Download - ISO 9001 PPT04
-
8/2/2019 ISO 9001 PPT04
1/61
Presents an Overview of the
ISO 9000:2000 Revisionsto the ISO 9000:1994 Standards
the Move from Conformance to Performance
-
8/2/2019 ISO 9001 PPT04
2/61
Outline
Why Changes are Needed
Principles and Approaches Driving the
Changes
Clause by Clause Review of NewRequirements
Transition Guidance
Audit Implications
-
8/2/2019 ISO 9001 PPT04
3/61
Current ISO 9000 Standards areSuccessful
Why Change a Good Thing?
ISO 9000 is the most successful standardin 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 oforganizations
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.
-
8/2/2019 ISO 9001 PPT04
4/61
Current ISO 9000Standards 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 toperformance excellence models (like MBNQA)required by evolving user and customer needs)
-
8/2/2019 ISO 9001 PPT04
5/61
One World One Quality System
Current standards contain loopholes
Too many companies have only sought to meetminimum requirements and then only by twistingthe intent of the existing standards
There is a growing demand forperformance excellence
ISO 9001:1994 does not require continual
improvement
ISO 9001:2000 is process/performance oriented anddoes require continual improvement of the QMS, butby itself is not viewed as a performance excellence
model
ISO 9000 2000 i h
-
8/2/2019 ISO 9001 PPT04
6/61
ISO 9000:2000 is thefoundation for
Performance Excellence
Competitive
Advantage
Efficient
Quality Management System
Effective
Quality Management System
Business Vision
Performance Excellence
Malcolm Baldrige Criteria
Performance ImprovementISO 9004:2000
Baseline Performance:
ISO 9001:2000
-
8/2/2019 ISO 9001 PPT04
7/61
EXERCISE #1
List your organizations three most significant challengesor business needs over the next 2-3 years (consider anyexternal changes that will affect your organization):
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
What are your organizations goals and objectives?1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
How can you use ISO 9001:2000 to help deal with
business needs and external challenges?___________________________________________________________
___________________________________________________________
___________________________________________________________
-
8/2/2019 ISO 9001 PPT04
8/61
ISO 9000:2000 is based on EightQuality Management Principles
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Continual Improvement
Factual Approach to Decision Making
Mutually Beneficial Supplier Relationships
-
8/2/2019 ISO 9001 PPT04
9/61
Customer Focus
Organizations depend on theircustomers and therefore should:
understand current and future customerneeds,
meet customer requirements, and
strive to exceed customer expectations.
-
8/2/2019 ISO 9001 PPT04
10/61
Leadership
Leaders should:
establish unity of purpose and direction ofthe organization, and
create and maintain the internal
environment in which people can becomefully involved in achieving theorganizations objectives.
-
8/2/2019 ISO 9001 PPT04
11/61
Involvement of People
People at all levels are the essence
of an organization, and
their full involvement enables theirabilities to be used for the organizations
benefit.
-
8/2/2019 ISO 9001 PPT04
12/61
Process Approach
Organizations need to do more thansimply monitor process outputs,(typically through inspection activities)
they must also control all processinputs, (people, facilities/equipment,material and methods)
and, they must establish appropriatecontrols over the transformationactivities (if desired results are to beachieved consistently and efficiently)
-
8/2/2019 ISO 9001 PPT04
13/61
What is a Process?
Activity that transforms input into output
ActivityInput Output
Resources:
PeopleFacilities/EquipmentMaterialMethods
Results:
ProductsServicesPerformance
-
8/2/2019 ISO 9001 PPT04
14/61
How is a Process Managed?
ActivityInput Output
Right Resources:
Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods
Desired Results:
Quality ProductsQuality ServicesCustomer Satisfaction
Monitor & Measure the Processmake sure the inputs are right, the transformationactivities consistently work, and the desired resultsare achieved, then - improve the process as needed
-
8/2/2019 ISO 9001 PPT04
15/61
How is a Process Measured?
