ISO 13485:2016 Standard – Maintaining documented procedure for Human resources

Human resources is considered a resource for the realization of an Medical device product, its components, or related services and has objectives that are derived from the type of the Medical device, the strategy of the organization, and the processes that operate the QMS. Clause 6.2—Human resources aims to ensure competence of personnel involved in the QMS. Competence in the context of quality management is developing the ability to apply appropriate qualifications, skills, and knowledge to the right activities or operations with the goals of achieving planned results. The needs for competences should be defined in a systematic way that can fulfill these goals and objectives and meet product and safety specifications and regulatory requirements. Training and qualifying should be planned in order to enhance the achievement of these goals, objectives, product and safety specifications, and regulatory requirements.

Maintaining documented procedure

The organization shall maintain one or more documented processes with the following objectives:

• Establishing competence—Defining the required competence for operating the QMS and performing activities of product realization
• Providing needed training—The identification of the required training needs for achieving the competence of employees and the planning of activities for providing that training
• Ensuring awareness of personnel—Increasing the motivation and devotion of employees regarding the QMS

In Section 6.2 of the book ISO 13485:2016 – A Complete Guide to Quality Management in the Medical Device Industry, I discuss all these issues and suggest many techniques for achieving these requirements and implementing them in the QMS. These techniques must be described in your documented procedure. Basically, the following issues shall be covered by the documented procedure (or more, if you choose):

• Describe how training is identified in order to maintain the competence of employees:Who is responsible for the identification? What are the principles for identifying the training needs (education, regulatory requirements, knowledge, experience, etc.)? What are the records, for example, job description?
• Describe how training is managed in the QMS: How employees are trained upon employment, How an employee is certified for his or her role, How ongoing training is planned and provided,  Which records are expected: training plan, training program, and so on
• Describe how employees and their competence are evaluated.
• Describe how awareness is being implemented and increased in the QMS.

This documented procedure shall be submitted to the controls suggested in clause 4.2.4—Control of documents.