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Awareness toAwareness to
ISO 9001:2000ISO 9001:2000
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Tutors Introduction
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Course Structure
Lectures and value
added discussions on
each topic.Workshops to enable
delegates to increase
their understanding
regarding ISO 9001:2000
version and to
experience Quality
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ISO
International
Organization
for
Standardizatio
n
ISO9000
OHSAS18001
ISO14001
SA8000
ISO/TS
16949
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INTRODUCTIONINTRODUCTION
1
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Origin
MIL-STD-9858
(1940s)
AQAP1
(NATO)
1970s
BS5750
1979
ISO 9000:87
ISO 9000:94
ISO 9001:2000
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What is ISO? International Organization for Standardization
Develops standards do not certify companies
Around 140 countries members
Around 13000 standards produced
Technical Committees are formed to produce
standards
TC 176 for ISO 9000 International Organization for Standardization
Email: [email protected]
Web: http://www.iso.ch
http://www.bsi.org.uk/iso-tc176-sc2.
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ISO 9000:2000
Family of Standards CORE STANDARDSCORE STANDARDS
ISO 9000:2000 Fundamentals and Vocabulary ISO 9001:2000 QMS Requirements ISO 9004:2000 Guidelines for Performance Improvement
SUPPORTING STANDARDSSUPPORTING STANDARDS
ISO 10005:1995 Guidelines for Quality Plans ISO 10006:1997 Guidelines for Project Management ISO 10007:1995 Guidelines for Configuration Mgt ISO 10011-1, -2, -3 on Auditing ISO 10012-1 & -2, Quality Assurance for Measuring Eqpt. ISO 10013:1995 Guidelines for Quality manuals
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ISO 9000:2000 Family of
Standards
ISO/TR 10014:1998 Guidelines for
managing economics of quality
ISO 10015 Guidelines for Training ISO/TR 10017:1999 Guidelines on
Statistical techniques
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QMS
Quality
Management System A System of coordinated activities which
is meant to direct and control an
organization with regard to quality.or
(satisfying your customer by managing your
resources, through a standardized system)
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Design ControlDesign Control
Human ResourceHuman Resource
ControlsControls Records,Records,Documents, &Documents, &
Change ControlsChange Controls
Material, EquipmentMaterial, Equipment
&&
Facility ControlsFacility Controls
Production &Production &
Process ControlsProcess Controls
Corrective &Corrective &
PreventivePreventive
ActionsActions
ManagementManagement
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QUALITY MANAGEMENT
PRINCIPLESWhat are they?
The basic principles onwhich the ISO
9000:2000 standards
are basedQuality
ManagementPrinciples
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Principles of new Standard
Basedoneightquality
management
principles
Leadership
Process
approach
Involvement
ofpeople
System
approachto
Managemen
t
Continual
improvement
Factual
approachto
decision
making
Mutual
beneficial
supplier
relationship
Customerfocus
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Organization depend on their customers andOrganization depend on their customers and
therefore should understand current andtherefore should understand current and
future customer needs, meet customerfuture customer needs, meet customer
requirements and strive to exceed customerrequirements and strive to exceed customer
expectations.expectations.
PRINCIPLE 1
CUSTOMER-FOCUSED
ORGANISATION
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People at all levels are the essence of an
organisation and their full involvement
enables their abilities to be used for theorganisations benefit.
PRINCIPLE 3
INVOLVEMENT OF PEOPLE
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PRINCIPLE 4
PROCESS APPROACH
A desired result is
achieved more efficiently
when related resourcesand activities are
managed as a process.
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Identifying, understanding
and managing a system ofinterrelated processes for
a given objective improves
the organizations
effectiveness and
efficiency.
PRINCIPLE 5
SYSTEM APPROACH TO
MANAGEMENT
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PRINCIPLE 6
CONTINUAL IMPROVEMENT
Continual improvement
should be a permanent
objective of theorganization.
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Effective decisions are based on the
analysis of data and information.
PRINCIPLE 7
FACTUAL APPROACH
TO DECISION MAKING
PRINCIPLE 8
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PRINCIPLE 8
MUTUAL BENEFICIAL
SUPPLIER RELATIONSHIPSAn organization and its
suppliers are
interdependent, and amutually beneficial
relationship enhances the
ability of both to createvalue.
