1. Management Overview of
ISO 9001 : 2000
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

2. Consolidation of the ISO 9000 Series
ISO 9001, ISO 9002 and ISO 9003 are now integrated into one certification standard, ISO 9001:2000.
All organizations will now be ISO 9001 certified.
The differentiation of design / no design will be done through the scope statement on the ISO 9001 certificates.
Exclusion of any activities (i.e. design) must be stipulated and justified in the Quality Manual.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

3. Consolidation of the ISO 9000 series
Previous 20 standards now replaced by four:
ISO 9000: QMS Fundamentals & vocabulary
ISO 9001: QMS Requirements
ISO 9004: Guidance for QMS performance improvement
ISO 19011: Guidelines for auditing
To be further supported by technical reports (ISO , ISO , etc.)
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

4. The Use of ISO 9004 as a Management Tool
ISO 9004 includes all of ISO 9001 plus additional items to consider for improvement ideas.
ISO 9004 should be regularly used throughout the organization to lead beyond the basics of ISO 9001 and improve the QMS during:
QMS Development,
Internal Audits,
Preventive Action,
Management Reviews.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

5. ISO9000:2000 Management Overview
New Structure & Focus
The ISO 9001:1994 model for Quality Assurance and the familiar 20 elements did not adequately achieve the intent to ADD VALUE.
The ISO 9k2k Standards are now modelled for Quality Management with 5 Major clauses:
Quality Management System (QMS)
Management Responsibility
Resource Management
Product Realization
Measurement, Analysis & Improvement
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

6. ISO9000:2000 Management Overview
New Structure & Focus
Significantly less emphasis on procedures and records.
Significantly more emphasis on management involvement and a system that works to achieve the goals of your business.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

7. Quality Management Systems vs. Business Management Systems:
QMS
BMS
Quality Management Systems vs. Business Management Systems:
Your BMS =
QMS+
FMS+
HS&EMS+
ERP+ HR
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

8. Quality Management Systems vs. Business Management Systems:
Your QMS is not something you do separately from your BMS “because ISO requires it”!
QMS
BMS
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

9. ISO9000:2000 Management Overview
New Structure & Focus
ISO 9001 & 9004 are based on the 8 Management System Principles:
customer focus
leadership
involvement of people
process approach
system approach
continual improvement
factual approach to decision making
mutually beneficial supplier relationships
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

10. ISO9000:2000 Management Overview
New Structure & Focus
Food for Thought:
Your business is a set of interactive processes, not 20 elements of ISO
Your QMS is the means of controlling these processes and ensuring that the desired output is effectively and efficiently achieved...
Why would you define and manage your QMS based on 20 fragmented elements of a standard?
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

11. ISO9000:2000 Management Overview
The Process Approach
“A desired result is achieved more efficiently when activities and related resources are managed as a process.”
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

12. The Process Approach Controls Inputs Process Activities + Resources
(e.g. procedures, operators, gaging, tooling, maintenance, etc.)
Inputs
Process
Activities +
Resources
Outputs
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ISO9000:2000 Management Overview

13. The System Approach to Management
“Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.”
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ISO9000:2000 Management Overview

14. ISO9000:2000 Management Overview
The System Approach
The organization must identify the sequence & interactions of the QMS processes in the Quality Manual.
Process A D B C
Inputs
Outputs
Controls
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ISO9000:2000 Management Overview

15. System Approach of ISO 9k2kU S T O M E R C U S T O M E R
Continual Improvement of the
Quality Management System S a t I s f c o n
Management
responsibility R e q u I r m n t s
Resource
management
Measurement, analysis,
improvement
Product
Product
Input
Output
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ISO9000:2000 Management Overview

16. ISO9000:2000 Management Overview
Customer Focus
“Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.”
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ISO9000:2000 Management Overview

17. ISO9000:2000 Management Overview
Customer Focus
Information on Customer perception as to whether the organization has met their requirements must be collected, reviewed and appropriately acted upon (8.2.1).
The methods of doing this are not prescribed by the standard but should be objective, representative of the customer base, and ADD VALUE.
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ISO9000:2000 Management Overview

