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ISO 15189 Certification

ISO 15189 Certification

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ISO 15189 Certification

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  1. QualitySystemsEnhancement ISO 15189 | Medical Laboratories Requirements for Quality and Competence Those having medical laboratory applications should take into consideration implementation of special Disaster Recovery processes in the event of any possible emergency situation such as the recent Covid 19 virus. It is essential to follow cGMP requirements without any violation. To be ahead of standard requirements, the Disaster Recovery Plan should include social distancing, increased sanitation, and use of Personal Protective Equipment (PPE). This Disaster Recovery Plan must cover the initial handling of incoming raw materials and all processes up to and including dispatch. ISO 15189 certification https://enhancequality.com/standards/iso-15189-medical-laboratories-requirements-for-quality-and-competence/

  2. Other standards to consider for integration include ISO 15378:2017 for addressing those with packaging processes; ISO 17025, Quality Management Systems for Laboratories to address emergency situations; and ISO 15189:2017, Medical Laboratories requirements for quality and competence support of ISO 15189 https://enhancequality.com/standards/iso-15189-medical-laboratories-requirements-for-quality-and-competence/

  3. The following Bullets reference information for the 2012 revision and will be updated soon. • ISO Consulting services are required to assist organizations in building a comprehensive quality management system to meet all requirements of ISO 15189 • ISO Consulting services can build a QMS that can prepare organizations with a robust system to produce quality products and services • ISO Consultants assist in meeting “Annex SL, a section of the ISO/IEC Directives part 1 that prescribes how ISO Management System Standard (MSS) standards should be written.” which in turn meets ISO 15189 requirements • A good ISO consulting firm provides training to top management in promoting Risk-Based Thinking, Process Approach, and Continual Improvement • ISO Consultants assist in developing a comprehensive, simplified QMS to meet all requirements of ISO 15189 and 3rd Party Certification Body stage 1 audit requirements. The stage 1 audit from Certification Bodies vary depending on the selected Certification Bodies which verifies the documented system meeting all the requirements of ISO 15189 certification • https://enhancequality.com/standards/iso-15189-medical-laboratories-requirements-for-quality-and-competence/

  4. Quality Management System Consulting is the practice of assisting small, medium and large organizations in developing, training, implementing, and maintaining a documented quality management system for achieving ISO 15189 certification. Quality Management Consultants can prepare your facilities to have a Quality Management System (QMS) and associated documents/records to show as evidence of having implemented the system. Quality Management System Consultants assist facilities to prepare documentation to show as evidence of having a streamlined process that ensure quality product or service every time without fail. https://enhancequality.com/standards/iso-15189-medical-laboratories-requirements-for-quality-and-competence/

  5. Quality Management System Consultants assist to build a robust system which compels task performers to have defined roles, responsibilities and controls to ensure quality. • Quality Management System Consultants assist organizations to identify all manufacturing and nonmanufacturing processes and facilitate in establishing process performance metrics or process performance indicators (Key Process Indicators = KPIs) to effectively monitor and measure organizations intended Goals and Objectives. • Quality management consultants provide clarifications on which standard is to be followed for medical laboratories and avoid confusion between ISO 13485 and ISO 15189 • Audits are unbiased, structured and documented evaluation of any given international standards such as ISO 15189, ISO 10993-1, ISO 14001, ISO 15189, ISO 45001, ISO 50001, ISO 55001, ISO 22000, ISO 27001, IATF 16949, AS 9100, AS 9110, AS 9120, BRC, FSSC 22000, SQF, TL 9000, and recording the results. • 1st Party Audit: Audits performed by a team within the facility is called 1st Party Audit • 2nd Party Audit: Audits performed by organizations on their suppliers is called 2nd Party Audit • 3rd Party Audit: Audits performed by Certification Bodies is known as a 3rd party audit • 3rd Party audit Certification Bodies (Accredited by International Accreditation Forum =IAF) perform the audits on the organizations to grant ISO 15189 Certifications with demonstrated evidence of conformity to all the requirements of ISO 15189:2012 https://enhancequality.com/standards/iso-15189-medical-laboratories-requirements-for-quality-and-competence/

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