Comparison: ISO 15189 vs ISO 17025 - Section 5

5.1 Personnel
A much expanded section of ISO 15189 has been devoted to the responsibilities and functions of the lab director with specific emphasis that the medical lab service should be directed by a person with an appropriate level of competence. Detailed responsibilities of the director are included in ISO 15189, whereas ISO/IEC 17025, although referring to competence, has no corresponding text.

Clause 5.1.3 of ISO 15189 states “the laboratory shall be directed by a person or persons having executive responsibility and the competence to assume responsibility for the services provided. Competence is here understood as the product of basic academic, post-graduate, and continuing education, as well as training and experience of several years in a medical laboratory.”

Clause 5.1.4 of ISO 15189 states “the responsibilities of the laboratory director or designees shall include professional, scientific, consultative or advisory, organizational, administrative, and educational matters”

The laboratory director or designees for each task should have the appropriate training and background to be able to discharge the following responsibilities:
a) provide advice…about the choice of tests, the use of the lab service and the interpretation of lab data
b) serve as active member of the medical staff for those facilities served, if applicable and appropriate
c) relate and function effectively with accrediting and regulatory agencies, administrative officials, the healthcare community, and the patient population
d) define, implement and monitor standards of performance and quality improvement
e) implement the quality management system
f) monitor all work to determine that reliable data are being generated
g) ensure that there are sufficient qualified personnel with adequate documented training and experience
h) plan, set goals, develop and allocate resources appropriate to the medical environment
i) provide effective and efficient administration of the medical lab service, including budget planning and control with responsible financial management
j) provide educational programs for the medical and lab staff and participate in educational programs of the institution
k) plan and direct research and development
l) select and monitor all referral labs for quality of service
m) implement a safe lab environment
n) address any complaint, request or suggestion from users of lab services
o) ensure good staff morale

The lab director need not perform all responsibilities personally. However, it is the lab director who remains responsible for the overall operation and administration of the lab., for ensuring that quality services are provided for patients.

Clause 5.1.6 of ISO 15189 states “ personnel shall have training specific to quality assurance and quality management for services offered.”

Clause 5.1.10 of ISO 15189 states “employees shall be trained to prevent or contain the effects of adverse incidents.”

Clause 5.1.11 of ISO 15189 states “the competency of each person to perform assigned tasks shall be assessed following training and periodically thereafter. Retraining and reassessment shall occur where necessary.”

Although ISO 17025 requires the lab to identify the training needs of personnel and provide the relevant training, the emphasis on continuing education is greater in ISO 15189. ISO 15189 mentions the requirement for continuous professional judgements, more than once. Furthermore, there is a particular requirement that staff receive relevant training in quality assurance and quality management as well as health and safety. It is also required that an assessment of competence be conducted as part of the training procedures and that this be conducted periodically thereafter.

5.2 Accommodation and environmental conditions

Safety requirements in ISO 15189 are covered under clauses 5.1 Personnel, 5.2 Accommodation and environmental conditions, 5.3 Laboratory equipment, 5.4 Pre-examination procedures, and 5.7 Post examination procedures. ISO 15189 not only requires lab personnel to be trained in safety procedures, but also that patients and visitors, such as personnel attending the lab to effect repairs and maintenance, are to be protected from potential risk.


5.3 Laboratory equipment

The contribution of the diagnostic manufacturers in maintaining the quality of medical lab services is explicitly acknowledged in ISO 15189, whereas such reference is not included in ISO/IEC 17025.

ISO/IEC 17025 has no corresponding text.

ISO 15189 indicates that equipment includes instruments, reference materials, consumables, reagents and analytical systems, as applicable.

5.3 Laboratory equipment

5.3.2 - a documented and recorded programme of preventive maintenance and calibration that follows manufacturer's recommendations. Also, manufacturer's instructions, operator's manuals, or other documentation may be used to establish requirements for compliance with relevant standards.

5.3.4 - manufacturer's instructions may be used to establish acceptance criteria, procedures, and frequency of verification for maintenance and/or calibration.

5.3.6 - equipment must be maintained in a safe working condition. Manufacturer's specifications or instructions or both must be used as necessary.

5.5 Examination procedures

5.5.3 - the procedure must be based in whole or in part on the instructions for use, written by the manufacturer, provided that they are in accordance with 5.5.1 and 5.5.2 and that they describe the procedure as it is performed in the lab.

5.6 Assuring quality of examination procedures

5.6.3 means for providing confidence in the results must be applied including documentation of statements regarding reagents, procedures or the examination system when traceability is provided by the supplier or manufacturer.

A definition for lab equipment has been provided to include instruments, reference materials, consumables, reagents and analytical systems. This definition therefore broadens the calibration and maintenance program of equipment to cover demonstration of proper function of reagents and analytical systems.

5.4 Pre-examination procedures

Medical labs are required to provide information on sample collection for service users, that include self-collecting patients, sample collectors, and sample reception staff. Although sample collection may be carried out by nursing staff in or by medical doctors, the responsibility for proper collection is that of the lab. The lab is also expected to have frequent communication and liason with sample collection personnel to ensure that instructions are understood and followed.

5.8 Reporting of results

The establishment of critical levels for all examinations and turnaround times that reflect the clinical need, are specific requirements for medical testing. These critical alert levels could be dependent upon population, sex, age or method. Labs must therefore determine their own requirements in those areas according to their own circumstances. Medical labs will be well aware of this need.

ISO 15189 does not provide a definition for turnaround time. An interpretation is that it is the period of time from sample collection through to receipt of results by the requesting clinician, or from when samples are received by the lab to the issue of the results. In the latter case, the collection of samples is not under the direct control of the lab. Both situations are possible and may even exist within the on lab. The turnaround time must reflect the clinical needs.

It should also be noted that there is a requirement to monitor the transportation of samples to ensure that samples are received within an appropriate timeframe. The essence of this requirement is based on clinical needs and patient care