ch. 6 quality management systems

8/8/2019 Ch. 6 QUALITY Management Systems

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TOTAL QUALITYMANAGEMENT

Ch. 6

QUALITY

MANAGEMENT

SYSTEMS


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QUALITY MANAGEMENT SYSTEMS

The International Organization for Standardization (ISO)was found in 1946 in Geneva Switzerland.

The mandate is to promote the development of

international standards to facilitate the exchange of

goods and services worldwide.ISO Technical Committee (TC) 176 developed a series

of international standards for quality systems, which

were first published in 1987.

The standards (ISO 9000,9001 and 9004) were

intended to be advisory and were developed for use in

two party contractual situations and internal auditing.


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Most countries have adopted the ISO 9000 series astheir national standards.

In the United States , the national standards arepublished by the American National Institute/

American society for quality (ANSI/ASQ) as theANSI/ASQ Q9000 series.

In the two party system , the supplier of the productor service would develop a quality system thatconfirmed to the standard. The customer would thenaudit the system for acceptability.

As this practice is extremely costly, it is replaced by athird party registration system.


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A quality system registration involves theassessment and periodic surveillance audit of the

adequacy of a suppliers quality system by a third

party, who is a registrar

When a system confirms to the registrarsinterpretation of the standard, the registrar issues a

certificate of registration to the supplier.

This registration ensures customers or potential

customers that a supplier has a quality system in

place and it is being monitored.


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Benefits for ISO Registration

ISO standards are needed because the customersand market are suggesting or demanding complianceto a quality system.

There is a needed improvement in processes or

systems and a desire for global deployment of productor services

In order to maintain or increase market share , manyorganizations are finding they must be in conformancewith an ISO standard.

Internal benefits that can be received fromdeveloping and implementing a well-documentedquality system can far outweigh the externalpressures


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ISO 9000 series of standards

ISO 9000 Series of standards is generic in scope,and can be tailored to fit any organizations needs,

whether it is large or small , a manufacturer or a

service organization.

Its purpose is to unify quality terms and definitionsused by industrialized nations and use those terms to

demonstrate a suppliers capability of controlling its

processes.

The standards require an organization to say what it

is doing to ensure quality, then do what it says, and

finally document or prove that it has done what it said


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The three standards of the series

ISO 9000:2000 Quality Management Systems (QMS) Fundamentals and vocabularydiscusses the fundamental

concepts related to the QMS and provides the terminology

used in the other two standards.

ISO 9001:2000- (QMS) - requirements is the standardused for registration by demonstrating conformity of the QMS to

customers, regulatory, and the organizations own

requirements.

ISO 9004:2000 (QMS) Guidelines for performanceimprovementprovides guidelines that an organization can use

to establish a QMS focused on improving performance.


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Sector Specific Standards

ISO 9000 system is designed as a simple systemthat can be used by any industry.

Other systems have been developed that are

specific to a particular industry such as automotive

or aerospace. These systems use the ISO 9001 as the basic

framework and modify it to their needs.

There are currently three other quality systems:

1. AS 9100

2. ISO/TS 16949

3. TL 9000


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1. AS 9100-Aerospace industry quality system,released by Society of Automotive Engineers in

May 1997.

Its development and release represents the first

attempt to unify the requirements of NASA , DOD

and FAA while specifying the aerospace industry

business needs.

In march 2001 , the International AerospaceQuality Group (IAQG) aligned AS 9100 with ISO

9001:2000


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2. ISO/TS 16949 This standard is entitled QualitySystems Automotive Suppliers- Particular Requirementsfor the Application of ISO 9001.

It harmonizes the supplier quality requirements of the U.S.

big three as provided in QS 9000 third edition with the

French, German, and Italian Automakers. The standard Has been Approved by Asian Automakers.

The goal of this technical specification is the development

of fundamental quality systems that provide a continuous

improvement, emphasizing defect prevention, and thereduction of variation and waste in supply chain.

There are three basic levels:

1. ISO9001,

2. sector-specific requirements and

3. company-specific requirements.


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3. TL 9000 The Quality Excellence for Suppliers ofTelecommunications Forum (QuEST) wrote TL900 toconsolidate the various quality system requirements within

the telecommunications industry.

It is the specific set of requirements based on ISO9001 the

defines the design, development, production, delivery,installation, and maintenance to telecommunications

products and services.