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Process
Any activity that takesinputs and converts them
to outputsProcess ApproachProcess Approach
The systematic identification andThe systematic identification andmanagement of these activities andmanagement of these activities and
the interaction between activities.the interaction between activities.
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E l P h i
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Example - Purchasing
Process
Performance Measurements
Delivery status On-time, Onspec, etc
Supplier evaluation
Outputs
Receipt ofMaterial onright condition
Right QualityRight Quantity
Right Time
PurchasingProcedure
Interactions toStorageInspection andTestingManufacturingFinance
Inputs Demand for
material
Item specsand Date
Suppliersource
Supplierscapability tomeet ourrequirements
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Process Approach Model
ManagementManagement
responsibilityresponsibility
Measurement,Measurement,
analysis andanalysis and
improvementimprovement
ResourceResource
managementmanagement
ServiceService
realizationrealizationOutputInput
ProductProduct
CONTINUAL IMPROVEMENT OF THEQUALITY MANAGEMENT SYSTEM
C
US
T
O
ME
R
S
a
t
is
f
a
c
t
i
o
n
C
US
T
O
M
ER
R
e
q
u
i
r
e
m
e
n
t
s
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Important changes
More emphasis on customer satisfaction
Commitment to comply with legal and statutory requirements
Need to review suitability of quality policy
Need to define quantified and measurable quality objective atdifferent functions and levels
More emphasis on human resource management
Re-evaluation of suppliers on the basis of their performance
Analysis of data for continual improvement
Need to maintain suitable work environment
Term Subcontractor replaced with Supplier and Supplier
replaced with organization
Exclusions defined
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The Structure
00 IntroductionIntroduction11 ScopeScope22 Normative referenceNormative reference
33 Terms and definitionsTerms and definitions44 Quality management systemQuality management system
requirementsrequirements55 Management responsibilityManagement responsibility
66
Resource managementResource management
77 Product realizationProduct realization88 Measurement, analysis andMeasurement, analysis andimprovementimprovement
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System Requirements /
Structure of the Standard
Provision of
resources(6.1)
Human
resources(6.2)
Infrastructures(6.3
)
Work
environment(6.4)
6 Resource
Management
General
requirements (4.1)
Documentation
Requirements(4.2)
Management
Commitment(5.
1)
Customer focus
(5.2)
Quality
policy(5.3)
Planning(5.4)
Responsibility,
authority &
communication(
5.5)
ManagementReviews (5.6)
5 Management
Responsibility
8
Measurement
Analysis &
improvement
4 Quality
Management
System
7 Product
Realization
General (8.1)
Monitoring &
measurement(8.2)
Control of NCP(8.3)
Analysis of data(8.4)
Improvements(8.5)
Planning(7.1)
Customer
related
processes(7.2
)
Design &
development(7.3)
Purchasing(7.4)
Production &
service
provision(7.5)
Control of monitoring &measuring devices(7.6)
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0.4 Compatibility with other
Management Systems
Standard is intended to be
compatible with other managementsystems
It is aligned with ISO 14000 to
enhance compatibility Standard does not include
requirements for other management
system such as EMS, OHSM or
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1.2 ApplicationsRequirements may be excluded if not
appropriate due to :
nature of product
customer requirements applicable regulatory requirements
Exclusions must:
Not affect ability to provide conformingproduct
Be limited to clause 7
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4 Quality Management
System
4.1 General Requirements
Establish, document, implement,
maintain and continually improve QMS inaccordance with the standard.
4 2 G l
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4.2 General
Requirements To implement the QMS the Organization shall
Identify and manage processes necessary for QMS
Determine the sequence and interaction of processes
Determine criteria and methods to ensure effectiveoperation and control of the process
Ensure availability of information needed to support the
operation and monitoring of processes
Measure, monitor, analyze processes and act asnecessary to achieve planned results and continual
improvements
Manage the process in accordance with the standard
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4.2 Documentation
Requirements General Extent
Size and type of
organization
Complexity andinteraction of processes
Competence of personnel
Note3 (Documentation
may be in any type of
media)
To Include
Documented procedures
required by standard
Documents required byorganization to ensure
effective operation and
control process
Note 1 (Where the termdocumented procedure
appears)
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4.2.2 Quality Manual
The organization shall establish a
Quality Manual that include:
Scope of QMS
Documented procedures or reference
to them
Description of interaction between theprocess of QMS
4.2 Documentation
Requirements
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4.2.3 Control of Documents Documents required by the QMS shall be controlled
Approve, Review, Ensure current & relevant version,Identification of external origin documents, Prevent
unintended use of obsolete documents. 4.2.4 Control of Quality Records
Documented Procedure shall be established foridentification, storage, protection, retrieval, retentiontime and disposition.
