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04/17/2023 Quality Managment System 1
04/17/2023 Quality Managment System 2
Quality Management system(Total Quality Management)
Presented by: Aqib Zia Qaisar Mehmud
Amir ishaq
Presented to: Sir Sajjid Ali
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Sequence of presentation
• The ISO• Evolution of ISO• Introduction of ISO• Importance of ISO• ISO benefits• ISO 9000 Family• ISO 9000 series• ISO survey• Sector Specific standards• ISO 9000 Requirements• Implementation• Documentation• Internal Audit• Registration
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The ISO
In London, in 1946, 65 delegates from 25 countries meet to discuss the future of International Standardization. In 1947, ISO officially comes into existence with 67 technical committees (groups of experts focusing on a specific subject).
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Introduction of ISOISO
Composed of 90 member countries
US. Rep is (ANSI)
176 (TC)
ISO 9000 as national standards
FDA
(Like wise)
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ISO 9000
• ISO 9000 is among ISO most well known standards ever.
• They are implemented by more than a million organizations in some 175 countries.
• ISO 9000 helps organizations to implement quality management.
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Quality management
• ISO 9001 is for quality management. • Quality refers to all those features of a product (or service) which are required by
the customer.• Quality management means what the organization does to • ensure that its products or services satisfy the customer's quality requirements
and• comply with any regulations applicable to those products or services.
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Generic standards
ISO 9000 is generic standards. Generic means that the same standards can be applied: • to any organization, large or small, whatever its product or service,• in any sector of activity, and• whether it is a business enterprise, a public administration, or a
government department.
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Generic standards (cont.)
Generic also signifies that • no matter what the organization's scope of activity• if it wants to establish a quality management system, ISO 9000 gives
the essential features
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Management system
• Management system means what the organization does to manage its processes, or activities in order that • its products or services meet the organization’s objectives, such as• satisfying the customer's quality requirements, • complying to regulations, or • meeting environmental objectives
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Standards for exchange goods
For Two party Contractual situations
Internal
Importance of ISO
Conf
orm
ation
of
qual
ity a
ssur
ance
Both supplier and customer
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Benefits of ISO Registration
ISO 9000
Benefits
Eliminate process
errors and inefficiency
Your customer
get consistent
quality products
increase market
share and profitabilit
yEnhance customer
satisfaction
Internal effectivene
ss and efficiency
Easy approval of bank loans
and business licenses
Easy market
entry for new
product
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ISO 9000 Benefits
Eliminate process errors
and inefficiency
Your customer get consistent
quality products
increase market share and
profitabilityEnhance customer
satisfaction
Internal effectiveness and efficiency
Easy approval of bank loans and
business licenses
Easy market entry for new
product
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Examples for Benefits of Registration
• The American institute of Certified Public Accountants (AICPA) now has a quality system that works, and there was a 4% increase in gross margins, which was the largest improvement in their history.
• North town Ford automobile dealership in Toronto, Ontario raised customer satisfaction and loyalty by 20% and it had 55% increase in customers who would recommend the dealership.
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The ISO 9000 family
• ISO 9001 Is the standard That gives the requirement for a Quality management system.• ISO 9001:2008 Is the latest, improved version.• It Is the only standard in the ISO 9000 family That Can bé used for
certification.• There are 16 other standards in the family That Can help an
organisation on specific aspects such as performance improvement, auditing, training…
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ISO 9000 Series
• ISO 9000 (a guide)• ISO 9001 (a set of requirements for the quality system of the supplier)• ISO 9002 (product standards)• ISO 9003 (final inspection and testing)• ISO 9004 (guidelines for developing and implementing quality system
principles, structure, auditing and review)
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The ISO Survey
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The ISO Survey (cont.)
• The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486.• This was increase of 6 % over 2006 when the total was 896 929
certificates. • Certificates had been issued in 175 countries compared to 170 the
previous year.
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Sector specific Standards
ISO 9000 systems are simple and that can be used in any industryBut some other systems are developed only specific sectors to particular industry Such as automotive or aerospace.
AS9100
ISO/TS 16949
TL 9000
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Sector specific Standards Cont.…
Quality Excellence for Suppliers of Telecommunication Forum (QuEST).
TL9000
Motorola, Lucent and telecom service provider such as AT&T, Verizon. etc
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Sector specific Standards Cont.…
It is based on ISO 9001 that specific set of requirement that define the design development ,production ,maintenance, and installation of telecommunication products and services.
TL9000
Benefits
• Continues improvement• Enhanced relationship• Efficient management of external audit• Worldwide standards , competitiveness
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Sector specific Standards Cont.…
TL9000
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Sector specific Standards Cont.…
AS9100Officially released may 1997.
Unify the requirements of NASA,FAA,DOD.
