introduction to iso 9000:2000 - wil-zone
TRANSCRIPT
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Vilmos BerényiH2509 Esztergom-Kertváros, Hőtáv u. 59
Hungary
+36703806768, fax: +3633319117
Brief Introduction to the ISO9001:2000 and Quality Principles
Vilmos BerényiH2509 Esztergom-Kertváros, Hőtáv u. 59
Hungary
+36703806768, fax: +3633319117
Brief Introduction to the ISO9001:2000 and Quality Principles
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Objective
Introduce myself and this projectIntroduce myself and this project
Highlight important tasks and changes due to the ISO 9001 StandardHighlight important tasks and changes due to the ISO 9001 Standard
Briefly introduce the system requirements of the ISO 9001 StandardBriefly introduce the system requirements of the ISO 9001 Standard
Introduce the concept of ISO 9001 StandardIntroduce the concept of ISO 9001 Standard
Discussion about quality and management definitionsDiscussion about quality and management definitions
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International standards• ISO 9000:2005, Fundamentals and Vocabulary,
describes the fundamentals of a QMS and specifiesthe terminology for a QMS.
• ISO 9004: 2000 Quality management systems -Guidelines for performance improvements, QMS,Guidelines for performance improvement
• ISO 14001:2004 Environmental managementsystems. Requirements with guidance for use
• ISO 28001 – OHS Standard• ISO 27001 – ISMS Standard• ISO 17025:2005 - General requirements for the
competence of testing and calibrationlaboratories.
• GMP, GLP, validation and qualification
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ISO 9001: 2000Quality management systems -
Requirementsspecifies requirements for a QMS…• where an organization needs to
demonstrate its ability to provideproducts that meet customerrequirements and applicableregulatory requirements and aims toenhance customer satisfaction.
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Definitions• Product
– The result of a process.• Service
– An intangible product that is the result of at least one activityperformed at the interface between the supplier and the customer.
• Management System– The set of interrelated or interacting elements to establish policy
and objectives and to achieve those objectives.
• Nonconformity– The nonfulfillment of a requirement.
• Requirement– A need or expectation that is stated, generally implied, or obligatory.
• Process– A set of interrelated or interacting activities which transform inputs
into outputs.
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Definitions• Quality
– The degree to which a set of inherent characteristicsfulfills requirements.
• Quality Manual– A document specifying the quality management system
of an organization. They vary in detail and format to suitthe size and complexity of an individual organization.
• Documentation– Written material defining the process to be followed (e.g.
test procedure, quality manual, operation sheets).• Record
– A document stating results achieved or providingevidence of activities performed.
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Definitions• Quality Policy
– The overall intentions and direction of anorganization related to quality as formallyexpressed by top management.
• Quality Objective– Something sought, or aimed for, related to quality.
The objectives are generally based on the qualitypolicy of an organization and specified for relevantfunctions and levels in the organization.
• Scope– The scope of registration defines the company
sites, product lines, and operations covered by anISO 9001 certificate.
