ISO 13485
You need a trusted auditor for your (Medical Device/ Pharmaceutical) certification. Choose Smithers Quality Assessments (SQA) for personal, expert assessment services, tailored to your business needs.
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ISO 13485 was established in 2003 as an international standard for the design, manufacture and distribution of medical devices. While compatible with the quality management standard ISO 9001, ISO 13485 requires proof of implementation and maintenance, but not continuous improvement.
SQA offers ISO 13485 certification to organizations worldwide. Companies achieving ISO 13485 certification benefit from:
- enhanced safety controls in the work environment
- documentation for preventive and corrective actions
- alignment with FDA and other regulatory regulations
- improved products and services
- enhanced communication with suppliers
An audit performed by SQA resulting in ISO 13485 certification provides your business:
- Clear and well-communicated best practices for design, manufacture and distribution of medical and pharmaceutical devices
- Established supplier quality, implementing a process that facilitates supplier quality programs
- More consistent auditing performance.
Why choose SQA as your ISO 13485 auditor?
SQA has a “No Surprises” philosophy that reduces the uncertainty of the ISO 13485 standard. By becoming an integral part of your team, and providing you with easy-to-follow ISO 13485 audit checklists and worksheets, we get to know your business and help you thoroughly prepare. This reduces stress, helps facilitate the certification process and maintain your certification status.
We maintain open communication with you throughout the entire process. We welcome your feedback and discussion in an objective manner.
Our proprietary certification process is designed to provide objective, value-added feedback on your business performance. Our auditors also are required to pass an industry competency test, which ensures you have the most knowledgeable auditors working to help you with the ISO 13485 certification process.
At the end of the assessment, we conduct a closing meeting where findings, recommendations and improvement plans (if necessary) are discussed. If the audit is successful, you receive your ISO 13485 certification, followed by surveillance and renewal activities to ensure maintenance.
Call SQA today to discuss your ISO 13485 auditor needs. You also can transfer your certification to SQA. Contact us at 330.762.4231 today!