The 4th edition of ISO 15189:2022 (2003/2007/2012/2022) was published in December 2022. The transition period for the implementation of the new ISO 15189:2022 standard is set until 5 December 2025.

Laboratories should start the internal transition process immediately. To ensure sufficient time, clinical laboratories can focus on the following steps:

1. Begin with a GAP analysis to identify changes in regulatory requirements relevant to the clinical laboratory and plan for necessary adjustments to the Quality Management System (QMS).
2. Identify all stakeholders and document their expectations, focusing on the new requirements defined in ISO 15189:2022.
3. Consolidate and design the approach to risk and opportunity management (make sure risks and opportunities are reported in the new standard and identify their scope).
4. Check whether competency criteria have been established for each function (laboratory management and laboratory staff) and whether they are regularly reviewed.
5. Monitor internal audit and management review schedules to assess the implementation of new regulatory requirements and the effectiveness of your EMS.

In December 2022, the International Organization for Standardization (ISO) published the new version of ISO 15189. This standard specifies requirements for the quality and competence of medical laboratories, including requirements for point-of-care testing (POCT). Point of care testing (POCT) is a form of testing in which tests are performed near or even at the point of care of the patient.

The transition period for accredited medical laboratories to comply with the new standard extends until December 2025. At the end of the transition period, a medical laboratory's accreditation under ISO 15189:2012, as well as its POCT accreditation under ISO 22870:2016 in conjunction with ISO 15189:2012, will not be recognized under the EA Multilateral Agreement (EA MLA).

Together, 37 National Accreditation Bodies have signed the European Accreditation Mutual Recognition Agreement (EA MLA) for medical tests and have accredited over 3,800 medical laboratories. At the 52nd General Assembly, held on 23 November 2022, members decided that the preferred standard for accreditation of medical laboratories is EN ISO 15189 - Medical laboratories - Requirements for quality and competence. In addition, EN ISO/IEC 17025 may be used for activities not directly related to the patient, if a national regulatory authority requires accreditation of the medical laboratory according to EN ISO/IEC 17025 - General requirements for the competence of testing and calibration laboratories.

ISO 45001: The new International Standard for Occupational Safety and Health.

The OHSAS 18001:2007 standard for Occupational Health and Safety Management Systems, which specified the requirements for an Occupational Health and Safety Management System, was published in 2018 as the ISO 45001:2018 International Standard by ISO International.

The main changes in ISO 45001:2018 compared to OHSAS 18001:2007 are:

1. The new standard is aligned with ISO 9001:2015 and ISO 14001:2015, making it easier for companies to develop and implement integrated Management Systems.

2. A new requirement for a risk-based approach combined with a process-based approach is introduced.

3. The new standard includes the need to take into account in health and safety all persons working under the responsibility of a company (employees, office staff, suppliers, crews, subcontractors).

4. Other important changes include active employee participation in the OSH management system, increased responsibility of top management, consideration of opportunities and systematic assessment of the root causes of accidents.

ISO 9001:2015 and ISO 14001:2015. New versions.

On 15 September 2015, ISO International published new versions of the popular ISO 9001:2015 and ISO 14001:2015 standards. Companies certified to these standards will have a three-year period to adapt to the new required frameworks. Certificates issued under the previous ISO 9001:2008 and ISO 14001:2004 standards will no longer be valid after September 2018.

The main changes in the new version of ISO 9001:2015 include:

- Explicit requirement for risk management to support and improve understanding and implementation of the process approach.
- Fewer prescriptive requirements.
- Reduced emphasis on bureaucracy.
- Improved applicability to services.
- Requirements for defining the boundaries of the Quality Management System.
- Increased emphasis on the organizational context.
- Increased requirements for leadership.
- Increased focus on achieving desired outcomes to improve customer satisfaction.

- The key changes in the new version of ISO 14001:2015 include:

- Increased emphasis on managing environmental issues within the strategic planning of business processes.
- Increased emphasis on leadership.
- Adding proactive actions to protect the environment, such as sustainable resource use and reducing climate change.
- Improving environmental performance.
- Considering the product life cycle when considering environmental issues.
- Adding a communication strategy.