Records shall be: Established and maintained to provide evidence. Legible, readily identifiable and retrievable.
4.2 Documentation
Requirements
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5 Management Responsibility
5.1 ManagementCommitment
5.2 Customer Focus
5.3 Quality policy
5.4 Planning 5.4.1Quality
objectives
5.4.2 Quality
Planning
5.5 Responsibility, authorityand communication
5.5.1 Responsibility &
authority
5.5.2 Managementrepresentative
5.5.3 Internal
communication
5.6 Management Review
5.6.1 General
5.6.2 Review input
5.6.3 Review output
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5.1 Management
Commitment Provide evidence of commitment to
the development and improvement ofQMS by:
Communicating the importance ofmeeting customer and
legal/regulatory requirements. Establishing quality policy and
objectives.
Management Reviews
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5.2 Customer Focus
Top Management shall ensure that
customer needs & expectations are
determined, converted into requirements
& fulfilled with the aim of achievingcustomer satisfaction
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5.3 Quality Policy
Appropriate to the purpose oforganization.
Commitment to meeting
requirements and continualimprovements
Frame work for establishing and
reviewing quality objectives
Communicated and understood
at appropriate levels
Is reviewed for continuing
suitabilit
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5.4 Planning
5.4.1 Quality Objectives
Establish quality objectives at relevant
functions and levels
Objectives must be measurable and
consistent with the quality policy including
the commitment to continual improvement
Include those needed to meet
requirements for product
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5.4 Planning
5.4.1 Quality Objectives (Cont)
Quality Objectives should be: Specific Measurable Achievable Realistic / Related Time Bound
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5.5 Responsibility, Authority
and Communication
5.5.1 Responsibility and
authority
Functions and theirinteraction, responsibilities
and authorities shall be
defined and communicated
to facilitate effective qualitymanagement
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5.5.2 Management
RepresentativeMember of the management who has
responsibility and authority for ensuring that processes of the QMS are
established and maintained Reporting on performance of QMS
including needs for improvement Promoting awareness of customer needs
and requirementsNote: Responsibilities may include liaison
with external parties in relation to QMS
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5.5.3 Internal Communication
Ensure communication between various
levels and functions regarding the
processes of the QMS and theireffectiveness
5 6 M t R i
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5.6 Management Review
5.6.1 General
Review of QMS by topmanagement at plannedinterval to; ensure QMS suitability,
adequacy and effectiveness Evaluate the need for
changes to QMS including
policy and objectives
Records from ManagementReviews shall be
maintained (see 4.2.4).
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5.6.2 Review Input
Review performance and improvementopportunities related to: Audit results
Customer feedback Process performance and product
conformance Status of preventive and corrective
actions Follow up actions from earlier reviewsChange that could affect the QMS
Recommendations for improvement
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5.6.3 Review Output
Output to include actions related to
improvement of the effectiveness QMS
and its processes
improvement of product related to
customer requirements
resource needs
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6 Resource Management
6.1 Provision of resourses
6.2 Human resources
6.2.1 General
6.2.2 Competence, awareness and
training
6.3 Infrastructure
6.4 Work environment
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6.1 Provision of Resources
The organization shall determine and
determine the resources needed for :
implement and maintain the QMS and
continually improve its effectiveness.
Enhance customer satisfaction by
meeting customer requirements.
