QUALITY SYSTEMS 1 UNIT 5

GE 406 Total Quality Management

Syllabus
Need for ISO 9000 and other Quality systems, ISO 9000:2000 Quality systems-
Elements, Implementation of Quality system, Documentation, Quality Auditing,
QS 9000, ISO 14000-concept, requirements and benefits.
QUALITY SYSTEMS
Introduction
The International Organization for Standardization (ISO) was founded in 1946
in Geneva, Switzerland, where it is still based. Its mandate is to promote the
development of international standards to facilitate the exchange of goods and
services worldwide. ISO is composed of more than 90 member countries.
v The United States representative is the American National Standards Institute
(ANSI).

v The ISO Technical Committee (TC) 176 developed a series of international

standards for quality systems, which were first published in 1987.
v 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.
v The standards have become universally accepted.
v Most countries have adopted the ISO 9000 series as their national standards.
Like- wise, thousands of organizations throughout the world have quality systems
registered to the standard.
v In the United States, the national standards are published by the American
National Institute / American Society for Quality (ANSI/ASQ) as the ANSI/ASQ
Q9000 series.
v A quality system registration involves the assessment and periodic surveillance
audit of the adequacy of a supplier's quality system by a third party, who is a
registrar.
v When a system conforms to the registrar's interpretation of the standard, the
registrar issues a certificate of registration to the supplier.
v This registration ensures customers or potential customers that a supplier has a
quality system in place and it is being monitored.

NEED FOR ISO 9000 AND OTHER QUALITY SYSTEMS

• There are various reasons for implementing a quality system that conforms to an
ISO standard.
• The primary reason is that customers or marketing are suggesting or demanding
compliance to a quality system.
• Other reasons are needed improvements in processes or systems and a desire
for global deployment of products and services.
• As more and more organizations become registered, they are requiring their
subcontractors or suppliers to be registered, creating a snowball effect.
• Consequently, in order to maintain or increase market share, many organizations
are finding they must be in conformance with an ISO standard.
• Internal benefits that can be received from developing and implementing a well-
documented quality system can far outweigh the external pressures.
• ISO 9000 and other Quality Systems are needed to achieve improvements and
benefits in the following areas.
• To improve internal quality which is measured by the percent of scrap, rework,
and nonconformities at final inspection?
• To increase production reliability that is measured by the number of breakdowns
per month, percent of time dedicated to emergencies, and percent of downtime
per shift.
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• To improve external quality that is measured by product accepted by customers

without inspections, claims of nonconforming product, and returned product.
• To improve time performance that is measured by time to market, on-time
delivery, and throughput time.
• To reduce cost of poor quality that is measured by external nonconformities,
scrap, and rework.
While practicing the above quality systems prevention and appraisal costs are
increased.
ISO 9000 SERIES OF STANDARDS
The ISO 9000 Series of Standards is generic in scope. By design, the series
can be tailored to fit any organization's needs, whether it is large or small, a
manufacturer or a service organization.
v It can be applied to construction, engineering, health care, legal, and other
professional services as well as the manufacturing of anything from nuts and
bolts to spacecraft.
v Its purpose is to unify quality terms and definitions used by industrialized nations
and use those terms to demonstrate a supplier's capability of controlling its
processes.

v .ISO 9001: 2000 - Quality Management Systems (QMS) - Requirements is the

standard used for registration by demonstrating conformity of the QMS to
customers, regulatory, and the organization's own requirements.
v ISO 9004:2000-Quality Management System (QMS) - Guidelines for performance
improvement provides guidelines that an organization can use to establish a
QMS focused on improving performance.

SECTOR SPECIFIC STANDARDS

The ISO 9000 system is designed as a simple system that could 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: AS9100, ISO / TS
16949, and TL 9000.
• One of the problems with sector-specific standards is the need for suppliers with
customers in different industries to set up quality systems to meet each sector's
requirements.

AS 9100
This aerospace industry quality system was officially released by the Society
of Automotive Engineers in May 1997.
v Its development and release represents the first attempt to unify the
requirements of NASA, DOD, and FAA, while satisfying the aerospace
industry's business needs.
v In March 2001, the International Aerospace Quality Group (IAQG) aligned
AS9100 with ISO 9001:2000.
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v These additions are accepted aerospace approaches to quality practices and

general requirements. Aerospace organizations in Europe, Japan, and the U.S.
will certify registrars and auditors

ISO / ITS 16949

This standard is entitled Quality Systems Automotive Suppliers-Particular
Requirements for the Application of ISO 9001.
• . There are three basic levels: (I) ISO 9001, (2) sector-specific requirements
and (3) company-specific requirements, and if appropriate levels for division-
specific, commodity-specific, and part-specific requirements.
• Registrars will need to be certified to the standard and their number will be
limited.
• It is assumed that this standard will show the same rate of improvement as QS
9000.

TL 9000
The Quality Excellence for Suppliers of Telecommunications Forum wrote TL
9000 to consolidate the various quality system requirements within the
telecommunications industry.
v It is a specific set of requirements based on ISO 9001 that defines the design,
development,production,delivery,installation, maintenance of telecommunications
products and services.
v Figure shows the structure of the TL 9000 standard and its five layers. The first
layer is the ISO 9000 requirements

Structures of TL 9000 Requirements

v The unique feature of the standard is the use of the metrics specified in the QSM
book to communicate and monitor actual results.

v Cost and performance-based metrics provides information to enable the industry

to measure progress and evaluate results of quality system implementation.

ISO 9001 QUALITY SYSTEM REQUIREMENTS

The application of a system of processes within an organization, together with their
identification and interactions and the managing of these processes, is referred to as
the process approach. This approach emphasizes the importance of:
• Understanding and fulfilling the requirements.
• The need to consider processes in terms of value added.
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• Obtaining results of process performance and effectiveness.
• Continual improvement of processes based on objective measure.

For the five required clauses, the system is shown in Figure.

Model of a Process-based Quality Management System

1. Scope
The purpose of the standard is for the organization to demonstrate its ability to
provide a product that meets customer and regulatory requirements and achieves
customer satisfaction.
• This purpose is accomplished by evaluating and continually improving the
system, rather than the product.
• The requirements of the standard are intended to be applicable to all types and
sizes of organizations.
• Requirements in Clause 7, Product Realization, that are not appropriate to the
organization, can be excluded.

2. Normative Reference
ISO 9000:2000 Quality Management Systems - Fundamentals and
vocabulary are a normative reference that provides applicable concepts and
definitions.

