Description

ISO/IEC 17025:2017 - Risk Management Requirements & Implementation in Laboratories

Master Proactive Risk Management to Enhance Laboratory Competence and Result Reliability

 

In an era where accuracy and reliability are non-negotiable, a proactive approach to risk management is critical for any laboratory's success. The ISO/IEC 17025:2017 standard explicitly requires laboratories to address risks and opportunities to ensure consistent operation and improved performance. This focused course provides you with the essential knowledge and practical tools to effectively implement a risk-based thinking framework within your laboratory's Quality Management System. By focusing on real-world scenarios and proven techniques, including principles and risk assessment techniques, you will learn to identify, assess, and mitigate risks, thereby enhancing the quality, reliability, and confidence in your laboratory's results.

 

Actionable takeaways for your Job Role

By the end of this course, you will be able to confidently:

  • Interpret ISO/IEC 17025:2017 Requirements related to risk and opportunity management within a laboratory context, including Clause 8.5 requirements for planning actions to address risks and opportunities.

  • Understand the Principles of Risk Management as outlined in ISO 31000:2018 and their application in laboratory operations, including the risk management framework and process.

  • Apply Risk Assessment Techniques such as Failure Mode and Effects Analysis (FMEA) as per IEC 31010:2019 to identify and evaluate potential failures in laboratory processes.

  • Develop and Implement Effective Risk Mitigation Plans including preventive actions, corrective actions, and contingency plans.

  • Integrate Risk Management into Key Laboratory Processes like equipment maintenance, personnel training, method validation, and procedural controls.

  • Apply Knowledge Practically through interactive workshops and case studies tailored to laboratory environments.

 

Quality & Excellence Performance Metrics

Post-training, you will drive these quality parameters to ensure operational excellence, in your job-role:

  • Successfully identify and document risks associated with laboratory activities, including those from operations and relationships with personnel.

  • Plan actions to address risks and opportunities that are proportional to the potential impact on the validity of laboratory results.

  • Integrate risk-based thinking into the management system and evaluate the effectiveness of actions taken.

  • Implement robust procedures that proactively reduce non-conformities through risk identification and mitigation.

  • Ensure that the laboratory's management system achieves its intended results and prevents negative effects.

 

Course Curriculum

The course is structured into digestible modules, designed for optimal learning flow:

  • Module 1: Overview of ISO/IEC 17025:2017 and Introduction to Risk-Based Thinking.

  • Module 2: Principles, Framework, and Process of Risk Management - Understanding ISO 31000:2018 and its application in laboratory operations .

  • Module 3: Risk Assessment Techniques for Laboratories: Practical application of tools like FMEA as per IEC 31010:2019.

  • Module 4: Mitigating and Controlling Risks in Laboratory Operations: Preventive measures, corrective actions, and contingency plans.

  • Module 5: Practical Workshops, Case Studies, and Interactive Q&A Sessions: Real-life scenarios including equipment maintenance, personnel training, and procedural controls.

 

Job Roles That Will Benefit

This course is essential for professionals responsible for maintaining and improving the quality and reliability of laboratory operations, including:

  • Quality Managers and Technical Managers in Laboratories

  • Laboratory Technicians and Calibration Specialists

  • Internal Auditors and Assessors

  • Quality Professionals and Consultants

  • Regulatory Body Personnel

 

Prerequisites

While there are no formal prerequisites for attending this training, it is highly recommended that participants have a basic understanding of laboratory operations or quality management concepts to maximize their learning.

 

Course Features & Included Materials

  • Focused Content: Concentrate on the specific requirements of ISO/IEC 17025:2017 related to risk management and opportunities .

  • Interactive Sessions: Engage in hands-on workshops and scenario-based exercises to reinforce understanding .

  • Expert-Led Sessions: Participate in dedicated Q&A sessions with experienced quality and accreditation professionals .

  • Comprehensive Learning Materials: Digital Learning Materials covering key concepts, frameworks, and risk assessment templates.

  • Knowledge Evaluation: Gauge your understanding with Pre and Post-training Evauation.

  • Certificate of Training: Earn a verifiable, with a unique ID and QR code, soft-copy certificate issued via the QCI training portal. Validate your achievement anytime at https://pathshala.qcin.org/.

 

Enroll Today and Fortify Your Laboratory Against Risk!

Invest in your skills to build a more resilient, reliable, and robust laboratory operation through effective risk management.

 

For more information, please contact:

Rohit Varshney at rohit.varshney@qcin.org or call +91 97735 00376