Hi everyone,
Many suppliers (e.g. PCB manufacturers) are ISO 9001 qualified. However, this does not exactly meet the requirements of a medical device company that requires their high risk suppliers to be QMS certified to ISO 13485. Without ISO 13485 certification, how can we ensure these ISO 9001 suppliers to meet a medical company's quality requirements? Exercise 100% inspection and frequent audits?
Many suppliers (e.g. PCB manufacturers) are ISO 9001 qualified. However, this does not exactly meet the requirements of a medical device company that requires their high risk suppliers to be QMS certified to ISO 13485. Without ISO 13485 certification, how can we ensure these ISO 9001 suppliers to meet a medical company's quality requirements? Exercise 100% inspection and frequent audits?