The Striking Differences Between ISO 15189 and ISO 17025

differences between ISO 15189 and ISO 17025

What are the Differences Between ISO 15189 and ISO 17025? How will these differences affect an organization?

ISO 15189 and ISO 17025 are both international standards that relate to the competence and quality of testing and calibration laboratories. In this article, we shall be covering the the differences between ISO 15189 and ISO 17025.

What is ISO 17025?

ISO 17025 is a general standard that applies to all types of testing and calibration laboratories, regardless of the industry they operate in. It specifies the general requirements for the competence, impartiality, and consistent operation of these laboratories. Like ISO 15189, it covers management, personnel, infrastructure, and processes and procedures, but it is not specific to any particular industry or sector.

What is ISO 15189?

ISO 15189, on the other hand, is specific to medical laboratories and sets out the requirements for quality and competence in medical laboratory testing. It covers all aspects of the laboratory, including management, personnel, infrastructure, and the laboratory’s processes and procedures. The standard is intended to ensure that medical laboratories produce accurate and reliable results that can be trusted by patients, healthcare providers, and regulatory authorities.

ISO 15189 includes an additional requirement that specifies the QMS shall include IQC and participation in interlaboratory comparisons such as external quality assessment schemes. Medical laboratories participate in extensive internal quality control and proficiency testing/external quality assessment and must ensure that they manage these activities in an integrated fashion. This may be similar to ISO 17025 requirements. However, medical laboratories may not be able to find ‘off-the-shelf’ proficiency tests.

Differences Between ISO 15189 and ISO 17025

ISO 15189 and ISO 17025, have by time become more similar. During the previous versions, ISO 15189 and ISO 17025 were very different, as ISO 15189 was more risk based than ISO 17025. In fact, during the last revision of ISO 17025, a risk-based approach was implemented, which brought both ISOs further close to each other.

The following is a clause-by-clause description of the differences between ISO 15189 and ISO 17025 standards, most of which may be more of a term definition rather than a difference. Thus, one would be quite right in saying that ISO 17025 follows the concepts of ISO 15189, with both ISO standards being derived from ISO 9001.

With regards to management requirements, the content of specific requirements does not necessarily match. While each standard contains the exact requirements, here are the specific additional points included in ISO 15189:

4.3 | ISO 15189 includes two minor points regarding the identification of controlled documents: in addition to the date of issue and revision, page numbering, number of pages, and the authority for the issue specified in ISO/IEC 17025, ISO 15189 specifies “title”.

4.4 | ISO 15189 uses a different title than the one in ISO 17025 in order to emphasise on service agreements. Such agreements, may include external or internal agreements with suppliers or patients. 

  • 4.4.1 | ISO 15189 does not include the note explaining that a contract may be any written or oral agreement. Therefore, accreditation bodies may need to specify that the term “contract” does not only apply to a legal document. 

4.5 | ISO 15189 uses a different title to outline the need to review arrangements with referral services (laboratories performing additional or confirmatory testing) and consultants who provide second opinions. 

  • 4.5.2 | Arrangements need to be reviewed so it is clear what is expected of the referral laboratory or consultant, including who is responsible for interpreting the results. The referring laboratory, not the referral laboratory, is responsible for reporting the findings. 

4.6 | ISO 15189 has changed this requirement about purchasing records, using it to specify that an inventory control system for supplies and records is maintained. 

4.7 | ISO 15189 specifies that appropriate professional staff shall advise the choice of tests to be ordered, the frequency with which they should be reordered, and the appropriate sample to be tested. It also requires that an interpretation of the results is to be given to the patient.  Another component of this requirement is to specify that laboratory professional staff meet with clinical staff regarding the use of laboratory services and consult on scientific matters, documenting these meetings. 

4.8  | ISO 15189 uses the title “Resolution of complaints” to replace the ISO/IEC 17025 title “Complaints”. 

4.9  | ISO 15189 specifies that policies and procedures must consider the “medical significance” of nonconforming examinations and, if necessary, notify the requesting clinician. 

4.10 | ISO 15189 section 4.10 is “Corrective action”, which is section 4.11 in ISO/IEC 17025. 

