ISO 15189:2012

Lakshy Management Consultant Pvt. Ltd. is one of the largest and leading ISO 15189 consultants in India. We are transnational ISO certification consultants with clients in India, USA, UK, Saudi Arabia, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong Kong, UAE, Qatar, Oman, Russia etc. We provide quick, result oriented and easy to implement consultation and training for ISO 15189 certification.

We have been associated with organizations across the world for their ISO 15189 certification project. Whether you are a small organization or a multinational corporate, our proven consultation solutions will ensure that you implement ISO 15189 standard in the most effective manner with timely project completion.

ISO 15189 quality management system implementation with the consultants and experts of Lakshy Management Consultant Pvt. Ltd. not only assures 100% successful ISO 15189 certification but also improves process performance and business operations.

Consultants of our organization assist your company in your quality management context through ISO 15189 certification to get your company ISO 15189 certified quickly with the ease of implementation and in the most cost effective manner. We make sure that ISO 15189 standard implementation does not just become a documentation activity but also a way of life for the organization that lays a foundation for Total Quality Management and quality conscious organizational culture.

We offer onsite and online consultation solutions for ISO 15189 certification. Our customers have been utilizing our services not only for initial certification consultation but also for post certification consultation to ensure that our consultants regularly add value to the business processes of our customers and their process & quality standardization initiatives.

Our ISO 15189 certificate consultation services include awareness training, quality policy - objectives workshop, gap analysis, documentation design including manuals, procedures, work instructions, formats etc., implementation assistance & training, internal auditor training, lead auditor training, assistance in conducting internal audit, pre-assessment audit and everything required to ensure a 100% successful ISO 15189 certification audit within scheduled project completion time period.

Biggest benefit an organization gets out of ISO 15189 QMS is improvement in business process control through process standardization. No matter what benefits you are looking for from ISO 15189 certification, we will make sure that your organization benefits from ISO 15189 implementation and certification.

ISO 15189 Medical laboratories — Particular requirements for quality and competence include the quality management system requirements particular to medical laboratories. The standard was developed by the International Organization for Standardizations’ 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.

• 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 be 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 labs 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

Management Requirements (Clause 4) – 15 Management Requirements

• 4.1: Organization 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 do 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.