ISO 13485:2016

Medical devices-Quality management systems

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 and applicable regulatory requirements. Such organizations can be 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). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

01. Scope
02. Normative references
03. Terms and definitions
04. Quality management system
05. Management responsibility
06. Resource management
07. Product realization
08. Measurement, analysis and improvement

Benefits of ISO 13485:2016 Medical devices- Quality Management System Certification:

01. To increase the brand value
02. To reach new markets
03. To operate more efficiently
04. To meet statutory and regulatory requirements
05. To identify and address risks
06. To meet customer requirement & demand
07. To get international acknowledgement and recognition
08. To enhance customer satisfaction by effective application
09. To develop the systematic management in the organization
10. To reduce the cost, defect & waste by increasing quality
11. To make consistent with Quality and increase Efficiency
12. To help organizations to develop and improve performance

Why Choose GlobCertify?

01. Highest priority to Customers
02. Timely processing
03. Prompt reply to Customers
04. Highest cooperation
05. Qualified and experienced Auditors
06. Integrated Management Systems Certification

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