ISO certification in Madurai | ISO 13485 Certification Consultants Coimbatore

What is ISO 13485

ISO 13485 is an International Standard for Effective establishment and implementation of Medical Device Quality Management Systems.

How it works

ISO 13485 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 and applicable regulatory requirements

Who can use

	Organizations which are involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support) can go for this ISO 13485 implementation.
	ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
	Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated.

	To Widen market opportunities
	Compliance to the requirements of customers & global regulators
	To comply with Country specific requirements
	Minimize costs
	It Emphasis on a risk-based approach like identifying the potential risks, Cataloging, taking steps to reduce or remove, Creating mitigating action plans, Creating incident plans if risks to manifest and Document all plans, actions and other artifacts.
	ISO 13485 introduces new regulations for monitoring and managing suppliers such as Transparency and insight into a supplier's performance, Re-evaluations of supplier performance on a regular basis, Documented assessments of potential risks, together with mitigating actions.

	Gap assessment
	Establish, Document Quality Manual
	Comply with regulatory requirements
	Standardize procedures
	Train & Implement standardized procedures
	Risk Assessment & Management
	Complaince across all workflow steps
	Analysis of Data
	Internal Audit
	Management Review
	Monitor & Maintain System
	Applying to Certification body
	Certification Audit
	Continual Improvement

What is ISO 13485

How it works

Who can use

Will ISO 13485 Address my challenges

Why should I get certified to ISO 13485 Medical devices - Quality management systems

How do I get certified

	Execute business in a highly regulated industry.
	Demonstrate to customers and regulators that you have made a serious commitment to quality for your medical devices.

ISO 13485:2016 Medical devices - Quality management systems

What is ISO 13485

How it works

Who can use

Will ISO 13485 Address my challenges

Why should I get certified to ISO 13485 Medical devices - Quality management systems

How do I get certified