March 2001: International Aerospace Group aligned AS9100 with ISO 9001 :2000
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Sector specific Standards Cont.…
ISO/TS 16949
Particular requirements for application of ISO 9001
Relevance to automotive Suppliers
QS 9000 (1994) by Ford , general motors
Fundamental of QS…
• Continuous improvement• Emphasizing defect prevention• Reduction of variation and waste in supply chain.
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Sector specific Standards Cont.…
ISO/TS 16949
Levels of standardW.r.t requirements
Company
Sector-specific
ISO 9001
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ISO 9001 RequirementsClauses of standard
ScopeNormativ
e Reference
Terms and
Definitions
QMS
Management
Responsibility
Resource Manage
ment
Product Realizatio
n
Measurement, analysis
and improvemen
t
Informative Clauses Compulsory Clauses
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Model of a process QMS
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Scope
Purpose of standard is….
• Product meets customer and regulatory requirements
• Customer satisfaction
Purpose accomplished by...
Evaluating & continually improving the systemRather then Product
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Normative Reference
ISO 9000:2000 QMS
• Fundamentals and vocabulary are a normative reference that provides applicable concepts and definitions
Terms and definitions• http://www.praxiom.com/iso-definition.htm
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Quality Management system (QMS)
Organization shall
• Establish• Document• Implement• And maintain QMS• Continually improve its effectiveness
Organization shall also…
a) Identify needed processesb) Determine sequence and interactionc) Determine criteria and methods for effective operationd) Ensure the availability of resourcese) Monitor, measure and analyze the processesf) Implement actions to planned results
General requirements
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Documentation• Statements of quality policy and quality objectives• Quality manual• Document procedures• Needed documents to ensure effective planning• Required records
Quality Management system (QMS) cont.…
Quality Manual• The scope of QMS with details and justification for any exclusions• The documented procedure or reference to them • Description of the interaction among the QMS processes
Control of Documents
• Approve documents prior to sue• Review , update and re approve as necessary• Identify the currents revision status• Ensure that current versions are available at point of use• Ensure that documents are legible and readily identified• Identify and distribute documents of external origin
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Control of record
Quality Management system (QMS) cont.…
A documented procedure shall be established to define the control needed for the identification, storage, protection, retrieval, retention time, and disposition of records.
Management ResponsibilityManagement commitment
• Communicating the need to meet customer, legal, and regulatory expectation• Establishing a quality policy• Ensuring that quality objectives are established• Conducting management reviews• Ensuring the availability or resources
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Customer focus
Management Responsibility cont.…
Quality policy
• Appropriate to the organizations mission• Includes commitment to comply with requirements and continually improve the
effectiveness of the QMS• Provides the framework for establishing and reviewing the quality objectives• Communicated and understood with in the organization• Is reviewed for continuing stability
Planning
Quality objectives
Quality Management system planning
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Responsibility, authority, and communication
Responsibility and authority
Management representative:
• Ensuring that processes needed for QMS are established implemented and maintain
• Reporting to top management on the performance of the QMS and any need of improvement
• Ensuring the promotion of awareness of customer requirements throughout the organization
Internal communication:
Management Responsibility cont.…
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Management review
Management Responsibility cont.…
General
Review input
• Results of audits• Customer feedback• Process performance and product conformity• Status of corrective and preventative performance• Follow up actions from past management reviews • Changes that could affect the QMS• Recommendation for improvement
Review output
• Improvement of the effectiveness of the QMS and its processes• Improvement of the product related to customer requirements• Recourse needs.
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Provision of resources
Resource management
• To implement and maintain the QMS and continually improve its effectiveness
• To enhance customer satisfaction by meeting customer requirements
Human ResourcesGeneral
Competence awareness and training
• Determine the necessary competence for personal performing work affecting product quality
• Provide training or take other action to satisfy these needs• Evaluate the effectiveness of the action taken • Ensure that its personal are aware of the relevance and importance of
there activities• Maintain appropriate records of educations training skills and experience
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Infrastructure
Resource management
• Buildings work space and associated utilities• Process equipment• Supporting services
Work envoirement
Product realization
Planning of product realization• Quality objectives and requirements for the products• Need to established processes documents and provide resources
specific to the product • Require verification, validation, monitoring, inspection and test
activities specific to the product and the criteria for product acceptance• Records needed to provided evidence that the realization processes and
resulting product or service meet requirements.