ActivityInput Output
Right Resources:Qualified PeopleRight Facilities/EquipmentCorrect MaterialsProven Methods
Desired Results:Quality ProductsQuality ServicesCustomer Satisfaction
EfficientNo Waste
EffectiveDesired Results Achieved
-
8/2/2019 ISO 9001 PPT04
16/61
System Approach
Organizations must understand asystem is a set of interrelatedprocesses, and
the output of one process is the input toone or more subsequent processes, so ...
It is critical to manage the white space(or interface) between processes to ensurethat the overall system is effective
-
8/2/2019 ISO 9001 PPT04
17/61
Continual Improvement
Continual improvement of the
organizations overall performanceshould be a permanent objective:
improvement must be a planned activity ifthe organization desires to improve overallperformance and capabilities.
-
8/2/2019 ISO 9001 PPT04
18/61
Plan Do
Act CheckQMS
Results
Baseline PerformanceImprovement Objective
Improve Process
through PDCA Cycle
Measure/Monitor Results Against Objectives -
Improve Process and Change QMS as Needed
to Achieve and Sustain Desired Results
The QMS must be used forcontinuous improvement ...
-
8/2/2019 ISO 9001 PPT04
19/61
Factual Approach toDecision Making
Effective decisions are:
based on the analysis of data andinformation.
-
8/2/2019 ISO 9001 PPT04
20/61
Mutually BeneficialSupplier Relationships
An organization and its suppliers are
truly inter-dependent, and
a mutually beneficial relationship enhancesthe ability of both to create value.
-
8/2/2019 ISO 9001 PPT04
21/61
EXERCISE #2
Pick one of the eight quality management principles andlist three of the most important actions you think anorganization should take in applying this principle.
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
How well does your organization do each of the actionsidentified above?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
What can your organization do to more fully utilize theprinciple?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
-
8/2/2019 ISO 9001 PPT04
22/61
The ISO 9000:2000 standardsinclude 3 documents...
ISO 9000:2000Quality Management Systems -Fundamentals and Vocabulary
ISO 9004:2000Quality Management Systems -
Guidelines for Performance Improvements
ISO 9001:2000Quality Management Systems -
Requirements
ISO 9000 2000 t d d
-
8/2/2019 ISO 9001 PPT04
23/61
ISO 9000:2000 standardsreplace many existing ISO
documents...
Revises/Replaces:- ISO 8402:1994
- ISO 9000-1:1994
ISO 9000:2000Quality Management Systems -
Fundamentals and Vocabulary
Revises/Replaces:
- ISO 9004-1, 9004-2, 9004-3 and 9004-4
(all previous editions, 1994-1994)
ISO 9004:2000Quality Management Systems -
Guidelines for PerformanceImprovements
Revises/Replaces:- ISO 9001:1994- ISO 9002-1994- ISO 9003:1994
ISO 9001:2000Quality Management Systems -
Requirements
-
8/2/2019 ISO 9001 PPT04
24/61
Other ISO documents are alsobeing revised for consistency...
