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Process workshop
AGENDA
ISO 9001 ISO 9001 is the internationally recognised standard for the quality management of businesses. It applies to the business processes that create and control the products and services an organisation supplies. It prescribes systematic control of activities to ensure that the needs and expectations of customers are met. It is designed and intended to apply to virtually any product or service, made by any process anywhere in the world.
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ISO 9001:2008
Customer Focus Customer Focus Leadership Leadership Involvement of People Involvement of People Process Approach Process Approach System Approach to Management System Approach to Management Continual Improvement Continual Improvement Factual Approach to Decision Factual Approach Making to Decision Making Mutually Beneficial Supplier Mutually Beneficial Supplier Relationships Relationships
ISO 9001:2008
Principles to Requirements The 8 principles are woven into 5 main elements of ISO 9001:2008
Documentation Management Resources Product/Service Improvement
Processes
demonstrate organizations ability to consistently provide product, meeting customer & applicable regulatory requirements enhance customers satisfaction through effective application of the system including processes for its continual improvement and assurance of conformity to customer and applicable regulatory requirements
C U S T O M E R S
R e q u I r e m e n t s
Resource management
S a t I s f a c t I o n
Input
Product
Product Output
C U S T O M E R S
Management responsibility 1 Management commitment 2 Customer focus 3 Quality Policy 4 Planning Quality objectives
Management responsibility
6 Management review
Resource management
1 Provision of resources 2 Human resources 1. General 2. Competence, awareness and training 3 Infrastructure 4 Work environment
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Product realization
Product realization
1. Design and development outputs 2. Design and development review 3. Design and development verification 4. Design and development validation
4 Purchasing
Product realization
1. Control of production and service provision 2. Validation of processes for production and service
provision 3. Independent and traceability 4. Customer property 5. Preservation of product 6 Control of monitoring and measuring devices
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Measurement, analysis and improvement 1 General 2 Monitoring and measurement 1. Customer satisfaction 2. Internal audit 3. Monitoring and measurement of processes 4. Monitoring and measurement of product 3 Control of non-confirming product 4 Analysis of data 5 Improvement 1. Continual improvement 2. Corrective action 3. Preventive action
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ISO 9001:2008
Leadership is not committed Leadership is not involved Executive management does not function as a team Poor implementation strategy Poor internal or external consulting advice Focus on certificate / not on effectiveness
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ISO 9001:2008
Effective Measurements = Effective Management ISO 9001:2008 expects effective measurements system for management control and action Based on effective measurements, products and processes are improved to directly impact customer satisfaction
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The Deming Cycle for improvement is the cornerstone of all Management Systems
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1. PLAN: Design or revise business process components to improve results 2. DO: Implement the plan and measure its performance 3. CHECK / STUDY: Assess the measurements and report the results to decision makers 4. ACT: Decide on changes needed to improve the process
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What are the benefits 9001? Improve the ability to identify weaknesses in the system on systematic basis Participation of employees would help to enhance the systems capability Improved communication between among employees Improved consistency in quality and deliveries Continual improvement culture Improved customer trust Establish the expectations of employees
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Certification Audit
Stage 1 Documentation Review Stage 2 - Audit of Implementation based on Standards and QMS
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AGENDA
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Process workshop
Approach
Program Objectives
Phase 3
Certification
Phase 2
Implement Systems
Phase 1
QMS Framework
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Approach
Steps CUSTOMER S.N. Bhobe engaged Techserv Project Initiation Proposal made Objectives were defined Contract drawn up Scope was discussed Schedule reviewed and accepted Contract Signed QMS Design QMS templates designed MR Appointed Discussed QMS Templates Quality coordinator Appointed Meetings with BU Heads Schedules were drawn QMS Implementation Identified scope for ISO 9001 QMS Templates approved TECHSERV CONSULTING
Certification
Outcome
Contract Signed Basic Understanding arrived at QMS Architecture finalized Project Kick-off
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Approach
Steps CUSTOMER TECHSERV CONSULTING
Project Initiation Arrange for process review meets Document Process for Design Document Process for Supervision Co-ordinate Meetings Co-ordinate & update of comments Document Quality Policy ISO 9001 Scope statement Establishing Quality Objectives Approve QMS Design QMS Advise on process design Participate in the Review meets Incorporate Review comments Maintain QMS artifacts Baseline the QMS ISO 9001 : 2008 Orientation
QMS Design
QMS Implementation
Certification
Outcome
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Approach
Steps CUSTOMER Implement the processes Project Initiation Internal Audits Improve the process Corrective Actions QMS Design Preventive actions Management Review Establish Internal Audit team QMS Implementation Internal Auditors Training Advise on process improvements Internal Audit of QMS Advice on Certification Readiness TECHSERV CONSULTING
Certification
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Approach
Steps CUSTOMER TECHSERV CONSULTING
Project Initiation
Select a Certification Agency Identify Certification Agency Document Review Co-ordinate Audits Process Improvement
QMS Design
Advise on Audit Findings Closure Implementation Audit Advise on way forward Process Improvements Certification
QMS Implementation
Certification
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Process workshop
AGENDA
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Process workshop
Certification Requirements
Quality Management System ISO Model Awareness Process Awareness Quality Policy awarenes Quality Objectives Certification Scope Process Improvement Culture Exclusions Customer Feedbacks Customer Complaint System Quality Planning Evidences Management Involvement Management Commitment Internal Audits Corrective / Preventive actions Management Reviews Calibration evidences Client Acceptance evidences Client Requirements evidence Control of Documents
Compliance to Regulations
Process workshop
AGENDA
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Process workshop
Perseverance Management Involvement Management Commitment Implementation rigour Internal Audit effectiveness Quality of Management Reviews Quality of Corrective / Preventive actions Employee participation Measurement systems Never prepare for audits Process Improvements culture
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Process workshop
Any Queries ?
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Process workshop
Thank you!
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