ISO 13485 Training

We offer two types of ISO 13485 training:

1. Awareness training – Provides employees with an overview of ISO 13485 and their responsibilities
2. Internal auditor training – Designed for those responsible for maintaining the system

Both of our ISO 13485 training classes are conducted on-site by one of our quality management system consultants, all of which have extensive hands on medical device manufacturing experience. This ensures that your team will get a high quality ISO 13485 training session tailored to the needs of your organization. The training session is usually conducted at your facility but can be held at a nearby off-site facility if desired. These training classes are included in our ISO 13485 quality system implementation services.

ISO 13485 Awareness Training (1 or 2 days – depending on depth of coverage desired)

What your team will learn in this intensive ISO 13485 training class:

• Overview of the ISO13485:2003 standard and the implications to your company.
• The responsibility of senior management.
• Why the process approach makes sense.
• Setting objectives and defining responsibilities.
• Benefits of adopting the standard and regulatory requirements.
• Who needs to be involved within the company.
• Creating the quality policy manual.
• Role of design and development, purchasing, production, record keeping, customer communications.
• Continuous improvement, how and why.
• Process validation, monitoring and traceability, control of measurement devices and data analysis.

Optional: Day two provides a more in-depth look at ISO 13485:2003 and how it relates to other international regulations.

ISO 13485:2003 Internal Auditor Training (2 days or 3 days if hands-on training audit will be conducted)

What your team will learn in this intensive training class:

• Overview of ISO 13485:2003, FDA Good Manufacturing Practice (GMP), CE Marking and Canadian Medical Device Regulations (CMDR).
• Requirements for incident reporting, technical files, and risk analysis.
• Management responsibilities to customers, to the quality policy, and to employees.
• Resource management: personnel, materials, infrastructure and facilities.
• Product realization from the planning stages through design development through interaction with customers.
• Ways to measure, evaluate, and improve performance within the organization.

The overview above describes Days 1 and 2 of the training. Day 3 is designed for new auditors or as a refresher course for existing auditors. Day 3 involves conducting a hands-on mock internal audit of specific aspects of your facility and processes. This is a great opportunity for your internal auditors to take what they learned in the classroom during the previous two days and apply it in a real world setting in your company.

ISO 13485:2003 training for a fixed fee, regardless of how many employees attend

Our training is provided for a set fee plus expenses*. This makes it a great value for companies that need to train two or more employees. On-site ISO 13485 training gives your employees the opportunity to ask questions and ensures that every employee is receiving consistent information at the same time. Please contact us for more information or a free proposal on our ISO 13485 training classes.