3. Terms and Definitions

For the purposes of this standard, the terms and definitions given in ISO
9000:2000 apply. In addition the supply chain is defined as:
Supplier Organization Customer
4. Quality Management System (QMS)

4.1 General Requirements

The organization shall establish, document, implement, and maintain a QMS
and continually improve its effectiveness. The organization shall
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v Identify needed processes such as management activities, provision of
resources; product realization and measurement,
v Determine their sequence and interaction,
v Determine criteria and methods for effective operation and control of these
processes,
v Ensure the availability of resources and information necessary to support and
monitor these processes,
v Monitor, measure, and analyze these processes,
v Implement actions to achieve planned results and continual improvement of
these processes.
v Outsourced processes that affect the quality of the product shall be identified
and included in the system.

4.2 DOCUMENTATION
4.2.1 General Documentation shall include
• Statements of a quality policy and quality objectives,
• A quality manual,
• required documented procedures,
• needed documents to ensure effective planning, operation, and control of
processes,
• Required records.
A procedure or work instruction is needed if its absence could adversely affect
the product quality.
v The extent of the documentation will depend on the organization's size and type
of activities.
v For example: a small organization may verbally notify a manager of an
upcoming meeting, whereas a large organization would need written
notification.
v The standard should satisfy the contractual, statutory, and regulatory
requirements and the needs and expectations of customers and other
interested parties.
v Documentation may be in any form or type of medium.
4.2.2 Quality Manual

A quality manual shall be established and maintained that includes

• The scope of the QMS with details and justification for any exclusions,

• The documented procedures or reference to them, and

• A description of the interaction among the QMS processes.

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4.2.3 Control of Documents.

Documents required by the QMS shall be controlled. A documented procedure shall

be in place to define the controls needed to

v Approve documents prior to use,

v Review, update, and re-approve as necessary,

v Identify the current revision status,

v Ensure that current versions are available at the point of use,

v Ensure that documents are legible and readily identified,

v Identify and distribute documents of external origin, and

v Provide for the prompt removal of obsolete documents and suitably identify any
that may be retained.

v Documented procedure means that the procedure is established, documented,

implemented, and maintained.

4.2.4 Control of Records.

Records shall be established and maintained to provide evidence of

conformity to requirements and the effective operation of the QMS.

• A documented procedure shall be established to define the controls needed for

the identification, storage, protection, retrieval, retention time, and disposition of
records.

• Records can be used to document traceability and to provide evidence of

verification, preventive action, and corrective action.

5. MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
Top management shall provide evidence of its commitment to the
development, implementation, and continual improvement of the QMS by
v Communicating the need to meet customer, legal, and regulatory
expectations,
v Establishing a quality policy,
v Ensuring that quality objectives are established,
v Conducting management reviews, and
v Ensuring the availability of resources.
v Top management is defined as the person or group of people who directs
and controls an organization.
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5.2 CUSTOMER FOCUS

Top management shall ensure that customer requirements are
determined and met with the aim of enhancing customer satisfaction.

5.3 QUALITY POLICY

Top management shall insure that the quality policy
v Is appropriate to the organization's purpose or mission,
v Includes a commitment to comply with requirements and continually improve the
effectiveness of the QMS,
v Provides a framework for establishing and reviewing the quality objectives, (d) is
communicated and understood within the organization, and
v Is reviewed for continuing stability.
v The quality policy gives the overall intention and direction of the organization
related to quality.

5.4 PLANNING
5.4.1 Quality Objectives.
Top management shall ensure that quality objectives are established at
relevant function and levels within the organization and include product
requirements.
• They shall be measurable and consistent with the quality policy.
• In addition, they should ensure that customer expectations are met. Quality
objectives are something sought or aimed for related to quality.
5.4.2 Quality Management System Planning.

Top management shall ensure that the planning of the QMS is accomplished
in order to meet the requirements of the QMS as stated in the General
Requirements, Element 4.1, as well as the Quality Objectives, 5.4.1

5.5 RESPONSIBILITY, AUTHORITY, AND COMMUNICATION

5.5.1 Responsibility and Authority
Top management shall ensure that responsibilities and authorities are defined
and communicated within the organization.
v Responsibilities can be defined in job descriptions, procedures, and work
instructions.
v Authorities and interrelationships can be defined in an organization chart.

5.5.2 Management Representative

Top management shall appoint a member of management, regardless of

his/her other duties, that shall have the responsibility and authority that includes

• Ensuring that processes needed for the QMS system are established,
implemented, and maintained,

•
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• Reporting to top management on the performance of the QMS and any need for
improvement, and

• Ensuring the promotion of awareness of customer requirements throughout the

organization.

• Appointment of a member of top management as the representative can

contribute to the effectiveness of the QMS.

5.5.3 Internal Communication

Top management shall ensure that appropriate communication channels are

established within the organization and that communication takes place regarding
the QMS.

v Typical communication techniques are management workplace briefing,

recognition of achievement, bulletin boards, e-mail, and in-house news
brochures.

5.6 MANAGEMENT REVIEW

5.6.1 General
Top management shall review the QMS at planned intervals to ensure its
continuing suitability, adequacy, and effectiveness.
This review shall include assessing opportunities for improvement and the
need for changes to the QMS including the quality policy and quality objectives.
Records from the reviews shall be maintained.

5.6.2 Review Input

The input to the review shall include information on

v Results of audits,

v Customer feedback,

v Process performance and product conformity,

v Status of corrective and preventative performance,

v Follow-up actions from previous management reviews,

v Changes that could affect the QMS, and (g) recommendations for improvement.

5.6.3 Review Output

• The output from the review 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

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• (c) Resource needs.

• Top management can use the outputs as inputs to improvement opportunities.

6. Resource Management
6.1 PROVISION OF RESOURCES
The organization shall determine and provide the-resources needed
v To implement and maintain the QMS and continually improve its effectiveness,
and
v To enhance customer satisfaction by meeting customer requirements. Resources
may be people, infra- structure, work environment, information, suppliers, natural
resources, and financial resources.
v Resources can be aligned with quality objectives.

6.2 HUMAN RESOURCES

6.2.1 General
Personnel performing work that affects product quality shall be competent on
the basis of appropriate education, training, skills, and experience.

6.2.2 Competence, Awareness and Training

The organization shall

v Determine the necessary competence for personnel performing work affecting

product quality,

v Provide training or take other actions to satisfy these needs,

v Evaluate the effectiveness of the actions taken,

v Ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives,
and

v Maintain appropriate records of education, training, skills, and experience.

Competency is defined as the demonstrated ability to apply knowledge and skills.
ISO 10015 Guidelines for Training will help organizations comply with this
standard.

