ISO 13485 is a highly coveted and important certification that companies earn by passing a stringent yearly audit with specific requirements in regards to translations for the Medical Device Manufacturing industry. The audit centers on the requirements for a comprehensive quality and risk management system (QMS) to be implemented based on a series of steps comprising best practices for translations in this key industry.
A quality management system (QMS) is a collection of business processes focused on achieving your quality policy and quality objectives, what your customer wants and needs. It is expressed as the organizational structure, policies, procedures, processes and resources needed to implement quality management.
The International Organization for Standardization (ISO) standard is well known and respected standard and is considered the benchmark in this area. It was first established and published in 2003, and is tailored to the industry's quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard. While it remains a stand-alone document, ISO 13485 is generally harmonized with the ISO 9001.
ISO 9001 is a more overall general company certification which centers on the quality control formation and maintenance of a comprehensive quality management system. This system is used within all of the major departments within a company structure. The certification ensures that best practice are met and that processes are developed and maintained in a consistent and transparent way for monitoring, tracking and evaluation purposes.
The ISO 9001 requires that an organization demonstrate continual improvement, whereas ISO 13485 requires only that the certified organization demonstrate the quality system is effectively implemented and maintained.
Additionally, the ISO 9001 requires a customer services feedback and monitoring system is kept in regards to customer satisfaction. This system is used as a benchmark to measure results from year to year. This ensures that issues that arise are handled in systematic way be identifying the root causes and solutions are implemented with the emphasis on continual systems improvements.
A yearly audit is also performed to review the quality management system and to ensure processes are maintained monitored and improvement is demonstrated.
American Language Services is proud to work with SAI Global for many years. They assist us with our process and documentation improvements and yearly ISO Audits, which are part of the ISO accreditations process.
About SAI Global:
SAI Global is a worldwide leader and provider of quality management systems certification and supplier assessments. They help organizations manage risk, achieve certification and drive business improvement by providing training courses, registration audits, and supplier management programs. SAI Global, has an extensive network of auditors is strategically located to provide better local service in any North American market and also to serve your registration needs globally.
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