The revised standard of ISO 15189:2022 includes a greater focus on clinical risk and the impact of services on patients. The standard has undergone structural reorganization to bring it in line with ISO 17000-series standards. As officials of Global Manager Group wrote in a press note that the company is always committed to giving the best and quick solution for the document requirements for newly released or revised ISO standard for their global customers. The team of Laboratory accreditation management system was working hard on the documentation preparation, since the release of the final draft copy of this revised ISO 15189:2022 standard. As documentation auditing team of Global Manager Group has confirmed that the ISO 15189:2022 documents and training kits are at the final review stage and will be available to purchase online very soon, approx. date of release will be the first week of February 2023.
The ISO 15189:2022 standard outlines the requirements for proficiency and quality in medical laboratories. This standard specifies how the medical laboratory must plan and carry out appropriate responses to potential hazards and opportunities for improvement. ISO 15189 is useful to users, government regulators, and accreditation organizations as they verify or recognize the competence of medical labs by the laboratory. It also applies to medical laboratories as they create their management systems and assess their competence. Additionally, there have been several modifications applied to both the standard as well as the ISO 15189 documents.
Documentation, personnel access, proof of commitment, competence and quality, and competence and quality are the four categories used by the new ISO 15189 document to categorize the general standards for management system documentation. With particular subsections on record generation, record amendment, and record retention, it also goes into considerably more detail about document control. The ISO 15189 documentation kit as per revised version 2022, is more comprehensive and free sample document templates, as well as a DEMO with the list of documents covered including procedures, SOPs, formats, etc., for its management as per sections with sub-sections, will be provided with the release of the documentation kit. Another notable change is that ISO 15189:2022 specifies that the management system documents may be included in a quality manual but are not required to do so. Previously, ISO 15189:2012 mandated that the laboratory should develop and maintain a quality manual.
The ISO 15189:2022 documents are easily editable as per the organizations requirements and it takes care of all the sections and sub-sections to give better confidence as well as improve the system. To stay updated for the ISO 15189:2022 documents, visit here: https://www.globalmanagergroup.com/Eshop
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Global Manager Group offers a wide range of consulting services like Quality management, environment management system, food safety system, information security system as well as occupational health and safety management system. With specialization in Consultancy for ISO 9001:2015, ISO 14001, ISO 22000, HACCP Codex Document, etc, Global Manager Group becomes a leading name among the ISO consultants of the world. Global Manager Group is one of the preferred Management and ISO certificate consultants, having more than 1800 clients across India. The company has a popular web portal which is selling readymade documents and training presentations for various international systems and management certifications. For more details visit: www.globalmanagergroup.com