6.3 INFRASTRUCTURE
The organization shall determine, provide, and maintain the infrastructure
needed to achieve conformity to product requirements.
• Buildings, workspace, and associated utilities,
• Process equipment (both hardware and software), and
• Supporting services (such as transport or communication).
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6.4 WORK ENVIRONMENT

v The organization shall determine and manage the work environment needed to
achieve conformity to product requirements.
v Creation of a suitable work environment can have a positive influence on
employee motivation, satisfaction, and performance.

7. PRODUCT REALIZATION
7.1 PLANNING OF PRODUCT REALIZATION
The organization shall plan and develop the processes needed for product
realization. Planning of product realization shall be consistent with the requirements
of the other processes of QMS
v Quality objectives and requirements for the product;
v The need to establish processes, documents, and provide resources specific to
the product;
v Required verification, validation, monitoring, inspection, and test activities specific
to the product and the criteria for product acceptance; and
v Records needed to provide evidence that the realization processes and resulting
product or service meet requirements..

7.2 CUSTOMER-RELATED PROCESSES

7.2.1 Determination of Requirements Related to the Product
The organization shall determine
v Requirements specified by the customer, including the requirements for
delivery and post-delivery activities,
v Requirements not stated by the customer but necessary for specified or
intended use, where known,
v Statutory and regulatory requirements related to the product, and
v Any additional requirements determined by the organization.

7.2.2 Review of Requirements Related to the Product

The organization shall review the requirements related to the product. This
review shall be conducted prior to the organization's commitment to supply a product
to the customer and shall ensure that

v Product requirements are defined,

v Contract or order requirements differing from those previously expressed are

resolved, and

v The organization has the ability to meet the defined requirements.

v Records of the results of the review and actions arising from the review shall be
maintained.
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7.2.3 Customer Communication

The organization shall determine and implement effective arrangements for

communicating with customers in relation to

• Product information,

• Inquiries, contracts, or order handling, including amendments, and

• Customer feedback, including customer complaints.

7.3 DESIGN AND DEVELOPMENT

7.3.1 Design and Development Planning
The organization shall plan and control the design and development of the
product. During the design and development planning, the organization shall
determine
v The design and development stages,
v The review, verification and validation that are appropriate to each design and
development stage, and
v The responsibilities and authorities for design and development.
v The organization shall manage the interfaces between different groups involved
in design and development to ensure effective communication and clear
assignment of responsibility.

7.3.2 Design and Development Inputs.

Inputs relating to product requirements shall be determined and records maintained.

These shall include

v Functional and performance requirements,

v Applicable statutory and regulatory requirements,

v Where applicable, information derived from previous similar designs, and

v Other requirements essential for design and development.

v These inputs shall be reviewed for adequacy. Requirements shall be complete,

unambiguous and not in conflict with each other.

7.3.3 Design and Development Outputs.

The outputs of design and development shall be provided in a form that

enables verification against the design and development input and shall be approved
prior to release. Design and development outputs shall

• Meet the input requirements for design and development,

•
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• Provide appropriate information for purchasing, production, and for service

provision,

• Contain or reference product acceptance criteria, and

• Specify the characteristics of the product that are essential for its safe and
proper use.

7.3.4 Design and Development Review

At suitable stages, systematic reviews of design and development shall be

performed in accordance with planned arrangements

v To evaluate the ability of the results of design and development to meet

requirements, and

v To identify any problems and propose necessary actions.

v Participants in such reviews shall include representatives of functions

concerned with the design and development stage(s) being reviewed.

v Records of the results of the reviews and any necessary actions shall be
maintained.

v Risk assessment such as FMEA, reliability prediction, and simulation

techniques can be undertaken to determine potential failures in products or
processes.

7.3.5 Design and Development Verification.

Verification shall be performed in accordance with planned arrangements to

ensure that the design and development outputs have met the design and
development input requirements

v . Records of the results of the verification and any necessary actions shall be
maintained. Verification confirms, through objective evidence, that the specified
requirements have been fulfilled.
7.3.6 Design and Development Validation.

• Design and development validation shall be performed in accordance with

planned arrangements to ensure that the resulting product is capable of
meeting the requirements for the specified application or intended use, when
known.

• Wherever practicable, validation shall be completed prior to the delivery or

implementation of the product.

• Records of the results of validation and any necessary actions shall be

maintained.

• Validation confirms, through objective evidence, that the requirements for a

specific intended use have been fulfilled.
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7.3.7 Control of Design and Development Changes
Design and development changes shall be identified and records maintained.
v The changes shall be reviewed, verified and validated, as appropriate, and
approved before implementation.
v The review of design and development changes shall include evaluation of the
effect of the changes on constituent parts and product already delivered.

7.4 PURCHASING
7.4.1 Purchasing Process.
The organization shall ensure that purchased product conforms to specified
purchase requirements.
• The type and extent of control applied to the supplier and the purchased
product shall be dependent upon the effect of the purchased product on
subsequent product realization or the final product.
• The organization shall evaluate and select suppliers based on their ability to
supply product in accordance with the organization's requirements
.

7.4.2 Purchasing Information

Purchasing information shall describe the product to be purchased, including

where appropriate

v Requirements for approval of product, procedures, processes, and

equipment,

v Requirements for qualification of personnel, and

v QMS requirements.

v The organization shall ensure the adequacy of specified requirements

prior to their communication to the supplier.

7.4.3 Verification of Purchased Product

The organization shall establish and implement the inspection or other

activities necessary for ensuring that purchased product meets specified purchase
requirements.

7.5 PRODUCTION AND SERVICE PROVISION

7.5.1 Control of Production and Service Provision
The organization shall plan and carry out production and service provision
under controlled conditions. Controlled conditions shall include, as applicable
v The availability of information that describes the characteristics of the product,
v The availability of work instructions, as necessary,
v The use of suitable equipment,
v The availability and use of monitoring and measuring devices,
v The implementation of monitoring and measurement, and
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v The implementation of release, delivery, and post-delivery
activities.

7.5.2 Validation of Processes for Production and Service Provision

The organization shall validate any processes for production and service
provision where the resulting output cannot be verified by subsequent monitoring or
measurement
Validation shall demonstrate the ability of these processes to achieve
planned results as follows
• Defined criteria for review and approval of the processes,
• Approval of equipment and qualification of personnel,
• (c) Use of specific methods and procedures, (d) requirements for records and
(e) revalidation.

