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Presented by

KRUNAL JANI

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ISO 9001 SERIES & BUSINESS PROCESS


IMPLEMENTATION

The key points of reference:


ISO 9001:2015
ISO 9001: 2008
Which is due for revision in 2012/13

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

Involving People

Making
Mutually Beneficial
Supplier Relationships
Risk Assessment

Process Approach
System Approach

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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

RECORDS

FILES

SPECIFICATION

METHOD

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 IMPLEMENTATION

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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NIALL SERVICES Pvt. Ltd.


YOUR QUESTIONS?

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