ISO 13485 is the international standard that specifies requirements for a quality management system (QMS) where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. ISO is the International Organization for Standardization (www.iso.org), an independent, non-governmental membership organization and the world's largest developer of voluntary International Standards, headquartered in Geneva, Switzerland. Requirements of ISO 13485 are specific to organizations providing medical devices, regardless of the type or size and can be used by any organization involved in one or more stage(s) of the life-cycle of a medical device.
The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for QMSs. Compliance with ISO 13485 is often recognized as the first step in achieving compliance with European regulatory requirements. The Standard excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements so organizations whose QMS conforms to ISO 13485 cannot claim conformity to ISO 9001 unless their QMS also conforms to all the requirements of ISO 9001. QMSs are not equivalent to product and service standards. If any requirement(s) is/are not applicable due to the nature of the medical device(s) for which the QMS is applied, the organization does not need to include such a requirement(s) in its QMS. If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS.
Learn from Omnex's QMS experts on how to implement and/or audit ISO 13485 systems including risk management methodology with disciplined problem solving methods.
Services that we offer:
- Gap analysis and implementation planning for single or multiple sites
- Integrated Management Systems of multiple Quality Management Systems such as ISO 13485, ISO 9001, ISO 14001 and with US or international regulatory requirements integrated
- Product Realization risk using project risk, safety characteristics, DFMEA, PFMEA, MSA, Control Plans including medical devices first article
- Global MDSAP Program implementation
- Supplier Development Programs
- Implementation of medical devices identification and traceability requirements
- Lean and Six Sigma implementations
- Training and Workshops
- Transitioning to ISO 13485:2016
- ISO 13485:2016 Understanding and Documenting and E-LEARNING: Understanding ISO 13485:2016
- ISO 13485:2016 Internal Auditor Training
- ISO 13485:2016 Lead Auditor Training
- ISO 14971:2013 Risk Management - Overview
- ISO 14971- Practical Risk Management using DFMEA
- ISO 14971- Practical Risk Management using PFMEA