Lead Auditor of the Quality Management System according to the requirements of the PN-EN ISO 9001:2015 standard

Goals

The objectives of the training Lead Auditor of the Quality Management System according to the requirements of the PN-EN ISO 9001:2015 standard :

Providing participants with the knowledge and skills necessary to conduct audits of quality management systems according to the requirements of PN-EN ISO 9001:2015 in compliance with PN-EN ISO 19011:2018.

Upcoming dates for the "Lead Auditor of Quality Management Systems according to the requirements of PN-EN ISO 9001:2015" training:
• 06-10.07.2026

Program

DAY 1

• 9:00 AM - 9:45 AM:
- Introduction to the training.
- Participants' introduction.
- Information about the course, principles of continuous assessment, and (if necessary) questions from participants.

• 9:45 AM - 10:30 AM: Overview of the requirements of the ISO 9001:2015 standard:
- The essence of quality and the quality management system,
- Annex SL and related standards,
- Terms and definitions,
- The PDCA model and its application in the ISO 9001 standard.

• 10:45 AM - 12:15 PM:
- Continuous assessment exercise - review of solutions and discussion. - Overview of ISO 9001:2015 requirements:

- Context and leadership,
- Stakeholders,
- QMS scope and process approach (policy/objectives/processes),
- QMS feedback/review.

• 12:30 - 14:00: Overview of ISO 9001:2015 requirements:
- QMS planning,
- Support/resources,
- Operational activities.

• 14:30 - 15:15: Overview of ISO 9001:2015 requirements:
- Communication within the quality management system,
- Documented information from the system and process levels.

• 15:15 - 16:00: Overview of ISO 9001:2015 requirements:
- Improvement and continual improvement of the QMS. - Continuous assessment exercise - risk-based PDCA.

DAY 2

• 9:00 AM - 9:45 AM:
- Recapitulation of the topics covered during Day 1 of the course. Discussion.
- ISO 19011:2018:
- Principles of auditing according to the standard,
- Types and levels of audits,
- Auditor competencies.
- ISO 17021 requirements - certification/accreditation issues.

• 10:00 AM - 11:30 AM: Assessment process:
- Audit scope,
- Initial visit,
- Audit phases,
- Audit team management,
- Audit preparation.

• 11:45 AM - 1:15 PM:
- Continuous assessment exercise - Document review.
- Conclusions, summary, and discussion.

• 1:30 PM - 2:15 PM: Planning an on-site audit
- Criteria,
- Objectives,
- Roles and interdependencies,
- Audit plan.

• 2:30 PM - 4:00 PM:
- Risks and opportunities in auditing.
- On-site audit - components of the opening meeting.
- Working in groups - preparation for the opening meeting.
- Homework - discussion of the assignment.

DAY 3

• 9:00 AM - 9:45 AM:
- Recapitulation of the topics covered during Day 2 of the course. - Discussion, including the individual work assigned as homework the previous day.
- Introduction to auditing activities

• 10:00 - 11:30:
- Continuous assessment exercise - opening meeting.
- Summary, conclusions, discussion.
- Audit supervision

• 11:45 - 14:00: Conducting an audit study using a list of questions:
- Higher and lower-order audit questions
- Auditor's action plan
- Continuous assessment exercise: developing a list of higher-order audit questions related to the analyzed case study

• 14:30 - 16:00:
- List of audit questions: Presentation of exercise results + discussion of possible evidence to be obtained.
- Continuous assessment exercise – Building an auditor's action plan in relation to the analyzed case study.
- Homework (to be completed individually) – discussion of the task.

DAY 4

• 9:00 AM - 9:45 AM:
- Recapitulation of the thematic issues covered during Day 3 of the course.
- Discussion of the previous day's homework assignment.

• 9:45 AM - 11:15 AM:
- Objectives and tasks of the audit:
- Verification of quality management system components
- Collection and verification of evidence
- Audit methods and techniques
- Audit procedure techniques
- Sample selection and questioning
- Following the lead – the so-called audit trail
- Audit and auditor etiquette
- Continuous assessment exercise – Diagnosing the degree of compliance based on objective evidence.
- Discussion

• 11:30 - 15:00:
- Diagnosing the degree of compliance based on objective evidence
- Continuous assessment exercise – on-site audit activities
- Active listening
- Gathering audit evidence
- Collaborating within the audit team
- Collaborating with the auditee on audit results (the teams perform audit activities in relation to the case study analyzed throughout the course).

• 15:15 - 16:00:
- Identifying nonconformities.
- Continuous assessment exercise – preparing and presenting records on nonconformities and improvement potential.

DAY 5
• 9:00 AM - 10:30 AM:
- Evaluation of audit results.
- Reporting of results:
- Audit team meeting.
- Audit closing meeting.
- Audit report.

• 10:45 AM - 11:30 AM: Continuous assessment exercise – reporting of audit results.
• 11:45 AM - 1:15 PM:
- Nonconformities vs. recommendations.
- Post-audit activities and assessment of their effectiveness.
- Continuous assessment exercise – assessment of the effectiveness of post-audit activities (CA).

• 1:45 PM - 2:00 PM: Discussion and summary of results from the continuous assessment system - Introduction to the final exam.

• 2:00 PM - 4:00 PM: Exam.

INFORMATION FOR PARTICIPANTS: This training is conducted according to the IRCA (International Register of Lead Auditors) curriculum. Prerequisites for those wishing to participate include knowledge of the requirements of the ISO 9001 standard (including the terminology and concept of requirements), as well as knowledge of the basic elements of a quality management system and an understanding of the inter-process relationships based on leadership, quality policy and objectives, planning, implementation, maintenance, and continuous improvement of the management system. In addition, each participant should have their own copy of the ISO 9001:2015 standard for the extensive exercise blocks during the course.

The price includes: trainer time, electronic training materials, and a paper certificate.