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ISO 9001:2000 – Model
CU
STO
MER
SC
USTO
MER
S
Quality Management
System
5.ManagementResponsibility
7. ProductRealization
6. ResourceManagement
8. MeasurementAnalysis andImprovement
Requirements
Satisfaction
Continual Improvement ofthe Quality Management System
ConsumptionProduct
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Principles of new standard
Based on eightquality
management
principles
Based on eightquality
management
principles
LeadershipLeadership
ProcessapproachProcessapproach
Involvementof people
Involvementof people
Systemapproach to
Management
Systemapproach to
ManagementContinual
improvementContinual
improvement
Factualapproach to
decisionmaking
Factualapproach to
decisionmaking
Mutualbeneficialsupplier
relationship
Mutualbeneficialsupplier
relationship
Customerfocus
Customerfocus
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Principles of new standardCustomer focus
•Organization depends customers•Understand current & future customer needs.•Meet / exceed customer expectations
Leadership•Leaders establish purpose & direction of the organization•Should create & maintain environment to achieveorganization’s objectives
Involvement of People•People of all levels are essence of an organization•Their full involvement for organization’s benefit
Process approachDesired results are achieved more efficiently when activities and
resources are managed as process
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Principles of new standardSystem approach to Management
Identifying, understanding and managing interrelated process as asystem contributes to the organization’s effectiveness & efficiency
Continual improvementsContinual improvement of the organization’s overall performance
should be a permanent objective of the organization
Factual approach to decision makingEffective decisions are based on the analysis of data and information
Mutually beneficial supplier relationships•An organization & its suppliers are interdependent•Mutually beneficial relationship enhances the ability of both tocreate value
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Expectations of the ISO 9001 Standard
Avoid the application of systems that are separate from theorganization’s business process
Avoid the application of systems that are separate from theorganization’s business process
Enable the development of a Quality system that is fullyintegrated into the normal operations of organization’s business
Enable the development of a Quality system that is fullyintegrated into the normal operations of organization’s business
Enable Continual improvements of the system for enhancedcustomer satisfaction
Enable Continual improvements of the system for enhancedcustomer satisfaction
Enable compliance to statutory & regulatory requirementsEnable compliance to statutory & regulatory requirements
Avoid inconsistency and redundant documentationAvoid inconsistency and redundant documentation
Create documentation system extent correlated to company sizeCreate documentation system extent correlated to company size
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INPUT OUTPUT
RESOURCES
ACTIVITY
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Process approach
Process definitionSet of interrelated or interacting activities which transforms
inputs into outputs
Process definitionSet of interrelated or interacting activities which transforms
inputs into outputs
Ensurecontinual
improvements
Ensurecontinual
improvementsIdentify theprocesses
Identify theprocesses
Do it for all value adding processesDo it for all value adding processes
Establishmeasuring
criteria
Establishmeasuring
criteria
Identify theInteractions
to otherprocesses
Identify theInteractions
to otherprocesses
Identify theInputs &outputs
Identify theInputs &outputs
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Process approach –Continual improvements of Process
PDCA CycleProcesses in terms
Of Added ValueDO
Continual improvementsof Processes based onobjective measurements
ACTION
Measure results of processPerformance and effectiveness
- Objective MeasurementsCHECK
Understandings &meeting requirements
PLAN
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PLAN: establish the objectivesand processes necessary to deliverresults in accordance with customerrequirements and organizationalpoliciesDO: implement the processes
CHECK: monitor and measureprocesses and product againstpolicies, objectives andrequirements
ACT: take actions to continuallyimprove process performance.
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E.g. - Purchasing Process
Performance Measurements
•Delivery status – On-time, On spec,NCP etc
•Supplier evaluation
Performance Measurements
•Delivery status – On-time, On spec,NCP etc
•Supplier evaluation
Outputs• Receipt of
Material on rightcondition
• Right QualityRight Quantity
• Right Time
Outputs• Receipt of
Material on rightcondition
• Right QualityRight Quantity
• Right Time
PurchasingProcedure
PurchasingProcedure
Interactions to•Storage•Inspection and Testing•Manufacturing•Finance
Interactions to•Storage•Inspection and Testing•Manufacturing•Finance
Inputs• Required item /
quantity / date• Applicable specs• Supplier source• Suppliers
capability tomeet ourrequirements
Inputs• Required item /
quantity / date• Applicable specs• Supplier source• Suppliers
capability tomeet ourrequirements
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Provision ofresources