7.5.3 Identification and Traceability Where appropriate

The organization shall identify the product by suitable means throughout

product realization.

v The organization shall identify the product status with respect to monitoring
and measurement requirements.

v Where traceability is a requirement, the organization shall control and record

the unique identification of the product..

7.5.4 Customer Property

• If any customer property is lost, damaged, or otherwise found to be unsuitable

for use, this shall be reported to the customer and records maintained.

• Customer property can include intellectual property.

7.5.5 Preservation of Product

The organization shall preserve the conformity of product during internal processing
and delivery to the intended destination.

v This preservation shall include identification. handling, packaging, storage, and

protection.

v Preservation shall also apply to the constituent parts of a product.

7.6 CONTROL OF MONITORING AND MEASURING DEVICES.

The organization shall determine the monitoring and measurement to be

undertaken and the monitoring and measuring devices needed to provide evidence
of conformity of product to determined requirements

• Be calibrated or verified at specified intervals or prior to use, against

measurement standards.

• Be adjusted or re- adjusted as necessary,

• Be identified to enable calibration status to be determined,

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• Be safeguarded from adjustments that would invalidate the

measurement result, and

• Be protected from damage and deterioration during handling, maintenance and

storage.

• This shall be undertaken prior to initial use and reconfirmed as necessary

8. MEASUREMENTS, ANALYSIS, AND IMPROVEMENT

8.1 GENERAL

The organization shall plan and implement the monitoring, measurement,

analysis, and improvement processes needed

v To demonstrate conformity of the product,

v To ensure conformity of the QMS, and

v To continually improve the effectiveness of the QMS.

v This shall include determination of applicable methods, including statistical

techniques, and the extent of their use.

8.2 MONITORING AND MEASUREMENT

8.2.1 Customer Satisfaction As one of the measurements of the performance of the
QMS, the organization shall monitor information relating to customer perception as to
whether the organization has met customer requirements

• 8.2.2 Internal Audit The organization shall conduct internal audits at planned
intervals to determine whether the QMS

• Conforms to the planned arrangements, to the requirements of this standard, and

to the requirements established by the organization, and

• Is effectively implemented and maintained.

8.2.3 Monitoring and Measurement of Processes

v The organization shall apply suitable methods for monitoring and, where
applicable, measurement of the QMS processes.

v . When planned results are not achieved, correction and corrective action
shall be taken, as appropriate, to ensure conformity of the product.

8.2.4 Monitoring and Measurement of Product and Service.

• The organization shall monitor and measure the characteristics of the product
to verify that product requirements have been met.

• This shall be carried out at appropriate stages of the product realization

process in accordance with the planned arrangements.
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• Evidence of conformity with the acceptance criteria shall be

maintained

8.3 CONTROL OF NONCONFORMING PRODUCT

v The organization shall ensure that product which does not conform to product
requirements is identified and controlled to prevent its unintended use or
delivery.
v By taking action to eliminate the detected nonconformity;
v By authorizing its use, release or acceptance under concession by a relevant
authority and, where applicable, by the customer; and
v By taking action to preclude its original intended use or application.
v Records of the nature of nonconformities and any subsequent actions taken,
including concessions obtained, shall be maintained

8.4 ANALYSIS OF DATA

The organization shall determine, collect, and analyze appropriate data to
demonstrate the suitability and effectiveness of the QMS and to evaluate where
continual improvement of the effectiveness of the QMS can be made.
v Customer satisfaction,
v Conformity to product requirements,
v Characteristics and trends of processes and products, including opportunities
for preventive action, and
v Suppliers.

8.5 IMPROVEMENT
8.5.1 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 preventive actions, and management
review.
v 8.5.2 Corrective Action The organization shall take action to eliminate the cause
of non- conformities in order to prevent recurrence.
v Corrective actions shall be appropriate to the effects of the nonconformities
encountered.
v A documented procedure shall be established to define requirements for
reviewing nonconformities determining the causes of nonconformities action
taken.

8.5.3 Preventive Action.

v The organization shall determine action to eliminate the causes of potential

nonconformities in order to prevent their occurrence.
v Preventive actions shall be appropriate to the effects of the potential problems
IMPLEMENTATION OF QUALITY SYSTEMS
There are a number of steps that are necessary to implement a quality management
system.
Top Management Commitment
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The most important step in implementing a quality system that will meet or exceed
an ISO 9000 standard is to acquire the full support of upper management.
v The chief executive officer (CEO) must be willing to commit the resources
necessary to achieve certification.
v This is critical to the success of the project. Without the CEO's support, the
process may continuously run into unnecessary roadblocks or even be doomed
to failure.

2. Appoint the Management Representative

• Once the commitment has been made, the process can proceed by adopting a
project team approach and treating it the same as any other business
undertaking. The next step is the appointment of a management representative.

• The representative can be a member of the top management group who is able
to ensure that the quality system is effectively implemented, documented, and
maintained

3. Awareness
This step requires an awareness program.
v Because the process is going to affect every member of the organization as well
as require their input, it stands to reason that everyone should understand the
quality system.
v They should know how it would affect day-to- day operations and the potential
benefits.
v This information can be relayed through short, one-hour awareness training
sessions.

4. Appoint an Implementation Team

After everyone has been informed of the organization's intentions to develop the
quality system, an implementation team should be assembled.
• This team should be drawn from all levels and areas of the organization so that it
is representative.
• Committees for each of the five clauses may be used.
• The team should identify the QMS processes and their sequence and interaction

5. Training
The implementation team, supervisors, and internal audit team should be trained.
This activity can be accomplished by sending team leaders for training and having
them train the other team members.

6. Time Schedule
This activity develops a time schedule for the implementation and registration of the
system.
v
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v This time frame will vary, depending on the size and type of organization and the
extent of its existing quality system

7. Select Element Owners

The implementation team selects owners for each of the system elements.
• Many of these owners will be members of the implementation team.
• Owners may be assigned more than one element..

8. Review the Present System

Perform a review of the present quality system.
v Copies of all the quality manuals, procedures, work instructions, and forms
presently in use are obtained.
v These documents are sorted into the system elements to determine what is
available and what is needed to complete the system.
v This activity is a gap analysis and can be performed by the element owners and
their teams or by an external consultant.

9. Write the Documents

Prepare written quality policy and procedure manuals-they can be combined into one
document.
• Write appropriate work instructions to maintain the quality of specific functions.
• This process should involve every employee, because the best person to write a
work instruction is the one who performs the job on a regular basis

10. Install new system

Integrate the policies, procedures, and work instructions into the day-to-day workings
of the organization, and document what is being done.
v It is not necessary for all elements to be implemented at the same time.
v Be sure all people are trained.