18. ISO9000:2000 Management Overview
Customer Focus
The most common methods of collecting Customer Satisfaction data are customer surveys and customer report cards (when provided).
Other methods include measuring repeat orders, market share, industry benchmarking, capturing info. from sales visits, focus groups, and hiring consulting firms.
A good system will use multiple methods and compare data from multiple sources to comprehensively understand customer perceptions and balance out any potential biases.
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ISO9000:2000 Management Overview

19. ISO9000:2000 Management Overview
Customer Focus
Additionally, the organization must demonstrate that effective arrangements for communicating with customers are in place in relation to:
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ISO9000:2000 Management Overview

20. ISO9000:2000 Management Overview
Customer Focus
Product Information (7.2.3-a):
How well do you communicate your product information to your customers?
Consider the experiences of using your favorite store Catalogue, or browsing Amazon.com or ebay...
Were you satisfied with these experiences?
How do you know what your customers think about your ability to communicate information that they are looking for?
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ISO9000:2000 Management Overview

21. ISO9000:2000 Management Overview
Customer Focus
Enquiries, contracts, and order handling, including changes (7.2.3-b):
Now consider the “buying experience” with these same companies and ask the same questions…
How do you think your customers feel about the ordering experience with your company? What about your quoting and order amendment processes?
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

22. ISO9000:2000 Management Overview
Customer Focus
Customer feedback, including complaints (7.2.3-c)
Consider that a customer can be more loyal when you handle their problems to their satisfaction (or delight) vs. them never having a problem at all.
Your want to know whether your customers are satisfied with how you handle their feedback (even positive) and complaints.
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ISO9000:2000 Management Overview

23. Factual Approach to Decision Making
“Effective decisions are based on the analysis of data and information.”
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ISO9000:2000 Management Overview

24. Factual Approach to Decision Making
Plan Do
Check
Act
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ISO9000:2000 Management Overview

25. Analysis of Data & Measurement
More Food for Thought:
Consider all the records and data that you collect and store in your company...
How are each of these used for analysis, training, and improvement purposes?
If you can’t answer this question for nearly every record you spend time and money collecting then why do you do it?
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

26. Comprehensive Measurement & Improvement Model
Effective Communication
Planning & Resource Management
Quality Policy
Strategic QMS Objectives /
CSAT Metrics
QMS Process / Departmental Metrics and Objectives
Project / Product / Individual Metrics & Objectives
Factual & Logical Approach to Decision Making
Identification, Collection & Analysis of Records / Data
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ISO9000:2000 Management Overview

27. Analysis of Data & Measurement
The Quality Policy must provide the framework for establishing strategic objectives (5.3).
Measurable, documented, tactical objectives at relevant functions and levels of the organization must be established to support the strategic objectives (5.4.1).
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ISO9000:2000 Management Overview

28. Analysis of Data & Measurement
The QMS Processes must be Monitored and/or Measured (8.2.3).
Product specific objectives must be established (7.1-a).
Customer Satisfaction must be measured (8.2.1).
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ISO9000:2000 Management Overview

29. Continual Improvement
“Continual improvement of the organization’s overall performance should be a permanent objective of the organization.”
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ISO9000:2000 Management Overview

30. Continual Improvement
The organization shall implement actions necessary to achieve planned results and continual improvement of the QMS processes (4.1-f).
Top management shall provide evidence of its commitment to the development and implementation of the QMS and continually improve its effectiveness (5.1).
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

31. Continual Improvement
(8.1) The organization shall continually improve the effectiveness of the QMS through the use of the…
Quality Policy
quality objectives
internal audits
analysis of data
corrective and preventive actions
management reviews
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

32. Analysis of Data, Measurement & Improvement
Plan Do
Check
Act
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

33. Strategic Quality Planning
Analysis of Data, Measurement & Improvement
Strategic Quality Planning
Top Management shall ensure that:
The planning of the QMS is carried out in order to meet the requirements in NOTE: Take some time to review 4.1!
Plans are in place to achieve the quality objectives (5.4.2-a).
No requirement for plans to be documented - Caution: verbal plans are only effective in certain situations.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

34. Analysis of Data, Measurement & Improvement
Tactical Quality Planning
Top Management shall ensure that:
any changes to the business that affect the QMS are identified and that planning occurs to ensure that the integrity of the QMS is maintained (5.4.2-b).
changes that could affect the QMS are identified in Management Reviews (5.6.2-f).
Examples: New IT/MRP systems, new / updated equipment, new or changed products / processes, organizational changes, etc.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

