1. “ the Move from Conformance to Performance “
Presents an Overview of the
ISO 9000:2000 Revisions
to the ISO 9000:1994 Standards
“ the Move from Conformance to Performance “
Presented by:
Date:
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Outline
Why Changes are Needed
Principles and Approaches Driving the Changes
Clause by Clause Review of New Requirements
Transition Guidance
Audit Implications
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3. Current ISO 9000 Standards are Successful … Why Change a Good Thing?
ISO 9000 is the most successful standard in ISO history and is accepted world-wide
Nearly 400,000 registrations world-wide with registrants in over 150 countries from all continents
Being applied in a wide variety of organizations
Over 40 “sectors” or industry classifications
- led by: electrical/optical equipment, metal products, construction, machinery, wholesale/retail trade
- but growing in acceptance by many others, including: engineering, information technology, health/social work, utilities, transportation, public administration, education, other services.
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4. Current ISO 9000 Standards Need Revision ...
Bias
Wording/terms biased towards manufacturing
Problems with the 20 element model
Difficult for small businesses to adapt
“Flow” incompatible with how companies do business
Incompatible with other models (ISO EMS e.g.)
Not sufficiently “forward looking”
Does not smoothly facilitate the move from “baseline” (effective) quality management to “performance excellence” models (like MBNQA) required by evolving user and customer needs)
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5. “One World … One Quality System”
Current standards contain “loopholes”
Too many companies have only sought to meet “minimum requirements” and then only by “twisting the intent” of the existing standards
There is a growing demand for “performance” excellence
ISO 9001:1994 does not require continual improvement
ISO 9001:2000 is process/performance oriented and does require continual improvement of the QMS, but by itself is not viewed as a “performance excellence” model
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6. ISO 9000:2000 is the foundation for Performance Excellence
Business Vision
Performance Excellence
Malcolm Baldrige Criteria
Performance Improvement
ISO 9004:2000
Baseline Performance:
ISO 9001:2000
Competitive
Advantage
Efficient
Quality Management System
Effective
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7. EXERCISE #1
List your organization’s three most significant challenges or business needs over the next 2-3 years (consider any external changes that will affect your organization):
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
What are your organization’s goals and objectives?
How can you use ISO 9001:2000 to help deal with business needs and external challenges?
___________________________________________________________
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8. ISO 9000:2000 is based on Eight Quality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
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Customer Focus
Organizations depend on their customers and therefore should:
understand current and future customer needs,
meet customer requirements, and
strive to exceed customer expectations.
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Leadership
Leaders should:
establish unity of purpose and direction of the organization, and
create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.
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Involvement of People
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.
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Process Approach
Organizations need to do more than simply monitor process outputs, (typically through inspection activities)
they must also control all process inputs, (people, facilities/equipment, material and methods)
and, they must establish appropriate controls over the transformation activities (if desired results are to be achieved consistently and efficiently)
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13. Activity that transforms input into output
What is a Process?
Activity that transforms input into output
Activity
Input
Output
Resources:
People
Facilities/Equipment
Material
Methods
Results:
Products
Services
Performance
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14. How is a Process Managed?
Monitor & Measure the Process
make sure the inputs are right, the transformation
activities consistently work, and the desired results
are achieved, then - improve the process as needed
Activity
Input
Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
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15. How is a Process Measured?
Efficient
No Waste
Effective
Desired Results Achieved
Activity
Input
Output
Right Resources:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
Desired Results:
Quality Products
Quality Services
Customer Satisfaction
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System Approach
Organizations must understand a system is a set of interrelated processes, and
the output of one process is the input to one or more subsequent processes, so ...
It is critical to manage the “white space” (or interface) between processes to ensure that the overall system is effective
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17. Continual Improvement
Continual improvement of the organization’s overall performance should be a permanent objective:
improvement must be a planned activity if the organization desires to improve overall performance and capabilities.
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18. The QMS must be used for continuous improvement ...