11. Internal Audit

Conduct an internal audit of the quality system.
• This step is necessary to ensure that the system is working effectively and to
provide management with information for the comprehensive management
review.
• Minor corrections to the system are made as they occur. A cross-section of
trained people should be used for the audit team.

12. Management Review

Conduct a management review. The management review is used to determine the
effectiveness of the system in achieving the stated quality goals. The system is
revised as needed.
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13. Pre assessment
This step is optional. If a good job has been done on the previous steps,
preassessment is not necessary.

14. Registration
This step has three parts:
• choosing a registrar,
• submitting an application,
• Conducting the registrar's system audit.
A registrar's audit usually lasts one to three days and will consist of an opening
meeting to describe the process the auditors will follow, the audit itself, and a closing
meeting to discuss the findings of the audit.
• Over documentation or documentation that is too complex.
• Using external consultants without internal ownership and involvement. Limiting
documentation to text rather than other types of media.
• Neglecting to obtain top management's involvement.
• Developing a system that does not represent what actually occurs.
DOCUMENTATION

A quality system is the method used to ensure that the quality level of a product or
service is maintained.

The system documentation can be viewed as a hierarchy containing four tiers, as

shown in Figure

Documentation Pyramid

Policy
The first tier of documentation is the policy manual. This is the document that defines
what will be done and why.
v A quality policy manual should be written so it is clear, precise, practical, and
easy to understand.
v The why can be stated just once as a quality policy statement?
v This statement should be a short, simple definition of the organization's quality
intentions.
QUALITY SYSTEMS 20 UNIT 5
Procedure
The second tier of documentation is the quality procedures.
• These procedures describe methods that will be used to implement and
perform the stated policies.
• The procedures define who should perform specific tasks, when the task
should be done, and here documentation will be made showing that the task
was performed.
• Procedures should be oriented so that they apply to all areas within the
organization..

Work Instructions
Work instructions are usually department, machine, task, or product oriented and
spells out how a job will be done.
v These instructions are the most detailed of the documentation hierarchy.
v A work instruction may be in the form of a detailed drawing, recipe, routing sheet,
specific job function (for example, turn nut four turns clockwise), photograph,
video, or simply a sample for comparison of conformity

Records
Records are a way of documenting that the policies, procedures, and work
instructions have been followed.
• Records may be forms that are filled out, a stamp of approval on a product, or a
signature and date on some type of document, such as a routing sheet.
• Records are used to provide traceability of actions taken on a specific product
or batch of products..

Document Development
Although documentation is required by the system, its most important purpose
is to provide guidelines for internal quality management.
v In this respect it can be considered one approach to the road of continuing quality
improvement and business success.
v This preexisting documentation is the starting point for developing the documents
necessary for registration.
Writing the Documents

The basic thought to keep in mind when writing the documents is to create
simplicity out of complexity.

• To accomplish this objective, the documents must be simple and concise.

• Simplicity can be obtained by having one idea addressed per paragraph, short
subject verb-object type sentences, and a simple paragraph-numbering system
QUALITY SYSTEMS 21 UNIT 5

Format Example

• When designing the manuals, simplicity and ease of use should determine the
structure to be used.

• A cover page will list the organization name and location as well as the title of
the document. to determine that:

They are clearly defined and do not differ from the original proposal or sales offer.
• Any differences are resolved and any changes are appropriately recorded and
affected people notified.
• Wirco Castings Inc. has the ability to meet them.

Quality System Audits

After the policies, procedures, and work instructions have been developed and
implemented.

v This activity is accomplished through the internal audit, which is one of the key
elements of the ISO 9000 standard.

v All elements should be audited at least once per year and some more frequently,
depending on need.

Objectives
There are five objectives of the internal audit. They are to:

• 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.
QUALITY SYSTEMS 22 UNIT 5

• Provide continued improvement in the system through feedback to management.

• Cause the auditee to think about the process, thereby encouraging possible
improvements.
Auditor
Audits should be performed by qualified individuals who have received training in
auditing principles and procedures.
v Training programs are available from ASQ and RAB. Training should include
classroom information as well as practical demonstration by the trainer and a
critiqued audit by the trainee.
v To be able to audit efficiently, an individual should possess good written and oral
communication skills, be a good listener, and be good at taking notes.
v Other skills should include the ability to concentrate on the task at hand and not
be distracted by other activities that are taking place at the same time, be
observant and questioning, and be able to separate relevant facts from other
information.
v The auditor should be objective, honest, and impartial. Of course, the auditor
should be prepared by being knowledgeable about the standards.

Techniques
During the actual audit, there are a number of techniques that the auditor should
employ.
• The objective is to collect evidence, and there are three methods: examination
of documents, observation of activities, and interviews.
• The easiest method is to examine the documents.
• The auditor should start with the quality manual to determine that the policies
cover the QMS standards, and that they are controlled and assessable.
• Next, the documents are examined in a systematic manner.
• . Document control ensures that documents are identified with a title, revision
date, and responsible owner;
• documents are readily available to users;
• a master list by department or function for procedures, work instructions, and
records is appropriately located;
• there are no obsolete documents at workstations; and
• Changes follow a prescribed procedure.
• Observation of activities is also an easy method that requires an aptitude for
detail.
• Use the appropriate type of question.
• There are open questions, closed questions, clarifying questions, leading
questions, and aggressive questions.

Procedure
Before the audit takes place, an audit plan and checklist should be prepared
by the lead auditor.
As much time is spent planning as doing.
QUALITY SYSTEMS 23 UNIT 5
The contents of an audit plan should identify the activity or department
to be audited; list the procedures, documents, and regulatory requirements involved;
name the audit team; and list who is to be notified of the audit and who will receive
audit reports

v The purpose of the audit is to determine how well the quality system has been
implemented and maintained.
v In large organizations, an escort should be provided by the area being audited.

Audit Schedule Example

Audit Matrix Example

QUALITY SYSTEMS 24 UNIT 5

. Separate reports are prepared for each nonconformance and should include:

v The element title and a unique identification number such as NC 7.2.3, where the
NC stands for nonconformance and the other numbers give the element number.
v . Where the nonconformance was observed.
v Objective evidence used as a basis for the nonconformance.
v The nonconformance worded as closely as possible to the language of the
requirement.

At the closing meeting, the lead auditor presents a summary of the audit findings
along with the evidence that supports them.

• An estimate is made of when the final report will be issued.