6 2 H R
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6.2 Human Resources
6.2.1 General
Those who have responsibilities defined
in the QMS must be competent on the
basis of appropriate education, training,skills and experience
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6.2.2 Competency, Awareness
and Training Identify competency needsProvide required trainingEvaluate the effectiveness of
training providedEnsure staff is aware of
relevance and importance oftheir activities and contribution
to achieving quality objectivesMaintain appropriate records of
education, training, qualification
and experience
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6.3 Infrastructure
Identify, provide and maintain theinfrastructure needed to achieve product
conformity
This shall include :
Workspace & associated utilities
Equipment, hardware and software
Supporting services (transport or
communication)
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7 Product Realization
7.1 Planning of product realization
7.2 Customer related processes
7.3 Design & development7.4 Purchasing
7.5 Production & service operation
7.6 Control of measuring &
monitoring devices
7 1 Pl i f P d t
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7.1 Planning of Product
Realization
Sequence of process to achieve product
Consistent with QMS and documented to suit
method of operations
Quality objectives and requirements for theproduct
The need for processes, documentation,
resources and facilities specific to the product Verification and validation activities and
acceptance criteria
Records
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7.2 Customer Related
Processes
7.2.1 Determination of requirements
related to the product
7.2.2 Review of product requirements
7.2.3 Customer communication
7 2 1 Determination of
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7.2.1 Determination of
requirements related to the
product
Product requirements specified by thecustomer including requirements for
delivery and post-delivery activitiesRequirements not specified but necessary
for intended or specified use
Obligations related to product, includingregulatory and legal requirements
any additional requirements determined bythe organization
7 2 2 Review of requirements
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7.2.2 Review of requirements
related to the product
Review identified requirements and ensure
before commitment to supply product that;
Product requirements are defined
For verbal orders requirements are confirmed Difference between tender and contract are
resolved
Organization has ability to meet therequirements
Records of the results arising from the review
shall be recorded.
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7.2.3 Customer Communication
Identify and implement arrangements for
communication with customers relating to:
product information
inquiry, contract or order handling,
including amendments
Customer feedback including complaints
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7.3 Design & Development
7.3.1 Design & development planning
7.3.2 Design & development inputs
7.3.3 Design & development outputs
7.3.4 Design & development review
7.3.5 Design & development verification
7.3.6 Design & development validation 7.3.7 Control of design and development
changes
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7.4 Purchasing
7.4.1 Purchasing process
7.4.2 Purchasing information
7.4.3 Verification of purchased product
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7.4.1 Purchasing Process
Purchased product meets requirements
Type & extend of control depends on effect
purchased product may have on realization
processes and their outputSelects suppliers based on their ability to
supply conforming product
Define criteria for selection and periodicevaluation and re-evaluation of suppliers
Results of evaluation and follow up actions
must be recorded
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7.4.2 Purchasing Information
Purchasing information shall describe the
product to be purchased, including where
appropriate:
Requirements for approval ofproduct,procedures, processes and
equipment.
Requirements for qualification ofpersonnel.
Quality management system
requirements.
7 4 3 Verification of
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7.4.3 Verification of
Purchased Product
Identify and implement activities needed to
verify purchased product
Where organization or its customer
purpose verification at supplier premises,organization must specify in purchasing
information:
verification arrangements method of product release.
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7.5.1 Control of production and
service provision
7.5.2 Validation of processes for
production and service provision 7.5.3 Identification and traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
7 5 1 Control of production and
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7.5.1 Control of production and
service provision
Control production & services operationsthrough:
Availability of information specifying product
characteristics Work instructions available where necessary Use and maintenance of suitable equipment Availability & use measuring and monitoring
devices Implementation of monitoring activities Implementation of defined processes for
release, delivery and post delivery activities
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7.5.2 Validation of Processes
Validation arrangements must be definedand must include as applicable qualification of the process
qualification of equipment and personnel use of defined methodologies &
procedure
requirements for record re-valuation
7 5 3 Id tifi ti &
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7.5.3 Identification &
Traceability
Where appropriate identify product through
all stages of operations
Identify status with respect to
measurement & monitoring requirements
Where traceability is required control &
record unique identification of product
I can not rememberI can not remember
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7.5.4 Customer Property
Care for customers property being underorganizations control or being used by
organization
Identification, verification, protection &
maintenance of customer property
provided for use or incorporation
Any customer property that is lost,
damaged or found un- suitable must berecorded & reported to customer
Customer Property -
tangible / intangible
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7.5.5 Preservation of Product
