ISO 9001:2000

1
ISO 90012000
afhofmann

• Practical Guidance to Implementation

III International Congress for Micro/Small
Industry Mexico City May 22, 2001
KPMG Quality Registrars Inc.

2
Presentation Objectives

• Contents of ISO 90012000
• Commitment Required by Organization
• Keys to successful implementation
• Questions

3
Content of ISO 90012000 - Overview
ISO 90012000
4
A Quality System

• Formalizes the processes within the organization
  which are so important to meet the business
  objectives that they need a systematic approach.

Say what you do! Do what you say! Document what
youve done! Measure the difference! Act on it!
5
Business Process Flow
Quality Management System Continual Improvement
Continuous ImprovementCycle
C U S T O M E R
Satisfaction
Management Responsibility
Measurement, Analysis, Improvement
Resource Management
Input
Product and/or Service Realization
Output
A P C D
Quality Management System
6
Structure of ISO 9001

• Based on a Business Process Model rather than
  the artificial 20 element structure in 90011994.
• 20 Elements have become 5 Major Clauses
• 4.0 Quality Management System (general
  requirements, documentation requirements, quality
  manual, control of documents and records)
• 5.0 Management Responsibility (policy,
  objectives, planning, customer focus, QMS,
  management review)
• 6.0 Resource Management (human resources,
  facilities, work environment)
• 7.0 Product and/or Service Realization
  (contract, design, purchasing, production,
  calibration)
• 8.0 Measurement, Analysis and Improvement
  (monitoring, audit, control of NC, continual
  improvement, customer satisfaction)

7
Summary of New Requirements

• Items now explicit in ISO 90012000 that your QMS
  must address
• Measurement of customer satisfaction and/or
  dissatisfaction
• Customer communication
• Continual improvement
• Facilities and work environment
• Internal communication
• Departmental and functional objectives
• Employee awareness
• Training competency, effectiveness

8
ISO 90012000

• Implementation Commitment

9
Implementation Commitment

• Full support by Top Management
• Implementation is planned, consistently
  communicated and appropriate training provided
• Regular review of progress - audit
• Successes are identified and celebrated
• Maximum use is made of existing methods

10
Implementation Commitment

• Establishment of organizational direction through
  policy
• Setting of objectives and targets
• Definition of metrics
• Provision of resources and removal of road blocks
• Assessment of customer risk
• Consistent reinforcement of positives

11
Implementation Commitment

• Establishment of direction through policy
• - Strategic framework for the organization
• - Commitment to customer and stakeholders
• - Framework for measurement and improvement

12
Implementation Commitment

• Setting of Objectives and Targets
• - Linked to customer needs
• - Measurable and Meaningful
• - Risk Based

13
Implementation Commitment

• Metrics
• - Monitoring direct measurables
• - Monitoring of audits of processes
• - Monitoring of customer indicators
• - Action when different from plan

14
Implementation Commitment

• Resources
• - Adjustment where metrics indicate
• - Recognition and removal of road blocks
• to improvement
• - Measurement of Improvement
• - Review of Strategy for continued fit

15
Implementation Commitment

• Assessment of Customer Risk
• - Identification of key needs, past and future
• - Review of delivery systems and personnel
• - Optimization of resources to consistently
  deliver against needs

16
ISO 90012000

• Keys to Success

17
Keys to Success

• Map your processes
• Maximum use of existing systems
• Assign ownership of process steps
• Identify sub-processes and controls/procedures
• Obtain management direction for policy, goals,
  targets and metrics
• Training, Training, Training
• React to measures

18
Keys to Success

• A time line for activities usually six to 18
  months
• A focus point, someone responsible to encourage
  each stakeholder
• Regular status meetings with Senior Management
• Regular communication on progress to everyone
• An external resource to assist with
  interpretations

19
Keys to Success

• Have Fun!

20
Keys to Success

• Quotation
• You do not have to do this
• Survival is not compulsory !
• Dr. W. Edwards Deming

21
Questions ?