• 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.
• 2. List the non-conformances and copies of all nonconformance reports.
• Outline procedures for corrective action and subsequent follow-up.
ENVIRONMENTAL MANAGEMENT SYSTEM
In 1991, ISO formed the Strategic Advisory Group on the Environment (SAGE),
which led to the formation of Technical Committee (TC) 207 in 1992.
v The mission of TC 207 is to develop standards for an environmental
management system (EMS) which was identified as ISO 14000.
v Like the ISO 9000 standards, which do not address the performance of the
product or service, the committee used the concept that the standards addressed
the process rather than the end goal.
v Thus, they are process standards rather than performance standards.

v TC 207 has established six sub-committees: environmental management

systems, environmental auditing, environmental labeling, environmental
performance evaluation, life-cycle assessment, and terms and definitions covers
terms and definitions that are common to both areas.

ORGANIZATIONAL EVALUATION STANDARDS

These standards consist of three categories: Environmental Management System
(EMS), Environmental Auditing (EA), and Environmental Performance Evaluation
(EPE).
v ISO 14001, entitled, "Environmental Management Systems-Specifications with
Guidance for Use," gives the elements that organizations are required to conform
to if they seek registration.
v This standard is the heart of the standards and will be discussed in greater detail
later in the chapter.
v The standards given below support the EMS.
v ISO 14004, entitled, Environmental Management Systems-Guidelines on
Principles, Systems, and Supporting Techniques, provides supplementary
material.
v ISO 14010, entitled, "Guidelines for Environmental Auditing-General Principles on
Environmental Auditing," provides information for internal or external auditing.
QUALITY SYSTEMS 25 UNIT 5
v ISO 14011, entitled, "Guidelines for Environmental Auditing-Audit
Procedures- Auditing of Environmental Management Systems," provides
information on how to plan and conduct an audit. Some topics are audit team,
audit plan, implementation, and report.
v ISO 14012, entitled, "Qualification Criteria for Environmental Auditors Performing
Environmental Management System Audits," covers information on auditor
qualifications, training, and personal attributes and skills.
v ISO 14031, entitled, "Guidelines on Environmental Performance Evaluation,"
presents information on recording information to track performance.

Organizational Evaluation Standards

PRODUCT EVALUATION STANDARDS
They consist of three categories:
v Environmental Aspects in Product Standards (EAPS),
v Environmental Labeling (EL),
v Life-Cycle Assessment (LCA).
"Environmental Aspects in Product Standards," is designed to help writers develop
product standards. Writers should carefully consider the environmental
consequences when developing criteria, elements, and characteristics that go into
the standard.

Product Evaluation Standards

v ISO 14020, entitled, "Environmental Labeling-Basic Principles for All

Environmental Labeling," provides guidance on the goals and principles that
should be used in all labeling programs.
v ISO 14021 entitled, "Environmental Labeling-Self-Declaration of Environmental
Claims:.
v ISO 14022, entitled, "Environmental Labeling-Symbols," provides a standard set
of symbols for use by organizations.
QUALITY SYSTEMS 26 UNIT 5
v ISO 14023, entitled, "Environmental Labeling-Testing and Verification
Methodologies," provides information on the appropriate methods to use to
confirm the genuineness of the product as stated by the environmental label.
v ISO 14024, entitled, "Environmental Labeling-Practitioner Programs: Guiding
Principles, Practices, and Certification Procedures for Multiple Criteria Programs,"
establishes criteria for third-party labeling or seal programs.
v ISO 14040, entitled, "Life-Cycle Assessment-Principles and Framework,"
provides an overview of the practice, applications, and limitations of LCA. Life-
cycle assessment attempts to determine the long-range environmental effect of a
product.
v ISO 14041, entitled, "Life-Cycle Assessment-Goals and Definition/Scope and
Inventory Analysis," is intended to provide guidelines for the preparation, conduct,
and critical review of the life-cycle inventory analysis.
v ISO 14042, entitled, "Life-Cycle Assessment-Impact Assessment," is intended to
use the results of the inventory analysis to evaluate the significance of potential
environmental impacts

v ISO 14043, entitled, "Life-Cycle Assessment-Improvement Assessment," is in-

tended to provide information to improve the total environmental performance of
a product system..

CONCEPTS OF ISO 14001

This standard provides organizations with the elements for an environmental

management system (EMS), which can be integrated into other management
systems to help achieve environmental and economic goals.

• It describes the requirements for registration and/or self-declaration of the

organization's EMS.

• Demonstration of successful implementation of the system can be used to

assure other parties that an appropriate EMS is in place.

. The basic approach to EMS is shown in Figure

v It begins with the environmental policy, which is followed by planning,
implementation and operation, checking and corrective action, and management
review. The approach follows the PDSA cycle.
v There is a logical sequence of events to achieve continual improvement. Many of
the requirements may be developed concurrently or revisited at any time
QUALITY SYSTEMS 27 UNIT 5

Environmental Management System Model

The standard is not intended to create non tariff barriers or to change an
organization's legal obligations.
• In addition, it does not include aspects of occupational health and safety
management, although an organization may include these aspects in the
documentation.
• . Environment is defined as the global surroundings in which an organization
operates and includes air, water, land, natural resources, flora, fauna,
humans, and their interaction.
• Environmental aspect is defined as an element of an organization's activities,
products, or services that can interact with the environment
• Environmental impact is defined as any change, whether adverse or
beneficial, wholly or partially resulting from an organization's activities,
products, or services.
• Environmental objective is an overall environmental goal, arising from the
policy statement, that an organization sets for itself and which is quantified
when practical.
• There are four sections to the standard-scope, nonnative references,
definitions, and EMS requirements and an informative annex.

Requirements of ISO 140012

The standard is divided into six parts or clauses and has a total of 18 requirements.
The numbering system used is identical to the standard.

4.1 General Requirements

The organization shall establish and maintain an environmental management system
that includes policy, planning, implementation and operation, checking and corrective
action, and management review.
v These requirements are given in the rest of the standard. Because the document
is available to the public and other stakeholders, the organization may wish to
include in this narrative a brief description of the company
v . In addition, this clause is a, good place to include manual control and
distribution. In developing the EMS, keep it as simple as possible..
QUALITY SYSTEMS 28 UNIT 5

4.2 Environmental Policy

The organization's policy statement should be based on its mission and values

• Identification of legislative and regulatory requirements.

• Identification of environmental aspects of its activities, products, or services that
can have significant impact and liabilities.
• Identification of existing activities with suppliers.
• Identification of existing management policies and procedures.
• Feedback from investigation of previous incidents of noncompliance.
• Identification of opportunities for competitive advantage.
• Identification of benchmarking opportunities.
4.3 Planning
This area contains four elements: environmental aspects, legal and other
requirements, objectives and targets, and environmental management program(s).

