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Documentation of a Quality Management System

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. Hierarchy of Documents. Level “A” – Policies What to do Level “B” – Processes How it happens Level “C” – Procedures

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Documentation of a Quality Management System

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  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.

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