Description

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

Master Risk-Based Thinking to Enhance Laboratory Competence, Impartiality, and Consistency

 

In today's dynamic laboratory environment, proactive risk management is essential for ensuring the accuracy, reliability, and validity of test and calibration results. The ISO/IEC 17025:2017 standard introduced risk-based thinking as a core principle, replacing the previous preventive action approach. This focused training is your definitive guide to understanding and implementing the risk management requirements of the standard. By concentrating on practical tools, methodologies, and real-life laboratory scenarios, you will gain the knowledge to identify, assess, mitigate, and monitor risks across all laboratory processes — enhancing your management system, satisfying accreditation body expectations, and improving overall laboratory performance.

 

Actionable takeaways for your Job Role

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

  • Interpret the Risk Management Requirements of ISO/IEC 17025:2017, understanding the shift from preventive action to risk-based thinking.

  • Understand the Role of Risk in the laboratory management system, including its impact on impartiality, confidentiality, and validity of results.

  • 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.

  • Identify and Assess Risks related to personnel competence, equipment, methods, environment, sampling, and data handling.

  • Develop and Implement Risk Mitigation Plans with practical, proportionate, and effective controls.

  • Integrate Risk Management with other laboratory processes including internal audits, management reviews, corrective actions, and document control.

  • Document Risk Management Activities in a structured and auditable manner, including risk registers and risk treatment plans.

  • Link Risk Management to Continuous Improvement by identifying opportunities arising from risk assessment.

  • Prepare for Accreditation Assessments with clear evidence of risk-based thinking throughout your laboratory QMS.

 

Quality & Excellence Performance Metrics

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

  • Identify risks affecting laboratory operations, impartiality, and validity of results.
  • Assess risks using appropriate methodologies (likelihood, impact, detection).
  • Develop and implement proportionate risk controls and mitigation measures.
  • Identify and evaluate risks to impartiality and independence.
  • Integrate risk management with internal audits, management reviews, and corrective actions.
  • Identify opportunities for improvement arising from risk assessment.
  • Document risk management activities in a structured, auditable format.
  • Evaluate competence of personnel in risk identification and management.
  • Develop and maintain risk management documentation for accreditation assessments.
  • Use risk insights to drive process improvements and reduce nonconformities.

 

Course Curriculum

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

  • Module 1: Introduction to Risk-Based Thinking: The Shift from Preventive Action to Risk Management in ISO/IEC 17025:2017

  • Module 2: Understanding the Risk Management Requirements: Clause-wise Analysis of Risk-Related Requirements

  • Module 3: Risk Assessment Methodologies for Laboratories: FMEA, HAZOP, Risk Matrices, and Other Practical Tools

  • Module 4: Identifying and Assessing Laboratory Risks: Personnel Competence, Equipment, Methods, Environment, Sampling, and Data Handling

  • Module 5: Managing Impartiality Risks: Identification, Assessment, and Mitigation of Threats to Impartiality

  • Module 6: Risk Mitigation and Control: Developing proportionate and effective risk treatment plans

  • Module 7: Integrating Risk Management with QMS Processes: Internal Audits, Management Reviews, Corrective Actions, and Document Control

  • Module 8: Documentation and Evidence: Risk Registers, Risk Treatment Plans, and Auditable Records

  • Module 9: Practical Workshop: Conducting a Risk Assessment for a Real-Life Laboratory Scenario

 

Job Roles That Will Benefit

This training is essential for professionals involved in laboratory management, quality assurance, and operations, including:

  • Laboratory Managers, Quality Managers, and Technical Managers

  • Internal Auditors and Quality Assurance Personnel in testing and calibration laboratories

  • Technical Staff seeking to understand and apply risk-based thinking

  • Accreditation Consultants and Professionals supporting laboratories

  • Regulatory and Compliance Personnel working with laboratory activities

  • Management Representatives and QMS Coordinators

 

Prerequisites

While there are no formal prerequisites, it is highly recommended that participants have a working knowledge of ISO/IEC 17025:2017 or prior experience with laboratory operations and quality management systems to maximize their learning from this training.

 

Course Features & Included Materials

  • Focused Content: Dedicated training specifically on risk management requirements and implementation—no repetition of unrelated clauses.

  • Interactive Sessions: Engage in practical exercises and workshops applying risk management to real-life laboratory scenarios.

  • Case Studies: Analyze risk management examples from testing and calibration laboratories.

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

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

  • 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 Embed Risk-Based Thinking in Your Laboratory!

Don't let risk management be a compliance burden—turn it into a strategic advantage. Gain the knowledge and practical tools to identify, assess, and mitigate risks effectively in your laboratory. Demonstrate your commitment to competent, impartial, and reliable laboratory services under the revised standard. Satisfy accreditation body expectations and drive continual improvement through proactive risk-based thinking.

 

For more information, please contact:

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