ISO 15189 NABL consultants for ISO 15189 NABL Certification, ISO 15189 NABL implementation and ISO 15189 NABL training. ISO 15189 NABL consultants in Mumbai India for ISO 15189 NABL Accreditation.
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What is ISO 15189 ?ISO 15189 Medical laboratories — Particular requirements for quality and competence specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardisations's Technical Committee 212 (ISO/TC 212). ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to users of the laboratory service, the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency and the lab's role in the education and training of health care staff.
While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
Benefits of ISO 15189 accreditation :-
Requirements of ISO 15189 :-Management Requirements (Clause 4) – 15 Management Requirements
Technical Requirements (Clause 5) – 8 Management Requirements
2. Accommodation and environmental conditions
|3. Lab equipment|
4. Pre-examination procedures
5. Examination procedures
6. Assuring quality of examination procedures
|7. Post-examination procedures
8. Reporting of results
What we offer for ISO 15189 accreditation?With a team of highly competent consultant and technical experts, you are sure to kick start your ISO 15189 accreditation journey with us in full confidence.
We provide you the following services for your ISO 15189 accreditation project :-
- Awareness training
- Gap analysis of your existing system
- Process mapping and process definition
- Documentation including manuals, procedures, work instructions, test instructions, check lists, formats etc.
- Assistance in proficiency testing, inter laboratory comparison and measurement of uncertainty
- Assistance in documentation implementation
- Internal auditor training and conduct of internal audit
- Pre assessment audit and pre certification audit.
- Assistance during the entire phase of accreditation audit
- Post certification assistance in system maintenance.
Contact us today at firstname.lastname@example.org to get ISO 15189 accreditation for your laboratory and achieve sustainable competitive advantage in the market.