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Despite the fact that working within an outdated, worn-out quality system feels tedious, time-consuming and redundant, many medical device companies are hesitant to modify it.
The ISO 9000 quality system is set by the International Organization for Standardization and contains universal standards for a quality assurance system that ensures uniform specifications and products.
For example, Ford, Chrysler and General Motors have agreed to include the complete ISO 9000 Standard in their supplier quality system requirements, but have expanded many sections.
Furthermore, it assures the quality system is maintained and effectively implemented.
Most important, many managers insist the process of creating, documenting and establishing the controls for a quality system actually is a catalyst for improving quality.
When the manual has been reviewed, on-site inspection of the manufacturing facility takes place to verify that the described quality system is in place, procedures are being followed with proper documentation, and that the end-product or service meets customer requirements.
In a preliminary needs assessment of the business, the team focused on the quality system as the key to future improvements.
QS-9000 specifically states that suppliers are responsible for developing the quality system of their vendors.
The new standard not only has adopted ISO 9001 in its entirety but has added interpretations and supplemental quality system requirements, along with common and customer-specific demands.

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