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DAVID BURNS

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ISO 9000 SERIES & BUSINESS PROCESS IMPLEMENTATION

The key points of reference:

ISO 9001: 2008

Which is due for revision in 2012/13 Provides an appropriate point of reference

ISO 9000: Series

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

SESSION 1
GENERAL INFORMATION

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ISO 9000 & 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 9000 & 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 9000 & 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 9000: 2008

Customer Focus
Leadership Involving People

Continual Improvement
Factual Decision

Process Approach
System Approach

Making Mutually Beneficial Supplier Relationships

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ISO 9000 & 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 9000 & 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 9000 & 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 9000 & 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 9000 & BUSINESS PROCESS

Process Based Systems (Inspection) Managing a Process (scope of operation)

INPUT SITE-VISIT PROCESS INSPECTION OUTPUT DATA REPORT

SPECIFICATION
SCOPE

METHOD

RECORDS

FILES
DATA

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

Internal Audits (Guideline: ISO 10011)

Programme based on importance / status. Evaluation of system against ISO 9001: 2008 Proof of auditor independence How this is achieved Who decides what to audit?

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

SESSION 2
ISO 9001: 2008 - THE STANDARD

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ISO 9000 & 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 9000 & BUSINESS PROCESS IMPLEMENTATION

2. NORMATIVE REFERENCES
Make references to: Applicable: Standards, PAS, Directives, Codes, etc. appropriate to the Scope

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

3. TERMS & DEFINITIONS

The business terms defined within the trade As understood by the organisation

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ISO 9000 & 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 9000 & BUSINESS PROCESS IMPLEMENTATION

5. MANAGEMENT RESPONSIBILITY (5.1 Commitment)

Leadership Change Management Improvement

Communication

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

5. MANAGEMENT RESPONSIBILITY (5.2 Customer)

Customer focus Customer requirements Customer expectations Customer satisfaction

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ISO 9000 & 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 9000 & 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 9000 & 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 9000 & BUSINESS PROCESS IMPLEMENTATION

6. RESOURCE MANAGEMENT (6.4 Work environment)

Personnel Building Workspace Process Equipment

To achieve product conformity

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

7. PRODUCT REALISATION
Planning of product (production control) Customer related processes Review of requirements Customer communication

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ISO 9000 & 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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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

When you can measure what you are speaking about and express it in numbers, you know something about it. When you cannot express it in numbers, your knowledge is of a meagre and unsatisfactory kind.
Lord Kelvin Physicist

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ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

The measures in an organisation are at the very heart of it, we behave according to those measures.
Tom Peters Thriving on Chaos

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YOUR QUESTIONS?

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