1. Documentation of a Quality Management System Viki Massey Quality Coordinator A Joint Venture of London Health Sciences Centre and St. Joseph’s Health Care London

2. Hierarchy of Documents Level “A” – Policies – What to do Level “B” – Processes – How it happens Level “C” – Procedures – How it’s done Others – Forms – Records

3. Policy (Level A) Development Audience – Management – Assessors – New Employees Address “Big Picture” – What are we about? – Why do we do what we do? Address Key Elements

4. Process (Level B) Development Audience – Management – Assessors – Staff – Process Improvement Teams Address the path of workflow Describe how things happen here

5. Process Development Generally Flow Charts or Table Benefits of Flow Charts: Identify essential steps Shows dead ends Redundancies Identify overly complex flows Identify responsibility

6. Procedure Development Audience – Assessors – Staff Address specific steps Layout that enables the user to perform task correctly

7. Document Management Document Control – Document organization Document Development – New documents and changes to existing documents

8. Document Control Master index Master file Document numbering / revision Distribution Archiving

9. Document Numbering Purpose of numbering – Unique identifier – Quick cue to the content of the document Chem-qseIMP-B-1234 rev 03 Lab – QSE – Level – Number - Revision

10. Document Distribution Electronic vs. Paper Distribution Electronic – determine accessibility by individual, department – Read / Write access Paper – Official copies only – Location of binders – Updating copies

11. Document Archiving Electronic vs. Paper Electronic – ability to do an electronic comparison Paper – Storage – Organization

12. QMP-LS Quality Manual Instructions Policies Usually 1 volume Electronic or paper Easy to update Available / used by all personnel Maintained by quality manager Will be validated during assessment

13. QMP-LS Quality Manual Content Description of laboratory Quality policy statement Laboratory policies (may include processes) References to supporting process and procedures Reflect actual practice

14. Quality Manual Review Prior to each assessment visit, labs submit a copy of their quality manual to QMP-LS QMP-LS will assess the physical aspects of the manual (i.e. table of contents, introduction, glossary etc) QMP-LS will conduct a pre-assessment of the facility’s policies as defined by the requirements. A report will be provided for the benefit of both the facility and the OLA assessment team to highlight those areas for which further information or validation is sought.