1. ISO 9001: 2015 BUSINESS PROCESS IMPLEMENTATION GENERAL AWARENESS
ISO 9001 Made Easy by Dr.Bassam Salama

2. ISO 9001 & 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
ISO 9001 Made Easy by Dr.Bassam Salama

3. ISO 9001 & 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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4. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Management System Design
Discussed and reviewed the existing systems
Plot the department / functions
Identify the key in-puts / out-puts (forms used)
The internal customer / supplier (records)
Collate / agree the documentation (format)
Completed the draft “business system manual”
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5. The Eight Quality Management Principles Applied to ISO 9001: 2015
Customer Focus
Leadership
Involving People
Process Approach
System Approach
Continual Improvement
Factual Decision Making
Mutually Beneficial Supplier Relationships
Risk Assessment
ISO 9001 Made Easy by Dr.Bassam Salama

6. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Quality Policy & Objectives Policy : Commitment to requirements and continual improvement Quality Objectives : Measurable and defined, consistent with the Policy
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7. ISO 9001 & 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.
ISO 9001 Made Easy by Dr.Bassam Salama

8. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Training & Competence
Induction training
Equipment training
Product training
Evaluation of the effectiveness (appraisals)
Employee awareness of their importance
ISO 9001 Made Easy by Dr.Bassam Salama

9. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Processes (System & Product Realisation)
Identify the processes
Determine the sequence and correctness
Methods for operational control (forms)
System monitoring and measurement (records)
Information needed to support the effective management (business decisions).
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10. Process Based Systems (Inspection)
ISO 9001 & 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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11. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Internal Audits
Programme based on importance / status.
Evaluation of system against ISO 9001: 2015
Proof of auditor independence
How this is achieved
Who decides what to audit?
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12. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
SESSION 2
ISO 9001: THE STANDARD
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13. ISO 9001 & 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.)
ISO 9001 Made Easy by Dr.Bassam Salama

14. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
2. NORMATIVE REFERENCES
Make references to: ISO 9001:2015
Applicable: Standards, PAS, Directives, Codes, etc. appropriate to the Scope
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15. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
3. TERMS & DEFINITIONS
The business terms defined within the trade
As understood by the organisation
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16. ISO 9001 & 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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17. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
5. MANAGEMENT RESPONSIBILITY
(5.1 Commitment)
Leadership
Change Management
Improvement
Communication
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18. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
5. MANAGEMENT RESPONSIBILITY
(5.2 Customer)
Customer focus
Customer requirements
Customer expectations
Customer satisfaction
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19. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.1 Provision of resources)
Determine and provide resources
For the quality management system
For meeting customer requirements
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20. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.2 Human resources)
Determine and provide resources for
Personnel requirements
Quality system awareness training
Training and experience records
Evaluation and induction
ISO 9001 Made Easy by Dr.Bassam Salama

21. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.3 Infrastructure)
Computer system and information technology
Materials, plant and equipment
Environment
Transport and communication
ISO 9001 Made Easy by Dr.Bassam Salama

22. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.4 Work environment)
Personnel
Building
Workspace
Process
Equipment
To achieve product conformity
ISO 9001 Made Easy by Dr.Bassam Salama

23. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
7. PRODUCT REALISATION
Planning of product (production control)
Customer related processes
Review of requirements
Customer communication
ISO 9001 Made Easy by Dr.Bassam Salama

24. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
8. MEASUREMENT, ANALYSIS AND IMPROVEMENT
Monitoring and measurement of:
Customer satisfaction
Internal (quality system) auditing
Process performance / improvement
Product conformity / non-conformance
ISO 9001 Made Easy by Dr.Bassam Salama