⚠️  UPDATE NOTICE ON NEW UPDATE OF THIS GUIDANCE STANDARD:

Important: This course was developed under the previous international guidance standard ISO 9001:2015. On 16 September 2026, ISO published ISO 9001:2026, which replaces it.

What changed: 

• Quality culture and ethical behaviour are now explicit. Top management must promote them, and staff awareness requirements now include them.
• Risks and opportunities are separated more clearly. Clause 6.1 is restructured into sub-clauses.
• Climate change is now part of the organisation's context. You must decide whether it is a relevant issue for your QMS.
• The quality policy must reflect the organisation's context and support its strategic direction.
• Wording and structure have been clarified to align more closely with other ISO management system standards.

What this means for you right now:  ISO 9001 is a certifiable requirements standard, so there is a formal transition period. Certificates issued against ISO 9001:2015 stay valid during that period, which is expected to last three years from publication (until around September 2029, pending International Accreditation Forum confirmation). The core principles and most requirements taught in this course still apply. The changes are targeted updates, not a full redesign.

Please note: This course will be updated to align with ISO 9001:2026 soon. We'll share more information soon.

Introduction to this course: 

This course guides you through the essentials of managing external providers to ensure an effective Quality Management System. Learn how to evaluate, select, and monitor suppliers to comply with industry standards and regulations, enhancing product quality and patient safety. If you’re seeking to enhance compliance, quality, and oversight of external providers, then this course is for you. 

Who should attend: 

This course is designed for quality professionals, supply chain managers, and regulatory compliance officers in the life sciences industry looking to enhance their supplier management skills and ensure compliance with ISO 9001:2015 standards.

Learning Outcomes: 

By the end of this lesson, you will be able to:

• Identify ISO 9001:2015 requirements for supplier management.

• Explain the significance of supplier qualification in maintaining quality.

• Implement criteria for evaluating and monitoring external providers.

What will I gain: 

Participants will gain skills to manage suppliers effectively, ensuring compliance with ISO 9001:2015 and enhancing product quality and safety.

Prerequisites: 

No specific prerequisites are needed, but a basic understanding of quality management principles and supply chain processes is beneficial.

Additional information: 

Course duration:01:14:50

Course code/version (effective date): L-81/v1.0 (06/02/2024)