Customers and suppliers receive a number of benefits

including continuous improvement, enhanced

customer/supplier relations, efficient management of

external audits, worldwide standards, increased

competitiveness which results in overall cost reduction,

industry benchmarks for performance metrics and a

platform for improvement initiatives.


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ISO 9001 Requirements

The standard has eight clauses: NormativeReferences, Definitions, Quality Management

systems, Management responsibility, resource

management, Product And / Or Service Realization,

and Measurement, Analysis and improvement.

The first three clauses are for information while the

last five are requirements that an organization must

meet.

The number system used in the standard is followed

in this section.


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The application of a system of processes within anorganization, together with their identification and

interactions and the managing of these processes, it is

referred to as the process approach.

The process approach emphasizes the importance of:1. Understanding and fulfilling the requirements

2. The need to consider processes in terms of value added

3. Obtaining results of process performance and

effectiveness4. Continual improvements of processes based on objective

measures.


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Modelofa Process- Based QualityManagement System

5. Measurement

responsibility

4. QMSContinual

improvement

8. MeasurementAnalysis and

Improvement

7. Product

Realization

6. Resource

Management

Input

RequirementsOutput

Product

CustomerSatisfaction


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1. Scope- the purpose of standard is for theorganization to demonstrate its ability to provide a

product that meets customer and regulatory

requirements and achieves customer satisfaction.

This purpose is accomplished by evaluating andcontinually improving the system, rather than the

product. The requirements of the standard are

intended to be applicable to all types and size of

organizations. Requirements in clause 7, Productrealization, that are not appropriate to the

organization, can be excluded.


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2. Normative Reference ISO 9000:2000Quality Management Systems- Fundamentals and

Vocabularyare a normative reference that

provides applicable concepts and definitions

3. Terms and Definitions For the purposes ofthis standard, the terms and definitions given in

ISO9000:2000 apply.In addition, the supply chain is defined as:

Supplier Organization Customer


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ISO 9001 Requirements4. QualityManagement Systems (QMS)

4.1 General RequirementsThe Organization shall establish , document, implementand maintain a QMS and continually improve itseffectiveness.

The organization shall;

a) Identify needed processes such as management activities,provision of resources, product realization andmeasurement,

b) Determine their sequence and interaction

c) Determine the criteria and methods for effective operation

and control of these processesd) Ensure the availability of resources and informationnecessary to support and monitor theses processes

e) Monitor, measure and analyze these processes

f) Implement actions to achieve planned results and

continual improvement of these processes.


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4.2 Documentation4.2.1 General Documentation shall include

a) Statements of a quality policy and qualityobjectives

b) A quality manual

c) Required documented procedures

d) Needed documents to ensure effective planning,operation, and control of processes, and

e) Required records

The extent of documentation depends upon theorganizations size and type of activities; thecomplexity of the processes and their interactions;and the competency of the employees.


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4. QualityManagement Systems (QMS)

4.2 Documentation4.2.2Quality ManualA quality manual shall

be established and maintained thatincludes;

a) The scope of the QMS with details andjustification for any exclusions

b) The documented procedures or reference to

them, andc) A description of the interaction among the

QMS processes


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4.2 Documentation

4.2.3Control of documents Documents required by the QMSshall be controlled. A documented procedure shall be in place todefine the control needed to;

a) Approve documents prier to use

b) Review , update, and re-approve as necessary

c) Identify the current revision statusd) Ensure that the current versions are available at the point of use

e) Ensure that the documents are legible and readily identified

f) Identify and distribute documents of external origin, and

g) Provide for the prompt removal of the obsolete documents andsuitably identify any that may be retained.

Documented procedure means that the procedure is established,documented, implemented and maintained.

They are required in elements 4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, and8.5.3.


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4.2 Documentation

4.2.4 Control of Records Records shall be established andmaintained to provide evidence of conformity torequirements and the effective operations of the QMS.

They shall be legible, readily identifiable and retrievable.

A document procedure shall be established to define thecontrols needed for the identification, storage, protection,retrieval, retention time , and disposition of records.

Records can be used to document traceability and toprovide evidence of verification, preventive action, andcorrective action.