4.11  | ISO 15189 section 4.11 is “Preventive action” in section 4.12 in ISO/IEC 17025. 

4.12  | ISO 15189 section 4.12 is “Continual Improvement, which is section 4.10 “Improvement” in ISO/IEC 17025. 

4.13  | ISO 15189 uses the title “Control of records”, section 8.4 in the ISO/IEC 17025, which deals with “control” issues like procedures for identification, collection, indexing, access, storage, maintenance and safe disposal. 

4.14  | ISO 15189 specifies that “Evaluation and audits” need to emphasize areas to demonstrate evaluation and ensure conformity with continuous improvement. Requirement 4.14.5 links internal audit findings directly to management review. 

4.15  | ISO 15189 specifies that “Management review” is an activity that ensures continuing stability and effectiveness in support of patient care. 

  • 4.15.2  | Contains a long list of what shall be taken into account during the management review 
  • 4.15.3  | Objectiveness of the laboratory’s contribution to patient care is to be monitored and evaluated objectively. 

5.1 | Personnel requirements are laid out quite differently in ISO 15189 than in ISO/IEC 17025, including specific requirements for the laboratory director. 

  • 5.1.4  | Specifies the responsibilities for professional, scientific, consultative or advisory organization, administrative and educational matters relevant to the laboratory’s service. It says that these people need appropriate training and background for these duties: 
    • Educational and professional qualifications; 
    • Copy of certification or license; 
    • Previous work experience; 
    • Job descriptions; 
    • Induction course for new staff to the laboratory environment; 
    • Training in current job tasks; 
    • Competency assessments; 
    • Records of continuing education and achievements; 
    • Reviews of staff performance; 
    • Reports of accidents and exposure to occupational hazards;
    • Immunization records of staff.


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5.2  |  ISO 15189 requirements for “Accommodation and environmental conditions” are essentially the same as those in ISO/IEC 17025 section 5.3, with these additions: 

  • 5.2.2  |  Laboratory design considers minimizing the risk of injury and occupational illness, patient, employee and visitor safety (protecting from recognized hazards). 
  • 5.2.4  |  in consideration of design, it is essential that the environment does not affect the performance of specimen collection and the equipment utilized for this purpose. 

5.3  |  ISO 15189 describes this section as le “Laboratory equipment, reagents and consumables” instead of section 5.4 in the ISO/IEC 17025 “Equipment. 

5.4  |  ISO 15189 uses the title “Pre-examination procedures” to replace the ISO/IEC 17025 title “Sampling” (section 5.7), and it contains elements of ISO/IEC 17025 section 5.6 “Measurement traceability” and also 5.8 “Handling of test and calibration items”. 

  • 5.4.3  |  The request form shall hold sufficient information to identify the patient and the requesting physician.
    This form or an electronic equivalent should allow space for the inclusion of, but not be limited to, the following:

      • Unique identification of the patient; 
      • Name or other unique identifiers of the physician.
      • Type of sample and the anatomic site of origin;
      • Tests requested; 
      • Relevant clinical information to the patient, which should include sex and date of birth, as a minimum; 
      • Date and time of sample collection; 
      • Date and time of receipt by the laboratory. 
  • 5.4.4  |  Specific instructions for collecting and handling samples shall be documented and implemented by the laboratory and made available to those responsible for sample collection.
  • 5.4.5  |  Samples shall be traceable to an identified individual, typically by request form. The laboratory should not accept samples lacking proper identification. 
  • 5.4.6  |  The laboratory shall monitor the transportation to the laboratory in order to ensure that they are transported: 
      • Within a time appropriate to the nature of the analysis requested, 
      • Within a temperature range specified and with the proper preservatives to ensure sample integrity, 
      • Ensures safety for the person transporting such samples.
      • Acceptance criteria shall be documented for acceptance or rejection of samples. If a deviation occurs, the samples may be accepted, provided that the final report shall indicate the deviation.