Improve Process
through PDCA Cycle
Results
Baseline Performance
Plan Do
Act Check
Measure/Monitor Results Against Objectives - Improve Process and Change QMS as Needed to Achieve and Sustain Desired Results
QMS
Improvement Objective
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19. Factual Approach to Decision Making
Effective decisions are:
based on the analysis of data and information.
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20. Mutually Beneficial Supplier Relationships
An organization and its suppliers are truly inter-dependent, and
a mutually beneficial relationship enhances the ability of both to create value.
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21. EXERCISE #2
Pick one of the eight quality management principles and list three of the most important actions you think an organization should take in applying this principle.
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
How well does your organization do each of the actions identified above?
What can your organization do to more fully utilize the principle?
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22. The ISO 9000:2000 standards include 3 documents...
Quality Management Systems -
Fundamentals and Vocabulary
ISO 9001:2000
Quality Management Systems -
Requirements
ISO 9004:2000
Quality Management Systems -
Guidelines for Performance Improvements
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23. ISO 9000:2000 standards replace many existing ISO documents...
Quality Management Systems -
Fundamentals and Vocabulary
ISO 9001:2000
Quality Management Systems -
Requirements
Revises/Replaces:
- ISO 8402:1994
- ISO :1994
Revises/Replaces:
- ISO 9001:1994
- ISO
- ISO 9003:1994
ISO 9004:2000
Quality Management Systems -
Guidelines for Performance Improvements
Revises/Replaces:
- ISO , , and (all previous editions, )
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24. Other ISO documents are also being revised for consistency...
the Joint Working Group on
Auditing Document
ISO/TS 16949
International Automotive Standard -
Quality System Requirements
in Sep 2001 will likely replace:
- ISO (for QMS)
- ISO (for EMS)
released in 4th quarter 1999 as a “harmonized” US and European standard, for these standards:
- QS 9000 (US)
- EAQF (France)
- VDA6.1 (Germany)
- AVSQ (Italy)
only ISO/TS will be upgraded to ISO 9001:2000
however, ISO has granted permission for continued (indefinite) use of QS-9000
Other sector specific
Quality System
Requirements Documents
with revisions due out after issuance
of ISO 9000:2000 include:
- Aerospace: AS 9100
- Telecommunications: TL 9000
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Role of ISO 9000:2000
Defines quality management
principles
terms and definitions
fundamentals:
- systems approach
- process approach
- continual improvement
ISO 9000:2000 is a “normative reference” (i.e. part of the requirements), and replaces:
ISO 8402:1994 and ISO :1994
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Role of ISO 9001:2000
Specifies quality system requirements:
for achieving customer satisfaction
applicable to entire enterprise
note: “permissible exclusions” (like
design) are limited to requirements
within Clause 7 - Product Realization,
and your registrar must verify they
are not part of your business
ISO 9001:2000 replaces:
ISO 9001/2/3:1994
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Role of ISO 9004:2000
Provides guidelines for performance improvement, based on
quality management principles and approaches defined in ISO 9000, and
continual improvement of the quality management system itself
note: however, ISO 9004 is NOT intended as a
guideline for implementing or assessing
implementation of ISO 9001 requirements
ISO 9004:2000 replaces:
ISO , , &
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28. ISO 9001 and ISO 9004 are the “Consistent Pair”
comprised of the following 8 clauses:
1. Scope
2. Normative references (part of the requirements)
3. Terms and definitions
4. Quality management system
5. Management responsibility
6. Resource management
7. Product (and/or service) realization
8. Measurement, analysis & improvement
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30. ISO 9001:2000 implements the PDCA improvement cycle
Plan
Clause 5. Management responsibility - everything flows from Management who define the requirements for the system
Clause 6. Resource management - from these requirements the resources will be identified and management must ensure they are provided and applied within the system Do
Clause 7. Product (and/or service) realization - the necessary process are established and carried out
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31. ISO 9001:2000 implements the PDCA improvement cycle
Check
Clause 8. Measurement, analysis and improvement - processes and products will be monitored and measured against policies, objectives and requirements for the product and results/opportunity for improvement reported
Act
Clause 8. Measurement, analysis and improvement - acting upon data reported in the check cycle, improvement actions can be taken - directly, or as an output of the Management Review process (Clause 5.6)
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32. Clause 4 - Quality management system
4.1 General requirements - New: must define processes to be managed (including out-sourced processes - which typically include design, training, calibration, heat treat, etc.); determine the sequence and interaction of these processes; determine the criteria and methods needed to ensure these processes are effective; and take actions to improve these processes
4.2 Documentation requirements - New: documentation requirements less prescriptive; however, at a minimum must include a quality manual and the following six documented procedures: Control of Documents (Clause 4.2.3), Control of Quality Records (Clause 4.2.4), Internal Audits (Clause 8.2.2), Control of Nonconforming Product (Clause 8.3), Corrective Action (Clause 8.5.2), and Preventive Action (Clause 8.5.3).