They are required in elements 5.5.6, 5.6.3, 6.2.2, 7.2.2,7.3.4, 7.3.6, 7.3.7, 7.4.1, 7.5.2, 7.6, and 8.2.4.


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ISO 9001 Requirements5. Management Responsibility5.1 MANAGEMENT COMMITMENT

Top Management shall provide evidence of its commitmentto the development , implementation, and continualimprovement of the QMS by,

a. Communicating the need to meet customer, legal andregulatory expectations

b. Establish a quality policy

c. Ensuring that quality objectives are established

d. Conducting management reviews

e. Ensuring the availability of resources

5.2 CUSTOMER FOCUS

Top Management shall ensure that customer requirementsare determined and met with the aim of enhancing customersatisfaction


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ISO 9001 Requirements5. Management Responsibility5.3 QUALITY POLICY

Top Management insure that the quality policy,

a. Is appropriate to the organizations purpose or mission

b. Includes a commitment to comply with requirements andcontinually improve the effectiveness of the QMS

c. Provides a framework for establishing and reviewing thequality objectives

d. Is communicated and understood within the organization ,and

e. Is reviewed for continuing stability

The quality policy gives the overall intention and direction ofthe organization related quality.


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ISO 9001 Requirements5. Management Responsibility5.4 PLANNING

5.4.1 Quality Objectives Top management shall ensure thatquality objectives are established at relevant functions andlevels within the organization and include productrequirements.

They shall be measurable and consistent with the quality

policy and should also ensure that customers expectationsare met

5.4.2 QualityManagement System Planning Topmanagement shall ensure that the planning of the QMS is

accomplished in order to meet the requirements of theQMS as stated in the General Requirements.


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5. Management Responsibility5

.5

RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.1 Responsibility and Authority Top managementshall ensure that responsibilities and authorities aredefined and communicated within the organization.

5.5.2Management Representatives Topmanagement shall appoint members of management,regardless of their other duties, that shall have theresponsibility and authority that includes

a. Ensuring that processes needed for the QMS system areestablishes, implemented and maintained

b. Reporting to top management of the performance of theQMS and any need for improvement

c. Ensuring the promotion of awareness of customer

requirements throughout the organization


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5. Management Responsibility

5.5 RESPONSIBILITY, AUTHORITY AND COMMUNICATION

5.5.3 Internal Communication Top management shallensure that appropriate communication channels are

established within the organization and that

communication takes place regarding the QMS.

Typical communication techniques are management

workplace briefing , recognition of achievement, bulletin

boards, e-mails, and in-house news brochures


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5. Management Responsibility5

.6 MANAGEMENT REVIEW

5.6.1 General Top management shall review the QMS atplanned intervals to ensure its continuing suitability,adequacy and effectiveness.

5.6.2 Review Input The input shall include information ona. Results of audit

b. Customer Feedback

c. Process performance and product conformity

d. Status of corrective and preventative performancee. Follow-up actions from previous management reviews

f. Changes that could affect the QMS, and

g. Recommendations for improvement


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5. Management Responsibility

5.6 MANAGEMENT REVIEW

5.6.3 Review Output The output shall include any

decisions and actions related to

a. Improvement of the effectiveness of the QMS and its

processes

b. Improvement of the product related to customer

requirements, and

c. Resource needsTop Management can use the outputs as inputs to

improvement opportunities


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6. ResourceManagement

6.1 PROVISION OF RESOURCES

The organization shall determine and provide the

resources needed,

a. To implement and maintain QMS and continually

improve its effectiveness, and

b. To enhance customer satisfaction by meeting customer

requirements.

Resources may be people, infrastructure , workenvironment, information, suppliers, natural resources

and financial resources.

Resources can be aligned with quality objectives


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ISO 9001 Requirements6. ResourceManagement

6.2 HUMAN RESOURCES

6.2.1 General Personal performing work that affects productquality shall be competent on the basis of appropriateeducation, training, skills and experience

6.2.2 Competence, Awareness and Training The

organization shalla. Determine the necessary competence for personnel

performing work affecting product quality.

b. Provide training or take other actions to satisfy the needs,

c. Evaluate effectiveness of the actions taken

d. Ensure that its personnel are aware of the relevance andimportance of their activities and how they contribute to theachievement of the quality objective.