Humanresources
Infrastructures
Workenvironment
6 ResourceManagement
Generalrequirements
DocumentationRequirements
Planning
Customerrelatedprocesses
Design &development
Purchasing
Production &serviceprovision
ManagementCommitment
Customer focus
Quality policy
Planning
Responsibility,authority &communication
ManagementReviews
5 ManagementResponsibility
8MeasurementAnalysis &improvement
System Requirements / Structure of theStandard
4 QualityManagementSystem
7 ProductRealization
General
Monitoring &measurement
Control of NCP
Analysis of data
Improvements
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4 - Quality management system
4.1 General
requirements
Identificationof processesrequired
Criteria and
methods to ensure
Operation & control
Availability ofinformation &resources for
operation & control
Monitoring and
Measuring of
processes
Continual
improvements
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4 - Quality management system
Quality Policy
Quality Objectives
Quality Manual
Procedures required by the Standard
Procedures required for planning, operation & control of Organization activities
Records
4.2 Document requirements
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Qualityobjectives
Procedures
Instructions, standards, regulations
Records
Qualitypolicy
Quality manual
DOCUMENTATION SYSTEMSTRUCTURE
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5.6Responsibilityauthority &communicate
5.4Planning
5 - Management Responsibility
5.1Managementcommitment
5.2Customerfocus
5.7ManagementReview
5.3Qualitypolicy
Qualityobjectives
QMSplanning
General
Reviewinputs
ReviewoutputsInternal
communication
Managementrepresentative
Responsibility& authority
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6 - Resource Management
Resources required toImplementing, monitoring & continualimprovementsEnhance Customer satisfaction by meetingcustomer requirements
Resources required toImplementing, monitoring & continualimprovementsEnhance Customer satisfaction by meetingcustomer requirements
Human ResourcesHuman Resources
InfrastructuresInfrastructures needed to achieve productconformity
InfrastructuresInfrastructures needed to achieve productconformity
Work environmentWork environment needed to achieve productconformity
Work environmentWork environment needed to achieve productconformity
ResourceManagementResource
Management
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6 - Human Resources
Competent on the basis of appropriateeducation, skill and experience
Competent on the basis of appropriateeducation, skill and experience
Define competencies for people performingwork affecting product quality
Define competencies for people performingwork affecting product quality
Provide training or actionsProvide training or actions
Evaluate effectiveness of the training / actionsEvaluate effectiveness of the training / actions
Employees should aware importance of theactivity being performed
Employees should aware importance of theactivity being performed
6.2Human
Resources
6.2Human
Resources
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7.6Control ofmonitoringmeasuringdevices
Control
Preservationof product
Validation ofprocesses
Identification &traceability
Customerproperty
7.5
Production& serviceprovision
Verification ofpurchasedproducts
Purchasingprocess
Purchasinginformation
7.4
Purchasing
Design planning
Design inputs
Design outputs
Design review
Design Changes
Design validation
Designverification
7.3
Design anddevelopment
7 - Product Realization
7.1
Planningof productrealization
Identification ofcustomerrequirement
Review ofcustomerrequirement
Customercommunication
7.2
Customerrelatedprocesses
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7 - Product Realization
Review of requirements relatedproduct prior to acceptance /commitment to customers - ability tomeet customer requirements
Review of requirements relatedproduct prior to acceptance /commitment to customers - ability tomeet customer requirements
Effective communication with customer in relation to
•Product information•Sales order handling•Customer feedback•Customer complaints
Effective communication with customer in relation to
•Product information•Sales order handling•Customer feedback•Customer complaints
Identification of Customer / Marketrequirements
•Specified by customer•Requirements taken for granted•Statutory / Regulatory requirements
Identification of Customer / Marketrequirements
•Specified by customer•Requirements taken for granted•Statutory / Regulatory requirements
7.2
Customer relatedprocesses – (Sales)
7.2
Customer relatedprocesses – (Sales)
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7 - Product Realization
Supplier evaluationSupplier evaluation
Verification of purchased product –Inspection and testing
Verification of purchased product –Inspection and testing
Degree of control depends on effects ofsubsequent processes and effect on finalproduct
Degree of control depends on effects ofsubsequent processes and effect on finalproduct
7.4
PurchasingPurchasing is donein controlled mannerto ensure thatpurchased productsconforms to specificrequirements
7.4
PurchasingPurchasing is donein controlled mannerto ensure thatpurchased productsconforms to specificrequirements
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7 - Product Realization
Product characteristics(Specs)
Product characteristics(Specs)
Procedures and work instructionsProcedures and work instructions
Suitable equipments to manufacture.Monitoring and inspection & testing
