Basic Quality Awareness
ISO 9001:2015
Quality Management System
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• Introduction of ISO 9001:2015• Why ISO 9001:2015• Quality – benefits / risks / cost• Waste factors• ISO Structure• Mandatory requirements• Implementation stages• Certification bodies• Certification process
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Content
What is ISO?
ISO = Greek meaning ‘equals to..’• International Organisation for Standardisation
• Based in Geneva, Switzerland• Symbol
• structure• quality • assurance• competitive edge • confidence
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What do they do?
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Write up standards for
the world
What is ISO 9000 Series?
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• A set of terms and definitions• ISO 9000:2015
S A set of guidelines of requirements to establish a QMS
• ISO 9001:2015
S A set of guidelines for continuous improvement• ISO 9004:2015
What are these requirements?
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S A set of guidelines of requirements to establish a QMS
• ISO 9001:2015
• Requirements examples
• licenses so we can use our cars• taxes• UIF• rates / lights / water
• ISO 9001 too has requirements• however, not legislated
What are these requirements? cont…
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S A set of guidelines of requirements to establish a QMS
• ISO 9001:2015
PoliciesProcedures
Work InstructionsDocumentation
RecordsMandatory
requirements
What is ISO 9001:2015?
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• ISO 9001 - international • standard that has specific requirements
for a QMS.
• Consistency and assurance
• meet or exceed expectations• regulatory and statutory requirements• company obligations
• not specific to any one industry or size
What is ISO 9001:2015…?
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• 2015 = the year the standard came into effect (current)
• Previous version = ISO 9001:2008
• Prior = ISO 9001:2000
• Before = ISO 9001:1994
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Some Quality Quotes
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Avoiding Defects
DON’T
Accept Build Ship
DEFECTS
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Good Quality Brings…
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Benefits of ISO 9001:2015
• Enhances customer satisfaction• Improved productivity and efficiency• Elimination of waste• Reduced cost and increased savings• Increased profitability• Acquire new skills• Boost staff morale• Gain a competitive advantage
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8 Wastes
T R I M W O O D TRI
MWOOD
T r a n s p o r t a t i o n
I n v e n t o r yM o t i o nW a i t i n gO v e r – P r o d u c t i o nO v e r – P r o c e s s i n gD e f e c t s
R e s o u r c e s
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Poor Quality - Different Forms
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Cost of Rework?
Cost of the Wall Cost of Rework
Price Increase??? Fuel, material, etc
What we built
What we supposed to build
Whats wrong here?
Please note!!! Numbers are fictitious
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Risk of Poor Quality?
S Reputational damageS Rework / more materialsS Time and labourS Customer complaintsS Low self-esteemS Increased transport costS Uncertain future S Lost confidenceS Unhappy managementS Additional costS Time is money
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Why ISO 9001:2015?
QA and customer satisfaction
Processes for improvement(efficiencies /
productivity / waste)
Conformity to applicable statutory
and regulatoryrequirements
Process driven /approach – meet
company requirements
Identify risk and opportunities
Reduce cost
Continualimprovement(cost savings /
systems/processes)
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• Continual improvement
• Employee involvement
• Customer focus
• Leadership
8 Principles of Quality Management
• Process approach
• Systematic approach for management
• Mutually beneficial supplier relationship
• Factual approach to decision making
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How / What to Consider?
Conduct a Gap Analysis ( Internal Audit)
Interview / talk to stakeholders
Management Review
Checklist
Minutes
Risk Based Thinking
Register
Business Plan
SMART
Objectives and Targets
Controls
Objectives and Targets
Continual Improvements
Non-conformances
Opportunities
Register
Training
Policies / Procedures
Work Instructions
Register
Minutes Register
Objectives and Targets
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ISO 9001:2015 in a nutshell
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ISO 9001:2015 in a nutshell
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ISO 9001:2015 – P D C A
Start’s H
ereEnds Here
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Mandatory Documents and Processes
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Mandatory Documents and Processes
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Mandatory Documents and Processes
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Implementation Stages
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Certification Bodies??
Bottom line Consider cost
Technischer Überwachungsverein(Technical Inspection Association)
Société Générale de Surveillance(General Society of Surveillance)
Deutsche Gesellschaft zur Zertifizierung von Managementsystemen (DQS)
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Certification Process
Contact CB for Quotes
• Compare cost
CB Selection – determine
dates
• Arrange Stage 1 Audit (pre-processes
Complete Gaps (if any)
– Stage 2• Submit plan
Get Certified
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How Long Does Certification Take?
• Depends on organisation• Commitment and availability• Complexity• Size• Industry• Resources
• Could be anything from 4 months onwards • small company - < 20 staff – 4 to 6 months
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The End – Thank You
Any Questions???