4.3.1 ENVIRONMENTAL ASPECTS

.ISO 14004 lists nine issues that can be considered in an organization's procedures for the
identification of aspects and their impacts.

v What are the environmental aspects of the organizations activities, products, and
services?
v . Do the organization's activities, products, or services create any significant
adverse environmental impacts?
v Does the organization have a procedure for evaluating the environmental
consideration, for example, sensitive environmental areas?
v Does the location of the organization require special environmental consideration,
for example, sensitive environmental aspects and their associated impacts?
v How will any intended changes or additions to activities, products, or services
affect the environmental aspects and their associated impacts?
v How significant or severe are the potential environmental impacts if a process
failure occurs?
v How frequently will the situation arise that could lead to the impact? 8. What are
the significant environmental aspects, considering impacts, likelihood, severity,
and frequency?
v Are the significant environmental impacts local, regional, or global in scope?
.

4.3.2 LEGAL AND OTHER REQUIREMENTS

The standard requires the organization to have a procedure to identify and have
access to all legal and other requirements to which it subscribes.
• In general, legal environmental requirements are those attributed to
governmental legislative and regulatory action.
• Other requirements usually include industry codes of practice, contracts,
agreements with public authorities, and no regulatory guidelines.
QUALITY SYSTEMS 29 UNIT 5
4.3.3 OBJECTIVES AND TARGETS
The organization shall establish and maintain these objectives and targets at each
relevant function and level.
v They shall be consistent with the policy statement, especially in regard to the
prevention of pollution.
v In addition to the environmental aspects, and the legal and other requirements
which were previously discussed, this clause also requires that the organization
consider:
. ISO 140041ists different forms of objectives, such as:

• Reduce waste and the depletion of resources.

• Reduce or eliminate the release of pollutants in the environment.
• Design products to minimize their environmental impact in production, use, and
disposal. Control the environmental impact of sources of raw material.
• Minimize any significant adverse environmental impact of new developments.
Promote environmental awareness among employees and the community.
4.3.4 ENVIRONMENTAL MANAGEMENT PROGRAM(S)
The organization shall establish and maintain a program(s) for achieving the
objectives and targets.
This requirement can be achieved with a simple form. It will require completion of the
following items:

v State the objective/target.

v State the purpose (How the objective/target will suppol1 the policy).
v Describe how the objective/target will be achieved.
v State the program (team) leader.
v Designate departments and individuals responsible for specific tasks.
v Establish the schedule for completion of the tasks.
v Establish the program review, which will include format, content, and review
schedule.

4.4 Implementation and Operation

This area contains seven elements: structure and responsibility; training, awareness,
and competency; communication; EMS documentation; document control;
operational control: and emergency preparedness and response.

4.4.1 STRUCTURE AND RESPONSIBILITY

Roles, responsibilities, and authorities shall be defined, documented, and
communicated for all personnel affecting the EMS.
v They must be given the freedom and authority to take the necessary actions. An
organization chart is one method to show the flow of authority.
v A management representative must be appointed and given the authority to
ensure that this standard is being met and to periodically repol1 to senior
management the status of EMS with the aim of improvement.
v The management representative can only be as effective as their involvement.
v Senior management must provide the resources in terms of people, technology,
and money to implement and maintain an effective system that achieves its
objectives.
QUALITY SYSTEMS 30 UNIT 5

4.4.2 TRAINING, AWARENESS, AND COMPETENCY

Training needs should be evaluated on a regular basis, usually annually, to ensure
their effectiveness.
v There are two types of training: general awareness and job competency. General
awareness includes the importance of conformance to the EMS, the relationship
of significant environmental impacts to the employees' work activities, employee
roles and responsibilities, and potential consequences of failing to follow specific
operating procedures.
v Records must be maintained to document that the training requirements have
been met.
At a minimum, this training should include:

Record of training needs assessments. Task competency requirements. Training

procedures. Training plans.
Records of training delivered to specific employees.

Registrar's audits will require these documented records, and they will be valuable
for internal operations and litigation defense if needed.

4.4.3 COMMUNICATION
• A key aspect of any management program is communication with all
stakeholders. The standard requires that procedures shall be established and
maintained for internal communication among all employees.
• Effective communication up, down, and laterally should ensure that questions
are answered and that understanding is complete and accurate.
• Internal environmental communication procedures should address reporting
on environmental activities to:

• Demonstrate management's commitment to the environment and EMS.

• Handle concerns and questions about environmental aspects of the
organization's activities, products, and services.
• Inform appropriate employees of all legal and regulatory changes and all
changes to the EMS.
• Raise awareness of the organization's environmental activities.
• Ensure that all employees are aware of objectives, targets, programs, and
achievements..

In addition, procedures shall be established for receiving, documenting, and

responding to relevant external communication from interested parties
Further more, the organization shall consider processes for external communication
of its environmental aspects and record its decision to implement or to not implement
those processes.

4.4.4 ENVIRONMENTAL MANAGEMENT SYSTEM DOCUMENTATION

The organization shall establish and maintain information, in paper or electronic
form, to describe the core elements of the system and their interaction and provide
direction to applicable related documents.
v ISO 14000 requires a documentation system very similar to ISO 9000, which
makes integration of the two systems very easy.
QUALITY SYSTEMS 31 UNIT 5

v The organization must show that it is actually practicing what the documentation
states. In other words, "Say what you do and do what you say."

4.4.5 DOCUMENT CONTROL

This element requires that procedures be established and maintained to control all
EMS documents.

• Provisions must be made for the review and approval of documents for
adequacy before they are issued and after any changes.

• The purpose of document control is to ensure that appropriate and current

issues of documents are in place at all locations.

• Obsolete documents must be removed and destroyed or stored in a safe place if

retention for legal purposes is necessary. Documents shall be legible, dated,
readily identifiable and easily located. .
• The best document control system is the simplest one that meets the needs of
the organization and ISO 14000.
• If the organization has an existing system such as ISO 9000, it can be used as a
model.
Organizational charts and other forms of documentation can be used to clearly
define core elements of the system and how they relate to Level 2 procedures.
The organization may wish to list environmental aspects; objectives; targets; and
legal, regulatory, and other requirements at this level. 1 Level 2, the procedure level,
describes what the organization does to meet

Documentation Hierarchy

• Level 1 policy. There are 17 procedures and while only three are explicitly
required to be documented, it is best from an effectiveness standpoint to
document all 17.
QUALITY SYSTEMS 32 UNIT 5
• Level 3, the practice level, describes the work instructions by
which operating personnel perform their tasks.
• They are step-by-step instructions dealing with activities required by the
standard. Organizations involved with TQM or ISO 9000 will already have
these activities documented.
• Level 4, the proof level, is the location of all forms, records, drawings, and so
forth that represent the objective evidence or proof of the performance of the
EMS.
• It is important to note that the system should be an efficient one and not a
bureaucratic one-keep it simple.

