ISO 9000:2000
ISO 9001:2000
ISO 9001: 2008
Quality management system

Different Quality Management Systems
Standard for Laboratory Quality Systems
QMS for medical devices and related services
Good Manufacturing
Practice for manufacturers of medical goods
Quality Management System
for all organisations
QMS for aerospace industry
QMS for automotive industry
Capability Maturity Model for software development
ISO 9001:2000
TL 9000
GMP
AS 9000
ISO/IEC 17025
CMM
ISO 13485:2003
ISO/TS 16949
QMS in the telecommunication sector
www.iei.liu.se/content/1/c6/09/62/40/QMS_miljo.ppt

Core principles of QMS
nStandardised and documented processes
qDocuments that describe what is done in the organisation to identify and achieve the customers’
requirements
q
nConformance
qAn audit trail, so that it is possible to see the system working as described in the documents
q
nMonitoring and measurement
qRecords to prove that it has been working according to plan
nImprovement!
www.iei.liu.se/content/1/c6/09/62/40/QMS_miljo.ppt

Implementation strategy vs. maturity of quality management
Maturity of quality management
Low level
High level
Implementation strategy
Standardising practice
Business as usual
Business as usual
Practising standard
Radical change
Development
www.iei.liu.se/content/1/c6/09/62/40/QMS_miljo.ppt

ISO
nsome 157 national Standard institutes
na non-governmental organization
nits members are not delegations of national governments
nvoluntary standards on technology
nonly standards required by the market
ncentral secretariat in Geneva, Switzerland
nISO's national members pay subscriptions that meet the operational cost of ISO's Central
Secretariat
jet2
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www.iso.org

ISO 9000 and quality management
nQuality refers to all those features of a product (or service) which are required by the customer.
nQuality management  means what the organization does to:
nensure that its products or services satisfy the customer's quality requirements and
ncomply with any regulations applicable to those products or services
nenhance customer satisfaction, and
nachieve continual improvement of its performance.
n
nISO 9000 – generic standards
nGeneric means that the same standards can be applied:
nto any organization, large or small, whatever its product or service,
nin any sector of activity, and
nwhether it is a business enterprise, a public administration, or a government department.
n
n„Boosting quality to differentiate yourself from the competition“ ????
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt

ISO 9000
nAn international set of standards for quality management.
nApplicable to a range of organisations from manufacturing to service industries.
nISO 9001 applicable to organisations which design, develop and maintain products.
nISO 9001 is a generic model of the quality process that must be instantiated for each organisation
using the standard.

Management systems in general and ISO 9000
nTo be really efficient and effective, the organization can manage its way of doing things by
systemizing it.
nNothing important should be left out.
n Everyone should be clear about who is responsible for doing what, when, how, why and where.
nManagement system standards provide the organization with an international, state-of-the-art model
to follow.
nnot product standards.
n
nISO 9000 family standards
nThey are not product standards
nThey are not service standards.
nThey are process standards.
nThey can be used by product manufacturers and service providers.
n
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt

Hierarchy of Quality
Jehlanový diagram
Quality
Management
Quality Assurance
Quality Control
Advanced Auditing covers QA and QM more effectively
Basic “conformance” auditing covers QC level

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ISO 9000:2000 Family
ISO
9000
ISO
9001
Technical
Reports
ISO
9004
ISO
19011
ISO
10012
Audits
Measurement
Guidelines
Quality management systems - Requirements
Quality management systems - Fundamentals & vocabulary
Quality management systems -
Guidelines for performance improvement
Annexes A & B for information only
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ISO 9001 gives the requirements
for what the organization must
do to manage processes affecting
quality
of its products and services.
There are 16 other standards in the family
that can help an organization on specific
aspectssuch as performance improvement,
auditing, training…

