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:
http://www.iso.ch/iso/en/CatalogueDetailPage.CatalogueDetail?CSNUMBER=26301&scopelist=CATALOGUE

Terms and Definitions

accreditation
procedure by which an authoritative body gives formal recognition that a body or person is
competent to carry out specific tasks [ISO Guide 2 :1996]

annual joint review
annual review of employee/employer requirements, undertaken to establish mutually acceptable
objectives for a defined period of time

audit
systematic, independent and documented process for obtaining audit evidence and evaluating it
objectively to determine the extent to which audit criteria are fulfilled [ISO 9000:2000]
NOTE
Clinical audit is audit applied to clinical activities

corrective action
action to eliminate the cause of a detected nonconformity or other undesirable situation
NOTE
Corrective action is taken to prevent reoccurrence whereas preventative action is taken to prevent
occurrence [ISO 9000:2000]

department
section of a laboratory in which a single pathology discipline pursues its activities

effectiveness
extent to which planned activities are realised and planned results achieved
[ISO 9000:2000]
NOTE
Clinical effectiveness is effectiveness applied to clinical activities

efficiency
relationship between the result achieved and the resources used [ISO 9000:2000]

examination
set of operations having the object of determining the value or characteristics of a property
NOTE
In some countries and disciplines (e.g. microbiology) examination is the total activity of a number of tests,
observations or measurements [ISO 15189:2003]

laboratory director
competent person(s) with responsibility for, and authority over, a laboratory
[ISO 15189:2003]

laboratory management
person(s) who manage the activities of the laboratory headed by the laboratory director
[ISO 15189:2003]

materials
consumables, calibrators, reagents, calibration material used in the performance of an examination

medical laboratory
clinical laboratory
laboratory for the biological, microbiological, immunological, chemical, immunohaematological,
haematological, biophysical, cytological, pathological or other examination of materials derived
from the human body for the purpose of providing information for the diagnosis, prevention and
treatment of disease in, or assessment of the health of, human beings, and which may provide a
consultant advisory service covering all aspects of laboratory investigation including the
interpretation of results and advice on further appropriate investigation
NOTE These examinations also include procedures for determining, measuring or otherwise describing the
presence or absence of various substances of micro-organisms. Facilities which only collect or prepare
specimens, or act as a mailing or distribution centre, are not considered to be medical or clinical laboratories,
although they may be part of a larger laboratory network or system.
[ISO 15189:2003]

multidisciplinary laboratory
laboratory in which two or more pathology disciplines work in an integrated manner

nonconformity
nonfulfilment of a requirement [ISO 9000:2000]

organisation
group of people and facilities with an arrangement of responsibilities, authorities and relationships
[ISO 9000:2000]

organisational structure
arrangement of responsibilities, authorities and relationships between people
[ISO 9000:2000]

post examination process
post analytical phase
processes following the examination including systematic review, formatting and interpretation,
authorisation for release, reporting and transmission of results and storage of samples of the
examinations [based on ISO 15189:2003]

pre examination process
pre analytical phase
steps starting in chronological order from the clinician’s request, including examination
requisition, preparation of the patient, collection of the primary sample, transportation to and
within the laboratory and ending when the examination procedure starts
[based on ISO 15189:2003]

premises
physical environment in which an organisation carries out particular functions

preventive action
action to eliminate cause of a potential nonconformity or other undesirable potential situation
NOTE
Preventive action is taken to prevent occurrence whereas corrective action is taken to prevent reoccurrence
[ISO 9000:2000]
procedure
specified way to carry out an activity or process [ISO 9000:2000]
NOTE
When the term ‘procedure’ is used in this document a written procedure is required which is subject to
document control, regular review and revision.

quality improvement
part of quality management focused on continually increasing effectiveness and efficiency
NOTE
the term ‘continual quality improvement’ is used when quality improvement is progressive and the
organisation actively seeks and pursues improvement opportunities [based on ISO 9000:2000]

quality management system
management system to direct and control an organisation with regard to quality
[ISO 9000:2000]

quality manual
document specifying the quality management system of an organisation
NOTE
quality manuals may vary in detail and format to suit the size and complexity of an individual organisation
[ISO 9000:2000]
see also www.iso15189.com

quality objective
something sought, or aimed for, related to quality
NOTE
Quality objectives are generally based on the organisation’s quality policy [ISO 9000:2000]

quality planning
part of quality management focused on setting quality objectives and specifying necessary
operational processes and related resources to fulfil quality objectives [ISO 9000:2000]

quality policy
overall intentions and direction of an organisation related to the fulfilment of quality requirements
as specified by laboratory management
NOTE
the quality policy should be consistent with the overall policy of the organisation and should provide a
framework for the setting of quality objectives [based on ISO 9000:2000]

record
document stating results achieved or providing evidence of activities performed
[ISO 9000:2000]

referral laboratory
external laboratory to which a sample is submitted for supplementary or confirmatory examination
procedure and report [ISO 15189:2003]

requirement
need or expectation that is stated, generally implied or obligatory [ISO 9000:2000]

review
activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject
matter to achieve established objectives [based on ISO 9000:2000]

revision
introduction of all necessary changes to the substance and presentation of a document to ensure its continuing suitability, adequacy, effectiveness to achieve established objectives

user
person or organisation using the services of the laboratory

user dissatisfaction (complaint)
user opinion of the degree to which the service provided has failed to meet their requirements

user satisfaction
user opinion of the degree to which the service provided has met their requirements

validation
confirmation, through the provision of objective evidence, that the requirements for a specific
intended use or application have been fulfilled [ISO 9000:2000]

work environment
set of conditions under which work is performed [ISO 9000:2000]

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