Employee Induction - ISO 13485

ISO 13485 2016 +A11 2021 

QMS.6.2.0.1 – QR – Employee Induction Template

Our Medical Device Quality Assurance and Regulatory Affairs document templates have been created by fully qualified and experienced professionals at Patient Guard, a Quality Assurance and Regulatory Affairs Service provider. The templates have been specially written to ensure that they meet the basic requirements needed for each clause/section of the standard or regulation the templates relate to. We have carefully curated the templates to ensure they are easy to follow and adapt to make them specifically modified to your business needs. All the templates are fully editable Microsoft word documents allowing you to have complete control over the templates which can then be modified to suit your company branding/marketing requirements.

Why would I need to complete induction forms for my employees?

• It is a requirement of ISO 13485 that organisations shall:
  • ensure employees are aware of the relevance and importance of their activities and how they contribute to the achievement of quality processes
  • maintain appropriate records of education, training, skills and experience.
• This is in part satisfied by maintaining records of employee inductions.
• In inducting new employees a company should aim to ensure that they understand the expectations, performance and culture of the Company. This template will help you structure, record, evidence and audit this process to the benefit of your organisation and Quality Management System (QMS).

How will using this template benefit my organisation?

• You will be able to ensure and provide evidence that your employees are well qualified for their positions.
• You will be able to standardise the process through which new employees are inducted/onboarded and ensure that they are well equipped for and capable of carrying out their duties.
• When well implemented with the aid of this template, the induction process can improve employee retention by helping them better understand their role and how they contribute to the company’s aims and objectives.

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.