The ISO 9000 Series of Standards
nSpecifies terminology and describes quality management systems
nWas initially released in 2000 along with ISO 9001, but was updated in 2005 per the normal 5 year
ISO review period
9004_2000_185x275.jpg 9000_2005_185x275.jpg 9001_2000_185x275.jpg
ISO 9000
ISO 9001
ISO 9004
•Specifies requirements for a quality management system
•Was expected to be updated in 2005, but because of a 3 year transition period from the 1994
version to the 2000 version, revision was delayed until 2008
•The aim is improvement of the performance of the organization and satisfaction of customer and
other interested parties.
•This standard is currently under revision and expected to be released with major changes in 2009.

nThe ISO 9000 “Family”
nISO 9000:2005 Quality management - Fundamentals and vocabulary
nISO 9001:2000 Quality management systems - Requirements
nISO 9004:2000 Quality management systems - Guidelines for performance improvements
nISO 10006:2003 Quality management - Guidelines for quality management in projects
nISO 10007:2003 Quality management systems - Guidelines for configuration management
nISO 10012:2003 Measurement management systems - Requirements for measurement processes and
measuring equipment
nISO 19011:2002 Guidelines for quality and/or environmental management systems auditing
n

The ISO Survey
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt


The ISO Survey (cont.)
nThe worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486.
nThis was increase of 6 % over 2006 when the total was 896 929 certificates.
nCertificates had been issued in 175 countries compared to 170 the previous year.
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt
www.iso.org

Benefits of ISO 9001 and ISO 9004
nInternational, expert consensus on state-of-the-art practices for quality and total quality (ISO
9004) management.
nCommon language for dealing with customers and suppliers worldwide in B2B.
nIncrease efficiency and effectiveness.
nModel for continual improvement.
nModel for satisfying customers and other stakeholders.
nBuild quality into products and services from design onwards.
nIntegrate with global economy.
nSustainable business
nUnifying base for industry sectors
nQualify suppliers for global supply chains
nTechnical support for regulations
nTransfer of good practice to developing countries
nTools for new economic players
nRegional integration
nFacilitate rise of services
n
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt

ISO 9001:2000 Process Approach
PROCESS
“set of interrelated or
interacting activities
which transforms
inputs into outputs
INPUT
OUTPUT
RESOURCES
CONTROLS
PRODUCT
PROCESS EFFICIENCY
Relationship between the result achieved and the resources used
PROCESS EFFECTIVENESS
Extent to which planned activities are realized and planned results achieved
A desired result is achieved more efficiently when activities and related resources are managed as
a process
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Process-based quality
Define product
Define processes
Organization and management
Develop product
Assess product quality
Assess processes quality
Quality OK?
Improve product
Standardise product
yes
no
nProcesses Include:
nManagement
nResources
nProduct realization
nMeasurement
Process Analysis:
Should be driving force
for defining amount of documentation,
taking into account the requirements
of ISO 9001:2000

Base of process approach
 Policy
 Planning
 Implementation and operation
 Performance assessment
 Improvement
 Management review
►ISO ISO 9001:2000, 9001:2008, ISO 9004:2000 and
►ISO 14001:2004 & OHSAS 18001:2007 standards
are based on PDCA (Deming „plan do check act circle“) concept,
therefore having similar structure
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As the Management Systems mature, effective use of the Deming Cycle will ensure continual
improvement
Ramp of Improvement