4.4.6 OPERATIONAL CONTROL

This element aligns operations and activities with the identified significant environ-
mental aspects, environmental policy, and environmental objectives and targets

v Cover situations where their absence could lead to deviations from the policy and
the objectives and targets.
v Stipulate operating criteria which are the details and instructions that would
normally be included in any process, procedure, or step-by-step work instruction.
v They include equipment to be used, materials required, process settings,
maintenance program, and so forth.
v Cover the identification of environmental aspects of goods and services and
communicate relevant procedures and requirements to suppliers and contractors.
v Ford Motor Co., which has registered all 140 facilities in 26 countries, requires its
suppliers to be certified to ISO 14001. Other major companies such as IBM,
General Motors, Xerox, and Honda of America also have made the same
stipulation.3

4.4.7 EMERGENCY PREPAREDNESS AND RESPONSE

Procedures are required to identify and respond to potential accidents and
emergency situations.
. Emergency plans should include at a minimum:

• Emergency organization and responsibilities of key personnel.

• Details of emergency services such as fire department and spill cleanup services.
Internal and external communication plans.
• Actions to be taken for the different types of emergencies.
• Information on hazardous materials and their impact, including information about
• Equipment and protective clothing.
• Training plans and testing for effectiveness.

These procedures shall be reviewed and revised, if necessary, especially after an

emergency. A checklist for lessons learned could include:

v Did we follow procedures?

v If not, why and how did we deviate?
QUALITY SYSTEMS 33 UNIT 5
v What did we do that was right?
v What did we do that was wrong?
v What procedural changes would result in a more effective response?

These questions can also be asked after any emergency drill or simulation, which
would test the procedures for their effectiveness.
4.5 Checking and Corrective Action
This area contains four elements: monitoring and 'measuring, nonconformance and
corrective and preventative action, records, and EMS audit.

4.5.1 MONITORING AND MEASURING

Effective decisions usually require quantifiable data.
• The organization is required to monitor and measure the key characteristics of its
objectives and activities in order to assess its performance in meeting
environmental operations and targets.
• Measuring equipment is of little value if it is not accurate or functioning properly.
• Procedures must be in place to control, regularly calibrate, maintain, and record
all EMS equipment, whether it belongs to the organization, employee, or an
outside agency.
• In addition, procedures are required to periodically evaluate compliance to
relevant regulations.

4.5.2 NONCONFORMANCE AND CORRECTIVE AND PREVENTATIVE ACTION

Procedures are required to define responsibility and authority for
v Handling and investigating nonconformance,
v Taking action to mitigate any impacts,
v Initiating corrective and preventative action.
Briefly, the process should include:

• Identifying the root cause of the nonconformance.

• Identifying and implementing the necessary corrective action.
• Implementing or modifying controls necessary to prevent a recurrence.
• Recording any changes in the written procedures.

Since operating personnel are usually the most knowledgeable people concerning
the process, they should be involved in the corrective and preventative action
activity.
4.5.3 RECORDS
Procedures are required for the identification, maintenance, and disposition of
environmental records such as training, audits, equipment calibration, and reviews.
v Records shall be legible, identifiable, and traceable to the activity, product, or
service.
QUALITY SYSTEMS 34 UNIT 5
v They should be readily retrievable; protected against damage,
deterioration, and loss; and provided with retention times.

4.5.4 EMS AUDIT

The purpose of this audit is to ensure that the EMS conforms to plans and is being
properly implemented and maintained.
• Internal or self-audit and external audit information should be distributed to senior
management to assist in the management review process.
• Audit procedures should cover the scope, frequency and methodologies, and
responsibilities and requirements for conducting audits and reporting results.
• The audit schedule should be based on the importance of the element and the
results of previous audits.

MANAGEMENT REVIEW
Management review and revision, if applicable, is required to ensure the continuing
suitability, adequacy, and effectiveness of the EMS
A fixed schedule of reviews is required to cover all the elements. ISO 14004
recommends that the review include:

• Review of environmental objectives and targets.

• Review of environmental performance against legal and other requirements.
Evaluation of the effectiveness of the EMS's elements.
• Evaluation of the continued suitability of the policy in light of changing legislation;
changing expectations; changing requirements of interested parties; changes in
activities, products, and services; new technology; lessons learned; market
preferences and expectations; and effectiveness of reporting and communication.

BENEFITS OF EMSEMS benefits can be categorized as global and

organizational.

GLOBAL BENEFITS
There are three global benefits:
v Facilitate trade and remove trade barriers,
v Improve environmental performance of planet earth,
v Build consensus that there is a need for environmental management and a
common terminology for EMS.
. ORGANIZATIONAL BENEFITS.
According to ISO 14004, an organization benefits from an EMS in a number of ways
as given below:

• Assuring customers of a commitment to environmental management.

• Meeting customer requirements, the primary reason for organizations to
become certified.
• Maintaining a good public/community relations image.
• Satisfying investor criteria and improving access to capital. .
•
•
QUALITY SYSTEMS 35 UNIT 5

• Increasing market share that results from a competitive advantage. After

certification, Acushnet Rubber obtained more business from European
customers.
• Reducing incidents that result in liability.
• Improving defense posture in litigation.

GE 406 Total Quality Management

Assignment V
Part A
1 What is ISO?
2. What is the difference between ISO 9000:1994 version and 2000 version?
3. What are the different types of organization to which ISO 9000 can be applied?
4. What is the importance of ISO?
5. What is non conformity?
6. What is the specialty in ISO 9000:2000 version?
7. What is ISO 14000 and its importance?
8. Define auditor and auditee?
9. Why internal auditing is required?
10. What are all the advantages of ISO 14000 system?

Part B
1. Explain the various clauses available in ISO 9000:2000 version.
2. Explain in detail the various activities to be carried out by a manufacturing industry
to obtain ISO 9000:2000 versions.
3. Explain the various clauses available in ISO 9000:14000 version.
4. Explain in detail the various activities to be carried out by an educational institution
to obtain ISO 9000:2000 versions.
5. Explain the required behavior of internal auditors and Auditees and the process of
internal auditing.
QUALITY SYSTEMS 36 UNIT 5