Objectives

The primary objective of this tender is to procure a training course on ISO 13485:2016, focusing on understanding, implementation, and internal auditing. The course aims to enhance the knowledge and skills of participants in the standards' requirements and audit processes.

Scope

The scope includes providing offsite training for a group of 7 people on ISO 13485:2016. The training must cover understanding, implementation, and internal audit aspects of the standard, delivered by a Service SETA accredited training provider with at least 5 years of experience. The training should include case studies, examples, assessments for competence, and training materials supplied by the facilitator.

Technical Requirements

• Training must be accredited by a recognized body such as IRCA or Exemplar Global, and the provider must be SAATCA approved.
• Training should be delivered offsite.
• Training materials must include case studies and examples.
• An assessment to determine participant competence must be included.
• The provider must have a valid Service SETA accreditation.
• Experience of not less than 5 years in ISO 13485:2016 understanding, implementation, and audit training is required.

Skills Requirements

• Proven experience in delivering ISO 13485:2016 training and internal audits.
• Accreditation as a SAATCA approved training provider.
• Ability to provide comprehensive training materials, including case studies and examples.
• Capability to assess and certify participant competence.
• Offsite training delivery skills.