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33. Clause 5 - Management responsibility
5.1 Management commitment - New: top management must demonstrate commitment to development and implementation of the quality system and continually improving its effectiveness
5.2 Customer focus - New: customer requirements (identified per Clause 7.2.1) must be met with the aim of enhancing customer satisfaction (a “perception” that must be measured per Clause 8.2.1)
5.3 Quality policy - New: quality policy must include commitment to meeting requirements and continual improvement of the effectiveness of the QMS, provide a framework for establishing/reviewing measurable quality objectives; and, quality policy must be periodically reviewed for continuing suitability
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34. Clause 5 - Management responsibility
5.4 Planning - New: establish measurable quality objectives at relevant functions and levels in the organization needed to meet product requirements (identified per Clause 7.1 a); and identify and plan quality system processes (identified per Clause 4.1)
5.5 Responsibility, authority and communication - New: management representative must promote awareness of customer requirements throughout the organization; internal communications regarding the effectiveness of the quality system must be established
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35. Clause 5 - Management responsibility
5.6 Management review - New: evaluate the need for changes to the quality system (including policy and objectives) by reviewing specified inputs (improvement opportunities) and reporting specified outputs (related management actions and resource needs)
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36. Clause 6 - Resource management
6.1 Provision of resources - New: determine and provide resources needed to implement and improve the QMS and address customer satisfaction
6.2 Human resources - New: determine needed competencies, evaluate effectiveness of actions taken to satisfy competency needs; and ensure employees are aware of the importance of their activities and how they contribute to achieving quality objectives
6.3 Infrastructure and 6.4 Work Environment - New: determine and manage the infrastructure (buildings, workspace, utilities, equipment and support services), as well as the work environment needed to achieve product conformance
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37. Clause 7 - Product realization
7.1 Planning of product realization - New: determine measurable quality objectives for contracts, projects and products
7.2 Customer-related processes - New: define the processes for communicating with the customer with regards to product information; inquiries, contracts or order handling, and customer feedback, including complaints
7.3 Design and development resources - New: design output to include appropriate information for purchasing, production and for service provision
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38. Clause 7 - Product realization
7.4 Purchasing - New: establish criteria for supplier evaluation and selection, and periodic re-evaluation
7.5 Production and service provision - New: Nothing, essentially the same as requirements contained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 of ISO 9001:1994
7.6 Control of measuring and monitoring devices - New: validate software used to verify product
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39. Clause 8 - Measurement, analysis and improvement
8.1 General - New: plan and implement monitoring, measurement, analysis and improvement processes
8.2 Monitoring and measurement - New: must measure and monitor customer satisfaction (note: customer satisfaction is any information relating to the customer’s “perception” of the organization’s ability to meet customer requirements); internal auditors must now be objective and impartial (vice “independent); and processes used to manage the quality system must be measured/monitored to the degree necessary to demonstrate they achieved planned results
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40. Clause 8 - Measurement, analysis and improvement
8.3 Control of nonconforming product - New: Nothing, essentially the same as requirements contained in Clause 4.13 of ISO 9001:1994)
8.4 Analysis of data - New: analyze data to determine quality system effectiveness and to provide information on customer satisfaction, supplier performance, product conformance, and process/product characteristics and trends used to identify opportunities for preventive action
8.5 Improvement - New: must improve effectiveness of the quality management system (note: accomplish through the use of quality policy, objectives, audit results, analysis of data, corrective/preventive actions, and management review)
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41. ISO 9000:2000 standards released December 2000
The final International Standard (IS) was released 15 December 2000 and is available now
Sector specific schemes are under review and ISO 9000:2000 based revisions will be issued soon:
Automotive: ISO/TS 16949
Aerospace: AS 9100
Telecommunications: TL 9000
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42. Essentially, you’ll have 3 years to transition to the new standards
Accredited registrations to ISO 9001/2/3:1994 may continue for up to 3 years (through 12/03)
Allows transition time for those “in progress”
Both new registrations and continuations of current registrations based on 1994 standards will expire on or before the end of CY 2003
Allows time for accredited organizations, registrars, and training activities/consultants
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43. So … what should organizations do NOW?
