EN 46001 Quality Manual Review Checklist

EN 46001 Quality Manual Review Checklist

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:

MDmedical devicesIMDimplantable medical devices

SMDsterile medical devicesAIMDactive 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: / ------
…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
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…
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) standardyesno

Rev. 10, 041198