Revisioning standards and ISO 9000
nall standards are subjects to periodic review = to determine whether it is still relevant, whether
it needs to be updated or whether it should be discarded
nthe review period is around 5-6 years
nfor ISO 9001 it is designed such that whenever there are significant changes to be done (major
revision) the next revision will be less significant (minor)
nsince the revisions issued in 2000 (implemented in individual countries until 2003) were major,
the next one will be minor = changes are more based on the clarification of the existing
requirements rather than including new ones
q
n
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ISO 9001:2000 and 2008 revision - changes
nReinforcement of Control over outsourced processes that affect product conformity to requirements
nManagement representative has to be a member of the organization management and not an external
individual
nCompetence of all personnel affecting conformity to product requirement must be controlled by the
organization
nAdditional guidance to explain the different methods on measuring and monitoring customer
satisfaction
nFor internal audits, the management of the audited unit must ensure that necessary corrections and
corrective actions are taken
nClarification that information systems are included as part of the company infrastructure, and
therefore the management system
nNew requirement to review the effectiveness of corrective and preventive actions
n
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Example of changes
nISO 9001: 2000
q…The design and implementation of an organization's quality management system is influenced by
varying needs, particular objectives, the products provided, the processes employed and the size
and structure of the organization…
nISO 9001: 2008
q…The design and implementation of an organization‘s quality management system is influenced by:
its business environment, changes in that environment, or risks associated with that environment;
its varying needs; its particular objectives; the products it provides; the processes it employs;
its size and organizational structure...
qThis International Standard can be used by internal and external parties, including certification
bodies, to assess the organization‘s ability to meet customer, statutory and regulatory
requirements applicable to the product, and the organization’s own requirements.
nFor the 1st time the word risk appears in ISO 9001
New in ISO 9001:2008
Text slightly changed in ISO 9001:2008
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Outsourcing is one area where significant clarification has been added, with three additional notes
to help the user with interpretation.
In several places the term "product quality" has been replaced with "conformity to product
requirements", putting the emphasis on conformity.
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt

ISO 9001:2008
nWhen will ISO 9001:2008 certifications be valid?
n
q1 year (Nov 15, 2009) after publication of ISO 9001:2008 all accredited certifications issued
shall be to
q ISO 9001:2008.
q
q24 months (Nov 15, 2010) after the publication of
q ISO 9001:2008, any existing certification issued to
q ISO 9001:2000 will not be valid
the9000store.com/.../ISO9001-2008StandardUpdates.ppt

ISO 9001:2000 Quality Management Systems –
Requirements
nStructural Content of the Standard
qForeword
qIntroduction
q1. Scope
q2. Normative reference
q3. Terms and Definitions
q4. Quality Management System
q5. Management Responsibility
q6. Resource Management
q7. Product Realization
q8. Measurement, Analysis and Improvement

nStandards are the key to effective quality management.
nThey may be international, national, organizational or project standards.
nProduct standards define characteristics that all components should exhibit e.g. a common
programming style.
nProcess standards define how the software process should be enacted.
Quality assurance and standards

nIntroduction
q0.1 General
q0.2 Process approach
q0.3 Relationship with ISO 9004- “consistent pair”
q0.4 Compatibility with other Management    Systems
n1 Scope
q1.1 General
q1.2 Application
n2 Normative Reference
qISO 9000:2000  Quality Management Systems -Fundamentals and Vocabulary
n3 Terms and Definitions
qAs provided in ISO 9000:2000 Quality Management Systems - Fundamentals and Vocabulary
qWherever the term “product” is used, it can also mean “service”
qSUPPLIER à ORGANIZATION à CUSTOMER
q
q
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n
ISO 9001:2000 Quality Management Systems – Requirements

n
n4 Quality management system
q 4.1 General requirements
q 4.2 Documentation Requirements
n4.1 General requirements
qThe organization shall establish, documents, implement and maintain a quality management system
and continually improve its effectiveness in accordance with the requirements of this International
Standard.
n a) identify the processes needed for the quality management system and their application
throughout the organization (refer clause 1.2 Application)
n b) determine the sequence and interaction of these
n processes
n c) determine criteria and methods needed to ensure that both the operation and control of these
processes are effective
n
q
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ISO 9001:2000 Quality Management Systems
Requirements