e. Maintain appropriate records of education, training, skills

and experience


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6. ResourceManagement

6.3 INFRASTRUCTUREThe organization shall determine , provide, and maintain theinfrastructure needed to achieve conformity to productrequirements

Infrastructure includes,

a. Building, workplace and associated utilities

b. Process equipment (hardware and software both)

c. Supporting services

6.4 WORK ENVIRONMENT

The organization shall determine and manage the workenvironment needed to achieve conformity to productrequirements. Creation of suitable work environment canhave a positive influence on employee motivation,

satisfaction and performance


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7. Product Realization

7.1 PLANNING OF PRODUCT REALIZATIONThis includes,

a. Quality objectives and requirements for the product

b. The need to establish processes, documents, and

provide resources specific to the product

c. Required verification, validation, monitoring, inspection

and test activities specific of the product and the criteria

for product acceptance, and

d. Records needed to provide evidence that the realization

processes and resulting product or service meet

requirements


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7.2 CUSTOMER- RELATED PROCESSES

7.2.1 Determination ofrequirements relatedtothe

product the organization shall Determine

a. Requirements specified by the customersb. Requirements not stated by customer but

necessary for specification

c. Statutory and regulatory requirements related to

productsd. Any additional requirements determined by the

organization


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ISO 9001 Requirements7. Product Realization

7.2 CUSTOMER_RELATED PROCESSES

7.2.2 Reviewofrequirements relatedtotheproduct Theorganization shall ensure that

a. Product requirements are determined

b. Contract or order requirements differing from those

previously expressed are resolved, andc. The organization has the ability to meet the defined

requirements

7.2.3 Customercommunication The organization shalldetermine and implement effective arrangements forcommunicating with customers in relation to,

a. Product information

b. Inquiries, contracts, or order handling, includingamendments

c. Customer feedbacks, including complaints


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7.3 DESIGN AND DEVELOPMENT

7.3.1 Design and Development Planning The organizationshall determine

a. The design and development stages

b. the review, verification and validation that are appropriate to

each design and development stagec. The responsibilities and authorities for design and

development

7.3.2 Design and Development Inputs These shall include

a. Functional and performance requirementsb. Applicable statutory and regulatory requirements

c. Where applicable, information derived from previous similardesigns

d. Other requirements essential for design and development


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7.3 DESIGN AND DEVELOPMENT7.3.3 Design and Development Outputs the output shall

a. Meet the input requirements for design and development

b. Provide appropriate information for purchasing, production

and for service provisionc. Contain and reference product acceptance criteria

d. Specify the characteristics of the product that are essential

for its safe and proper use

7.3.4 Design and Development Review Are performed

a. To evaluate the ability of the results of design and

development to meet requirements

b. To identify any problems and purpose necessary actions


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7.3 DESIGN AND DEVELOPMENT

7.3.5 Design and Development Verification The Verificationshall be performed in accordance with plannedarrangements to ensure that the design and developmentoutputs have met the design and development input

requirements7.3.6 Design and Development Validation shall be

performed in accordance with planned arrangements toensure that the resulting product is capable of meeting therequirements for the specified application or intended use ,

when known.7.3.7 ControlofDesign and Development Changes Design

and development Changes shall be identified, reviewed,verified, validated, and approved. Later record should bemaintained.


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7.4 PURCHASING

7.4.1 Purchasing Processes The organization shall ensure thatthe purchased product conforms to specified purchaserequirements. The type and extent of control applied to thesupplier and the purchased product shall depend upon thepurchased product on subsequent product realization or the final

product.7.4.2 Purchasing Information Purchase with appropriate

a. Requirements for approval of product, procedures, processes andequipments

b. Requirements for qualification of personnel

c. QMS requirements

7.4.3 Verification ofPurchased Product The organization shallestablish and implement the inspection or other activitiesnecessary for ensuring that purchased product meets specifiedpurchase requirements


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7.5 Production and Service Provision

7.5.1 ControlofProduction and Serviceprovision Theorganization shall plan and carry out production and service

provision under controlled conditions. Control conditions shall

include,

a. The availability of information that describes the characteristics ofthe product,

b. The availability of work instructions

c. the use of suitable equipments

d. The availability and use of monitoring and measuring devicese. The implementation of monitoring and measurements

f. The implementation of release, delivery, and post delivery

activities.


