ISO 13485 Medical Device Certification

ISO 13485

As ISO 13485 consultant we provide guidance about QMS for medical device industries and we make sure that our clients know the benefits of ISO 13485 Certification for their organization.

ISO 13485 Certification

Quality Management System for Medical Device Industries

ISO 13485 Certification for Medical devices is a quality management system required for regulatory purposes which is an ISO standard, it was published for the first time in 1996, that represents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.

ISO 13485 standard replaces earlier documents such as EN 46001 and EN 46002 (both 1997), the previously published standard was ISO 13485 (1996 and 2003), and ISO 13488 (also 1996).

The latest 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 & development, production, storage, distribution, installation, servicing of a medical device or provision of associated activities (e.g. technical support).

The ISO 13485 standard provides an effective framework to meet the comprehensive requirements for a medical devices quality management system.

For manufacturers and service providers both comply and demonstrate their compliance with regulatory requirements.

The requirements in ISO 13485 are used by suppliers or other external parties providing products or services to medical device manufacturers.

ISO 13485 Standard Benefits

  • Increase access to more markets worldwide with certification.
  • Outline how to review and improve processes across your organization.
  • Increase efficiency, cut costs and monitor supply chain performance.
  • Demonstrate that you produce safer and more effective medical devices.
  • Meet regulatory requirements and customer expectations.

The ISO 13485 standard supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent medical device design and development, production, installation, as well as delivery of medical devices, or related services, that are safe for their intended purpose.

The new edition is applicable across the whole supply chain and seeks to address the entire lifecycle of a medical device

Requirements of ISO 13485 2016

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.

” The new ISO 13485 2016 focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing, production control activities and other aspects of the quality management system”

While implementing the system, it is necessary to know the local applicable regulatory requirements and also any additional regulatory requirements, which you may have to comply due to an export of the product.

When designing the QMS are per ISO 13485, it is also necessary to understand the size of the company, the risk classification of the product and applicable exclusions and non-applicabilities

Operon Strategist is ISO 13485 consultant helps to create the documents for ISO 13485 certification. In the first phase.

Our special screen sharing module helps you create that documentation and provide adequate training.

This includes the creation of the SOP,s work instructions, Quality Manuals, VMP’s, Process Validation documentation etc.

In the second phase, we provide assistance to implement the system at Shop Floor and provide the need-based training to make sure that the system is adequately implemented.

On a routine basis, we monitor the system including the Management review meetings, Internal quality audits, Customer ComplaintsCAPA Management, Handling of Non-confirming Products etc.

We assist to maintain the complaint system and continual preparedness for the audits.