EN 46001 Quality Manual Review Checklist

Report no. ______Appendix Assessor: ______Date: ___ / ___ / ___ Page no. 1 of 4

4 Quality system requirements Location, comments A N

Document title: Document number: Revision level: Date of release:

MD medical devices IMD implantable medical devices SMD sterile medical devices AIMD active implantable medical devices

4.1 Management responsibility of 9001 applies ------4.2 Quality system of 9001 applies ------4.2.1 General, …procedures… of 9001 applies ------All MDs: ------…document specified requirements… …regulatory requirements… 4.2.2 Quality system procedures of 9001 applies ------All MDs: ------…technical files… 4.3 Contract review of 9001 applies ------4.4 Design control of 9001 applies ------4.4.4 Design input of 9001 applies ------All MDs: ------…safety requirements… 4.4.7 Design verification of 9001 applies ------All MDs: ------…maintain records… 4.5 Document and data control of 9001 applies ------4.5.2 Document and data approval and issue of 9001 applies ------All MDs: ------…one copy of obsolete. documents… …define lifetime of devices… …reference to 4.16… 4.6 Purchasing of 9001 applies ------4.6.3 Purchasing data of 9001 applies ------All MDs: ------…document retention for traceability… Reference to 4.8 Reference to 4.16 4.7 Control of customer-supplied product of 9001 applies ------4.8 Product identification and traceability of 9001 applies ------All MDs, a) Identification: ------EN 46001 Quality Manual Review Checklist

…segregate material for refurbishing… All MDs, b) Traceability: ------…procedures for traceability… Reference to 4.14.2 AIMDs: ------…extent of traceability…all components… 4.9 Process control of 9001 applies ------All MDs: ------A) Personnel: ------…requirements for cleanliness… B) Environmental control for …devices when: ------a) …supplied sterile… b) …supplied non-sterile for st. before use… c) …microbiological…particulate cleanliness d) …environmental conditions… …establish and document … environment …conditions controlled and monitored… C) Cleanliness of product ------Documented requirements for cleanliness, if ------a) …product cleaned prior to sterilization b) …supplied non-sterile to be cleaned prior to sterilization c) …supplied non-sterile and cleanliness is of significance d) process agents to be removed D) Maintenance ------Reference to 4.16 E) Installation ------Reference to 4.16 F) Special processes, records to contain: ------a) work instructions, b) date c) operator ID SMDs: ------…subject devices to validated … process Reference to 4.16 4.10 Inspection and testing of 9001 applies ------4.10.5 Inspection and test records of 9001 applies ------AIMD & IMD: ------…record ID of personnel EN 46001 Quality Manual Review Checklist

Reference to 4.16 4.11 Control of inspection, … equipment of 9001 applies ------4.12 Inspection and test status of 9001 applies ------4.13 Control of nonconforming product of 9001 applies ------4.13.2 Review and disposition of NC product of 9001 applies ------All MDs: ------…acceptance by concession..if regs met Reference to 4.16 …re-work instruction authorization 4.14 Corrective and preventive action of 9001 applies ------4.14.2 Corrective action of 9001 applies ------All MDs: ------…documented feedback system… …post-marketing surveillance… …all input investigated… …rational for no CA complaints… …regulatory authority notification… …procedures for recall… 4.15 Handling, storage, packaging, … of 9001 applies ------4.15.1 General, …procedures… of 9001 applies ------All MDs: ------…control product with limited shelf life… …or special storage conditions… …handling of used product… 4.15.4 Packaging of 9001 applies ------SMDs: …procedures for: ------a) …container maintains sterility… b) MD can be presented in aseptic manner… c) …package reveals that it was opened… AIMDs & IMDs: ------ID personnel on final labeling operation… 4.16 Control of quality records of 9001 applies ------All MDs: ------...retention => lifetime… but >= 2 years DHRs… Reference to 4.8 4.17 Internal quality audits of 9001 applies ------4.18 Training of 9001 applies ------All MDs: ------...special processes training or supervision… EN 46001 Quality Manual Review Checklist

4.19 Servicing of 9001 applies ------4.20 Statistical techniques of 9001 applies ------4.20.1 Identification of need of 9001 applies ------All MDs: ------...regular review of sampling methods…

Manual broadly meets requirements of the EN 46001 (2) standard yes  no 

Rev. 10, 041198