Introduction:

This course is a look at the ISO/IEC 17025:2005 requirements and ISO 19011:2011 guidelines to provide a detailed approach to the assessment of a laboratory’s competence through the use of applied internal audits. The course is applicable to all testing and calibration laboratories and it provides an understandable explanation of the international laboratory standard and how it should be applied and implemented. In this course, you will receive a detailed review of the A2LA accreditation process and you will also gain critical insight into the interpretation of the requirements of the ISO/IEC 17025 Standard. The course enables participants to be familiar with the basic concepts of implementation and management of a Laboratory Management System (LMS) as specified in ISO/IEC 17025. They will learn the different components of a LMS, including the quality manual, policy, required procedures, management review, internal audit and all the factors that can influence test and/or calibration results performed by a laboratory. This course enables participants to learn about the best practices for implementing and managing a laboratory management system (LMS) as specified in ISO/IEC 17025, as well as best practices for implementing quality controls. They will learn the different component of this standard, including the quality manual, policy, required procedures, management review, internal audit and all the factors that can influence test and/or calibration results performed by a laboratory. The course will enable the candidates to:

• Understand the fundamentals of laboratory management
• Know the key components of a laboratory management system in accordance with ISO/IEC 17025
• Introduce the concepts, approaches, methods and techniques allowing to effectively manage a LMS
• Understand the relationship between a laboratory management system, including quality management, controls and compliance with the requirements of different stakeholders of the organization
• Understand the management and technical requirements of ISO/IEC 17025
• Understand the implementation of a laboratory managements system in accordance with ISO/IEC 17025
• Understand the requirements of ISO/IEC 17025
• Know the concepts, approaches, methods and techniques allowing to effectively manage a laboratory management system
• Acquire the necessary knowledge to contribute in implementing a laboratory management system (LMS) as specified in ISO/IEC 17025

Course Objectives:

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

• Explain accreditation concepts and benefits
• Design an appropriate quality manual and supporting system documents
• Develop and implement required technical documents
• Discuss the difference between management reviews and internal audits
• Design and implement a detailed internal auditing program
• Select, train and qualify internal auditors
• Employ effective techniques for auditing
• Apply skills acquired to manage an audit team
• Develop an audit report based on findings and objective evidence collected
• Demonstrate how to handle difficult situations during audits

Who Should Attend?

Managers, Team Leaders, Line Managers, Superintendents, OE Champions, Quality and Project Managers, Supervisors, Executives, Internal and External Auditors, Members of IT Team, Health & Safety Managers, Risk Managers, Business Process Owners, Business Finance Managers, Business Risk Managers, Regulatory Compliance Managers, Project Managers, Continuity, Risk, Quality, IT and Environmental Managers, Anyone involved in the system development, implementation and maintenance, Regulatory Affairs Managers, Consultants, Anyone who is involved in ISO standards

Course Outline:

• Introduction to ISO/IEC 17025
• ISO/IEC 17025:2005 and background on its development
• Introduction to management systems and the process approach
• Fundamental principles of laboratory management system
• Implementation phases of ISO/IEC 17025 framework
• Continual improvement of a management system
• Conducting an ISO/IEC 17025 accreditation audit
• General requirements: presentations of the clauses 4 and 5 of ISO/IEC 17025
• Conformity assessment concepts
• Peer evaluation of accreditation bodies
• Accreditation benefits and process
• Management system concepts
• Ethical constraints
• Organizational structures
• Management system structures
• Document development and control
• Customer contract development
• Quality-critical services and supplies
• Customer feedback, complaints and nonconforming work
• Corrective actions and preventive actions
• Internal audits and management reviews
• Analyst competency
• Method validation
• Measurement uncertainty
• Equipment calibration and maintenance
• Measurement traceability
• Sample handling
• Quality control
• Results reporting
• Auditing principles and practices
• Review of ISO/IEC 17025 requirements and ISO 19011 guidelines for internal audits
• Benefits of assessments and internal audits
• Selecting, training and qualifying internal auditors and setting up an ongoing training program
• Communication skills and human relation aspects of an assessment
• Planning assessments and internal audits
• Conducting document reviews (gap analyses)
• Effective questioning and auditing techniques
• Conducting hands-on audits
• Gathering information and evidence
• Writing assessment findings and deficiencies
• Presenting report findings to the group
• A2LA assessor policies and procedures
• Implementing requirements from ISO/IEC 17025 and Certification Exam
• Documentation of a LMS
• Monitoring and reviewing process

COURSE LOCATIONS