PECB ISO 9001 Lead Implementer Training Course

This instructor-led, live training in South Africa (online or onsite) is aimed at beginner-level quality assurance professionals, regulatory compliance staff, medical device engineers, and any professionals involved in medical device manufacturing who wish to gain a foundational understanding of ISO 13485 to implement and maintain a compliant quality management system and ensure regulatory compliance in their organisations.

By the end of this training, participants will be able to:

• Understand the structure, purpose, and requirements of ISO 13485:2016.
• Learn about the quality management principles specific to medical devices.
• Gain insights into key processes and documentation required for compliance.
• Understand the steps to implement and maintain an ISO 13485 quality management system (QMS).

Organizations face a wide array of disruptions, ranging from natural disasters and information security breaches to other unforeseen incidents. Because these events are often unpredictable, robust preparedness becomes a critical differentiator, defining a business's resilience and future trajectory. Comprehensive planning is therefore essential to mitigate risks, curtail negative consequences, and manage the impact of disruptions. This approach ensures that daily operations remain uninterrupted and customer needs are consistently met.

Objectives

• Acquiring comprehensive knowledge of ISO 27001:2023
• Learning how to conduct audits in line with the standard
• Understanding industry best practices

Objectives

• Acquiring a thorough understanding of ISO 27001:2023
• Learning how to conduct audits in alignment with the standard
• Exploring industry best practices

Learning Outcomes

• Acquire insight into the updates introduced in the ISO 27001 2023 edition.
• Understand how to conduct audits in alignment with the standard.
• Discover industry best practices.

This instructor-led, live training session in South Africa (available online or on-site) is designed for intermediate to expert-level IT professionals seeking to enhance their skills and qualifications in information security or adjacent fields.

By the conclusion of this training, participants will be able to:

• Distinguish between ISO/IEC 27001:2013 and ISO/IEC 27001:2022.
• Gain the necessary knowledge and skills to effectively plan and implement the transition from the 2013 to the 2022 standard version.
• Apply learned concepts in real-world contexts, facilitating a smooth transition within their respective organisations.