ISO 15189 Accreditation / Certification

ISO 15189 Certification – Medical Laboratories — Particular necessities for quality and capability incorporate the quality management system prerequisites specific to medical laboratories. The standard was created by the International Organization for Standardizations’ Technical Committee 212 (ISO/TC 212). ISO/TC 212 relegated ISO 15189 to a working group to set up the standard based on general necessities for the skill of testing and calibration laboratories. This functioning and gathering included an arrangement of the laboratory service of the research facility administration, The assortment of patient samples, the translation of test outcomes, satisfactory turnaround times, how testing is to be given in a health-related crisis, and the lab’s job in the training of medical health care staff.

While the standard relates to ISO/IEC 17025 and ISO 9001, it is a unique standard as a whole and a document that considers the particular necessities of the medical environment and the significance of the medical laboratory to patient consideration.

Just like ISO/IEC 17025, ISO 15189 Accreditation incorporates five extra models for medical laboratories

• Giving guidance on the kind of test and testing that might be required.
• Cooperating with clinical staff with the lab liable for the nature of administration to clinicians referring patient samples for testing.
• Giving sentiments on results of testing relative to diagnosis and patient care.
• Gathering tests samples or giving data on assortment methods, test holders, and test volumes.
• Ethical practice.

1.  The Medical Lab acts as a legal and responsible entity. The Lab is Legally responsible for the Test reports, it issues
2. Improved national and global reputation
3. Continually improving data quality
4. Mutual Recognition Agreement (MRA) amongst various countries test report
5. Customer assurance on test results and reports and hence satisfaction
6. All test equipment are calibrated and be traceable to National Standards
7. Quality control checks will be carried out periodically
8. Meets regulatory specifications
9. Tests are validated and results compared with other accreditated Labs- to give assurance on the results and correctness.
10. Measurement of Uncertainty values and Error-values are explicitly calculated, defined within the results and reports.
11. Improves staff motivation

The requirement of ISO 15189 is divided into management and technical requirements.

Management Requirements are:

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

• Personnel
• Environmental and Accommodation requirements
• Lab equipment
• Pre-Examination procedures
• Examination and testing procedures
• Quality Assurance of Examination
• Post Examination procedure
• Reporting of results

Now obtaining ISO 15189 is a cup of tea with these easy steps.

1. Get Knowledge about ISO 15189.
2. Perform a Gap Analysis to study your drawbacks.
3. Plan your project to overcome your drawbacks.
4. Train your employees and personnel about the standard.
5. Documentation.

• • QMS Manual
  • QMS Processes and Procedures
  • Methods
  • Forms & records
  • Guidance during Test Methods Validation and Inter-Lab Comparison data and calculated z-score for each test parameter
  • Guidance during calculation of Measured Uncertainty values for each test parameter

6. Guidance on conducting risk/opportunity assessment.

7. Internal Audit Trainings & performing and guidance during Internal Audit.

8. External Audit by Certifying Body.

9. Obtaining Certification of Accreditation.

• Ascent World Is an Internationally accepted Consultancy, providing standard Certifications.
• We at Ascent have more than 10+ years of extensive experience, qualified staff to help up with the standard application in your organization. 
• We at Ascent provide the training and complete knowledge about the ISO 15189 standard and its implementation and importance. We are Ascent are Competent and Qualified on the following:
  1. 1. Knowledge about Documentation requirements
     2. Knowledge about Regulatory requirements
     3. Knowledge about test Methods documentation
     4. Knowledge about Test Methods Validation
        • Calculation of Z-Score
     5. Knowledge about Measurement of Uncertainty calculations
        1. Specific Trainings / Guidance given for both Type A and Type B calculations

• We at Ascent help you with the change in the industry strategy, regulations, and standard requirements that may impact your management system approach.
• We at Ascent provide accurate and complete detail of the costing with no hidden charges.
• We at Ascent are available 24X7 to provide help to our clients, customers.

Enjoy the benefits of ISO 15189 Certification today, by getting the quote for your company.