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Secure Success with ISO 15189 Accreditation for Medical Laboratories!

ISO 15189 Accreditation for Medical Laboratories

As a medical laboratory, providing accurate, reliable, and timely results is crucial for patients’ effective diagnosis and treatment. ISO 15189 accreditation for medical laboratories is an international standard that helps ensure the competence of medical laboratories and the quality of their results.

Introduction to ISO 15189 Accreditation for Medical Laboratories

ISO 15189 is focused on the medical laboratory, and its objectives are to satisfy interested parties. In such cases, stakeholders are not only customers, such as patients, but include internal or external involvement with the medical laboratory, such as professionals, suppliers and accreditation agencies. For this reason, the ISO focuses on a management system and medical laboratory technical specifications. A point to note that below are some terms which are commonly used in many standards:

  • Shall – A compulsory requirement;
  • Should – A recommendation;
  • May – Instructs permission;
  • Can – A possibility or a capability.

What Is ISO 15189 Accreditation for Medical Laboratories?

ISO 15189 is an international standard for medical laboratories to help them develop quality management systems, assess their competence and ensure that they function in line with industry and legal standards.

As part of every ISO, a quality manual is required. This is no different from an ISO 15189 accreditation process. This article will explain how the laboratory should function to a high standard.

Why Is ISO 15189 Accreditation for Medical Laboratories Important?

ISO 15189 accreditation for medical laboratories specifies the requirements for the management of a medical laboratory, including the design and operation of the laboratory, the assessment of technical and diagnostic performance, and the reporting of results. The standard is intended to ensure that medical laboratories are able to provide results that are fit for their intended purpose.

ISO 15189, like ISO 17025, is a mark to show competence and confidence awarded to medical laboratories. Nowadays, legal compliances require laboratories to be ISO 17025 accredited, so having medical laboratories up to ISO 15189 is even more crucial to show integrity, impartiality and competence.

What Are the Benefits of ISO 15189 Accreditation for Medical Laboratories?

Becoming certified with ISO 15189 can provide a number of benefits to a medical laboratory. It can help demonstrate the laboratory’s competence and commitment to quality, enhancing its reputation and trust among patients and healthcare providers. Certification can also support continuous improvement, as the standard requires regular assessment and review of the laboratory’s performance. 

Risk Reduction

With an ISO 15190 quality system, the organization will operate with a rigorous approach. For this reason, with good traceability and record structure, identification and planning mitigation measures for potential risks will be easier. This will give rise to risk reduction.

Cost

ISO 15189 accreditation can be expensive to run. However, improvement in the issue of results by assuring that they are technically valid and repeatable will save costs associated with retesting.

Legally Compliant

ISO 15189 accreditation for medical laboratories is not legally required. However, policymakers are pushing for more accredited labs and better certification. Therefore, it is essential to look at national legal compliances, where labs might be required to hold ISO 17025 accreditation. This would be equivalent to ISO 15189 for medical laboratories.

Competence And Efficiency Will Lead to Profit.

With improved competence of all staff, staff will be more motivated to continue progressing professionally and get up to speed with modern technologies. This will improve innovation and efficiency, giving rise to more profits.

Challenges For ISO 15189 Accreditation for Medical Laboratories

As with any accreditation certification, ISO 15189 does not come without challenges. Although this list could be exhaustive, and any organization should determine their own challenges, some common challenges will be summarized below to prepare any potential organization.

Trained Staff Turnover

Staff retention is always an issue when competency is required. In an ISO accredited lab, this is more crucial, when organizations spend time and money to train members of staff to a required level, which then moves on to other opportunities. Unfortunately, replacing competent staff is always resource-demanding, and organizations can never guarantee staff retention.

Equipment

The most significant resource in an accredited laboratory would be equipment. Equipment requires capital costs for purchasing, operating, maintaining, verifying and training personnel. Apart from this organizations must ensure that suppliers or manufacturers of such equipment are readily available to provide any required support to ensure proper running or corrective measures when needed.

Management Support

Management’s goal is to get the highest profit with the least amount of expenses. For this reason, ISO accredited laboratories may seem more expensive than profitable without proper support, as more validations and verifications will be required. This goes without saying; the costs of proficiency testing and internal quality controls that would be necessary with every batch of tests quickly pile up. Nonetheless, less repeatability of tests, and greater validity of results, together with an increase in markets, from compliance sectors, will ensure that the return on investment will be beneficial.

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Approaching ISO 15189 Accreditation for Medical Laboratories

To become certified to ISO 15189, a medical laboratory must undergo a rigorous assessment process. This typically involves a detailed review of the laboratory’s policies, procedures, and practices and on-site assessments of the laboratory’s technical capabilities and performance. The evaluation is carried out by a third-party certification body, accredited to certify medical laboratories to ISO 15189.

Once a medical laboratory has been certified to ISO 15189, it must maintain its certification by undergoing regular reassessments and continuing to meet the requirements of the standard. This can involve implementing any necessary corrective actions and making ongoing improvements to the laboratory’s policies, procedures, and practices.

ISO 15189 is very similar to ISO 17025 but is focused on medical laboratories. ISO 15189 describes technical requirements for:

  • Stakeholders,
  • Environmental resources,
  • Laboratory equipment,
  • Reagents, and consumables,
  • Pre-examination processes,
  • Examination processes,
  • Ensuring the quality of testing processes results,
  • Reporting of results,
  • The release of results,
  • Laboratory information management.

