Quality Management Systems

Quality: Principles and Requirements

• Purpose of the QMS and the 7 Fundamental Principles
• The “ISO 9000 family” – Purpose and Relationships
• Requirements of ISO 9001
• Context, interested parties, risks, and opportunities

Auditor/Lead Auditor of Quality Management Systems ISO 9001: 2015 – CQI & IRCA certificate

• Quality Management Systems: purpose of the standards, audits, and third-party certification.
• Audits on Quality Management Systems to establish the level of compliance with the standard:
  • Planning
  • Management
  • Reporting
  • Management of follow-up actions

Transition course for Auditor to ISO 9001:2015 – CQI & IRCA certificate

• The SL Annex
• The ISO 9001:2015 requirements
• Audit risk and management

Internal Auditor of Quality Management Systems

• The ISO 19011:2018
• Objectives, criteria, and phases of the Internal Audit
• Effectiveness and efficiency in the management of Internal Audits

Course for Auditor on Medical Device Management Systems – ISO 13485:2016

• Principles and requirements of the standard
• Audit approach and critical issues

Development of quality management systems and systems integration

• Mapping processes
• Identifying roles and responsibilities
• Drafting of corporate policy and objectives
• Identifying the context, stakeholders, risks, and opportunities
• Carrying out the Implementation
• Executing the Internal Audit
• Developing Integrated Management Systems according to PAS 99

Computerization of Management Systems

• Databases: managing data and benefits
• ACCESS elements: tables, forms, queries, reports, and macros
• Developing a management system on the ACCESS platform