Manuals, procedures, guidelines and forms are created in eiso's "Management System Establishment" and kept in the designated folder on your computer (recommended: AI Management System\00_Documents). This step reads that folder to build a document list, identifies the latest version (current version) among several versions of the same document and organizes the revision history, and tells you the related reference documents for each of the 16 step processes. It does not write new documents; missing mandatory documents are passed on to Management System Establishment to be written.
Output
- AIMS document list (Excel): document number · name · type · current Rev · revision date · approval · file location · related process · status (current, approval to be confirmed, inconsistent notation) / cleanup of old-version and duplicate files
- Reference documents by process: for each of Steps 1 to 16, the procedures, guidelines and forms that serve as the basis of that work (number, current Rev), check of required documented information (7.5.1), and the list of documents of external origin
- Revision history, rules for documented information control, and what to prepare in Management System Establishment
What to do in this step, by scope of application
| Development | Supply | Use |
|---|---|---|
| Confirmation of the current Rev and approval of model, data and verification technical documents (A.6.2.3·A.6.2.7), and the reference documents for the development procedure | Current versions, distribution and revision of user documentation, usage instructions and notices (A.8.2), and records of provision to customers | Current Rev, storage location and access control of usage guidelines, approval records, operational control registers and the original text of instructions |
Next steps
Previous steps: 1 AI Context Analysis · 2 AI Policy, Roles and Objectives · 4 AI System Inventory · 5 AI Risk Assessment · 6 AI System Impact Assessment · 7 Control Implementation and Statement of Applicability (SoA) · 8 Verification and Use Approval · 9 Operational Control · The results of this step feed into: 1 AI Context Analysis · 2 AI Policy, Roles and Objectives · 3 AI System Selection · 4 AI System Inventory · 5 AI Risk Assessment · 6 AI System Impact Assessment · 7 Control Implementation and Statement of Applicability (SoA) · 8 Verification and Use Approval · 9 Operational Control · 11 Monitoring, Change and Revision Control · 12 Internal Audit · 13 Legal Requirements Identification and Monitoring · 14 Management Review · 15 Nonconformity and Corrective Action · 16 Improvement