35. Leadership & Involvement of People
“Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.”
“People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.”
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

36. Leadership & Involvement of People
Top Management shall ensure that appropriate communication processes are established within the organization… (5.5.3)
Specific requirements for communicating information regarding the effectiveness of the QMS and the importance of meeting customer and regulatory requirements (5.5.3 & 5.1-a).
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

37. Leadership & Involvement of People
The organization shall ensure that all personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives (6.2.2-d).
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

38. ISO9000:2000 Management Overview
Resource Management
Management must determine and provide the resources needed to implement, maintain and continually improve the QMS, and to enhance customer satisfaction (6.1).
Top Management shall provide evidence of its commitment by… ensuring the availability of resources (5.1-e).
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ISO9000:2000 Management Overview

39. ISO9000:2000 Management Overview
Resource Management
Resource needs are a required Management Review item (5.6.3-c).
Infrastructure (buildings, equipment, utilities, IT, communications, etc.) needs to ensure quality must also be determined and provided (6.3).
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

40. ISO9000:2000 Management Overview
Resource Management
A system to determine competency needs and evaluate employee competencies must be established.
The effectiveness of any actions taken to satisfy competency needs must be evaluated (6.2.2-c).
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

41. Evaluation of Competence
Competency requirements must be determined for all positions / people that affect quality (6.2.2-a).
Examples – Qualification criteria in job descriptions, defined in QMS procedures, project plans, performance reviews…
Appropriate records to demonstrate that competency requirements have been met must be maintained (6.2.2-e).
Examples – Employment applications, resumes, degrees, professional certifications, training records, performance reviews...
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ISO9000:2000 Management Overview

42. Evaluation of Competence
Organizational Competency considerations:
Future demands (customer, technology, market)
Anticipated management and workforce succession needs
Changes in the processes and equipment
Individual competencies needed
Statutory and regulatory requirements, standards, directives, etc.
(ISO 9004 :2000)
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ISO9000:2000 Management Overview

43. Evaluation of Training Effectiveness
Consider Four Variables in the Training Equation:
1. The Trainee – Did they learn?
Controls – Qualification criteria, pre/post testing, trainer / supervisor assessments, performance reviews…
2. The Trainer – Could they Teach?
Controls – Qualification criteria / training for trainers, Trainee / management assessments of trainer performance, course evaluations…
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

44. Evaluation of Training Effectiveness
3. The Material – Did it adequately convey the necessary information?
Controls – Trainee / Trainer assessments of materials, internal audits, course evaluations, benchmarking… Consider the ability of an interactive video to convey information vs. pictures only vs. a written procedure only vs. verbal instruction only vs. a combination of all?
4. The Environment – Was it conducive to learning the material?
Controls – Defined environmental requirements and monitoring (temperature, noise, lighting, distractions, etc.), trainee evaluations…
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

45. Comprehensive Measurement & Improvement Model
Effective Communication
Planning & Resource Management
Quality Policy
Strategic QMS Objectives /
CSAT Metrics
QMS Process / Departmental Metrics and Objectives
Project / Product / Individual Metrics & Objectives
Factual & Logical Approach to Decision Making
Identification, Collection & Analysis of Records / Data
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

46. On Time Delivery example
Comprehensive Measurement & Improvement Model
On Time Delivery example
In order to achieve any improvement in OTD you must first collect and analyze appropriate data in order to understand the primary causes of late deliveries and establish realistic improvement goals.
Metrics, improvement objectives, plans and resource needs will then be identified and communicated throughout the organization.
By engaging the entire organization in this process and using the PDCA cycle you will ultimately achieve your OTD goals and increased customer satisfaction and organizational efficiency.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

47. ISO9000:2000 Management Overview
Course Summary
Say what you do…
Do what you say…
And make sure that it works!
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

48. Course Summary
The majority of the efforts needed to demonstrate compliance to ISO 9001:2000
lie with the management team.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview

49. ISO9000:2000 Management Overview
Course Summary
Run properly, by management, your QMS will help you achieve your business goals.
Revision: 8-Feb-2003
ISO9000:2000 Management Overview