ISO 13485 Certification
About ISO 13485
ISO 13485 is a specific quality management system for medical devices. The standard can be used by an organization in one or more stages of the life cycle of a medical device. Moreover, the standard requires the suppliers and other external parties which gives services to such organizations come under the standard requirement. 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 the consistent design, development, production, installation, and delivery of medical devices that are safe for their intended purpose. ISO 13485 Certification is a representation of the organization with high-quality medical devices and equipment. Regardless of its size, the certification is applicable to all the organizations that supply medical devices. It helps to satisfy the legal requirements and to meet the international standards.
Benefits of ISO 13485 Certification in business:
- Improves customer satisfaction
- Increase in productivity, profitability, and quality of products
- Global recognition of your business
- Effective quality management system
- Better workplace improves communications between employees and their job security
- Good leadership practices
- Meets applicable statutory and regulatory requirements for your business
Certification body IAS
Integrated assessment services(IAS) is a leading globally recognized ISO 13485 Certification Body in France and various locations across all over the world especially India, Malaysia, Singapore, Indonesia, Thailand, Philippines which are accredited by Universal Quality Accreditation Services(UQAS).
Also, we audit companies for ISO certifications in France by experienced and qualified auditors for effective implementation of ISO 13485 Certification in organizations,
Moreover, we are also offering internal & lead auditor training programs in various ISO management standards and product certification such as CE Certification, KOSHER GREEN, HALAL, ROHS, VAPT, GOST-R, BRC throughout the country and as a consultant for the organizations to implement ISO certification procedures and helps them to successfully get certified.
Procedure for ISO 13485 Certification:
- At first, Make an Enquiry in our website https://www.iascertification.com/contact-us/ or contact us by telephone based on your country/region.
- Download and fill the application form from our website and email info@iasiso.com, our representative will contact the organization for further procedures.
- After reviewing your applications, the certification audit process will begin.
- Our ISO 13485 Certification audit includes 2 stages.
- Stage 1 Audit: Readiness Audit(document review, site visit)
- Stage 2 Audit: Verifying the effectiveness of the fulfillment of ISO 13485.
- Based on the scope mentioned in the application form submitted by your organization, IAS initiates the ISO 13485 certification process for your company.
- IAS will come out with the audit plan to conduct audits.
- IAS team provide detailed audit report with a deviation report after the completion of an audit (if any deviation is noted during the audit)
- The time duration for NC closure between 60-90 days.
- Therefore, the corrections and corrective actions are reviewed and approved by the IAS audit team.
- Finally, the certificate of ISO 13485 issued with a validity of 3 years.
- After certificate issued, a surveillance audit will conduct by IAS-certification body every 12 months from the date of initial certification.
- IAS certification team also will plan and conduct the re-certification audit after the validity of initial certification is over.
- For instance, the organization has failed any terms and condition of IAS, the certificate will be suspended with prior notification