in Sep 2001 will likely replace:
- ISO 10011 (for QMS)- ISO 14011 (for EMS)
ISO 19011the Joint Working Group on
Auditing Document
with revisions due out after issuanceof ISO 9000:2000 include:
- Aerospace: AS 9100
- Telecommunications: TL 9000
Other sector specificQuality System
Requirements Documents
released in 4th quarter 1999 as a
harmonized US and Europeanstandard, for these standards:
- QS 9000 (US)- EAQF (France)- VDA6.1 (Germany)- AVSQ (Italy)
only ISO/TS 16949 will beupgraded to ISO 9001:2000
however, ISO has granted
permission for continued(indefinite) use of QS-9000
ISO/TS 16949International Automotive Standard -
Quality System Requirements
-
8/2/2019 ISO 9001 PPT04
25/61
Role of ISO 9000:2000
Defines quality managementprinciples
terms and definitions
fundamentals:- systems approach
- process approach
- continual improvement
ISO 9000:2000 is a normative reference(i.e. part of the requirements), andreplaces:
ISO 8402:1994 and ISO 9000-1:1994
-
8/2/2019 ISO 9001 PPT04
26/61
Role of ISO 9001:2000
Specifies quality systemrequirements:
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 theyare not part of your business
ISO 9001:2000 replaces:ISO 9001/2/3:1994
-
8/2/2019 ISO 9001 PPT04
27/61
Role of ISO 9004:2000
Provides guidelines for performanceimprovement, based on
quality management principles and approaches
defined in ISO 9000, and
continual improvement of the qualitymanagement system itself
note: however, ISO 9004 is NOT intended as a
guideline for implementing or assessingimplementation of ISO 9001 requirements
ISO 9004:2000 replaces:
ISO 9004-1, 9004-2, 9004-3 & 9004-4
-
8/2/2019 ISO 9001 PPT04
28/61
ISO 9001 and ISO 9004are the Consistent Pair
comprised of the following 8 clauses:1. Scope
2. Normative references (part of the requirements)
3. Terms and definitions4. Quality management system
5. Management responsibility
6. Resource management
7. Product (and/or service) realization
8. Measurement, analysis &
improvement
-
8/2/2019 ISO 9001 PPT04
29/61
Continual Improvement of the
Quality Management System
The Process-Based Quality
Management System
ManagementResponsibility
Product
Realization
ResourceManagement
MeasurementAnalysis &
Improvement
C
US
T
OM
E
R
REQ
U
IR
E
ME
N
TS
C
US
T
OM
E
R
SAT
I
SF
A
CT
I
ON
Product
Input Output
i l
-
8/2/2019 ISO 9001 PPT04
30/61
ISO 9001:2000 implementsthe PDCA improvement cycle
PlanClause 5. Management responsibility -
everything flows from Management who definethe requirements for the system
Clause 6. Resource management - fromthese requirements the resources will beidentified and management must ensure they areprovided and applied within the system
Do
Clause 7. Product (and/or service)
realization - the necessary process are
established and carried out
SO 900 2000 i l
-
8/2/2019 ISO 9001 PPT04
31/61
ISO 9001:2000 implementsthe PDCA improvement cycle
CheckClause 8. Measurement, analysis and
improvement - processes and products will bemonitored and measured against policies,
objectives and requirements for the product andresults/opportunity for improvement reported
Act
Clause 8. Measurement, analysis andimprovement - acting upon data reported in thecheck cycle, improvement actions can be taken -directly, or as an output of the Management
Review process (Clause 5.6)
Cl 4 Q li
-
8/2/2019 ISO 9001 PPT04
32/61
Clause 4 - Qualitymanagement system
4.1 General requirements - New: must defineprocesses to be managed (including out-sourcedprocesses - which typically include design, training,calibration, heat treat, etc.); determine the sequenceand interaction of these processes; determine the
criteria and methods needed to ensure theseprocesses are effective; and take actions to improvethese processes
4.2 Documentation requirements - New:
documentation requirements less prescriptive;however, at a minimum must include a quality manualand the following six documented procedures: Control ofDocuments (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).