n4.1 General requirements
n d) ensure the availability of resources and information necessary to support the operation and
monitoring  of these processes
n e) monitor, measure and analyze these processes, and
n f) implement actions necessary to achieve planned results and continual improvement of these
processes
n
n These processes shall be managed by the organization in accordance with the requirements of this
International Standard.
n
ISO 9001:2000 Quality Management Systems Requirements
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n4.2 Documentation requirements
q 4.2.1 General
q 4.2.2 Quality Manual
q 4.2.3 Control of documents
q 4.2.4 Control of records
q
n4.2.1 General
nThe quality management system documentation shall include:
n a) a quality policy and quality objectives, (documented statements)
n b) a quality manual
n c) documented procedures required by this International Standard, i.e. the following:
n 4.2.3 Control of documents
n 4.2.4 Control of records
n 8.2.2 Internal Audit
n 8.3 Control of nonconforming product
n 8.5.2 Corrective Action
n 8.5.3 Preventive Action
n d) documentation as required by the organization to ensure the effective planning, operation and
control of its processes, and
n e) records required by this International Standard
n (ref. 4.2.4)
ISO 9001:2000 Quality Management Systems Requirements
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Typical Quality Management System Documentation Hierarchy
Ref. ISO/TR 10013 - Guidelines for quality management system documentation
A. Includes the scope of the QMS, including details of and justification for any exclusions,
documented procedure (or reference to them), description of the interaction between the processes
of the QMS.
B. Describes the interrelated processes and activities required to implement the quality management
system.  Required where specified by the standard & where needed by the organization to ensure the
effective planning, operation and control of its
   processes
C.  Consists of detailed work documents.
Document Contents
Quality manual
(Level A)
Quality Management
System Procedures
(Level B)
Work instructions and other documents for quality management system
(Level C)
Note 1     The number of levels may be adjusted to meet the        organization’s needs.
Note 2     Forms may be applicable at all levels of hierarchy
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Quality Manual
nMinimum content specified in Clause 4.2.2
nScope of the Quality Management System, including details of and justification for any exclusions
nDocumented procedures established for the QMS, or references to them
nDescription of the interaction between processes of the QMS
n
nStructure of the manual is a decision for the organization based on:
nOrganization’s size
nOrganization’s complexity
nOrganization’s culture
nControlled in accordance with the requirements of Clause 4.2.3
elsmar.com/pdf_files/ISO%209001-2000.ppt

Additional Documentation
nProcess maps, process flow charts,and/or process descriptions
nOrganization charts
nSpecifications
nWork and/or test instructions
nProduction schedules
nApproved suppliers lists
nTest and inspection plans
nQuality plans
elsmar.com/pdf_files/ISO%209001-2000.ppt

Records
nRequirements for control of records are different from those for other documents
nAll records have to be controlled in accordance with the requirements of Clause 4.2.4
nOrganization are free to develop records that may be needed to demonstrate conformity of their
processes, products, and QMS
elsmar.com/pdf_files/ISO%209001-2000.ppt

Required Records (1 0f 2)
nManagement reviews (5.6.1)
nEducation, training, skills and experience (6.2.2e)
nEvidence that the realization processes and resulting product fulfill requirements (7.1d)
nDesign and development inputs (7.3.2)
nResults of design and development reviews (7.3.4)
nResults of design and development verification
nResults of design and development validation
nResults of review of design and development changes (7.3.7)
elsmar.com/pdf_files/ISO%209001-2000.ppt

Required Records (2 of 2)
nResults of supplier evaluations (7.4.1)
nTo demonstrate process validity where output cannot be measured (7.5.2d)
nThe unique identification of a product (7.5.3)
nCustomer property (7.5.4)
nBasis for calibration of measuring equipment (7.6a)
nResults of calibration (7.6)
nInternal audits (8.2.2)
nRelease of product (8.2.2)
nNonconforming product (8.3)
nResults of corrective action (8.5.2)
nResults of preventive action (8.5.3)
elsmar.com/pdf_files/ISO%209001-2000.ppt

