ISO 13485 vs. CFR820 White Paper

Elite vs cGMP (per ISO 13485 & CFR 820) X=required

  A B C D
Requirements ISO 9001 cGMP cGMP cGMP
Standard / Regulation Elite 13485 13485 CFR 820
Application Dx Raw Mtrl Non-IVD components / reagents
Medical Device /
IVD for EU market
Medical Device / IVD
for USA market
Compliance / Registration Registrar selected
by organization
Certification Body selected by organization Cert Body + Authorized
Rep &/or Notification
Body (Risk dependent)
USA FDA
Facility Registration X X X X w/FDA
Product Regulatory Registration _ _ Depending upon device risk category, CE Mark may require notification body # Depending upon device risk category, 510K/PMA may be required
Application Dx Raw Mtrl Non-IVD components / reagents Medical Device / IVD for EU market Medical Device / IVD for USA market
Compliance / Registration Registrar selected by organization Certification Body selected by organization Cert Body + Authorized
Rep &/or Notification
Body (Risk dependent)
USA FDA
Facility  Registration X X X X w/FDA
Product Regulatory Registration _ _ Depending upon device
risk category, CE Mark may require notification body #
Depending upon device
risk category, 510K/PMA may be required
Approved Finished Good Specification X X X X
Approved Raw Material Specification X X X X
Approved Intermediate Specification X X X X
Approved Analytical Methods X X X X
Release of final product by QC X X X X
OOS investigation led by QC X _ _ _
Release final product by QA (QA sig on CofA) _ X X X
Verified Analytical Methods and Specifications X X X X
Statistical Quality Control (SQC) Recommended, not required
Retest Date or Expiry Period using shipping stock X _ _ _
Stability study (Accelerated & long-term) storage
conditions
_ X X X
Stability study shipping conditions _ X X X
Master production procedure/record X X X X
Master packaging procedure/record w/batch traceability
to ea. bulk container & primary pkg components batch #s
X X X X
Label Master content in SAP only X _ _ _
Label Master content in SAP, controlled by QA using LTF _ X _ _
Label Master Control by QA using LTF for multi-lingual
text, Ar. Rep address and IVD symbols (non-SAP)
_ _ X X
Batch Record Review including label by QA X X X X
Critical Process Parameters determined X X X X
Risk Assessment (i.e. PFMEA) X X-Per ISO 14971 current version
Process Verification X _ _ _
Process Validation (where the resulting output cannot be
verified by subsequent monitoring or measurement)
_ X X X
Retainer Management of final product X X X X
Primary packaging component specifications X X X X
Inspection and Release of Primary packaging component X X X X
Assessment of deviation/nonconformance by QA/MRB X X X X
Assessment of change (MOC) requires QA approval X X X X
Reprocessing per approved work instruction X X X X
Reworking Only w/prior approval by
a Q_principal
_ _ _
Certificate of Analysis X X X X
Certificate of Origin X X Not required unless contains material
derived from bio-source
Risk Management Checklist / Approval Record X
(16422)
  X
(to be created)
Risk Assessment Packet (only upon customer request) X
(23427)
X
(23427)
   
Information for Use (IFU) sheets _ _ X X
Technical File (CE mark) / Device Master Record _ _ X X
Design records per ISO 9001 X _ _ _
Design records w/Risk Assessment (i.e. DFMEA) _ X-Per ISO 14971 current version
Special/specific dress/gowning (i.e. hair nets, no jewelry,
etc.) required to protect product
Recommended, not required X X X
Job specific training X X X X
GMP (ISO 13485/14969) training _ X X X
Calibration X X X X
Preventive Maintenance X X X X
Software Validation _ X X X
Equipment Validation (IQ/OQ) _ X X X
Cleaning procedures and verification X X X X
Cleaning validation _ X X X
Facility Water quality w/specs & monitoring X X X X
Distribution location meets Good Distribution Practices _ X X X
Material Storage areas (Zones mapped, temperature
controlled, backup power & monitored)
_ X X X
Controlled Distribution: only in those countries final
product registered w/local health authorities
_ _ X X
Distribution (temp monitoring during shipping),
excluded if shipping stability study data available)
_ X X X

For vendor qualification requirements see: PROC-GLOB-POL-024275
For appropriate qualifier/extended name suffix statements see: PROC-GLOB-REF-023112
For appropriate label disclaimer/usage statements see: PROC-GLOB-POL-000372

Materials

     
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