in 
   



Preview   - English
Cover Image
 

ISO 13485:2016
Medical devices - Quality management systems - Requirements for regulatory purposes


Be notified when this Standard is updated or amended - Add to StandardsWatch

Abstract

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.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization's quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

General Product Information

Document Type Standard
Status Current
Publisher:    ISO
Supersedes:
ISO/TR 14969:2004
ISO 13485:2003
ISO/FDIS 13485



Available Products          My Location  :
Product availability, format and price varies from country to country. Please Login/register.
Order   Format Device Compatibility Price [USD]
Preferred Currency

   

Add To Cart

PDF (Personal Use)
PC/Mobile  
$220.00
Published:   25 Feb 2016  
Pages: 36
     info icon.jpg No Sharing. No Copy/Paste. Print once. More info


Add To Cart

Hardcopy
--  
$220.00
Published:   25 Feb 2016  
Delivery Time:   5-10 days
Pages: 36

Table of Contents

Skip Navigation Links.

Tell a friend about this search result             

Suggestions