Quality management systems

04/17/2023 Quality Managment System 1


Quality Management system(Total Quality Management)

Presented by: Aqib Zia Qaisar Mehmud

Amir ishaq

Presented to: Sir Sajjid Ali


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


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).



Introduction of ISOISO

Composed of 90 member countries

US. Rep is (ANSI)

176 (TC)

ISO 9000 as national standards

FDA

(Like wise)



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.


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.


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.


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


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


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



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


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



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.


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…


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)


The ISO Survey


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.


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


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



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



TL9000



AS9100Officially released may 1997.

Unify the requirements of NASA,FAA,DOD.

March 2001: International Aerospace Group aligned AS9100 with ISO 9001 :2000



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.



ISO/TS 16949

Levels of standardW.r.t requirements

Company

Sector-specific

ISO 9001


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


Model of a process QMS


Scope

Purpose of standard is….

• Product meets customer and regulatory requirements

• Customer satisfaction

Purpose accomplished by...

Evaluating & continually improving the systemRather then Product


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


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


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


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


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


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 review


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.


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


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.


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


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.


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


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


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.


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



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


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


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


Implementation


Implementation


Documentation

policy

Work instruction

procedure

records

WHYStated once

Define what will be done

WHOWHENWHERE

HOW

Evidence


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.


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


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


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.


Business

Quality management systems