What is ISO 13485 Standard and why is it important?
ISO 13485 is a standalone quality management system standard for medical devices. The standard requires an organization to implement in one or more stages of the life cycle of a medical device so that it fulfills the Medical Device regulatory Compliances. The standard specifies the requirements of medical devices that help to be free from contaminants, sterilized, and maintain cleanliness in their entire life-cycle.
Moreover, the standards require the suppliers and other external parties who give services to such organization may also come under ISO 13485 requirements. ISO 13485 gives guidance to the organization to implement the quality management system effectively in medical device manufacturing or medical service-related organizations.
Importance of ISO 13485
The standard ISO 13485 ensures consistent design, development, production, installation, and delivery of safe medical devices. It helps to develop quality medical devices for their intended purpose. ISO 13485 Certification promotes the organization’s reputation for providing medical devices or medical services with high quality and safety. The ISO 13485 certification is applicable to all the organizations that supply medical devices.
What are the benefits of ISO 13485 Certification?
- Improves customer satisfaction
- Improve safety in using medical devices
- Increases productivity, profitability, and quality of products
- Global recognition of your business
- Effective quality management system
- Better workplace
- Ensures employees’ safety
- Good leadership practices
- Also, helps meet applicable statutory and regulatory requirements for your business
IAS – the top-searching ISO certification body in Germany
Integrated Assessment Services (IAS) is a leading globally recognized ISO 13485 Certification Body operating in Germany and other major EU countries, which is accredited by Universal Quality Accreditation Services (UQAS). IAS is predominant in auditing the client companies for their business growth and development since 2006.
IAS is incorporated in 7 major countries and operating its associates in 14 more countries under the guidance of IAS-INDIA.
We offer ISO 13485 Certification throughout the EU countries with the help of qualified auditors and technical expertise. We also act as a consultant for the organizations to implement ISO certification procedures to successfully get certified.
IAS also offers ISO management system certifications against ISO 14001, 27001, 50001, 22301, 22000, etc. Furthermore, we provide product certifications such as CE Marking, GOST-R, Green, GOST-R, Kosher, Halal, BRC, cGMP, etc.
What are the procedures to achieve ISO 13485 Certification?
- At first, Make an Enquiry in our website or contact us by telephone based on your country/region.
- Download and fill the application form and email firstname.lastname@example.org.
- After reviewing your application, the certification audit process will begin.
- IAS will come out with the audit plan based on the scope submitted by your organization to conduct audits.
- Stage 1 audit includes the document review and site visit
- After the completion of the audit, IAS will provide audit reports with a deviation report (if found any deviation).
- Stage 2 audit verifies the effective implementation of ISO 13485
- The time duration for NC closure between 60-90 days.
- After successfully implementing the non-conformities, IAS will issue the ISO 13485 certificate which is valid for 3 years.
- IAS also conducts a surveillance audit every 12 months from the date of initial certification and as well as the re-certification audit after the validity of the initial certification is over.