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7.5.2 Validation ofprocessesfor Production andservice

provision The organization shall validate any processes forproduction and service provision where the resulting output

cannot be verified by subsequent monitoring and measurement.

This includes any processes where deficiencies become apparentonly after the product is in use or the service has been delivered.

Validation shall demonstrate the ability of these processes to

achieve planned results. The organization shall have,

a. Defined criteria for review and approval of the processes

b. Approval of equipment and qualification of personnel

c. Use of specific methods and procedures

d. Requirements for records

e. Revalidation


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7.5.3 Identification andtraceability The organization shallidentify the product status with respect to monitoring andmeasuring requirements, where traceability is a requirement, theorganization shall control and record the unique identification ofthe product

7.5.4 Consumer Property The organization shall exercise carewith customer property while it is under the organizations controlor being used by the organization. The organization shouldidentify, verify, protect and safeguard customer property

7.5.5 Preservation ofproduct The organization shall preservethe conformity of product during internal processing and deliveryto the intended customer. Preservation includes, identification,handling, packaging, storage and protection.


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7.6 Controlofmonitoring andmeasuring devices

The organization shall determine the monitoring andmeasurement to be taken and the monitoring and measuringdevices needed to provide evidence of conformity of productto determine requirements. The organization shall establishprocesses to ensure that monitoring and measurement can

be carried out and are carried out in a manner that isconsistent with the monitoring and measurementrequirements. The measuring equipments shall;

a. Be calibrated or verified at specified intervals or prior to useagainst measurement standards

b. Be adjusted or readjusted as necessaryc. Be identified to enable calibration status to be determined

d. Be safeguarded from adjustments

e. Be protected from damage and deterioration duringhandling, maintenance and storage


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8. Measurement, Analysis and Improvement

8.1 General

The organization shall plan and implement the

monitoring, measurement, analysis and

improvement processes needed,

a. To demonstrate conformity of the product

b. To ensure conformity of the QMS, and

c. To continually improve the effectiveness of theQMS


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8.2 Monitoring andMeasurement8.2.1 Customer Satisfaction The organization shall

monitor information relating to customer perception as

to whether the organization has met customer

requirements8.2.2 Internal Audit The organization shall conduct

internal audits at planned intervals to determine

whether the QMS,

a. Confirms to the planned arrangements , to therequirements to the standard, and to the requirements

established by the organization

b. Is effectively implemented and maintained


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8.2 Monitoring andMeasurement8.2.3Monitoring andmeasurementofprocesses The

organization shall apply suitable methods for

monitoring and measurements of the QMS processes.

These methods shall demonstrated the ability of theprocesses to achieve planned results.

8.2.2 Internal Audit The organization shall monitor and

measure the characteristics of the product to verify that

product requirements have been met. This shall becarried out at appropriate stages of the product

realization process in accordance with the planned

arrangements.


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8.3 Control and Nonconforming ProductThe organization shall ensure that product which does

not conform to product requirements is identified and

controlled to prevent its unintended use or delivery by

different ways;

a. Taking action to eliminate the detected nonconformity.

b. By authorizing its use, release or acceptance under

concession by a relevant authority.c. By taking action to preclude its original intended use or

application


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8.4 AnalysisofDataThe organization shall determine, collect and analyze

appropriate data to demonstrated the suitability and

effectiveness of the QMS and to evaluate where

continual improvement of the effectiveness of the QMScan be made. The analysis shall provide information

relating;

a. Customer satisfaction.

b. Conformity to product requirements

c. Characteristics and trends of processes and products,

including opportunities for preventive action, and

d. Suppliers

ISO 9001 R i


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8.5 Improvement8.5.1 Continual Improvement The organization shall

continually improve the effectiveness of the QMS

through the use of the quality policy, quality objectives,

audit results, analysis of data, corrective and preventiveactions and management review.

8.5.2 Corrective Action The organization shall take

action to eliminate the cause of non conformities in

order to prevent recurrence. Corrective actions shall beappropriate to the effects of the nonconformities

encountered.

ISO 9001 R i t


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8.5 Improvement8.5.3 Preventive Action The organization shall determine

actions to eliminate the causes of potential nonconformities

in order to prevent their occurrence.

