Why ICS?
In today’s business climate, medical device manufacturers have realized that ISO 13485 quality management systems certification and registration can add real value to their organizations. Rather than just a simple checklist, the auditing process can help highlight weaknesses as well as strengths, which a llows companies to continually improve their processes to stay competitive. ICS works with our clients to understand their business and unique practices to ensure our clients get the most o ut of the auditing process.
ICS also offers services and benefits that other registrars don't, like:
- Dedicated Account Managers - An Account Manager is assigned to each client to provide a single point of contact.
- SWOT Anal ysis - A SWOT analysis is available with every audit which describes real strengths, weaknesses, opportunities, and threats in terms executive management can understand on top of the audit report which generally only explains compliance to various parts of the ISO standards.
- Client Portal - A secure client portal is available to house client documents such as audit plans, reports, and certificates for 24-hour access.
- Vibrant Auditor Mentoring & Customer Satisfaction Process - The professionals delivering audits are key to our success. We obtain our Clients' feedback on each auditor and work hard to incorporate our Client's improvement suggestions.
Our Auditing Approach
Our experienced and highly-skilled auditors are enthusiastic about their work and come to your company with a fresh perspective. They take the time to listen and understand your business so they can add value throughout the auditing process. We work together as partners with our clients to ensure audits are as efficient as possible to minimize any disruption during the audit. During each audit, we strive to reveal observations that can add value through reduced costs, increased efficiency, and decreased time to market.
What is ISO 13485?
ISO 13485 is an ISO standard, published in 2003, that represents the requirements of a comprehensive management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996 and ISO 13488 (also 1996).
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A fundamental difference, however, is that ISO 9001 requires the organization to demonstrate continuous improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Other specific differences include:
- The promotion and awareness of regulatory requirements as a management responsibility
- Controls in the work environment to ensure product safety
- Focus on risk management activities and design transfer activities during product development
- Specific requirements for inspection and traceability for implantable devices
- Specific requirements for documentation and validation of processes for sterile medical devices
- Specific requirements for verification of the effectiveness of corrective and preventive actions
Compliance with ISO 13485 is often seen as the first step in achieving compliance with European regulatory requirements. The conformity of Medical Devices and In-vitro Diagnostic Medical Device according to EEC-decrees 93/42/EEC, 90/385/EEC and 98/79/EEC must be assessed before sale is permitted. The result of acquiring ISO 13485 is authorization for CE-identification and permission to sell the high quality medical device in the European Union. |
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