Applicable Standard to Laboratory Management

Request a ISO 15189 Guideline document

   ISO 15189       iso 15189 certification quotation-request, ISO 9001 14001 27001 22000 13485 ohsas 18001 nabh nabl certification, training, implementation, certificate manual. ISO certification in Ahmedabad, Baroda,  Rajkot, Surat, Vaapi, Ankleshwar, Mumbai Bombay, Pune, Bangalore, Maharashtra, Gujarat, India USA, Canada, Europe, U.K., Europe, Asia & Africa, China Guideline

ISO 15189:2003 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
ISO 15189 implementation improves / leads to

  • POLICIES & OBJECTIVES set by 'top management'
  • Conformance to Legal and Regulatory Requirements
  • Recognition by regulators around the world of ISO 15189 as a good basis for addressing medical device design and manufacturing regulatory requirements
  • Controlled consistency of manufactured products
  • Managed productivity and efficiency, controlling costs
  • Competitive advantage and increased marketing and sales opportunities.
  • Improved customer perception of the organization's image, culture and performance.
  • improved internal and external Communications
  • greater understanding of the organization's processes
  • clear responsibilities and authorities agreed for all staff
  • improved use of time and resources
  • reduced wastage
  • greater consistency and traceability of products and services
  • Customer Confidence, Satisfaction and TRUST
  • Level of Assurance in Organisational QUALITY
  • Organisational PROFITABILITY
  • Ability to Differentiate Organisation for Competitive Advantage
  • Organisational Credibility & Reputation

Training
We offer a customized training programme on ISO 15189 for

Next Applicable Standard:  ISO 15189
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Other Applicable Standards
ISO 9001, ISO 29001, API.

ISO certification quotation-request, ISO 9001 14001 27001 22000 13485 ohsas 18001 nabh nabl certification, certification, training, implementation, certificate manual. ISO certification in Ahmedabad, Baroda,  Rajkot, Surat, Vaapi, Ankleshwar, Mumbai Bombay, Pune, Bangalore, Maharashtra, Gujarat, India USA, Canada, Europe, U.K., Europe, Asia & Africa, China.

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