iso 9000 - 2008 - awareness training

Presented byPresented by

DAVID BURNSDAVID BURNS

www.davidburns.co.uk/training 1

ISO 9000 SERIES & BUSINESS PROCESS IMPLEMENTATION • The key points of reference:

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

ISO 9000: Series Provides an appropriate point of reference


ISO 9000 & BUSINESS PROCESS IMPLEMENTATION

SESSION 1

GENERAL INFORMATION



• 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



• 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


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”


The Eight Quality Management Principles Applied to ISO 9000: 2008

Customer FocusLeadershipInvolving PeopleProcess ApproachSystem Approach

Continual ImprovementFactual Decision

MakingMutually Beneficial

Supplier Relationships



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



• 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.



• Training & Competence

• Competence:

• Induction training• Equipment training• Product training• Evaluation of the effectiveness (appraisals)• Employee awareness of their importance



Processes (System & Product Realisation)

Identify the processesDetermine the sequence and correctnessMethods for operational control (forms)System monitoring and measurement (records)Information needed to support the effective management

(business decisions).


ISO 9000 & 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



• 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?



SESSION 2

ISO 9001: 2008 - THE STANDARD



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.)



2. NORMATIVE REFERENCES

Make references to:Applicable: Standards, PAS, Directives,

Codes, etc. appropriate to the Scope



3. TERMS & DEFINITIONS

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



4. QUALITY MANAGEMENT SYSTEM

(4.1 General)

(4.2 Documentation)The structures, resources, commitment,

principles and policy towards supporting effective QMS implementation



5. MANAGEMENT RESPONSIBILITY

(5.1 Commitment)

LeadershipChange ManagementImprovementCommunication



5. MANAGEMENT RESPONSIBILITY

(5.2 Customer)

Customer focusCustomer requirementsCustomer expectationsCustomer satisfaction



6. RESOURCE MANAGEMENT

(6.1 Provision of resources)

Determine and provide resources

For the quality management systemFor meeting customer requirements




(6.2 Human resources)

Determine and provide resources for

Personnel requirementsQuality system awareness training Training and experience recordsEvaluation and induction




(6.3 Infrastructure)

Computer system and information technologyMaterials, plant and equipmentEnvironmentTransport and communication




(6.4 Work environment)

Personnel BuildingWorkspaceProcessEquipment

To achieve product conformity



7. PRODUCT REALISATION

Planning of product (production control)Customer related processesReview of requirementsCustomer communication



8. MEASUREMENT, ANALYSIS AND IMPROVEMENT

Monitoring and measurement of:

Customer satisfactionInternal (quality system) auditingProcess performance / improvementProduct conformity / non-conformance



“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



“The measures in an organisation are at the very heart of it, we behave according to those measures”.

Tom Peters — Thriving on Chaos


YOUR QUESTIONS?


iso 9000 - 2008 - awareness training

Documents

business process process

business integrity

business terms

draft business system

quality management system

effective qms implementation

evaluation of system

resource management