General Awarness

1. I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 1
ISO 9001: 2015
BUSINESS PROCESS
IMPLEMENTATION
GENERAL
AWARENESS

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 2

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 3

4. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Management System Design
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”
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 4

5. 1. Customer Focus
2. Leadership
3. Involving People
4. Process Approach
5. System Approach
6. Continual Improvement
7. Factual Decision Making
8. Mutually Beneficial Supplier Relationships
9. Risk Assessment
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M
S A L A M A
5
THE EIGHT QUALITY MANAGEMENT PRINCIPLES
APPLIED TO ISO 9001: 2015

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 6

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.
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 7

8. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Training & Competence
• Induction training
• Equipment training
• Product training
• Evaluation of the effectiveness (appraisals)
• Employee awareness of their importance
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 8

9. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Processes (System & Product Realisation)
1. Identify the processes
2. Determine the sequence and correctness
3. Methods for operational control (forms)
4. System monitoring and measurement (records)
5. Information needed to support the effective management
(business decisions).
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 9

10. 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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 10

11. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
Internal Audits
1. Programme based on importance / status.
2. Evaluation of system against ISO 9001: 2015
3. Proof of auditor independence
4. How this is achieved
5. Who decides what to audit?
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12. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
SESSION 2
ISO 9001: 2015 - THE STANDARD
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 12

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.)
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 13

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 14

15. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
3. TERMS & DEFINITIONS
The business terms defined within the trade
As understood by the organisation
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 15

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 18

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
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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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 21

22. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
6. RESOURCE MANAGEMENT
(6.4 Work environment)
Personnel
Building
Workspace
Process
Equipment
To achieve product conformity
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 22

23. ISO 9001 & BUSINESS PROCESS IMPLEMENTATION
7. PRODUCT REALISATION
Planning of product (production control)
Customer related processes
Review of requirements
Customer communication
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 23

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
I S O 9 0 0 1 M A D E E A S Y B Y D R . B A S S A M S A L A M A 24