality manual

5 Management responsibility

4.1.2,4.1.5 items a) and h), 4.2.1 and 4.2.3

5.1 Management commitment

4.1.2, 5.2.3 and 5.4.2

5.2 Customer focus

4.1.5 and 4.2.3

5.3 Quality policy

6 Resource management

4.1.5 a)

6.1 Provision of resources

4.1.5 g) and 5.1, Personnel

6.2.1 General

5.1.2, 5.1.6, 5.1.10 and 5.1.12

6.2.2 Competency, awareness and training

7 Product realization

4.10.1; 5.2, Accommodation and environmental

conditions; 5.3, Laboratory equipment; and 5.8, Reporting of results

7.1 Planning of product realization

4.4.Review of contracts

7.2.1 Determination of requirements related to the product

5.4.5; 5.6, Assuring the quality of examination procedures

7.5.3 Identification and traceability

8 Measurement, analysis and improvement

4.9, Identification and control of nonconformities

8.1 General

4.8, Resolution of complaints

8.2.1 Customer satisfaction

4.12, Continual improvement

8.5.1 Continual improvement

The second part of ISO 15189 presents the technical requirements that are directly applicable for technical accreditation of the clinical laboratory competence. Here, the laboratory world will more easily recognize the terminology, because it is more specific to clinical laboratories; for example, the main steps of the analytical procedures are called pre-examination, examination and post-examination procedures (usually called pre-analytical, analytical and post-analytical procedures by other accreditation standards, respectively). More than that, we will also recognize several similarities with several accreditation requirements from different accrediting agencies within the USA and from other countries all over the World. This can be clearly seen in Table 3, which provides a general description of the main ISO 15189 technical requirements.

Table 3: Knowing the technical requirements of ISO 15189:2003

ISO 15189:2003

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.

* According to ISO, competence is the result of basic academic and continuing education, training and experience of work.

The ISO 15189 standard also provides two important annexes. One of them has recommendations for LIS (Laboratory Information Systems) security. Differently from ISO 9001:2000, the ISO 15189 clearly describes Laboratory Information Systems recommendations in the annex B – System security, data entry and reports, data retrieval, system maintenance, etc. The other annex (annex C) is related to ethics in Laboratory Medicine. Considering the scandals that recently surfaced regarding Maryland General Hospital, this annex is very timely. Unfortunately, the sad events there show that we cannot take ethics in the laboratory for granted. We want to pinpoint here two basic quotes from this annex that, if they were followed, would have prevented the scandal:

“C.2.1 The general principle of healthcare ethics is that the patient's welfare is paramount. However, the relationship between the laboratory and the patient is complicated by the fact that there could also be a contractual relationship between the requester and the laboratory. Although this relationship (which is often commercial) can frequently be seen as the more important, the laboratory's obligation should be to ensure that the patient's welfare and interest are always the first consideration and take precedence.”

“C.5 Performance of examination: All laboratory examinations should be carried out according to appropriate standards and with the level of skill and competence expected of the profession. Any fabrication of results is completely unacceptable.”

Moreover, it is also important to note that NCCLS has three related guidelines that were reviewed this year and were very recently published (HS1-A2, GP22-A2 and GP26-A3) that have Quality as focus and are based on the ISO 9001:2000 and 15189:2003 standards: HS1-A2: A Quality management system model for healthcare; GP22-A2: Continuous quality improvement: integrating five key system components; and GP26-A3: Application of a Quality management system model for laboratory services. NCCLS is progressively aligning these guidelines, related concepts and terminology with the ISO standards. This correlation between ISO standards and NCCLS guidelines improves the consistency in this field and the feasibility of successful implementation. More than that, NCCLS is now helping to harmonize ISO concepts within healthcare services both in USA and at the international level. This alignment between NCCLS and ISO stresses the growing importance of ISO standards in the clinical laboratory arena. Altogether, they can also help clinical laboratories to tailor ISO requirements to their needs and design their quality management systems.

Accreditation processes are widely known in clinical laboratories and medical services in the USA. CAP, COLA and JCAHO have an established know-how in the field. Because of that, we believe that ISO 15189:2003 will be the starting point for the application of ISO standards in American clinical laboratories, and it will be progressively incorporated into the accreditation process and standards of these agencies.

However, the ISO-based certification process is not as familiar to American healthcare services, and very few labs are ISO 9001:2000 certified in the US (for the differences between accreditation and certification, please see the essay ISO-1). Although very well known in the majority of the other industries, ISO standards are relatively new in the context of health services. The ISO 15189 standard is finally catching the attention of American laboratories and accreditation agencies in the last few years. As more labs embrace accreditation based on ISO 15189, this will eventually make clear the strong synergy that exists between the accreditation with ISO 15189:2003 and the certification with ISO 9001:2000, and more labs will also seek the ISO 9001 certification.

We foresee the future of the implementation of both standards in the clinical laboratory in a very straight-forward way: the regulatory obligation will assure the application of ISO 15189 accreditation in the laboratory, but hopefully the quest for differentiation and continual improvement in these labs will also assure their certification according to the ISO 9001. This certification will be easily achieved if the laboratory is accredited by a standard that was developed using ISO 15189 as a basic guideline. It is very important to remember that the main goal of a quality management system is to help organizations to improve their performance and achieve continual improvement. It will depend more on the motives and the way the system is implemented than on the complexity of the technologies/methodologies adopted by the laboratory. So, the management and technical requirements from ISO 15189 should be synergistically complemented by the more complete Quality management system provided by ISO 9001:2000 certification.

The implementation of an Integrated Quality Management System based on ISO 15189:2003 accreditation and ISO 9001:2000 certification will be a very good opportunity to improve the quality of internal processes and achieve the best results in clinical laboratories. This IQMS can be considered one of the best ways to assure continual improvement and, as a bonus, it also makes it easier to evaluate the management and performance of the entire system. It suits perfectly the real world of our clinical laboratories, helping us to make the difficult liaison between the quality-driven nature of our services and the current performance-driven reality in the Health Care.

The application of a IQMS based on ISO 15189:2003 accreditation and ISO 9001:2000 certification will also better harmonize the technical and managerial approaches of the different Quality Management Systems available to clinical laboratories, reducing their complexity and hopefully avoiding that, despite of implemented, they are not correctly applied and, as a final result, the Quality itself is jeopardized.

About the Authors and their Institution

Rogério Rabelo, M.D., Ph.D.

Dr. Rabelo is the former Management Representative for Fleury Diagnostics’ Integrated Management System (ISO 9001:2000 and ISO 14001:1996). He is also a Medical Consultant in Clinical Chemistry/Medical Biochemistry and a Product Manager (High-volume, Automated Testing and POCT) at Fleury Diagnostics.

He got his M.D. from the Federal University of Goiás, in Brazil and his Ph.D. from the University of São Paulo, Brazil, with a joint research project developed at the Lady Davis Institute for Medical Research, McGill University, Canada. His post-doctoral training in Clinical Chemistry/Medical Biochemistry was done in the Department of Medical Biochemistry/Laboratory Medicine, Jewish General Hospital, McGill University, Canada. He has recently finished his MBA at University of São Paulo, Brazil.

Daniel Marques Périgo, R.Ph.

Mr. Périgo is the Integrated Management System (IMS) Coordinator responsible for Fleury Diagnostics’ Quality and Environmental Department.

He is a Pharmacist, graduated by University of São Paulo, Brazil, with specialization in Clinical Assays. He is also certified as specialist in both Quality Management and Productivity (by Vanzolini Foundation, from University of São Paulo) and Environmental Management (by the College of Public Health, University of São Paulo, Brazil).