Iso 13485 Training: Increase Employee Efficiency

By Author: Hayden Louie
Total Articles: 59
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The ISO 13485 standard is widely used in the medical device manufacturing industry as a medium to establish compliance with European medical device directive and Canadian medical device regulation etc. ISO 13485 training helps in increasing the efficiency and caliber of the people involved in this field.

There are several types of 13485 training but the most important one are as following:

Awareness training – It provides employees with general idea of ISO 13485 and their responsibilities.

Internal auditor training – It is designed for those who are responsible for maintaining the system.

The above mentioned training classes offer extensive hands on medical device manufacturing experience which ensures that your team will receive a high quality training session according to the needs of an organization.

Why to use ISO 13485 Training

To increase the standard of a company or an organization
To increase the responsibility of senior management
To create a process approach that make sense
Setting objectives and defining responsibilities
Benefits of adopting the ...
... standard and regulatory requirements
Helps in creating quality policy manual
Helps in better knowing the role of design and development, production, purchasing, record keeping and customer communications
An idea who should be involved within the company
Why and how a continuous improvement of the company should be maintained
Helps in knowing the validation, traceability, monitoring, control of measurement devices and data analysis etc

The ISO 13485 represents certain requirements for a complete management system, and for the designing and manufacturing of medical instruments and equipment. It as well entails that you have the capability to collect post market intelligence about the medical device.

This is such a standalone document that is required for an organization to maintain and implement a quality system. The document is very important as it is generally viewed as the first step for any medical device manufacturer in the process of achieving regularity and compliance. A better documentation structure for an organization need to get started from the quality policy as this policy helps in defining the regulations and standards of the company.

For more information about ISO 9001 Internal Audit, please visit www.qualityassociates.org