ISO 13485:2016 Certification
ISO 13485:2016 is an international standard specifically designed for Medical Devices Quality Management Systems (QMS). It outlines the 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.
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Understanding ISO 13485:2016
ISO 13485:2016 is an internationally recognized standard that specifies the requirements for a quality management system (QMS) specifically tailored for medical devices and related services. This standard outlines the criteria for an organization’s quality management system, ensuring that it consistently meets regulatory requirements, addresses customer satisfaction, and maintains the highest standards of safety and effectiveness in the medical device industry.
Benefits of ISO 13485:2016
Implementation
Enhanced Product Quality
ISO 13485:2016 ensures rigorous quality control throughout the product lifecycle. Implementing this standard leads to the production of high-quality medical devices, fostering confidence in both healthcare professionals and patients.
Global Market Access
Compliance with ISO 13485:2016 opens doors to international markets. Many countries and regulatory bodies recognize this standard, facilitating market entry and reducing barriers for businesses aiming to expand their reach globally.
Regulatory Compliance
ISO 13485:2016 helps organizations stay abreast of changing regulations and standards in the medical device industry. By adhering to these requirements, companies ensure their products comply with legal obligations, reducing the risk of regulatory issues and penalties.
Improved Risk Management
The standard integrates a systematic approach to risk management, allowing organizations to identify potential risks and implement preventive measures. This proactive risk management approach enhances patient safety and reduces liability.
Our 13485:2016 Service Package
Micro Business (1-10 Employees)
- ISO 9001 Certification: support for documentation and process implementation suitable for small businesses.
- ISO 9001 Certification: External audit by an accredited certification body to assess compliance with ISO 9001:2015 standards.
- Duration: 3 years
Small Business (11-50 Employees)
- Assistance with documentation, process mapping, and implementation. Includes training sessions and guidance tailored to your organization's needs
- ISO 9001 Certification: External audit by an accredited certification body to assess compliance with ISO 9001:2015 standards..
- Duration: 3 years
Medium Business (51-250 Employees)
- ISO 9001 Certification: Assistance in developing a quality management system aligned with ISO 9001:2015 requirements.
- ISO 9001 Certification: External audit by an accredited certification body to evaluate compliance with ISO 9001:2015 standards.
- Duration: 3 years
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Frequently Asked Questions
Understanding ISO 13485:2016
ISO 13485:2016 is an international standard specifying requirements for a Quality Management System (QMS) focused on medical devices. It outlines the criteria for organizations involved in the design, development, production, installation, and servicing of medical devices and related services.
ISO 13485:2016 ensures that medical devices meet quality and safety standards. It provides a framework for compliance with regulatory requirements, enhances product quality, and fosters customer confidence in the medical device industry.
ISO 13485:2016 is applicable to any organization involved in the medical device lifecycle, including manufacturers, suppliers, and service providers. It is especially crucial for companies seeking regulatory approval for their medical devices.
While both ISO 13485:2016 and ISO 9001 focus on quality management, ISO 13485:2016 is specific to the medical device industry. It includes additional requirements related to risk management, regulatory compliance, and product safety tailored for medical devices.
The time to obtain ISO 13485:2016 certification varies based on the organization’s size, complexity, and existing quality management practices. It typically takes several months to a year or more to implement the necessary changes, undergo audits, and achieve certification.
Yes, ISO 13485:2016 can be integrated with other management systems, such as ISO 9001 (Quality Management) or ISO 14001 (Environmental Management). Integration streamlines processes, reduces duplication, and enhances overall efficiency.
ISO 13485:2016 incorporates risk management processes specific to medical devices. It ensures systematic identification, assessment, and mitigation of risks associated with the devices, enhancing patient safety and reducing liability for manufacturers.
Yes, ISO 13485:2016 is applicable to organizations of all sizes, from large manufacturers to small-scale producers and suppliers. The standard’s flexibility allows it to be tailored to the specific needs and scale of the organization.
ISO 13485:2016 audits are conducted regularly, typically annually, to ensure the organization’s ongoing compliance and effective implementation of the standard. Internal audits are performed by the organization, and external audits are conducted by certification bodies to assess eligibility for certification renewal.