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Home > Medical Device > ISO 13485:2003 > ISO 13485:2003 Requirements

ISO 13485:2003 Requirements in brief

Clause 1: Scope	A Quality Management System for an organization that provides medical devices and services that meets customer requirements.
Clause 2: Normative Reference	ISO 9000:2005 which should be used along with ISO 13485 standards. It outlines the Quality Management Systems-Fundamentals and Vocabulary
Clause 3: Terms and Definitions	Gives definitions used in the standard, many of which are in addition to ISO 9001. In-vitro diagnostic reagents Software medical device Class of Medical Device Active Implantable Medical Device Active Medical Device Advisory Notice Customer Complaint Implantable Medical Device Labeling Medical Device Sterile Medical Device
Clause 4: General Requirements	Quality Manual with Scope of the QMS Required Procedures Required Forms & Records Control of Documents Control of Forms
Clause 5: Management Responsibility	Management Responsibility Quality Policy & Objectives Customer Focus & Customer Satisfaction Management Review
Clause 6: Resource Management	Personnel & Training Resource Management
Clause 7: Product Realization	Production of the product or service Planning Customer related processes and Customer Feedback Design Purchasing Process control Identification and Traceability Customer Property
Clause 8: Measurement, Analysis and Improvement	Requirements on monitoring processes to improve Customer Satisfaction Internal Audits Control of Non-Conforming Product Corrective and Preventive Action

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