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We are a small engineering/manufacturing firm that produces devices and software for several markets, including medical. We are about to apply for ISO 13485 certification, and are implementing a Quality Management System. Current and future products will be covered from initial design to end-of-life by the QMS. This, of course, is not true of older products, even though they are still being sold.
Can anyone provide some guidance on how to deal with products designed prior to ISO certification? Can they be "retrofitted" to become compliant with ISO standards? Note that in most cases, these legacy products are missing documents and records that our QMS specifies, and which would be difficult to reproduce.
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Steve Matthews
Manager, Technical & Quality Communications
Can anyone provide some guidance on how to deal with products designed prior to ISO certification? Can they be "retrofitted" to become compliant with ISO standards? Note that in most cases, these legacy products are missing documents and records that our QMS specifies, and which would be difficult to reproduce.
--
Steve Matthews
Manager, Technical & Quality Communications