The requirements for competence and quality in medical lab environments are laid forth in ISO 15189:2022 - Medical Laboratories, an international standard. It is essentially a standard that requires laboratories to create a strong, consistent quality management system to demonstrate their competency. In December 2022, an updated version of ISO 15189 was released, bringing with it a number of improvements, clarifications, and modifications to the 2012 version.
The key feature of the ISO 15189 standard is that it only applies to medical laboratories. As a result, it differs from ISO 9001, which specifies the standards for a quality management system in any type of organization, and ISO/IEC 17025, which specifies the general requirements for the competence of testing and calibration laboratories. These are most likely the other ISOs you've come across if you've recently begun the process of having your lab ISO accredited. ISO 15189 is critical for medical laboratories since it is a globally recognized accreditation that allows you to ensure the dependability, competence, integrity, and overall quality of the lab practices. ISO 15189 accreditation comprises an independent assessment of the medical laboratory that contains an examination of personnel qualifications and skills, equipment, components, and supplies, quality assurance, and analytical, pre-analytical, and post-analytical factors. It is critical to the perception of your entire organization as trustworthy, reputable, and competent by your consumers or business partners.
The advantages of obtaining ISO 15189 certification for a medical laboratory are numerous. It can contribute to proving the laboratory's expertise and dedication to quality, which will improve its standing and gain the trust of patients and healthcare professionals. As the standard necessitates regular evaluation and assessment of the laboratory's performance, certification can also assist in ongoing improvement. To achieve the full benefits of ISO 15189 accreditation, the organization must first adopt the standard and become certified with the support of an ISO 15189 consultant.
For ISO 15189:2022 Certification, Punyam.com, a top ISO and accreditation consultant in India, offers consulting services. They have extensive expertise in implementing ISO 15189:2022 for several types of medical laboratories, including pathology, microbiology, and clinical laboratories. In order to establish the ISO 15189 system and obtain certification, a team of Punyam's ISO 15189 consultants assists in the following ways:
- Micro-level survey for each and every test parameter of the laboratory and preparation of detailed Gap Analysis report,
- Preparation of applicable documents required by ISO 15189:2022 based on a detailed study of all activities of the laboratory, such as;
- ISO 15189 Quality Manual,
- Quality Procedures (Mandatory procedures required by the ISO 15189 standard),
- Standard Operating Procedures (SOPs) to control identified activities having risk potential to the test parameter,
- Formats to establish the objective evidence of implementation and to ensure control over all the activities,
- Sample Risk Assessment and Opportunity Sheet
- ISO 15189 awareness training to all levels of employees within the laboratory,
- Help in the effective implementation of the system by periodic visits till accreditation,
- Conduct an internal audit to check readiness for the accreditation,
- Conduct management review meetings in the presence of Top Management to guide the laboratory for effective implementation on all the issues related to management requirements and technical requirements.
Source: https://punyam.wordpress.com/2023/06/06/how-iso-15189-consultant-supports-to-simplify-the-medical-laboratories-accreditation-process/
