ISO 13485:2016 is an internationally recognized quality standard that encompasses specific requirements of an organization to demonstrate its ability to provide medical devices and related services that consistently meet customer as well as regulatory requirements. ISO 13485 is the most accepted standard worldwide for medical device manufacturers across the United States, Canada, Japan, Australia, Brazil and the European Union.
What is ISO 13485?
The requirements of ISO 13485 are applicable to all medical device organizations regardless of size, type and structure. ISO 13485 is beneficial for many organizations, as it is used by suppliers, as well as external parties that are involved with providing medical device products and services.
Third party review of an organization’s quality management system provides internal and external verification to customers of the monitoring, measurement and control of your processes, as well as builds confidence to meet applicable regulatory requirements. The standard is set to strive for continual process improvement and quality performance, as well as time and cost savings after implementation of this standard.
Organizations that are involved in one or more stages of the life-cycle, from design and development to production, storage/distribution, installation, or servicing of medical devices, benefit from our medical team’s expertise in quality management. As a valued partner, we ensure transparency and clarity throughout the audit process.
While DQS Inc. strives to create a safer world, ISO 13485 supports the reduction of unexpected risks and enhances management of those risks in order to meet the company’s desired goals. This enhancement not only increases the organization’s reputation in the eyes of their customers, but also includes a practical and effective solution to demonstrate a commitment to the regulatory requirements.
Benefits of ISO 13485
- 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 process starts with the client’s needs and expectations. DQS wants to learn about the client’s organization, its management system, size and types of operation. Together both parties will define objectives for the assessment and/or certification, including applicable standards and specifications.
DQS will provide a detailed offer for assessment and certification services, tailored to individual client needs, based on the information provided initially. A written contract will specify all relevant deliverables as well as applicable assessment and certification criteria.
A pre-audit can serve as initial performance or gap analysis, identifying strengths and areas for improvement. For larger assessment and certification projects a project planning meeting provides a valuable opportunity for the client to meet the lead assessor and develop a customized assessment plan for all functions and locations involved. Both services are optional.
The assessment procedure itself begins with review and evaluation of system documentation, goals, results of management review and internal audits. During this process, it will be determined whether the client’s management system is sufficiently developed and ready for certification. The assessor will explain findings and coordinate any required activities to prepare for the on-site system assessment.
The assigned auditor team will audit the client’s management system at the place of production or service delivery. Applying defined management system standards and specifications, the assessment team will evaluate the effectiveness of all functional areas as well as all management system processes, based upon observations, inspections, interviews, review of pertinent records, and other assessment techniques. The audit result, including all findings will be presented to the client during the closing meeting. Required action plans will be agreed upon as necessary.
The independent certification function of DQS will evaluate the audit process and its results, and decide independently about issuance of the certificate. The client receives an audit report, documenting the audit results. When all applicable requirements are fulfilled the client also receives the certificate.
Either semi-annually or at least once per year, there will be an on-site audit of the critical components of the management system. Improvement potential will be identified, with a focus on continual improvement and sustained effectiveness.
A management system certificate is valid for a limited period of time, frequently for a maximum of three years. At the end of this cycle, a re-audit will be carried out to ensure the ongoing fulfillment of all applicable requirements. Subject to this fulfillment, a new certificate will be issued.
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