ISO 13485

E18757

international standard medical device standard quality management system standard

ISO 13485 is an international quality management standard that specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services.

Statements (48)

Predicate	Object
instanceOf	international standard → medical device standard → quality management system standard →
abbreviationOf	International Organization for Standardization 13485 →
aimsTo	ensure consistent design of safe medical devices → ensure consistent production of safe medical devices → support regulatory compliance for medical devices →
appliesTo	organizations involved in design of medical devices → organizations involved in installation of medical devices → organizations involved in production of medical devices → organizations involved in servicing of medical devices → organizations providing related medical device services →
basedOn	ISO 9001 principles →
contains	requirements for management responsibility → requirements for measurement, analysis and improvement → requirements for product realization → requirements for resource management →
emphasizes	customer and regulatory authority satisfaction → product realization processes → regulatory compliance → risk-based approach to medical device quality →
focusesOn	quality management systems for medical devices →
hasType	voluntary consensus standard →
language	English →
publishedBy	International Organization for Standardization →
relatedTo	European Union medical device regulations → FDA quality system regulation for medical devices →
relevantTo	medical device design organizations → medical device distributors → medical device manufacturers → medical device service providers → sterilization service providers for medical devices →
scopeIncludes	complaint handling → control of monitoring and measuring equipment → corrective and preventive actions → design and development controls → document control → production and process controls → purchasing controls → record control → regulatory requirements for medical devices → risk management for medical devices → sterile medical device controls → traceability requirements → validation of processes for production and service provision →
usedFor	certification of medical device manufacturers → certification of medical device suppliers → demonstrating conformity to regulatory requirements →

Referenced by (2)

Subject (surface form when different)	Predicate
International Organization for Standardization →	issuesStandard
ISO 14971 →	relatedTo