5.5  |  ISO 15189 uses the title “Examination procedures” to replace the ISO/IEC 17025 title “Test and calibration methods and method validation”, and in this section, ISO 15189 addresses the verification of the procedure, which is covered in the ISO/IEC 17025 section 5.6 titled “Measurement traceability”. 

ISO 15189 includes a few additional items in the list of inclusions to a procedure, specifically interferences (e.g. lipaemia, haemolysis, bilirubinemia) and cross-reactions, alert/critical values, laboratory interpretation, and safety precautions. Here, ISO 15189 refers to biological reference intervals (i.e., normal reference ranges), noting that they need to be reviewed periodically and when testing changes are introduced to ensure they remain appropriate for the patient population. 

5.6  |  ISO 15189 uses the title “Ensuring the quality of examination procedures” to replace the ISO/IEC 17025 titles “Measurement traceability” (section 5.6) and “Assuring the quality of test and calibration results” (section 5.9). Specific differences of note are: 

  • 5.6.2  | This is where ISO 15189 addresses the need to determine measurement uncertainty (ISO/IEC 17025 section 5.4.6). 
  • 5.6.3  |  ISO 15189 acknowledges that formal interlaboratory comparisons are not available for all examinations in the medical laboratory testing scope. Therefore, whenever a proficiency test is unavailable, the laboratory shall develop a comparison for determining the acceptability of otherwise evaluated procedures. This comparison shall utilize externally derived challenge materials such as interlaboratory testing or matrix spiking. Laboratory management shall devise a plan to monitor the results of this comparison and participate in the implementation and recording of corrective actions. 

5.7  |  ISO 15189 includes a “Post-examination procedures” section that is not included in ISO/IEC 17025. 

  • 5.7.1  |  Authorized personnel shall review the results of examinations, evaluate them and authorize the release of results. Storage of the primary and laboratory samples shall follow approved policy.  Safe disposal of samples no longer required for examination shall be carried out per local regulations or recommendations for waste management. 

5.8  |  ISO 15189 uses the term “Reporting of results to replace the ISO/IEC 17025 title “Reporting the results” (section 5.10). It requires many of the same things but with a different language. However, additional requirements address the urgency of testing some medical samples, the need to determine and monitor turnaround times, and the confidentiality of information. They are: 

  • 5.8.3  |  An examination report should contain: 
      • Date and time of sample collection as well as the time of receipt 
      • Biological reference intervals
      • Identification of the person authorizing the release of results 
      • Date and time of the release of the report 

5.9  |  This section speaks about the general requirements for the release of results. This includes the details of who may release the results and to whom. 

Overview of the Differences Between ISO 15189 and ISO 17025

In conclusion, ISO 15189 and ISO 17025 are both international standards that relate to the competence and quality of testing and calibration laboratories. ISO 15189 is specific to medical laboratories and sets out requirements for quality and competence in medical laboratory testing, while ISO 17025 is a more general standard that applies to all types of testing and calibration laboratories, regardless of industry. Both standards aim to ensure that laboratories produce accurate and reliable results and that they are operated in a competent and consistent manner.

However, there are some key differences between the two standards, including their industry specificity and the specific requirements they outline. It is important for laboratories to carefully consider their specific needs and industry when choosing which standard to implement.

EAGER TO LEARN MORE ABOUT the Differences Between ISO 15189 and ISO 17025?

As an ISO management system consultant will make it his personal mission to put your company on a class of its own! Learn more on the laboratory medical management system that can be achieved through ISO 15189 accreditation! One can further understand the differences between ISO 15189 and ISO 17025 by reading in more detail about ISO 17025 Laboratory Management System and about ISO 15189 Accreditation for Medical Laboratories.

All management systems based on ISO Standards that are implemented should pertain directly to the organization’s objectives When it comes to ISO 15189 – Medical Laboratories Management System, the same mindset have to be applied. Have a look at the ISO Certification specialised by Industry to understand which ISO certifications and accreditations your laboratory can benefit from.

Luke offers a variety of ISO certification services that puts him as the leading ISO Certification consultant in Malta. He can efficiently help you achieve ISO accreditation. When ready, just call Luke Desira – he’ll be more than happy to lend a helping hand.

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