Obtain assistance from qualified sources
Obtain/conduct Management and Employee Awareness Training, Internal Auditor Training, and Process Management Training
Obtain/conduct a “Gap Analysis”
Obtain guidance from your Registrar
Obtain their transition plan, including provisions related to any sector specific schemes applicable to your organization (QS 9000 e.g.)
Develop/implement your transition plan
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Answers to FAQs ...
Do I have to change my system?
Not at the moment … HOWEVER, it would be beneficial to look at the new standards as soon as possible so you can get an idea of what new requirements are forthcoming …
Do I have to re-write my documents?
NO … HOWEVER, at a minimum, some adjustments will have to be made to address new requirements and cross reference quality system documentation to ISO 9001:2000
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45. Answers to FAQs (continued) ...
Will the changes affect my current registration / certification?
Yes. A transition plan will need to be approved by your registrar and incorporated into their regular audit routine
I am not yet registered. Should I pursue registration to the 1994 standards first?
Only if “timing” is an issue … either way your system design should be based on the new standards … consult with your Registrar to discuss options
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46. The Role of Internal Audits has shifted...
Effectiveness assessed in audit report
ISO
Management review
Internal audit
Internal audit
Management determines effectiveness by analyzing all available data and information
ISO
Customer satisfaction
Management review
Other data
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Audit Methodologies ...
Audit Planning
Evaluating QMS Documentation
Conducting Process Audits
Using Internal Audits to:
Verify QMS Effectiveness
Identify Opportunities for Improvement
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Audit Planning
The Shift to Process Audits
“Element” Audits, or Departmental Audits should give way to process audits - i.e. audit (from start to finish) key processes the organization has defined as critical to meeting the overall objectives of the organization
Note: The processes selected, as well as their sequence and interrelation, must make sense to the organization; however, they must address all requirements of ISO 9001:2000 and the policy and objectives of the organization.
Use Internal Audits for Improvement
Audit scope should clearly state if/when the purpose of the internal audit will “go beyond compliance audits” and be used to identify additional opportunities for improvement
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49. Evaluating QMS Documentation
Documentation requirements are less prescriptive
ISO 9001:2000 only “requires” a handful of “documented procedures” be in place
All QMS processes, however, must be controlled by either a documented procedure or well defined “system”
Evaluating System Adequacy
Assess organization’s compliance with documented procedures and/or other well defined responsibilities associated with the process under review (conformance)
Verify that the system is achieving the desired results (performance)
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50. Conducting Process Audits
Identify QMS Process “Owners”
Tools like “Deployment Flowcharts” can be invaluable in defining the sequence, interrelationship and responsibilities associated with QMS Processes
Evaluate “Conformance”
Tools like our “Checklist and Audit Guide” can be invaluable in verifying that the documented procedure or process complies with ISO 9001:2000 requirements
Evaluate “Performance”
Verify that the organization is collecting and using process performance data to monitor, measure and improve processes
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51. Conducting Top Management Interviews
The expanded role of top management requires more time be spent with them during internal audits to collect evidence of their commitment to:
Communicating importance of meeting requirements,
Establishing quality policy and objectives,
Conducting management reviews, and
Ensuring availability of necessary resources.
