What is ISO 13485?
The ISO 13485 standard is an effective solution to meet the numerous requirements of a QMS. The adoption of ISO 13485 provides practical foundations for manufacturers to meet medical device directives, regulations and responsibilities, as well as demonstrate commitment to the safety and quality of medical devices.
Like ISO 9001, 13485 seeks to implement a quality management system. The difference between them is that, while the first is a general quality management standard and can be implemented by any company or organization, ISO 13485 is a specific standard for medical devices and devices and quality management from their conception to manufacturing. . Because of this difference, the ISO 13485 standard must be implemented by companies related to the production of medical devices as well as any and all companies that provide services, products or components that will be inserted into a medical device.
What are the benefits of ISO 13485 certification?
Whether you are looking to operate internationally or expand your local operations, ISO 13485 certification can help you improve your overall performance, eliminating uncertainties, and expanding market opportunities. Companies that have this certification express their commitment to quality, both to customers and regulatory bodies.
- Increases access to global markets with certification;
- Describes how to review and improve processes across the organization;
- Increases efficiency and monitors supplier performance;
- Demonstrates that you produce safer and more effective medical devices;
- Meets regulatory requirements and customer expectations.
ISO 13485:2016 vs ISO 9001:2015
Annex SL provides the basic structure for most ISO Management Systems standards, such as ISO 9001:2015. However, ISO 13485:2016 is not based on the Annex SL structure. Some of the main differences between ISO 13485:2016 and ISO 9001:2015 include:
- Scope of each standard;
Structure (8 versus 10 sections); - Context of the Organization;
Documentation requirements; - Planning: consideration of risks and opportunities;
Process Approach; - No management representative clause in ISO 9001:2015;
- No clause on manual quality manual in ISO 9001:2015;
- Performance evaluation;
- Improvement.
Why choose Klaston Management to implement ISO 13485:2016 in your company?
- Customer focus and proven satisfaction – The Klaston Management shares the same goals as our customers: to help ensure product safety and compliance to market quickly in order to protect consumers, as well as our customers’ brands and reputations.
- Consultants with international experience– The consultants and auditors at Klaston Management have extensive experience in implementing and auditing the ISO 13485 standard. We are pioneers in Brazil in implementing and knowing-how about ISO 13485.
- Best investment– We work with segmented and customized implementation planning, ensuring that your company will pay a fair price for the implementation process.
Transition from ISO 13485:2003 to ISO 13485:2016
Klaston Management is ready to support your transition from ISO 13485:2003 to ISO 13485:2016 certification.
Contact us to discuss how we can help your company with implementation, Gap Analysis assessments, Preliminary Assessment, Training and Standard Transition