ISO 13485:2003 Requirements that overlap with ISO 9001

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Presentation transcript:

ISO 13485:2003 Requirements that overlap with ISO 9001 APPLICABLE RECORDS

ISO 13485:2003 Requirements that overlap with ISO 9001 APPLICABLE RECORDS

RECORDS IN MEDICAL DEVICE SECTOR* ISO 13485:2003 RECORDS IN MEDICAL DEVICE SECTOR* *RECORDS IN MEDICAL DEVICE SECTOR: More records may be applicable depending on Regional, National, International, product type or industry sector requirements

RECORDS IN MEDICAL DEVICE SECTOR* ISO 13485:2003 RECORDS IN MEDICAL DEVICE SECTOR* *RECORDS IN MEDICAL DEVICE SECTOR: More records may be applicable depending on Regional, National, International, product type or industry sector requirements