The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. The adoption of ISO 13485 provides a practical basis for manufacturers to handle regulations and responsibilities and demonstrates their commitment to the safety and quality of medical devices.
1.1. What is ISO 13485?
ISO 13485 is an independent QMS standard derived from the internationally recognized and accepted ISO 9000 quality management standard series.
ISO 13485 adapts the previous version of the ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. ISO 13485 is based on the concepts of the ISO 9001 process model, but is designed for regulatory compliance; therefore, it is more prescriptive in nature and requires a more thoroughly documented QMS.
ISO 13485 was written to support medical device manufacturers in designing a QMS that establishes and maintains the effectiveness of their processes. It ensures consistent design, development, manufacture, installation and delivery of medical devices that are safe for their purpose, right up to disposal.
Standard Certification’s approach to excellence Standard Certification selects and hires professionals to conduct ISO 13485 audits.
Candidates should have a general knowledge of the use of medical devices, as well as knowledge of design, manufacture or process. Our assessment team comes to Standard Certification with exceptional real industry experience.
They then go through rigorous in-house training and Standard Certification qualification processes, including best practice quality systems audit techniques, understanding critical production processes, and interpreting regulatory compliance expectations.
Standards Certification auditors are experts in the latest technology available and are continually trained on new requirements and future changes.
Standard Certification is always looking ahead to ensure our clients are well placed and prepared for future changes in compliance and regulatory environments.
Any medical device or IVD placed on the European market must comply with the relevant classification MDR and IVDR requirements or compliance and approval with the US FDA regulations for Medical devices:21CFR
Product and user safety is critical to medical device compatibility. ISO 13485 specifies requirements for a quality management system that can demonstrate a company’s ability to design and manufacture medical devices and IVDs that consistently meet applicable legal requirements and customer specifications.
Key benefits of ISO 13485 for our customers include:
- Provides consistency in what we do
- Identify ways to continually measure and improve
- Provides a risk-based approach
- Supports our customers’ trust and satisfaction
- Demonstrates proof of compliance with applicable regulations for safety and performance