ISO 9001:2000 Quality Management Systems  Requirements
n5 Management responsibility
q 5.1 Management Commitment
q 5.2 Customer Focus
q 5.3 Quality Policy
q 5.4 Planning
§5.4.1 Quality objectives
§5.4.2 Quality management system planning
q 5.5 Responsibility, Authority and Communication
§5.5.1 Responsibility and authority
§5.5.2 Management representative
§5.5.3 Internal Communication
q 5.6 Management review
§5.6.1 General
§5.6.2 Review input
§5.6.2 Review output
§
n
q
q
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n6 Resource management
q 6.1   Provision of resources
q 6.2 Human Resources
§6.2.1 General
§6.2.2 Competence, awareness and training
q 6.3  Infrastructure
q 6.4  Work environment
q
ISO 9001:2000 Quality Management Systems Requirements
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n7 Product realization
q 7.1 Planning of product realization
q 7.2 Customer-related processes
§7.2.1 Determination of requirements related to the product
§7.2.2  Review of requirements related to the product
§7.2.3  Customer communication
q 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 Control of design and development changes
q
q
q
ISO 9001:2000 Quality Management Systems Requirements
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n7 Product realization (cont’d)
q 7.4 Purchasing
§7.4.1  Purchasing process
§7.4.2  Purchasing information
§7.4.3  Verification of purchased product
q7.5 Production and service provision
§ 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
q 7.6 Control of monitoring and measuring devices
§
q
q
q
ISO 9001:2000 Quality Management Systems Requirements
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n8 Measurement, analysis and improvement
q 8.1 General
q 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
§ 7.5.5 Preservation of product
q 8.3 Control of nonconforming product
q 8.4 Analysis of data
q 8.5 Improvement
§8.5.1 Continual Improvement
§8.5.2 Corrective action
§8.5.3 Preventive action
§
q
q
q
ISO 9001:2000 Quality Management Systems Requirements
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Processes must be monitored and measured -
Measurement categories that need to be considered are:
ØQuality: Does the process consistently produce desired outputs?
ØDelivery: Does the process consistently deliver the outputs on time?
ØEfficiency: Does the process produce and deliver the outputs using the least amount of resources
necessary
ØOthers such as Cost, Safety, Regulatory Compliance, etc.
Too often only one of these categories is applied and that misleads management into thinking that
everything is alright.

nEncapsulation of best practice- avoids
repetition of past mistakes.
nThey are a framework for quality assurance processes - they involve checking compliance to
standards.
nThey provide continuity - new staff can understand the organisation by understanding the standards
that are used.
Importance of standards

Quality planning
nA quality plan sets out the desired product qualities and how these are assessed and defines the
most significant quality attributes.
nThe quality plan should define the quality assessment process.
nIt should set out which organisational standards should be applied and, where necessary, define
new standards to be used.

Review functions
nQuality function - they are part of the general quality management process.
nProject management function - they provide information for project managers.
nTraining and communication function - product knowledge is passed between development team
members.

Quality reviews
nThe objective is the discovery of system defects and inconsistencies.
nAny documents produced in the process may be reviewed.
nReview teams should be relatively small and reviews should be fairly short.
nRecords should always be maintained of quality reviews.

nComments made during the review should be
classified
qNo action. No change to the software or documentation is
required;
qRefer for repair. Designer or programmer should correct an identified fault;
qReconsider overall design.  The problem identified in the
review impacts other parts of the design. Some overall
judgement must be made about the most cost-effective way of solving the problem;
nRequirements and specification errors may
have to be referred to the client.
Review results

ISO 9001 (or 9004) certification and registration; accreditation
nCertification is known in some countries as registration.
nIt means that an independent, external body has audited an organization's management system and
verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 9004).
nAccreditation is like certification of the certification body.
nIt means the formal approval by a specialized body - an accreditation body - that a certification
body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business
sectors.
nCertificates issued by accredited certification bodies - and known as accredited certificates -
may be perceived on the market as having increased credibility.
n
nISO does not carry out certification or accreditation and does not issue or approve certificates.
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt

Certification of ISO 9000 (or other standards at all)
nCertification is not a requirement of ISO 9001 or ISO 9004.
nThe organization can implement and benefit from an ISO 9001 or ISO 9004 system without having it
certified.
nThe organization can implement them for the internal benefits without spending money on a
certification programme.
nCertification is a decision to be taken for business reasons:
n
qif it is a contractual, regulatory, or market requirement,
qIf it meets customer preferences
qit is part of a risk management programme, or
qif it will motivate staff by setting a clear goal.
www.iso.org/iso/ims-alerts_9001_14001_overview.ppt