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ISO 13485:2016

Overview

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 requirements and regulatory requirements applicable to medical devices and related services.

The primary objective of ISO 13485:2016 is to facilitate harmonized medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some of the requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions, organizations whose quality management systems conform to this International Standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.

Benefits of ISO 13485

By becoming certified in the ISO 13485 standard your company will:

  • Increase the probability of making safe and effective medical devices
  • Meet regulatory requirements
  • Help monitor the effectiveness of your supply chain

In addition, ISO 13485 helps to:

 

  • Increased Efficiency
  • Cost Savings
  • More Effective Risk Management and Quality Assurance
  • Improved ability to respond to Customer Requirements

Who Needs ISO 13485?

This International Standard specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services.

It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

How Kayzed Helps to Get Certified?

Kayzed Consultants is one of the largest & leading business management consulting organizations offering business management consulting services to organizations of all nature and size.

Our services are essential for businesses of all types whether it is to get products to market, meet contractual and regulatory requirements or improve quality, safety, efficiency and sustainability.

The core of our business is our people whose depth of knowledge and experience means they understand the issues that are important to your business and to meeting your goals.

Our ISO certification services cover training, gap analysis, documentation, implementation assistance, internal audit, pre-assessment audit, assistance in selection of the ISO certification body and ensuring successful completion of the ISO certification audit.

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