-
8/2/2019 ISO 9001 PPT04
33/61
Clause 5 - Managementresponsibility
5.1 Management commitment - New: topmanagement must demonstrate commitment todevelopment and implementation of the quality
system and continually improving its effectiveness
5.2 Customer focus - New: customerrequirements (identified per Clause 7.2.1) must be metwith the aim of enhancing customer satisfaction (a
perception that must be measured per Clause 8.2.1)
5.3 Quality policy - New: quality policy mustinclude commitment to meeting requirements andcontinual improvement of the effectiveness of theQMS, provide a framework for establishing/reviewingmeasurable quality objectives; and, quality policy
must be periodically reviewed for continuing suitability
Cl 5 M t
-
8/2/2019 ISO 9001 PPT04
34/61
Clause 5 - Managementresponsibility
5.4 Planning - New: establish measurablequality objectives at relevant functions and levelsin the organization needed to meet productrequirements (identified per Clause 7.1 a); andidentify and plan quality system processes (identified
per Clause 4.1)
5.5 Responsibility, authority andcommunication - New: managementrepresentative must promote awareness of
customer requirements throughout theorganization; internal communications regarding theeffectiveness of the quality system must beestablished
Cl 5 M t
-
8/2/2019 ISO 9001 PPT04
35/61
Clause 5 - Managementresponsibility
5.6 Management review - New: evaluate theneed for changes to the quality system (includingpolicy and objectives) by reviewing specified inputs(improvement opportunities)and reporting specifiedoutputs(related management actions and resource
needs)
Cl 6 R
-
8/2/2019 ISO 9001 PPT04
36/61
Clause 6 - Resourcemanagement
6.1 Provision of resources - New: determine
and provide resources needed to implement andimprove the QMS and address customersatisfaction
6.2 Human resources - New: determine
needed competencies, evaluate effectiveness ofactions taken to satisfy competency needs; andensure employees are aware of the importance oftheir activities and how they contribute to achievingquality objectives
6.3 Infrastructure and 6.4 WorkEnvironment - New: determine and manage theinfrastructure (buildings, workspace, utilities, equipmentand support services), as well as the work
environment needed to achieve product conformance
-
8/2/2019 ISO 9001 PPT04
37/61
Clause 7 - Product realization
7.1 Planning of product realization - New:determine measurable quality objectives forcontracts, projects and products
7.2 Customer-related processes - New: define
the processes for communicating with thecustomer with regards to product information;inquiries, contracts or order handling, and customerfeedback, including complaints
7.3 Design and development resources -New: design output to include appropriate informationfor purchasing, production and for service provision
-
8/2/2019 ISO 9001 PPT04
38/61
Clause 7 - Product realization
7.4 Purchasing - New: establish criteria forsupplier evaluation and selection, and periodic re-evaluation
7.5 Production and service provision - New:Nothing, essentially the same as requirementscontained in Elements 4.7, 4.8, 4.9, 4.15, and 4.19 ofISO 9001:1994
7.6 Control of measuring and monitoring
devices - New: validate software used to verifyproduct
Cl 8 M t
-
8/2/2019 ISO 9001 PPT04
39/61
Clause 8 - Measurement,analysis and improvement
8.1 General - New: plan and implementmonitoring, measurement, analysis andimprovement processes
8.2 Monitoring and measurement - New:
must measure and monitor customersatisfaction(note: customer satisfaction is anyinformation relating to the customers perception ofthe organizations ability to meet customer
requirements); internal auditors must now be
objective and impartial (vice independent); andprocesses used to manage the quality system mustbe measured/monitored to the degree necessary todemonstrate they achieved planned results
Cl 8 M t
-
8/2/2019 ISO 9001 PPT04
40/61
Clause 8 - Measurement,analysis and improvement
8.3 Control of nonconforming product -New: Nothing, essentially the same as requirementscontained in Clause 4.13 of ISO 9001:1994)
8.4 Analysis of data - New: analyze data to
determine quality system effectiveness and toprovide information on customer satisfaction,supplier performance, product conformance, andprocess/product characteristics and trends used toidentify opportunities for preventive action
8.5 Improvement - New: must improveeffectiveness of the quality managementsystem(note: accomplish through the use of qualitypolicy, objectives, audit results, analysis of data,corrective/preventive actions, and management review)
ISO 9000 2000 t d d
-
8/2/2019 ISO 9001 PPT04
41/61
ISO 9000:2000 standardsreleased December 2000
The final International Standard (IS)was released 15 December 2000 andis available now
Sector specific schemes are underreview and ISO 9000:2000 basedrevisions will be issued soon:
Automotive: ISO/TS 16949
Aerospace: AS 9100
Telecommunications: TL 9000
Essentially youll have 3
-
8/2/2019 ISO 9001 PPT04
42/61
Essentially, you ll have 3years to transition to the
new standards
Accredited registrations to ISO9001/2/3:1994 may continue for up to3 years (through 12/03)
Allows transition time for those in progress
Both new registrations andcontinuations of current registrations
based on 1994 standards will expireon or before the end of CY 2003
Allows time for accredited organizations, registrars,and training activities/consultants
So what should
-
8/2/2019 ISO 9001 PPT04
43/61
So what shouldorganizations do NOW?
