1

Introduction to Quality Management System concepts as required by ISO 9001

• Normative, regulatory and legal framework related to Quality.
• Fundamental principles of Quality.
• ISO 9001 certification process.
• Quality Management System (QMS).
• Detailed presentation of the clauses of ISO 9001.

2

Planning and Initiating an ISO 9001 audit

• Fundamental audit concepts and principles.
• Audit approach based on evidence.
• Preparation of an ISO 9001 certification audit.
• QMS documentation audit.
• Conducting an opening meeting.

3

Conducting an ISO 9001 audit

• Communication during the audit.
• Audit procedures (1/2): observation, document review, interview, sampling techniques.
• Audit procedures (2/2): technical verification, corroboration and evaluation.
• Audit test plans.
• Formulation of audit findings and documenting nonconformities.

4

Concluding and ensuring the follow-up of an ISO 9001 audit

• Audit documentation.
• Conducting a closing meeting and conclusion of an ISO 9001 audit.
• Evaluation of corrective action plans.
• ISO 9001 surveillance audit and Internal audit management program.

5

ANSI Accredited Certification Exam

• DOMAIN 1: FUNDAMENTAL PRINCIPLES AND CONCEPTS IN QUALITY MANAGEMENT.
• DOMAIN 2: QUALITY MANAGEMENT SYSTEM (QMS).
• DOMAIN 3: FUNDAMENTAL AUDIT CONCEPTS AND PRINCIPLES.
• DOMAIN 4: PREPARATION OF AN ISO 9001 AUDIT.
• DOMAIN 5: CONDUCT OF AN ISO 9001 AUDIT.
• DOMAIN 6: CONCLUSION AND FOLLOW-UP OF AN ISO 9001 AUDIT.
• DOMAIN 7: MANAGEMENT OF AN ISO 9001 AUDIT PROGRAM.