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.
The official source of ISO 13485 is the ISO 13485 page at Business.com
Featured Vendors
ISO 13485AQS Management Systems provides training and consulting services for ISO 13485. Training is offered both publicly and onsite.
www.aqsperformance.com
ISO 13485 Consultants for Medical Device & IVD CompaniesEmergo Group implements ISO 13485 quality systems. Specialists in CE Marking, FDA GMP compliance, 510k submissions and more. Offices worldwide.
EmergoGroup.com
Certification, Training & Consulting - All StandardsGuaranteed Training online & onsite. Certifications for all standards, including ISO 9001, AS9100, TL 9000, ISO 14001, ISO 13485, ISO 17025 & HACCP.
www.qualityuniversity.com
Public SeminarsFor 35 years, STAT-A-MATRIX has been offering public training in business process improvement, performance excellence, and regulatory compliance.
www.statamatrix.com
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