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Introduction to ISO 13485 Standard for

Medical Devices – Quality Management System By

Global Manager Group


What is ISO? ISO (International Organization for Standardization) is that the world’s largest developer of voluntary International Standards. International Standards provide state of the art specifications for product, services and sensible observe, serving to form trade additional economical and effective. Developed through world accord, they facilitate to break down barriers to international trade.

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What is ISO 13485? This international standard is predicated off the ISO 9001 international standard with specific requirements to fulfill regulatory needs. This commonplace, applicable on a voluntary base, was designed specially for medical device manufacturers; ISO 13485 addresses most or all of the standard system needs in markets as well as Europe, Australia, Japan and Canada.

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Why you need to implement and certify ISO 13485? • Minimize potential quality problems with third party audit with regular audit on your system to make sure that you just are perpetually in compliance with regulative laws to attenuate quality problems. • Increase public image and responsiveness by showing your commitment to quality assurance to your stakeholders and most significantly your potential customers. • Increase responsiveness to problems and non-conformists • Compliance to native and international rules for mercantilism and mercantilism of medical devices • A commonplace per-requirement for medical devices makers and designers

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Step for ISO 13485 Implementation

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Appoint consultants Perform a GAP Analysis Project Schedule Develop Process Mapping Develop Documentation Employee Training Implementation Establish quality goals Internal Audit Certification Audi

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Difference between ISO 13485 and ISO 9001 Standard ISO 13485 is predicated on the ISO 9001 quality management commonplace, but each standards don't seem to be fully congruent. In addition to the wants that area unit specifically associated with the medical devices, the each standards primal dissent in 2 points: ISO 13485 (Art. 8.2, 8.5) excludes ISO 9001 needs associated with continual improvement and client satisfaction. Both these ISO 9001 needs cannot be objective verified within the legal controlled sector. thus is in ISO 13485 the term "customer satisfaction" replaced by the term "customer fulfillment" and therefore the term "continual improvement" by the term "maintenance of efficiency". The legal laws need the observation of market devices, analysis of observations and, if necessary, acceptable corrective actions. Global Manager Group


Advantages of ISO 13485 Standard Here is what medical device manufacturers can hope to gain from having an ISO 13485 certification: • Faster and easier market access to countries that acknowledge the certification: North American country, Japan, South Korea, Brazil, Australia & New Zealand. • Reduce operational prices by lightness method deficiencies and rising potency • Increase client satisfaction by systematically delivering quality product and consistently addressing complaints • Proven commitment to quality through Associate in Nursing internationally recognized normal • Adds transparency to the approach complaints, police investigation or product remembers square measure handled

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Graph of ISO 13485 Implementation Phase 1: Preparation and development phase Top Management Decision & commitment

Team up & Planning development

Phase 2: Implementation phase

Train employees &monitoring system

Phase 3: Registration phase

Registration Audit

Preventive/ Corrective action

Undertake Gap Analysis Revise quality Manual documentation

Perform internal audit

Registration & Certification


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ISO 13485 Standard Certification