iso 9000 - 2008 - awareness training
Post on 01-Dec-2014
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Presented byPresented by
DAVID BURNSDAVID BURNS
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ISO 9000 SERIES & BUSINESS PROCESS IMPLEMENTATION • The key points of reference:
ISO 9001: 2008 Which is due for revision in 2012/13
ISO 9000: Series Provides an appropriate point of reference
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
SESSION 1
GENERAL INFORMATION
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
• Business today? - External
• Major contracts required ISO 9001• Supply chain assessed against ISO 9001• Purchasers rely on ISO 9001 certification
• Expected integrity of supply and continuous improvement
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
• Business today? - Internal
• Customer and contract focused• Require competitive advantage• Must be forward planning and pro-active• Risk assessment and loss prevention activities• Due diligence and self assessment
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION • Management System Design • (what did we do?)
1.Discussed and reviewed the existing systems
2.Plot the department / functions
3.Identify the key in-puts / out-puts (forms used)
4.The internal customer / supplier (records)
5.Collate / agree the documentation (format)
6.Completed the draft “business system manual”
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The Eight Quality Management Principles Applied to ISO 9000: 2008
Customer FocusLeadershipInvolving PeopleProcess ApproachSystem Approach
Continual ImprovementFactual Decision
MakingMutually Beneficial
Supplier Relationships
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
Quality Policy & Objectives
Policy - to include a commitment to meeting requirements and continual improvement
Quality Objectives - to be measurable and defined, consistent with the Policy
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
• Emphasis on Legal Requirements
• Customer contract needs and expectations • this must include:
• Regulatory and legal requirements • Product and business integrity
… as expected by any customer.
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
• Training & Competence
• Competence:
• Induction training• Equipment training• Product training• Evaluation of the effectiveness (appraisals)• Employee awareness of their importance
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
Processes (System & Product Realisation)
Identify the processesDetermine the sequence and correctnessMethods for operational control (forms)System monitoring and measurement (records)Information needed to support the effective management
(business decisions).
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ISO 9000 & BUSINESS PROCESS
Process Based Systems (Inspection)Managing a Process (scope of operation)
INPUT PROCESS OUTPUT
SITE-VISIT INSPECTION DATA REPORT
SPECIFICATION METHOD RECORDS FILES
SCOPE DATA
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
• Internal Audits (Guideline: ISO 10011)
• Programme based on importance / status.• Evaluation of system against ISO 9001: 2008• Proof of auditor independence• How this is achieved• Who decides what to audit?
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
SESSION 2
ISO 9001: 2008 - THE STANDARD
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
1. SCOPE
The Scope of the Quality Management System
Those parts of the business that are included within the system for certification (inspection services, product being inspected, report, etc.)
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
2. NORMATIVE REFERENCES
Make references to:Applicable: Standards, PAS, Directives,
Codes, etc. appropriate to the Scope
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
3. TERMS & DEFINITIONS
The business terms defined within the trade As understood by the organisation
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
4. QUALITY MANAGEMENT SYSTEM
(4.1 General)
(4.2 Documentation)The structures, resources, commitment,
principles and policy towards supporting effective QMS implementation
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
5. MANAGEMENT RESPONSIBILITY
(5.1 Commitment)
LeadershipChange ManagementImprovementCommunication
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
5. MANAGEMENT RESPONSIBILITY
(5.2 Customer)
Customer focusCustomer requirementsCustomer expectationsCustomer satisfaction
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.1 Provision of resources)
Determine and provide resources
For the quality management systemFor meeting customer requirements
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.2 Human resources)
Determine and provide resources for
Personnel requirementsQuality system awareness training Training and experience recordsEvaluation and induction
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.3 Infrastructure)
Computer system and information technologyMaterials, plant and equipmentEnvironmentTransport and communication
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.4 Work environment)
Personnel BuildingWorkspaceProcessEquipment
To achieve product conformity
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
7. PRODUCT REALISATION
Planning of product (production control)Customer related processesReview of requirementsCustomer communication
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
Monitoring and measurement of:
Customer satisfactionInternal (quality system) auditingProcess performance / improvementProduct conformity / non-conformance
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
“When you can measure what you are speaking about and express it in numbers, you know something about it. When you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind”.
Lord Kelvin — Physicist
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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION
“The measures in an organisation are at the very heart of it, we behave according to those measures”.
Tom Peters — Thriving on Chaos
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YOUR QUESTIONS?
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