ISO 9001 Consulting
QMS Process Variables
| QMS Variable | Variable Attributes |
| Materials | – Raw materials, wip, & finished goods – Inventory management – Non production materials & supplies – Inspections & Tests – Standards & Specifications – Supplier Management – Identification & Traceability – Handling & Preservation |
| Machine | – Production equipment & technology – Engineering & support – Inspection, measuring & test equipment – Tools, dies & fixtures – Maintenance & supplies – Equipment layout |
| Manpower | – Skills, knowledge & experience – Training – Responsibility & Authority – Motivation & Morale – Adequate staffing – Health & Safety |
| Mileu/
Environment |
– Building & facilities – Environment controls – HVAC and other utilities – Housekeeping, health & safety – Lighting, air quality & noise – Contingency/emergency measures |
| Methods | – Systems & Procedures – Inspection & Tests – Quality Plans & Checklists – Work Instructions – Bill of manufacture/assembly – Technology/automation – Process flowcharts – FMEA’s & process controls – Drawings & blueprints |
| Measurement | – Objectives/tracking/review/improvement – Standards/codes/regulations – Specifications/tolerances/criteria/tolerances – Operational data/statistics/SPC – Efficiency & effectiveness – Customer Satisfaction – Bench-marking |
| Management | – Leadership & Planning – Policies & Objectives – Commitment & involvement – Organization & resources – Follow-up & review – Communication |
| Markets | – Market share & penetration – Customer base – Channels of distribution – Market analysis & trends – Pricing & product positioning – Product/service range – Competition – Opportunities/challenges |
ISO 9001 Consulting-What are process variables?
How To Use These QMS Process Variables:
- Determine which of these process variable in the left hand column apply for each process identified in your QMS.
- Determine which of the variable attributes in the right hand column apply to that process variable (Reference the applicable QMS standard – ISO 9001; TS
16949: etc.)
- Implement appropriate controls for each of the variable attributes you have selected and verify their
effectiveness.
For more information on process variables and their controls, check out the eCourse “Understanding ISO 9001:2015“
ISO 9001 Consulting eCourse