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Quality Management System Documentation. Introduction Advantages of QMS documentation Organizational format of Traditional QMS Translation of ISO element to company manual Future of QMS. QMS Documentation. Advantages of Documented QMS Clear, concise statement to all (policies, duties, etc)
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Quality Management System Documentation Introduction Advantages of QMS documentation Organizational format of Traditional QMS Translation of ISO element to company manual Future of QMS
QMS Documentation Advantages of Documented QMS Clear, concise statement to all (policies, duties, etc) Consistent information to all (standardization) Uniform understanding of coy’s ops, resulting in consistency of action (process control) Easily distributed (controlled copies) Facilitate mgt change, revised, update (implementation) Permanence of approach ( Reduce learning curve (job rotation) Monitoring system (benchmark & yardsticks)
QMS Documentation Traditional Documentation format Setting out 3 or 4-tier format (forms and records from separate tier) Example of 4-tier Tier1 Quality Manual (objectives, policies, philosophies) Tier2 Procedures Manual (purpose, scope details 5W+1H Tier3 Job instructions (standard/specific work instructions) Tier4 Forms & Records
QMS Documentation Tier 1 – The Quality Manual Summary of coy’s general practices, definition of policies, objectives & organizational structure Overall picture of quality system, used as marketing tools and given to clients as information of staff/mgt duties. Tier 2 – Procedures Allocation of duties and responsibilities of activities Tier 3 – Instructions Tier 4 – demonstrates achievement, filling & retrieval system, use of std, pro-forma insp. checklists
QMS Documentation Typical Quality records
QMS Documentation Typical Quality records
QMS Documentation Typical Quality records
QMS Documentation Written documentation- ISO 9001 clause 4.1.3 –Management review “The supplier’s management with executive responsibility shall review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirements of this….Standard Record of reviews shall be maintained 4.16” Management review example from notes Management review example from Construction coy manual
QMS Documentation Future Direction of QMS Trend from multi-vol. format to 1 vol. Format Simplified system that address needs of coys New format allows processes to suit knowledge of users Requirements interpreted to coy operations Time and costs reduced Able to be design according to better level of maturity
QMS Documentation Questions List and explain 5 advantages of having a documented quality management system What is the difference between the format of a 3-tier and 4-tier traditional QMS? Explain the purpose and content of the 4 tiers of a traditional QMS How is the traditional QMS normally structured and how would the 4-tiers of the system be accommodated in the structure?