As you would know, ISO 13485 deals with the quality standards and requirements pertaining to the design and manufacture of medical devices. This ISO 13485 standard helps you to establish a full-fledged quality management system (QMS) in the processes of developing, manufacturing and employing medical equipment.
Currently, the medical device industry is undergoing a massive regulatory change. The ISO 13485:2016 is mandatory standard for these regulations. Thus, ISO 13485 Auditor Training and Competency development of the standard will help industries meet their compliance goals.
ISO 13485 Auditor Training – Risk based approach
The higher the risk associated with the work, the higher the requirement for ISO 13485 training. Both training and effectiveness checks should be proportionate to the risk involved in the person’s work and impact on quality.
The ISO 13485:2016 standard encourages manufacturers to look at training as a risk mitigation tool to minimize human errors, deviations and non-conformances. In the world of medical devices, when the root cause of a non-conformance is determined, it turns out to be inadequate training and the cost of non-compliance is enormous.
Requirements for ISO 13485:2016 Auditor Training
Here, The ISO 13485 standard emphasizes that it may be necessary to provide ISO 13485 Auditor Training to the end users of the medical devices manufactured by the organization. Such training may be required to educate the user to use the device safely and as per its intended use.
All personnel dealing with quality processes and specialized tasks need to have the necessary skills and competency to execute their roles under ISO 13485:2016. Competency can be gained through education, training, skills development and experience. So, The ISO 13485 standard requires the following:
- The process of establishing competency for each person must be documented. The ISO 13485 training needs are to be identified, the relevance of this ISO 13485 training needs must be provided. The frequency of training and how awareness is to be generated should also be documented. So, these are new requirements of the 2016 version of the ISO 13485 standard.
- The records of all training programs that an individual goes through are to be maintained. Typically, these records are managed as employee files along with ISO 13485 certificates. The competency of the trainer is also documented.
- The ISO 13485 Auditor Training effectiveness should be assessed.
- Each individual involved in a critical process needs to be fully aware of the relevance and importance of his/her work and its impact on product quality and quality objectives.
- Periodically The ISO 13485 Training is required to maintain a high level of competency in the organization.
Key points that focus by ISO 13485 Auditor
Here are some details on which the ISO 13485 auditors will focus on,
- Job descriptions for key positions
- Competency assessment/mapping for different roles
- Training needs identification
- Training calendars
- Training conducted
- Frequency
- Effectiveness monitoring
For instance, an internal auditor needs to know all the processes in the organization and how they are inter-related. The auditor also needs to understand the regulations and ISO 13485 standard, and have the necessary skills such as questioning, good listening and ability to reach out to the auditee.
To achieve ISO 13485 certification it is advisable to hire a consulting firm specializing in ISO 13485 that can help you build and implement an effective QMS, tailored to the specific needs of your organization. Learn more about ISO 13485 auditor training and how to find an ISO 13485 expert, please visit at www.punyamacademy.com
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ISO 13485 Certification Requirements 
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