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Customer related processes
Product realization
Determination of requirements related to the product
• Requirements specified by the customers including the requirements for delivery and post delivery activities
• Requirements not stated by the customer but necessary for specified or intended use, where known
• Statutory and regulatory requirements related to the product • Any additional requirements determined by the organization
Review of requirements related to the product
• Product requirements are defined • Contract or order requirements differing from those
previously expressed are resolved• The ORG has the ability to meet the defined requirements
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Customer communication
Product realization
• Product information • Inquires, contacts, or order handling, including amendments• Customer feedback, including customer complaints
Design and development
a) Design and development stagesb) Review verification, validation that are appropriate to each design and
development stagec) The responsibilities and authorities for design and development
Design and development planning
Design and development inputs
a) Functional and performance requirementsb) Applicable statutory and regulatory requirementsc) Where applicable, information derived from previous similar designd) Other requirements essential for design and development.
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Design and development output
Product realization
• Meet the input requirements for design and development• Provide appropriate information for purchasing, production
and for service provision• Contain or reference product acceptance criteria• Specify the characteristics of product
a) Evaluate the ability of the result of design and development to meet requirements
b) Identify any problems and propose necessary actions
Design and development review
Design and development verification
Design and development validation
Control of design and development changes
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Product realization
a) Requirements for approval of products, procedures, processes, and equipment's
b) Requirements of qualification of personnelc) QMS requirements
Purchasing information
Verification of purchase product
Inspection or other activities to verification of product
Purchasing Purchasing process
Production and service provisionControl of production and service provision
a) Availability of information that describes the characteristics of productb) Availability of work instructions as necessaryc) Use of suitable equipment'sd) Availability and use of monitoring and measuring devicese) Implementation of measuring and monitoringf) Implementation of release delivery and post delivery activates
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Validation of processes for production and service provision
Product realization
a) Define criteria for review and approval of processes b) Approval of equipment and qualification of personnelc) Use of specific methods and proceduresd) Requirements for records
Identification and traceability
Customer property
Preservation of product
Control of monitoring and measuring devices
a) Verified at specified intervals or prior to use, against measurement standardsb) Be adjusted or readjusted as necessaryc) Be identified to enable calibrated status to be determinedd) Be safeguarded from adjustments that would invalidate the measurement
result,e) Be protected from damage and deterioration during handling, maintenance.
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Measurement, Analysis, and Improvement
Generala) Define criteria for review and approval of processes b) Approval of equipment and qualification of personnelc) Use of specific methods and proceduresd) Requirements for records
Monitoring and measurement
Customer satisfaction
Internal audit
a) Conforms to the planed arrangements, to the requirements of the standard, and to the requirements established by the organization
b) Effectively implemented and maintain.Monitoring and measurement of processes
Monitoring and measurement of product and service
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Measurement, Analysis, and Improvement
Control of nonconforming producta) By taking action to eliminate the detected nonconformityb) By authorizing its use, release or acceptance under conation by a relevant
authorityc) Taking action to preclude its original intended use or application.
Analysis of dataa) Customer satisfactionb) Conformity to product requirementsc) Characteristics trends of processes and products, d) suppliers
Improvement Continual improvement
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Corrective action
a) Reviewing nonconformities b) Determining the causes of nonconformitiesc) Evaluating the need for action to ensure that nonconformities don’t recurd) Determining and implementing action needed e) Records of the results of action taker f) Reviewing corrective action taken
Measurement, Analysis, and Improvement
Preventive action
a) Determining potential nonconformities and their causesb) Evaluating the need for action to prevent occurrence of nonconformitiesc) Determining and implementing action needed d) Records of results of action taken e) Reviewing preventing action taken
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Implementation
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Implementation
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Documentation
policy
Work instruction
procedure
records
WHYStated once
Define what will be done
WHOWHENWHERE
HOW
Evidence
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Internal Audits
• Is the key elements of the ISO 9000• To checks policies, procedures, and instructions
have been developed and implemented• Elements should be audited at least once per year
and some more frequently,
Objectives
• Determine that actual performance conforms to the documented QMS.• Initiate corrective action activities in response to deficiencies.• Follow up on noncompliance items from previous audits.• Provide continued improvement in the system through feedback to management• Cause the auditee to think about the process, thereby encouraging possible
improvements.
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Internal AuditsAuditor
• Knowledge of requirements • Ability to communicate with team members and representatives • Ability to ask open-ended questions • Ability to synthesize information into systems • Ability to manage information in a confidential manner• Ability to relate observations to specific requirements
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RegistrationBy third party called registrar
Selecting Registrar
Registrar Accreditation Board (RAB), 1989 U.s Affiliated with American society of Quality (ASQ)
Criteria for selection of Registrar
Qualification and Experience
Certification Recognition
The Registration Process
Structure registration process, tailored to organizationResponsive to requestNo just evaluate , should recommendation for efficient
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Registration
Time and cost constraints
Auditor Qualifications
Lead timeTime and cost required for initial auditAdditional cost such as subcontracts (language ,expert skills knowledge
• Must Know the standards• Know the type of processes, the organization, and
customer• Have the knowledge, temperament, and experience to
be credible.
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