Preserve conformity of product during
internal processing and final delivery to
intended destination
Include identification, handling, packaging,storage and protection
This applies to constituent parts of product
7 6 Control of monitoring &
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7.6 Control of monitoring &
measuring devices
Calibrate & adjust measuring and monitoringdevices at specified intervals as prior to use
Traceability to international or nationalstandards. Where no such standard exist record
the basis Safeguard MMD from adjustments invalidating
calibration Protect MMD from damage or deterioration
during handling, maintenance or storage Record results of calibration Assess validity of previous results when devices
found to be out of calibration
1 Measurement Analysis
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1 Measurement, Analysis
and Improvement 8.1 General
8.2 Monitoring &
Measurement
8.2.1 Customersatisfaction
8.2.2 Internal audit
8.2.3 Monitoring and
measurement ofprocesses
8.2.4 Monitoring and
8.3 Control of non-
conforming product
8.4 Analysis of data
8.5 Improvement
8.5.1 Continual
improvement
8.5.2 Corrective action 8.5.3 Preventive action
G
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8.1 General
Define, plan & implement measurement
and monitoring activities needed to assure
conformance and achieve improvement
This include determination of the need and
use of applicable methodologies andstatistical techniques
8 2 M it i d M t
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8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction
Organization shall monitor information on
customer satisfaction and /or dis-
satisfaction
The methodologies for obtaining and
utilizing such information must bedetermined
8 2 2 I t l A dit
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Conduct periodic internal audit todetermine if QMS: Conforms to the requirements of the
standard
Has been effectively implemented &maintained
Plan the audit program considering: Status and importance of the activity results of previous audits
Define audit scope, frequency andmethodologies performed by personnel
not performing audited work
8.2.2 Internal Audit
8 2 2 I t l A dit
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The documented proceduremust cover:Responsibilities & authorities
for conducting audits Ensuring independenceRecording results and
reporting to management Timely corrective actions Follow up to verify & report
implementation of
verification results
8.2.2 Internal Audit
8.2.3 Measurement and
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Apply suitable methods for measurement
and monitoring of those realization
processes necessary to meet customers
requirements.
8.2.3 Measurement and
Monitoring of Product
8.2.3 Measurement and
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Measure & monitor product characteristics toverify conformance at appropriate stages of
realization processes
Evidence of conformity with the acceptance
criteria must be documented, records must
indicate the authority responsible for release
of product
Release or delivery must not proceed untilall the specified activities have been
completed unless otherwise approved by the
customer
8.2.3 Measurement and
Monitoring of Product
VERIF
IED19
/5/01 PASSED
PASSEDHOLDHOLD
8 3 Control of Non conforming
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8.3 Control of Non conforming
Product Documented procedures for control of
non conforming product to prevent
unintended use or delivery
Non conforming product shall be
corrected
Re-verify after correction
If non-conformance detected after
delivery take appropriate action It is often required that the proposed
rectification be reported for concession
to the customer, the end user,
regulatory or other body
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8.4 Analysis of Data
Collect & analyze data, determine suitabilityand effectiveness of QMS and to identifyimprovements that can be made
Data from measurement & monitoring &other related sourcesAnalyze data provide info on: Customer satisfaction and/or dissatisfaction Conformance to customer requirement Process, product characteristics and their
trends
Suppliers
8.5 Improvement
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p
8.5.1 Continual improvement
Planning for Continual Improvement The organization must plan and manage
processes necessary for continualimprovement of the QMS
Facilitate continual improvement using: quality policy objectives
audit results analysis of data corrective actions preventive actions
Mana ement Review
8 5 2 Corrective Action
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8.5.2 Corrective ActionOrganization must take corrective action to
eliminate the causes of non-conformance toprevent recurrence
Action appropriate to the impact of problem
Documented procedures shall definerequirements for: identifying non conformities determine the causes evaluating the need for corrective action determine corrective action needed and
implemented
Recording results of action
8 3 P i A i
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Organization must identify preventive actionto eliminate the causes of potential nonconformances to prevent occurrences
Actions appropriate to the impact of potential
problemDocumented procedures must define the
requirements for
Identification of potential non-conformances and their causes Determining and ensuring implementation
of preventive action needed
Recording results of action taken
8.5.3 Preventive Action
Situation Warranting
-
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Corrective Action
Identification of major non-conformance.
Large number of minor non-conformities.
The reoccurrence of a problem with aprocess or activity.
Non-conformities observed during audits.
Customer Complaints.Non-conforming deliveries from vendors.
Stages of Corrective &
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Preventive Action
REPORTING
INVESTIGATION
ACTION
FOLLOWUP
CLOSING
EXPECTED BENEFITS
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EXPECTED BENEFITS
Transparency in working at all level Data availability : Hidden Factors are open Creates Accountability
Planning & scheduling improved Rework & Rejection are known and being
controlled
Customer feedback through regular
surveys
Employees Participation enhanced Continuos Improvements Program launched
Market Reputation
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Thank
You