Suitable equipments to manufacture.Monitoring and inspection & testing
Product release, delivery and post deliveryProduct release, delivery and post delivery
Process validationProcess validation
Identification and traceabilityIdentification and traceability
Customers property
Material supplied by customers – e.g.. 3rd party blending
Customers property
Material supplied by customers – e.g.. 3rd party blending
7.5
Production andservice provision
Manufacturing /service provisionunder controlledcondition to ensureconformity of product
7.5
Production andservice provision
Manufacturing /service provisionunder controlledcondition to ensureconformity of product
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7 - Product Realization
7.6 Control of monitoring and measuring devicesControl and Calibration of equipments used for monitoring, inspection andtesting
- Also Reference materials
- Legal requirements
- GMP-GLP requirements (IQ-OQ-PQ)
7.6 Control of monitoring and measuring devicesControl and Calibration of equipments used for monitoring, inspection andtesting
- Also Reference materials
- Legal requirements
- GMP-GLP requirements (IQ-OQ-PQ)
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8 - Measurement, analysisand improvement
8.2
Monitoring &measurements
8.4
Analysis ofdata
8.5
Improvement
8.3Control ofnonconformingproduct
Measurement ofproduct
Internal audits
Customersatisfaction
Measurement ofprocesses
Correctiveaction
Preventiveaction
Continualimprovements
8.1
General
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8 - Measurement, analysisand improvement
To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
8.2 - Monitoring and Measurements•Customer satisfaction / perception•Internal audits - conformity planned arrangements of QMS and ISO9001•Monitoring and measurements of processes – to determine / demonstrate ability ofprocesses to achieve required results•Monitoring and measurements of product – Conformity to product requirements
8.2 - Monitoring and Measurements•Customer satisfaction / perception•Internal audits - conformity planned arrangements of QMS and ISO9001•Monitoring and measurements of processes – to determine / demonstrate ability ofprocesses to achieve required results•Monitoring and measurements of product – Conformity to product requirements
8.3 - Control of NCP•To assure that NCP products are identified and controlled to preventunintended use / delivery
8.3 - Control of NCP•To assure that NCP products are identified and controlled to preventunintended use / delivery
8.1 - To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
8.1 - To demonstrate•Conformity of the product•Conformity to QMS requirements•Continually improvements and the effectiveness of the system
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8 - Measurement, analysisand improvement
8.5 - ImprovementsContinual Improvements
•QMS needed to be continually improved
8.5 - ImprovementsContinual Improvements
•QMS needed to be continually improved
Corrective action•Actions to prevent recurrence of NCP, NCR etc•Includes reviews, determination of causes, need of action,implementation of action, review of action and maintenance ofrelevant records
Corrective action•Actions to prevent recurrence of NCP, NCR etc•Includes reviews, determination of causes, need of action,implementation of action, review of action and maintenance ofrelevant records
Preventive action•Actions against potential non conformities to avoid theiroccurrence•Includes identification of potential non conformities, cause, needfor action, implementation of action, review of action andmaintenance of records
Preventive action•Actions against potential non conformities to avoid theiroccurrence•Includes identification of potential non conformities, cause, needfor action, implementation of action, review of action andmaintenance of records
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business oriented. Less procedure orientedbusiness oriented. Less procedure oriented
Company wide involvementCompany wide involvement
Mutual benefit to all interested partiesMutual benefit to all interested parties
Customer focus than product focusCustomer focus than product focus
Continual improvementsContinual improvements
Less emphasis on documentationLess emphasis on documentation
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ISO 9001 PROJECT
• Interview and information gathering with allcolleagues to be involved
• Preparation of Quality Policy, Quality Manual andannual Quality Plan
• Defining and documentation of OperationalProcedures
• Quality Programs• Trainings for the management and operational
staff• Internal audit• Management review• Certification audit
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ISO 9001 PROJECT
• Quality Programs– Supplier or sub-contractors evaluation– Claim and Nonconformity handling– Justification of activities done (phone calling, e-
mail and oral messages– Calibration and maintenance of measuring
devices– Job descriptions an work instructions– Record keeping and identification– Competence and other specification
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ISO 9001:2000 – The Short Version:
Ø Writing down what you do.
Ø Doing what you write down.
Ø Provide visible evidence that you are doing whatyou wrote down (quality records).
Ø Identify errors in the process and opportunitiesto improve process.
Ø Use a preventive action method to identifyadditional essential processes.