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ISO 9001 Process Variables

Everything You Need To Know About ISO 9001 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

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
This page is a good summary of any QMS standard!!

Where can I get further help?
This article is an excerpt from my eBook, “Understanding ISO 9001:2008”. This book provides a complete and in-depth coverage of all ISO clause requirements and well as key quality management principles and concepts. It is an excellent guide for QMS development, maintenance or improvement.

Need Training or Consultancy help?
Ask Art Solutions has significant expertise in all of the implementation steps and can help you fast track your way to an effective and profitable QMS.
If you need help in developing or implementing your ISO 9001:2008 QMS, please call us at 905-593-8867 for a no obligation review of your needs.

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