Lead Auditor of Quality Management Systems ISO 9001

Course Details

Scheduled Events: On request
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

• Analysis the ISO/IEC 17021-1:2015 and ISO 19011:2018 standards to evaluate their interactions and impacts on audit management
• To provide the theoretical and operational knowledge to assess the correct implementation and effectiveness of a Quality Management System in accordance with ISO 9001:2015 requirements;
• To plan, prepare and effectively conduct 2nd and 3rd party audits, in accordance with ISO 9001:2015, ISO/IEC 17021-1:2015 and ISO 19011:2018.

Who will benefit?

Auditors and future auditors of QMS, Quality Managers, Coordinators and managers responsible for QMS implementation, Consultants and Designers of Quality Management Systems.

Course Agenda

Module 1 (2 days)

ISO/IEC 17021-1:2015, ISO/IEC 17021-3:2017  and UNI EN ISO 19011:2018  and annex SL _High Level Structure (HLS)

• Different types of Audit: Internal vs External
• The principles of accreditation standards and the relationship between the standards;
• The certification service: critical aspects of the process that impact the activities of Auditors / Lead Auditors
• The on-site audit process: from the assignment to the audit report
• Competency aspects of Auditors for Management Systems: ISO/IEC 17021-3:2017 scope and structure
• Risk Management System and Management System Standards framework – High Level Structure
• Documented information in the new Management Systems approach.
• Conducting Audit activities on HLS-based Management Systems
• Final exam for Module 1 (Common for other schemes)

 Module 2 (3 days)

The application of ISO/IEC 17021-1:2015 and ISO 19011:2018 for the assessment of Quality Management Systems (ISO 9001:2015):

• The ISO 9001:2015 Standard: elements for conformity assessment
  • ISO 9000:2015 Standard and Quality Management System Principles
  • PDCA, Process Approach and Risk-Based Thinking
  • Scope of application and applicability of the Standard’s requirements.
  • ISO 9001:2015 Standard requirements in Audit processes
  • The role of documented information in Quality Management Systems

• Audit Management:
  • Audit Programme – Stage 1 e Stage2
  • Activity Planning (with exercises)
  • On-site Activity Management – (exercises)
    • Opening Meeting
    • Evidence collection - communication during on-site activities;
    • Evidence evaluation
    • Formalisation of findings
    • Closing Meeting
  • Documentation drafting – Audit Report (with exercises)
  • Follow-up activities – Audit Follow-Up (with exercises).
• Competency aspects of Auditors for QMS: analysis of ISO/IEC 17021-3:2017
• Final Exam (to be held on the last day, comprising both written and oral tests lasting approximately 4 hours)

The detailed programme will be presented on the first day of the course and covers all the training requirements needed for the Auditor/Lead Auditor ISO 9001:2015 qualification.

Learning Assessments

• Certificate of competence, in case of successful completion of final exam
• Certificate of attendance, in case of non successful completion of final exam or no exam.

Duration

40 hours.

Scheduled Events

• Events will be planned on request (and published on this page).

Price

 1500€ (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language