ISO 13485 education and training is essential for any business that develops medical devices. ISO 13485 is an international quality management standard for the development and production of medical devices. The ISO 13845 policy was first published in 2003 in an effort to unify ISO 13485 procedures. Prior to 2003, ISO 13845 information was scattered about the ISO industry and medical devices did not have a standard of measurement. Medical device manufacturers did not have a benchmark that was simple to follow and would guarantee adherence to FDA guidelines for medical device production.

ISO 13485 standards have become more visible as the health care industry as a whole is being overhauled. As such, ISO 13845 info is constantly examined by quality professionals to ensure consistency. ISO 13845 resources are also becoming more readily available to industry professionals and to the general public. Currently, the ISO 13845 procedure is customer-focused and maintains quality objectives. The purpose of training for ISO 13485 is to:

1. Learn ISO 13845 procedures

2. Get an understanding of what an ISO 13845 requirement is for all medical devices

3. Learn how to implement an industry ISO 13485 standard

Action Steps
The best contacts and resources to help you get it done

Get ISO 13485 certification easily

ISO 13485 certification is necessary for any company planning to produce medical devices and sell the devices in any region that requires ISO quality management. Even if a company is not in the medical device manufacturing sector, the certification is a good move as it ensures to the public that the organization is compliant with FDA and ISO guidelines.

I recommend: Many companies achieve certification within four months. Certification Standards is a great site that offers information about how the general ISO 13485 certification process works. Quality Works has specific information regarding the ISO 13485 certification process, including how to get started.

Learn about 13485 training procedures

Materials regarding training for ISO 13485 for establishing procedures are widely available via the Internet. Document style training manual procedures are not as widely available, but do exist.

I recommend: Underwriters Laboratories has a comprehensive training that covers all aspects of setting up ISO 13485 training procedures. Bulltek also provides a substantial online manual that explains ISO 13485 training procedures.

Get ISO 13485 training using software

Document management, training, and management reviews are just some of the special features of ISO 13485 software. Customer complaint handling, audit controls, and supplier conformity are some of the other features of using ISO 13485 software. Software can simplify the ISO 13485 management process and can be cost-efficient.

I recommend: Caliso Consulting is a world leader in ISO 13485 training and education and provides detailed information about the basic components that are needed in any ISO 13485 software suite. The ISO Xpress also provides a comprehensive overview of ISO 13485 software suites as well as basic training information.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  Multinational corporations should be cognizant of the ISO 13485 standards for each country as the standards may be specific. Although ISO 13485 is an international benchmark, companies should be aware of the rules and regulations of each country where medical devices are sold.

The ISO 13485 standard applies to design, production, quality control and management practices of medical device manufacturing companies. ISO 13485 is an international standard that ensures product safety and efficacy. In addition, any medical device company that wants to sell their product in the European Union needs to receive ISO 13485 certification.

ISO 13485 certification focuses on management, quality control and training. You need to involve personnel at all levels of your company in order to implement an ISO 13845 policy. Several areas of your business will be reviewed and audited:

1. An ISO 13485 compliant work environment must promote product safety.

2. Inspection and traceability procedures must be in place for implantable devices.

3. Documentation must be available for sterile medical devices.

4. Policies for corrective and preventative actions must be part of your ISO 13485 plan.

Action Steps
The best contacts and resources to help you get it done

Go back to school to learn about ISO 13485 implementation

You should learn as much as possible about ISO 13485 standards before you start the certification process. This is important whether you go through the process alone or hire an ISO consultant to help you.

I recommend: BSI Management offers a variety of ISO 13485 training classes, including one called "Implementing ISO 13485:2003." You can attend the classes at one of their locations or request a quote for BSI to hold the training at your facility.

Give yourself an ISO 13485 policy check-up

Companies wishing to implement ISO 13485 need to assess their current management practices and quality control procedures. Your current practices may be fairly close to what the standard requires. However, you may find you have a lot of work to do.

I recommend: Caliso offers ISO 9001 and 13485 certification consulting. They can walk you through the entire ISO 13845 procedure from start to finish, including applying for federal funding to aid in the cost of certification. They also provide audits and training for ISO 13485.

Streamline management processes and ISO 13485 procedures with software

The best ISO 13485 software provides a paperless system to manage audits, corrective and preventative actions, training and performance reviews. In addition you may want an ISO 13485 system that includes training for ISO 13485 and operational forms and procedures.

I recommend: XISOX provides software for Document Control and ISO management and an add-on module for ISO 13485 that includes a quality manual, operational procedures and forms. You can get a web-based 15-day trial of the software; however, the trial only includes ISO 9001 forms.

Meet ISO 13485 training standards through employee education

The ISO 13485 standard requires all of your employees to understand the goals of ISO 13485 compliance. The training doesn't have to be time-consuming or elaborate, but it must meet ISO standards.

I recommend: The simplest solution for many employers is to have each employee complete the ISO 13485 training online. The 9000 Store offers online training priced by the number of employees taking the training. This makes it a cost-effective solution for small businesses. Large companies can request a quote for a site license for the training.

Tips & Tactics

Helpful advice for making the most of this Guide

• •  ISO 9001 and ISO 13485 are similar, although ISO 9001 requires companies to demonstrate continuing quality improvement. ISO 13485 only requires that the quality system be maintained.
• •  Part of ISO 13485 compliance is demonstrating that management understands and enforces regulatory requirements for medical devices sold in the United States.