Transcript 2000 Rev Overview - FREE - Rev 4-30-01

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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1
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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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,
administration,
education,
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3
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 14000 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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“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”
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ISO 9000:2000 is the
foundation for
Performance Excellence
Business Vision
Performance Excellence
Competitive
Malcolm Baldrige Criteria
Advantage
Performance Improvement
ISO 9004:2000
Baseline Performance:
ISO 9001:2000
Efficient
Quality Management System
Effective
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products Management
Quality
6
System
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?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
• How can you use ISO 9001:2000 to help deal with
business needs and external challenges?
___________________________________________________________
___________________________________________________________
___________________________________________________________
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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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What is a Process?
Activity that transforms input into output
Input
Activity
Output
Resources:
Results:
People
Facilities/Equipment
Material
Methods
Products
Services
Performance
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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
Input
Activity
Right Resources:
Output
Desired Results:
Qualified People
Quality Products
Right Facilities/Equipment
Quality Services
Correct Materials
Customer Satisfaction
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How is a Process Measured?
Efficient
No Waste
Input
Effective
Desired Results Achieved
Activity
Output
Right Resources:
Desired Results:
Qualified People
Right Facilities/Equipment
Correct Materials
Proven Methods
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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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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The QMS must be used for
continuous improvement ...
Improve Process
through PDCA Cycle
Plan
Act
QMS
Results
Do
Check
Measure/Monitor Results Against Objectives Improve Process and Change QMS as Needed
to Achieve and Sustain Desired Results
Improvement Objective
Baseline Performance
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Factual Approach to
Decision Making
• Effective decisions are:
 based on the analysis of data and
information.
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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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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?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
• What can your organization do to more fully utilize the
principle?
1. __________________________________________________________
2. __________________________________________________________
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3. __________________________________________________________
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The ISO 9000:2000 standards
include 3 documents...
ISO 9000:2000
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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ISO 9000:2000 standards
replace many existing ISO
documents...
ISO 9000:2000
ISO 9001:2000
Quality Management Systems -
Quality Management Systems -
Fundamentals and Vocabulary
Requirements
Revises/Replaces:
Revises/Replaces:
- ISO 9001:1994
- ISO 9002-1994
- ISO 9003:1994
- ISO 8402:1994
- ISO 9000-1:1994
ISO 9004:2000
Quality Management Systems -
Guidelines for Performance
Improvements
Revises/Replaces:
- ISO 9004-1, 9004-2, 9004-3 and 9004-4
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(all previous
1994-1994)
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23
Other ISO documents are also
being revised for consistency...
ISO 19011
ISO/TS 16949
the Joint Working Group on
International Automotive Standard -
Auditing Document
Quality System Requirements
in Sep 2001 will likely replace:
- ISO 10011 (for QMS)
- ISO 14011 (for EMS)
Other sector specific
Quality System
Requirements Documents
with revisions due out after issuance
of ISO 9000:2000 include:
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 16949 will be
upgraded to ISO 9001:2000
however, ISO has granted
- Aerospace: AS 9100
for continued
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(indefinite) use of QS-9000
24
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:
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ISO 8402:1994
and
ISO 9000-1:1994
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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:
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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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C
U
S
T
O
M
E
R
R
E
Q
U
I
R
E
M
E
N
T
S
Continual Improvement of the
Quality Management System
Management
Responsibility
Resource
Management
Measurement
Analysis &
Improvement
Product
Realization
Input
Product
Output
The Process-Based Quality
Management
System
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C
U
S
T
O
M
E
R
S
A
T
I
S
F
A
C
T
I
O
N
29
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
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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 processVisit
(Clause
5.6)for more
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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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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
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must be periodically reviewed
for
continuing
suitability
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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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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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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
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environment needed
achieve
product
conformance
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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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Clause 7 - Product realization
• 7.4 Purchasing - New: establish criteria for
supplier evaluation and selection, and periodic reevaluation
• 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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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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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
and
management review)
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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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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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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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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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The Role of Internal
Audits has shifted...
ISO
9001
1994
Internal audit
Internal audit
ISO
9001
2000
Customer
satisfaction
Other data
Effectiveness
assessed in
audit report
Management
determines
effectiveness by
analyzing all
available data
and information
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Management
review
Management
review
46
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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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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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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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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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 52
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achieve the great
desired
objectives.
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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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?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
• How can you use internal audits to enhance employee
awareness and involvement in quality management?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
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ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
1. Scope
1.1 General
1.2 Permissible Exclusions
2. Normative Reference
3. Terms and Definitions
4. Quality Management System
4.1 General Requirements
4.2 Documentation Requirements
4.2.1 General
4.2.2 Quality Manual
4.2.3 Control of Documents
4.2.4 Control of Quality Records
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ISO 9001:1994
1
2
3
4.2.1
4.5.2, 4.5.3
4.2.1
4.5
4.16
55
ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
5. Management Responsibility
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.4.1 Quality Objectives
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 9001:1994
4.1, 4.1.2.2, 4.2.1
4.3.2
4.1.1
4.1.1, 4.2.1
4.2.3
4.1.2.1
4.1.2.3
4.1.3
4.1.3
4.1.3
4.1.3
56
ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
6. Resource Management
6.1 Provision of Resources
6.2 Human Resources
6.2.1 Assignment of Personnel
6.2.2 Competence, Awareness, and Training
6.3 Infrastructure
6.4 Work Environment
7. Product Realization
7.1 Planning of Product Realization
7.2 Customer-Related Processes
7.2.1 Determination of Product Requirements
7.2.2 Review of Product Requirements
7.2.3 Customer Communication
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ISO 9001:1994
4.1.2.2
4.1.2.2, 4.2.3, 4.18
4.18
4.1.2.2, 4.9
4.9
4.2.3, 4.9, 4.10.1
4.3.2, 4.4.4
4.3
4.3.2
57
ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
7.3 Design and Development
7.3.1 Design and Development Planning
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
7.4.2 Purchasing Information
7.4.3 Verification of Purchased Products
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ISO 9001:1994
4.4.2, 4.4.3, 4.4.6,
4.4.7, 4.4.8
4.4.4
4.4.5
4.4.6
4.4.7
4.4.8
4.4.9
4.6.1, 4.6.2
4.6.3
4.6.4, 4.10.2
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ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Special Processes
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7.6 Control of Monitoring and Measuring Devices
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ISO 9001:1994
4.9, 4.10.3,
4.15.6, 4.19
4.9
4.8, 4.10.5, 4.12
4.7
4.15
4.11
59
ISO 9001:2000 to ISO 9001:1994
Mapping
ISO 9001:2000
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
8.2.4 Monitoring and Measurement of Product
8.3 Control of Nonconforming Product
8.4 Analysis of Data
8.5 Improvement
8.5.1 Continual Improvement
8.5.2 Corrective Action
8.5.3 Preventive Action
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ISO 9001:1994
4.10, 4.20.1
4.17
4.9, 4.20.1
4.10, 4.20
4.13
4.14, 4.20
4.1.3
4.14.1, 4.14.2
4.14.1, 4.14.3
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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
www.iso.ch
www.bsi.org.uk/iso-176-sc2
www.asq.org
www.isoqual.net
• Other questions?
ISO-ONLINE
Email: [email protected]
or call (502) 244-6183
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