ISO 9001: 2015

BUSINESS PROCESS IMPLEMENTATION

GENERAL AWARENESS
Presented by
Atif Munir

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ISO 9001 SERIES & BUSINESS PROCESS
IMPLEMENTATION
The key points of reference:
ISO 9001:2015
ISO 9001: 2008
ISO 9001: Series
Provides an appropriate point of reference

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ISO 9001 & BUSINESS PROCESS
IMPLEMENTATION

SESSION 1
GENERAL INFORMATION

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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

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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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ISO 9001 & 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 9001: 2015

Customer Focus Continual Improvement

Leadership Factual Decision Making
Involving People Mutually Beneficial Supplier
Process Approach Relationships
System Approach Risk Assessment

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ISO 9001 & 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 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.

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ISO 9001 & 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 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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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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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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ISO 9001 & BUSINESS PROCESS IMPLEMENTATION

SESSION 2
ISO 9001: 2015 - THE STANDARD

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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.)

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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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ISO 9001 & BUSINESS PROCESS
IMPLEMENTATION

3. TERMS & DEFINITIONS

The business terms defined within the trade

As understood by the organisation

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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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ISO 9001 & BUSINESS PROCESS
IMPLEMENTATION

5. MANAGEMENT RESPONSIBILITY
(5.1 Commitment)

Leadership
Change Management
Improvement
Communication

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ISO 9001 & BUSINESS PROCESS
IMPLEMENTATION
5. MANAGEMENT RESPONSIBILITY
(5.2 Customer)

Customer focus
Customer requirements
Customer expectations
Customer satisfaction

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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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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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ISO 9001 & BUSINESS PROCESS
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6. RESOURCE MANAGEMENT
(6.3 Infrastructure)

Computer system and information technology

Materials, plant and equipment
Environment
Transport and communication

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ISO 9001 & BUSINESS PROCESS IMPLEMENTATION

6. RESOURCE MANAGEMENT
(6.4 Work environment)

Personnel
Building
Workspace
Process
Equipment

To achieve product conformity

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ISO 9001 & BUSINESS PROCESS IMPLEMENTATION

7. PRODUCT REALISATION

Planning of product (production control)

Customer related processes
Review of requirements
Customer communication

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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

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YOUR QUESTIONS?

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