Preventive actions shall be appropriate to the effects of thepotential problems. A documented procedure shall be

established to define requirements;

a. Determining potential nonconformities and their causes

b. Evaluating the need for action to prevent occurrence.c. Determining and implementing action needed

d. Records of results of action taken

e. Reviewing preventive action taken.


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ImplementationThere are number of steps, necessary to implement a QMS;

Top management Commitment

Appoint the management representative

Awareness

Appoint an implementation Team

Training

Time Schedule

Select element owners

Review the present system

Write the documents

Install the new system Internal Audit

Management Review

Pre-assessment

Registration

D t ti


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Documentation

A quality system is the method used to ensurethat the quality level of the product or service is

unlimited.

The system documentation can be view as a

hierarchy containing four tiers.

All documentation moves from one level to the

next in a descending order.

If the system is properly structured, changes at

one level will seldom affect the levels above it ,

but may affect those below

Th D t ti P id


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The Documentation Pyramid

Policy

Procedures

Work Instructions

Or

Practices

Records

OrProofs

Define WHAT will be doneWHY

Stated once

WHO

WHEN

WHERE

HOW

Evidence

W iti th D t ti


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Writing the Documentation

The basic thought to keep in mind, when writing inthe documents is to create simplicity out of

complexity.

To accomplish this objective, the documents must

be simple and concise.A typical way to write and implement quality

documentation is to (Dassonville, 1999):

Choose a process-mapping approach

Organize a projectteam

Organizetheprojectintosteps

Askpeoplewho areinvolvedtoparticipate:

I t l A dit


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Internal Audits

After the policies, procedures and workinstructions have been developed and

implemented checks must be made to ensure that

the system is being followed and the expected

results are being obtained. This activity is accomplished through the internal

audit, which is one of the key elements of the ISO

9000 standard.

All elements should be audited at least once peryear and some more frequently, depending on

need.

Obj ti I t l A dit


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Objectives Internal AuditsThere are 5 objectives ;

Determine that actual performance conforms tothe documented QMS

Initiate corrective action activities in response to

deficiencies

Follow up on non compliance items from previousaudit.

Provide continued improvement in the system

through feedback to management.

Cause the auditee to think about the processes,

thereby encouraging possible improvements.

I t l A dit


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Internal AuditsAUDITORS-Audits should be performed by qualified

individuals who have received training in auditing

principles and procedures.

The auditor should be objective, honest and impartial.

The auditor should be prepared by being

knowledgeable about the standards.

TECHNIQUES- During the auditing, there are number oftechniques that the auditor should employ. The

objective is to collect evidence, and there are three

methods:1. Examination of documents,2. Observation of activities and

3. Interviews.

For effective communication , there must be mutual trust

between auditor and auditee.

Internal A dits


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Internal AuditsPROCEDURES-

B

efore the audit takes place, an audit plan andchecklist should be prepared by the lead auditor.

The content of an audit plan should, identify the

activity or department to be audited: list the

procedures, documents, and regulatory requirementsinvolved, name the audit team, and list who is to be

notified of the audit and who will receive audit reports.

The plan should also contain a schedule . This

schedule includes audit notification, audit conducted,

corrective action required, if any and follow up.

The audit itself has three parts, the pre audit meeting,

the audit and closing meeting

Internal Audits


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Internal Audits

The auditing report- will,

1. Have a cover sheet that includes the audit date,

names of the audit team, areas audited, distribution

list, a statement that the audit is only a sample, and a

unique reference number, and it will be signed by the

lead auditor.

2. List the non conformances and copies of all non

conformance reports.

3. Outline procedures for corrective action and

subsequent follow-up

Registration


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Registration

Quality system registration is the assessment and

audit of a quality system by a third party, known

as registrar. There are two parts:

1. Selecting a Registrar: based on, qualification and

Experience, certificate recognition, theRegistration process, time and cost constraints

and Auditor qualifications

2. The registration Process: the registration process

has six basic steps, application forregistration,document review, pre-assessment, assessment,

registration and follow up surveillance

Closing Comments


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Closing Comments

Third Party audits and registration are not a

requirement of the ISO 9000 standards.

The standards are written for contractual

situations between a customer and a supplier.

Registration is one way to demonstratecompliance to the standard.

The requirements specified in the standards are

aimed at preventing non conformities during all

stages of the business functions.

Before entering into a contract for registration,

management must be able to justify the cost

versus the potential gains in business.