For the scope of this ISO 15189, we shall focus only on the technical requirements, as the management system would be similar to the approaches of the other ISO documents.

5.1 Personnel

Several records need to be kept to ensure that personnel are trained and competent. Such records include:

  • Personnel qualifications,
  • job descriptions;
  • Induction course;
  • Training details per person;
  • reviews of staff performance;
  • personal papers of relevant skills.

5.2 Accommodation and Environmental Conditions

The laboratory shall have appropriate environmental conditions:

  • Controlled access
  • Medical information of patients;
  • Facilities for examination allow for correct performance;
  • Suitable communication systems

With regards to safety facilities, a laboratory should have the following:

  • Suitable storage facilities to ensure continuing integrity and preservation of sample material, documents, reagents and consumables.
  • Suitable staff facilities and patient sample collection facilities. The latter shall include separate reception/waiting and collection areas.

Proper facility maintenance and environmental conditions shall be maintained to functional and reliable requirements. Relevant records shall be kept as required by the applicable specifications and where they may influence the quality of the sample, results and/or the health of the staff.

ISO 15189 has chapters 5.3, 5.5, and 5.6, which require specifications for which there is no standardization of practices. For this reason, these shall be discussed to ensure proper attention.

5.3 Equipment Calibration and Metrological Traceability

The medical laboratory shall participate in programs to calibrate and verify its procedures and equipment. The bias (systematic error) defines the difference between the expected result and the accepted reference value. Measurement uncertainty is also measured to determine the dispersion of the independent results obtained under specific conditions and is generally expressed from the standard deviation of several replicates. During such validation data collection, traceable materials are to be used. When these materials are unavailable, appropriate alternative materials could be used.

5.5 Examination Processes Require:

5.5.1.1 Selection of examination procedure: new methods are selected based on purpose. For example, a blood bank screening test should ensure that a technique with high sensitivity is preferred to minimize the risk of post-transfusion infection. ISO 15189 does not consider the merits of choosing or recommending any approach to select a new test. However, it allows the user to base the decision on a literature review using validation cases of methods.

5.5.1.2 Verification of examination procedure: All test methods used without any changes are to be verified using performance criteria data from the manufacturer or peer-reviewed literature papers. Such verifications shall conform with the criteria stipulated by the laboratory performance claims, and management must ensure they are suitable.

5.5.1.3 Validation of examination procedure:  Modified, “in-house” methods or standard methods used outside their scope require a validation process. These methods are validated according to the clinical test purpose/intended use/impact of the result on the clinical decision. Therefore, the specifications, such as the total allowable deviation, allowable sensitivity or allowable specificity, are selected. ISO 15189 does not stipulate any specific method validation approach and does not display any targets. As with verifying non-modified tests, experimental data is involved in proofing such tests.

5.5.1.4 Measurement uncertainty of measured quantity values: Measurement uncertainty is for methods expressing quantitative results. For qualitative results, measurement uncertainty cannot be determined. Like ISO 17025, ISO 15189 does not recommend a plan to calculate measurement uncertainty. However, various standards or guidelines help laboratories determine good statistical measurement uncertainty. Some methods allow external quality assessment (EQA)/proficiency of testing (PT) data as a primary source for measurement uncertainty. However, these are not usually recommended due to the heterogeneity of the results and should only be used as a final resort. The PT is probably the most commonly used in medical laboratories with tests accredited to ISO 15189.

5.6 Ensuring Quality of Examination Results

Internal quality control: Internal quality control schemes are recommended, like in every accredited laboratory. However, no method is suggested. The most commonly used methods in labs are the “Westgard Rules”. However, using a multi-role QC approach does not automatically fulfil the required principles. The exponentially weighted moving average (EWMA) chart is an alternative to the Levey-Jennings charts. All these options depend on the lab’s resources, and management must ensure that reasonable quality control with the resources available is to be used.

External quality assessment: Medical laboratories must participate in programs for EQA/PT and shall provide documented evidence of corrective actions when results are out of specification. For instance, when an effect is out of acceptable group requirements, i.e., generally out of the +/- 2 z-score.

Conclusion

In conclusion, ISO 15189 accreditation for medical laboratories is a necessary international standard for their quality management. Becoming certified with ISO 15189 can provide several benefits, including enhanced reputation and trust, support for continuous improvement, and the assurance of delivering accurate, reliable, and timely results. Policymakers are advocating for more authorized labs and more stringent certification. This will increase earnings by improving innovation and efficiency.

Furthermore, when competency is required, staff retention is always a concern. This is especially important in an ISO accredited lab, where firms invest time and money to train employees to a certain level. Nonetheless, less repeatability of tests and more validity of results, together with an expansion in markets from compliance sectors, will assure a positive return on investment.

If you are a medical laboratory looking to improve the quality of your services, consider becoming certified to ISO 15189.

Eager to learn more about ISO 15189 Accreditation for Medical Laboratories?

Luke Desira is an ISO management system consultant whose main goal is 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! Read more to understand the difference that exists between ISO 15189 and ISO 17025.

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 help you achieve ISO accreditation efficiently. When ready, just call Luke Desira – he’ll be happy to lend a helping hand.

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