Quality Management System The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties. A few steps to ISO 9001 certification:
- Application/Enquiry Submits the application form to Inspeed Global (Application for Certification)
- Review of Application Inspeed Global reviews the application to check if the requisite services can be provided and accordingly prepares the quotation/ estimate and the contract (Certification audit contract).
- Audit planning Once the contract is signed, Inspeed makes the audit program and inform the client
- Assessment Initial certification includes two stages assessment. Recertification includes only one stage. The assessment is carried out by the team at the sites against the applicable criteria. The report is provided to client identifying the compliance level including any nonconformities.
- Verification of Non-conformities Client submits the implemented or proposed action based on the classification of non-conformity. Inspeed reviews the actions.
- Certification Decision Inspeed takes certification decision based on the report submitted by the audit team. If decision is in favor of grant of certification, a Certificate is Issued to the client (see sample certificate)
- Surveillance assessment Surveillance assessment are held as per the periodicity defined and agreed. First surveillance within 12 months from the date of the stage 2 audit. Certificate is maintained based on the outcome of the surveillance audit and compliance with the requirements.
- Recertification Before expiry of the certificate, recertification is planned and conducted
Medical Devices- QMS
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
The ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS. Adopting ISO 13485 provides a practical foundation for manufacturers to address the Medical Device Directives, regulations and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.
What are the benefits of being certified to ISO 13485?
Whether you are looking to operate internationally or expand locally, ISO 13485 Certification can help you improve overall performance, eliminate uncertainty, and widen market opportunities. Companies with this certification communicate a commitment to quality to both customers and regulators.
Increase access to more markets worldwide with certification.
Outline how to review and improve processes across your organization.
Increase efficiency, cut costs and monitor supply chain performance.
Demonstrate that you produce safer and more effective medical devices.
Meet regulatory requirements and customer expectations.