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.

ISO 15189 NABL accreditation consultants in India UAE Dubai Abu Dhabi Saudi Arabia Qatar Oman Kuwait USA Canada Africa Europe Middle East.

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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 :-

Improved national and global reputation and image of the laboratory.
Continually improving data quality and laboratory effectiveness.
Having a basis for most other quality systems related to laboratories, such as Good Laboratory Practices.
Mutual Recognition Agreement (MRA) amongst various countries test report is acceptable without repetition of analysis.
Customer satisfaction is achieved through introduction of Quality Management System which is a part of ISO 15189.
All test equipment will be calibrated and traceable to National Standards so that accuracy of results will be ascertained & maintained.
Laboratory will be participating in Inter laboratory Comparison program so that quality level of the lab with respect to other accredited lab can be determined.
Quality control checks will be carried out periodically by which system is always maintained.
National and international recognition (eg CTs)
Assurance to clients of good laboratory practice
Meets purchaser or regulatory specifications
Decision makers can rely on test results
Improves staff motivation and esteem
Ensure better support in the event of legal challenge
Saves money by getting it right the first time

Requirements of ISO 15189 :-

Management Requirements (Clause 4) – 15 Management Requirements

4.1: Organisation and Management
4.2: Quality Management System
4.3: Document Control
4.4: Review of Contracts
4.5: Examination by Referral Laboratories
4.6: External Services and Supplies
4.7: Advisory Services
4.8: Resolution of Complaints

4.9: Identification and Control of Nonconformities
4.10: Corrective Action
4.11: Preventive Action
4.12: Continual Improvement
4.13: Quality and Technical Records
4.14: Internal Audits
4.15: Management Review

Technical Requirements (Clause 5) – 8 Management Requirements

1. Personnel
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 info@lakshy.com to get ISO 15189 accreditation for your laboratory and achieve sustainable competitive advantage in the market.