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52. Interviewing “Process Owners”
Other managers (i.e. “Process Owners”) should be interviewed to collect evidence that:
Processes and improvement objectives are documented and planned,
Processes and needed resources are deployed,
Processes are monitored and measured, and
Actions are taken, as warranted by analysis of process data.
Note: Auditors should look for evidence that process
sequence and interrelationships are known
and interfaces are effectively managed to
achieve the desired objectives.
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53. Implications for Auditors
Opportunities
Find the “holes” as process linkages
Follow the way the business actually works
“Value-added”auditing
Challenges
Process Audits versus Element Audits
Fewer procedures
Less prescriptive requirements for realization processes
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54. EXERCISE #3
What are the three most significant changes included in ISO 9001:2000?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
What are the benefits of using internal audit results to aid in assessing effectiveness and the need for improvement?
How can you use internal audits to enhance employee awareness and involvement in quality management?
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
1. Scope
1.1 General -
1.2 Permissible Exclusions -
2. Normative Reference 2
3. Terms and Definitions 3
4. Quality Management System -
4.1 General Requirements
4.2 Documentation Requirements -
4.2.1 General , 4.5.3
4.2.2 Quality Manual
4.2.3 Control of Documents 4.5
4.2.4 Control of Quality Records
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
5. Management Responsibility -
5.1 Management Commitment 4.1, , 4.2.1
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning -
5.4.1 Quality Objectives , 4.2.1
5.4.2 Quality Management System Planning
5.5 Responsibility, Authority, and Communication -
5.5.1 Responsibility and Authority
5.5.2 Management Representative
5.5.3 Internal Communications -
5.6 Management Review
5.6.1 General
5.6.2 Review Input
5.6.3 Review Output
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
6. Resource Management -
6.1 Provision of Resources
6.2 Human Resources -
6.2.1 Assignment of Personnel , 4.2.3, 4.18
6.2.2 Competence, Awareness, and Training 4.18
6.3 Infrastructure , 4.9
6.4 Work Environment
7. Product Realization -
7.1 Planning of Product Realization , 4.9,
7.2 Customer-Related Processes -
7.2.1 Determination of Product Requirements 4.3.2, 4.4.4
7.2.2 Review of Product Requirements 4.3
7.2.3 Customer Communication
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
7.3 Design and Development -
7.3.1 Design and Development Planning , 4.4.3, 4.4.6,
4.4.7, 4.4.8
7.3.2 Design and Development Inputs
7.3.3 Design and Development Outputs
7.3.4 Design and Development Review
7.3.5 Design and Development Verification
7.3.6 Design and Development Validation
7.3.7 Design and Development Changes
7.4 Purchasing -
7.4.1 Purchasing Process , 4.6.2
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Products ,
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
7.5 Production and Service Provision -
7.5.1 Control of Production and Service Provision 4.9, ,
4.15.6, 4.19
7.5.2 Validation of Special Processes 4.9
7.5.3 Identification and Traceability 4.8, , 4.12
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices 4.11
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ISO 9001:2000 to ISO 9001:1994 Mapping
ISO 9001: ISO 9001:1994
8. Measurement, Analysis, and Improvement -
8.1 General ,
8.2 Monitoring and Measurement -
8.2.1 Customer Satisfaction -
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes 4.9,
8.2.4 Monitoring and Measurement of Product 4.10, 4.20
8.3 Control of Nonconforming Product 4.13
8.4 Analysis of Data , 4.20
8.5 Improvement -
8.5.1 Continual Improvement
8.5.2 Corrective Action ,
8.5.3 Preventive Action ,
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61. Where can I obtain more information?
On the world-wide web:
ISO web site
TC 176 web site
ASQ web site
ISO-ONLINE web site
Other questions?
ISO-ONLINE
or call (502)
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