Obtain assistance from qualified sources Obtain/conduct Management and Employee Awareness
Training, Internal Auditor Training, and ProcessManagement 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 yourorganization (QS 9000 e.g.)
Develop/implement your transition plan
-
8/2/2019 ISO 9001 PPT04
44/61
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 aspossible 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, someadjustments will have to be made to address newrequirements and cross reference quality systemdocumentation to ISO 9001:2000
Answers to FAQs
-
8/2/2019 ISO 9001 PPT04
45/61
Answers to FAQs(continued) ...
Will the changes affect my currentregistration / certification?
Yes. A transition plan will need to be approved byyour registrar and incorporated into their regular audit
routine
I am not yet registered. Should Ipursue 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
-
8/2/2019 ISO 9001 PPT04
46/61
The Role of Internal
Audits has shifted...
ISO9001
1994
Internal auditEffectivenessassessed in
audit report
Managementreview
ISO90012000
Customersatisfaction
Managementdetermines
effectiveness byanalyzing allavailable data
and information
Managementreview
Internal audit
Other data
-
8/2/2019 ISO 9001 PPT04
47/61
Audit Methodologies ...
Audit Planning
Evaluating QMS Documentation
Conducting Process Audits
Using Internal Audits to:
Verify QMS Effectiveness
Identify Opportunities for Improvement
-
8/2/2019 ISO 9001 PPT04
48/61
Audit Planning
The Shift to Process Audits
Element Audits, or Departmental Audits should giveway to process audits - i.e. audit (from start to finish)key processes the organization has defined as critical tomeeting the overall objectives of the organization
Note: The processes selected, as well as their sequence andinterrelation, must make sense to the organization; however, theymust address all requirements of ISO 9001:2000 and the policyand 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 andbe used to identify additional opportunities forimprovement
Evaluating QMS
-
8/2/2019 ISO 9001 PPT04
49/61
Evaluating QMSDocumentation
Documentation requirements are lessprescriptive
ISO 9001:2000 only requires a handful of documentedprocedures be in place
All QMS processes, however, must be controlled by eithera documented procedure or well defined system
Evaluating System Adequacy
Assess organizations compliance with documentedprocedures and/or other well defined responsibilitiesassociated with the process under review (conformance)
Verify that the system is achieving the desired results(performance)
-
8/2/2019 ISO 9001 PPT04
50/61
Conducting Process Audits
Identify QMS Process Owners
Tools like Deployment Flowcharts can be invaluablein defining the sequence, interrelationship andresponsibilities associated with QMS Processes
Evaluate Conformance Tools like our Checklist and Audit Guide can be
invaluable in verifying that the documented procedureor process complies with ISO 9001:2000 requirements
Evaluate Performance
Verify that the organization is collecting and usingprocess performance data to monitor, measure andimprove processes
Conducting Top
-
8/2/2019 ISO 9001 PPT04
51/61
Conducting TopManagement Interviews
The expanded role of top managementrequires more time be spent withthem during internal audits to collectevidence of their commitment to:
Communicating importance of meeting requirements,
Establishing quality policy and objectives,
Conducting management reviews, and
Ensuring availability of necessary resources.
Interviewing
-
8/2/2019 ISO 9001 PPT04
52/61
InterviewingProcess Owners
Other managers (i.e. Process Owners)should be interviewed to collect evidencethat:
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.
-
8/2/2019 ISO 9001 PPT04
53/61
Implications for Auditors
Opportunities Find the holes as process linkages
Follow the way the business actually works
Value-addedauditing
Challenges Process Audits versus Element Audits
Fewer procedures
Less prescriptive requirements for realizationprocesses
-
8/2/2019 ISO 9001 PPT04
54/61
EXERCISE #3
What are the three most significant changes included inISO 9001:2000?1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
What are the benefits of using internal audit results to aidin assessing effectiveness and the need for improvement?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
How can you use internal audits to enhance employeeawareness and involvement in quality management?
