ISO 13485:2016 | Medical Devices System
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ISO 13485:2016 | Medical Devices System
What is ISO 13485:2016?
ISO 13485:2016 outlines the requirements for a quality management system aimed at ensuring organizations can consistently provide medical devices and related services that meet both customer and applicable regulatory standards. This standard focuses on maintaining the effectiveness of the quality management system across the entire product lifecycle, ensuring the delivery of reliable medical devices.
Benefits of ISO 13485:2016
- Enhanced Quality Assurance: Guarantees a structured approach to managing quality during the design and manufacturing of medical devices.
- Regulatory Compliance: Aids organizations in adhering to industry-specific regulatory requirements for medical devices.
- Increased Market Access: ISO 13485 certification is globally recognized, facilitating entry into international markets.
- Risk Management: Emphasizes the need for effective risk management to ensure the safety and performance of medical devices.
- Continuous Improvement: Encourages a culture of continuous improvement, leading to higher-quality products and services.
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Frequently Asked Questions
We’ve compiled answers to some of the most common questions about certification.
ISO (International Organization for Standardization) is an independent, non-governmental international body that develops and publishes standards to ensure quality, safety, and efficiency across various industries and sectors. These standards help organizations deliver consistent, high-quality products and services.
Compliance certification is the process through which an organization verifies that it adheres to specific regulations, standards, or guidelines. Achieving certification demonstrates that the organization meets industry norms, ensuring credibility and compliance with legal or regulatory requirements.
A standard is an established set of guidelines, rules, or criteria that an organization or industry follows to ensure quality, safety, and consistency. Standards can be created for various aspects, including processes, products, services, and management systems, to maintain uniformity and meet customer expectations.
ISO 9001:2015 is an internationally recognized standard for quality management systems (QMS). It provides a framework for organizations to ensure their products and services meet customer requirements consistently, while also enhancing operational efficiency, continuous improvement, and customer satisfaction.
When choosing a certification body, it's crucial to select one that is reputable, accredited, and has expertise in your industry. Look for a body with a proven track record, experienced auditors, and a commitment to delivering high-quality services. Ensure they offer the specific certifications relevant to your business and meet global standards.
The cost of certification varies depending on the type of certification, the size of your organization, and the complexity of the processes involved. Certification bodies typically offer pricing based on these factors, which may include audit fees, training, and ongoing maintenance. Contact your chosen certification body for a customized quote based on your requirements.