ISO 13485:2016

MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEM

ISO 13485 Certification is a Quality Management System for the medical device industry where an organization needs to demonstrate its ability to manufacture, procure, store and sell medical devices and related services that consistently meet customer and applicable regulatory requirements.
Organizations can have multiple stages of lifecycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and other associated activities (e.g. technical support).
In simple words, ISO 13485 standard is a combination of ISO 9001 requirements with an additional set of medical device requirements.

ISO 13485 Certification

benefits of ISO 13485 CERTIFICATION TO YOUR ORGANIZATION

  • Credibility – Increase access to bigger market worldwide with the certification 
  • Process Approach – Increase efficiency, cut costs and monitor supply chain effectiveness
  • Quality Compliance – Demonstrate that you produce safer and more effective medical devices
  • Customer Satisfaction – Meet regulatory requirements and customer expectations 
  • Employee Engagement – Better people involvement to identify best solutions for improving processes
  • Business Excellence – Shorter lead times and better services through quality and process improvement initiatives 

BENEFITS OF ISO 13485 CERTIFICATION TO YOUR CUSTOMERS?

  • Provides management with a defined & efficient management process
  • Responsibility across the organization to achieve the objective
  • One of the criteria of a tender to qualify for some public sector work
  • Positive atmosphere & builds confidence in internal staff & customers
  • Identifies areas to improve & reduce iterations
  • Metrics to reduce resources (Men, Money, Machine, Material & Method)
  • Provides continuous assessment and improvement
  • Marketing opportunities
  • Improved customer retention and acquisition
  • Globally recognized standard inviting for international opportunities

Who can get ISO 13485 certification?

ISO 13485:2016 standard is applicable to organizations regardless of their size and their type. Requirements that are specified as applicable to medical devices shall also be applicable equally to associated services. 

Therefore, the standard is not only applicable to medical device manufacturers but also to supporting firms like subcontractors, stockists, suppliers and European Authorized Representatives.

What are the requirements of ISO 13485:2016?

General Requirements – This includes required documents like Quality Manual, documented procedures and records

Management Responsibilities – Resource identification for MR and planning of QMS (Resource Management)

Product Realization – Major concepts of planning and creation of the product like Design Controls, Risk Management, Document Control and Records Management & Supplier Management will be addressed as part of requirements

Culture of Evaluation & Continual Improvement – These requirements include customer satisfaction, internal audits, dealing with non-conformities and corrective actions

These concepts are based on Plan-Do-Check-Act cycle, which use the above-mentioned elements to implement, drive and maintain improvements within the processes.

What is ISO 9001 Certification?

What is ISO 9001 Certification?

A Quality Management System is a set of an interrelated or interacting elements that an organization uses to formulate its Quality Policies and Objectives and establishes processes needed to  achieving them

How to get an ISO Certification?

How to get an iso certification?

Here we have tried to guide our readers on How to get an ISO Certification without much hassle. We have tried to cover the different aspects that are important during ISO Certifications.

What is Total Quality Management?

Total Quality Management (TQM) is a systematic approach for management to achieve long-term success through customer satisfaction. It includes customer focus and integration of quality for continuous improvement.

what are the benefits of iso certification?

Answers to the most asked question, What are the Benefits of ISO Certification? Understand steps on using your ISO certification for improved processes, your brand image and overall growth in revenue.

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Bulgaria ISO 13485 Audit in Bulgaria ISO 13485 in Sofia ISO 13485 certification in Sofia ISO 13485 Consultant in Sofia ISO 13485 services in Sofia ISO 13485 Consulting services in Sofia ISO 13485 Audit in Sofia ISO 13485 in Canada ISO 13485 certification in Canada ISO 13485 Consultant in Canada ISO 13485 services in Canada ISO 13485 Consulting services in Canada ISO 13485 Audit in Canada ISO 13485 in Quebec City ISO 13485 certification in Quebec City ISO 13485 Consultant in Quebec City ISO 13485 services in Quebec City ISO 13485 Consulting services in Quebec City ISO 13485 Audit in Quebec City ISO 13485 in Toronto ISO 13485 certification in Toronto ISO 13485 Consultant in Toronto ISO 13485 services in Toronto ISO 13485 Consulting services in Toronto ISO 13485 Audit in Toronto ISO 13485 in Vancouver ISO 13485 certification in Vancouver ISO 13485 Consultant in Vancouver ISO 13485 services in Vancouver ISO 13485 Consulting services in Vancouver ISO 13485 Audit in Vancouver ISO 13485 in Montreal ISO 13485 certification in Montreal ISO 13485 Consultant in Montreal ISO 13485 services in Montreal ISO 13485 Consulting services in Montreal ISO 13485 Audit in Montreal ISO 13485 in Ottawa ISO 13485 certification in Ottawa ISO 13485 Consultant in Ottawa ISO 13485 services in Ottawa ISO 13485 Consulting services in Ottawa ISO 13485 Audit in Ottawa ISO 13485 in Calgary ISO 13485 certification in Calgary ISO 13485 Consultant in Calgary ISO 13485 services in Calgary ISO 13485 Consulting services in Calgary ISO 13485 Audit in Calgary ISO 13485 in Paraguay ISO 13485 certification in Paraguay ISO 13485 Consultant in Paraguay ISO 13485 services in Paraguay ISO 13485 Consulting services in Paraguay ISO 13485 Audit in Paraguay ISO 13485 in Peru ISO 13485 certification in Peru ISO 13485 Consultant in Peru ISO 13485 services in Peru ISO 13485 Consulting services in Peru ISO 13485 Audit in Peru ISO 13485 in Lima ISO 13485 certification in Lima ISO 13485 Consultant in Lima ISO 13485 services in Lima ISO 13485 Consulting services in Lima ISO 13485 Audit in Lima ISO 13485 in Ukraine ISO 13485 certification in Ukraine ISO 13485 Consultant in Ukraine ISO 13485 services in Ukraine ISO 13485 Consulting services in Ukraine ISO 13485 Audit in Ukraine ISO 13485 in Europe ISO 13485 certification in Europe ISO 13485 Consultant in Europe ISO 13485 services in Europe ISO 13485 Consulting services in Europe ISO 13485 Audit in Europe ISO 13485 in USA ISO 13485 certification in USA ISO 13485 Consultant in USA ISO 13485 services in USA ISO 13485 Consulting services in USA ISO 13485 Audit in USA ISO 13485 in Visakhapatnam ISO 13485 certification in Visakhapatnam ISO 13485 Consultant in Visakhapatnam ISO 13485 services in Visakhapatnam ISO 13485 Consulting services in Visakhapatnam ISO 13485 Audit in Visakhapatnam ISO 13485 in Mysore ISO 13485 certification in Mysore ISO 13485 Consultant in Mysore ISO 13485 services in Mysore ISO 13485 Consulting services in Mysore ISO 13485 Audit in Mysore

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