Hello and welcome to this video about Clause 6.2 Human Resources in ISO 13485.
ISO 13485 is a standard that specifies requirements for a quality management system for medical devices. Clause 6.2 focuses on the requirements related to human resources within an organization that is involved in the design, development, production, installation, and servicing of medical devices.
In this video, we will discuss the key aspects of Clause 6.2 and its importance for compliance with ISO 13485.
Firstly, let's look at what the clause actually says. Clause 6.2 Human Resources has three sub-clauses, which are as follows:
6.2.1 General
This sub-clause specifies that the organization shall determine the necessary competence for personnel performing work affecting product quality. This means that the organization should identify the skills, knowledge, and experience required for personnel to perform their job effectively and contribute to the quality of the medical devices produced.
The organization shall ensure that personnel are competent on the basis of appropriate education, training, skills, and experience. This requires the organization to provide appropriate training and education to its personnel to ensure that they possess the necessary skills and knowledge to carry out their work.
The organization shall maintain appropriate records of education, training, skills, and experience. This is important for tracking and documenting the qualifications and training of personnel to ensure that they are qualified to perform their assigned tasks.
6.2.2 Competence, awareness and training
This sub-clause focuses on the training and awareness of personnel. The organization shall ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives. This means that personnel should understand how their work contributes to the overall quality of the medical devices produced.
The organization shall provide training or take other actions to achieve the necessary competence of personnel. This requires the organization to provide training that is specific to the job requirements of personnel and the specific medical devices being produced.
The organization shall evaluate the effectiveness of the actions taken. This requires the organization to evaluate the effectiveness of the training provided to personnel to ensure that it is achieving the desired results.
6.2.3 Infrastructure
This sub-clause specifies that the organization shall provide and maintain infrastructure to achieve conformity to product requirements. This means that the organization should provide appropriate tools, equipment, and facilities to its personnel to enable them to perform their work effectively and efficiently.
The organization shall ensure that the infrastructure is suitable for the intended purpose. This requires the organization to assess the suitability of its infrastructure for the specific tasks being performed.
The organization shall ensure that the infrastructure is maintained. This requires the organization to maintain its infrastructure to ensure that it remains suitable for the tasks being performed.
Now that we have covered what Clause 6.2 says, let's look at why it is important.
The human resources of an organization play a critical role in the design, development, production, installation, and servicing of medical devices. The quality of the personnel's work has a direct impact on the quality of the medical devices produced. The requirements specified in Clause 6.2 help ensure that personnel are appropriately trained and qualified to perform their work, and that they have the necessary infrastructure to perform their work effectively.
In addition, compliance with Clause 6.2 helps ensure that an organization is meeting the requirements of ISO 13485. Compliance with this clause is a critical component of the overall quality management system for medical devices.
In conclusion, Clause 6.2 Human Resources is an important aspect of ISO 13485. It specifies requirements related to the competence and training of personnel, and the infrastructure required to achieve conformity to product requirements. Compliance with this clause is essential for an organization involved in the design, development, production, installation, and servicing of medical devices
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