Certifications

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

ISO 9001:2015 specifies requirements for a quality management system when an organization:

• Needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements
• Aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements

In October 2016, a new International Standard, IATF 16949:2016, replaced ISO/TS 16949:2009. The goal of this International Standard is the development of a quality management system that:

• Provides for continual improvement
• Emphasizes defect prevention
• Includes specific requirements and tools from automotive industry
• Promotes reduction of variation and waste in the supply chain

This International Standard, coupled with applicable customer-specific requirements, defines the fundamental quality management system requirements for automotive production, service and/or accessory parts organizations.