The ISO 13485 standard is intended for organizations in healthcare, such as manufacturers or service and product suppliers. It combines ISO 9001 requirements with specific requirements for the healthcare and medical industry. It focuses on regulatory and legislative requirements, controls, assessments, and tests. It includes requirements for corrective and preventive action verification.
Certification ISOCA - ISO 13485
IAF certificate valid for 3 years. Your company will be listed among the certified companies, and you will receive the certificate in a presentation frame with a label for your store.
You can publish this certificate on your website in .pdf format or as a logo.
ISO 13485 Documentation for Your Company
The documentation includes over 20 customized documents that you will use when implementing the ISO standard. Through this documentation, you will establish new processes and gain a different perspective on your company.
ISO Audit and Report
Our ISOCA auditor will help you set up the ISO 13485 process, and the auditor's report will evaluate your company.
Current Publication - Healthcare Facility Management Systems STN EN ISO 13485
This publication will assist you in adhering to ISO standards throughout your business's operations. Implementing the standard leads to process improvement in your company, ultimately resulting in increased company profits.