Location

Productivity and Quality Institute - Alexandria

Objectives

• Upon the successful completion of this course, each participant will be able to• Apply the latest techniques in laboratory quality management and its standard operational procedures, accreditation, documentation and auditing (laboratory auditing) based on ISO 19011:2017 requirements• Recognize the requirements of an ISO 17025:2017 accreditation and review the accreditation process• Design and develop laboratory documents (SOP) & quality manuals and recognize the information they should contain, employ an effective writing style as well as maintain documents and quality manuals up to date• Carryout an internal quality audit program for ISO 17025:2017 in accordance with ISO 19011:2018 requirements as well as initiate the sequence of activities involved in scheduling, planning, conducting, reporting on and closing out internal quality audits• Employ effective techniques of auditing and develop auditing procedures, scheduling and recording systems needed to sustain an auditing progra

Outcomes

• Understand the purpose of quality management system• Know what to document and how to document it• Be able to implement ISO 17025 in an effective and efficient manner• Understand the purpose and intent of the ISO 17025 standard• Learn how to correctly interpret the ISO 17025 requirements- including gray areas• Understand the ISO/IEC 17025:2017 requirements.• Learn how to coordinate a quality management system audit against ISO/IEC 17025:2017.• Be able to collect audit evidence and document observations, including techniques for effective questioning and listening.• Learn how to report the findings and conclusions

Course Contents

• ISO 17025:2017 requirements:• Accreditation• ISO/IEC 17025:2017; What the Standard Requires:• General requirements (2 sub)• Structural requirements (7 sub)• Resources requirements (6 sub)• Process Requirements (11 sub)• Management requirements (2 Options) – (9 sub).• Auditing requirements based on ISO 19011 principles:• Audit principles and types of audits.• Principles of auditing• Managing an audit programme• Competence and evaluation of auditors• Planning the audit;• Preparing for the on-site audit;• Conducting a document review;• Conducting the on-site audit;• Conducting interviews• Audit Finding.• Reporting on the audit;• Conducting audit follow-up.• Auditing workshops.• Role Plays on Audit activities.