1. __________________________________________________________
2. __________________________________________________________
3. __________________________________________________________
ISO 9001 2000 t ISO 9001 1994
-
8/2/2019 ISO 9001 PPT04
55/61
ISO 9001:2000 to ISO 9001:1994Mapping
ISO 9001:2000 ISO 9001:1994
1. Scope 1
1.1 General -
1.2 Permissible Exclusions -
2. Normative Reference 2
3. Terms and Definitions 34. Quality Management System -
4.1 General Requirements 4.2.1
4.2 Documentation Requirements -
4.2.1 General 4.5.2, 4.5.3
4.2.2 Quality Manual 4.2.1
4.2.3 Control of Documents 4.5
4.2.4 Control of Quality Records 4.16
ISO 9001 2000 t ISO 9001 1994
-
8/2/2019 ISO 9001 PPT04
56/61
ISO 9001:2000 to ISO 9001:1994Mapping
ISO 9001:2000 ISO 9001:1994
5. Management Responsibility -
5.1 Management Commitment 4.1, 4.1.2.2, 4.2.1
5.2 Customer Focus 4.3.2
5.3 Quality Policy 4.1.1
5.4 Planning -5.4.1 Quality Objectives 4.1.1, 4.2.1
5.4.2 Quality Management System Planning 4.2.3
5.5 Responsibility, Authority, and Communication -
5.5.1 Responsibility and Authority 4.1.2.1
5.5.2 Management Representative 4.1.2.3
5.5.3 Internal Communications -
5.6 Management Review 4.1.3
5.6.1 General 4.1.3
5.6.2 Review Input 4.1.3
5.6.3 Review Output 4.1.3
ISO 9001 2000 t ISO 9001 1994
-
8/2/2019 ISO 9001 PPT04
57/61
ISO 9001:2000 to ISO 9001:1994Mapping
ISO 9001:2000 ISO 9001:1994
6. Resource Management -
6.1 Provision of Resources 4.1.2.2
6.2 Human Resources -
6.2.1 Assignment of Personnel 4.1.2.2, 4.2.3, 4.18
6.2.2 Competence, Awareness, and Training 4.186.3 Infrastructure 4.1.2.2, 4.9
6.4 Work Environment 4.9
7. Product Realization -
7.1 Planning of Product Realization 4.2.3, 4.9, 4.10.1
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 4.3.2
-
8/2/2019 ISO 9001 PPT04
58/61
ISO 9001 2000 t ISO 9001 1994
-
8/2/2019 ISO 9001 PPT04
59/61
ISO 9001:2000 to ISO 9001:1994Mapping
ISO 9001:2000 ISO 9001:1994
7.5 Production and Service Provision -
7.5.1 Control of Production and Service Provision 4.9, 4.10.3,
4.15.6, 4.19
7.5.2 Validation of Special Processes 4.9
7.5.3 Identification and Traceability 4.8, 4.10.5, 4.127.5.4 Customer Property 4.7
7.5.5 Preservation of Product 4.15
7.6 Control of Monitoring and Measuring Devices 4.11
ISO 9001 2000 t ISO 9001 1994
-
8/2/2019 ISO 9001 PPT04
60/61
ISO 9001:2000 to ISO 9001:1994Mapping
ISO 9001:2000 ISO 9001:1994
8. Measurement, Analysis, and Improvement -
8.1 General 4.10, 4.20.1
8.2 Monitoring and Measurement -
8.2.1 Customer Satisfaction -
8.2.2 Internal Audit 4.178.2.3 Monitoring and Measurement of Processes 4.9, 4.20.1
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 4.14, 4.20
8.5 Improvement -
8.5.1 Continual Improvement 4.1.3
8.5.2 Corrective Action 4.14.1, 4.14.2
8.5.3 Preventive Action 4.14.1, 4.14.3
Where can I obtain more
-
8/2/2019 ISO 9001 PPT04
61/61
Where can I obtain moreinformation?
On the world-wide web:ISO web site www.iso.ch
TC 176 web site www.bsi.org.uk/iso-176-sc2
ASQ web site www.asq.org
ISO-ONLINE web site www.isoqual.net
Other questions?ISO-ONLINE Email: [email protected]
or call (502) 244-6183