BBA Semester V

BBA 502:Total Quality Management

Module IV: Quality Management Systems

Introduction to QMS, Requirement of QMS, ISO-9001:2008, Steps in preparation &

Implementation of ISO- 9001:2000, Environmental Management System/ ISO – 14000,
14001

• A quality management system (QMS) is defined as a formalized system that documents

processes, procedures, and responsibilities for achieving quality policies and objectives.
• A QMS helps coordinate and direct an organization’s activities to meet customer and
regulatory requirements and improve its effectiveness and efficiency on a continuous
basis.

• ISO 9001:2015, the international standard specifying requirements for quality

management systems, is the most prominent approach to quality management systems.
• While some use the term "QMS" to describe the ISO 9001 standard or the group of
documents detailing the QMS, it actually refers to the entirety of the system.
• The documents only serve to describe the system.

Requirement/importance of QMS

The organization shall establish, document, implement, and maintain a quality management
system and continually improve its effectiveness in accordance with the requirements of this
International Standard. The organization shall

1. determine the processes needed for the quality management system and their
application throughout the organization
2. determine the sequence and interaction of these processes,
3. determine criteria and methods needed to ensure that both the operation and control of
these processes are effective,
4. ensure the availability of resources and information necessary to support the operation
and monitoring of these processes,
5. monitor, measure (where applicable), and analyse these processes, and
6. implement actions necessary to achieve planned results and continual improvement of
these processes.

What are the documentation requirements of quality management systems?

The quality management system documentation shall include

1. documented statements of a quality policy and quality objectives,

2. a quality manual
3. documented procedures and records required by this International Standard, and
4. documents, including records, determined by the organization to be necessary to ensure
the effective planning, operation, and control of its processes.

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ISO-9001:2000

• ISO 9001:2000 is an internationally recognized standard within the ISO 9000 series that
focuses on quality management systems (QMS).
• It provides a framework for organizations to establish, implement, maintain, and improve
their quality management practices.
• ISO 9001:2000 sets out criteria for a QMS that helps organizations consistently meet
customer requirements, enhance customer satisfaction, and continually improve their
processes.
• By adopting this standard, organizations demonstrate their commitment to delivering high-
quality products and services.
• ISO 9001:2000 certification can enhance an organization's reputation, increase customer
confidence, and drive operational efficiency.
• It's a valuable tool for organizations looking to improve their quality management practices
and deliver exceptional outcomes.

Steps in Preparation & Implementation of ISO- 9001:2000

The documentation structure generally consists of different hierarchical levels. The contents of
different hierarchical levels are as follows:

1. Quality Manual : Quality Manual is a document which explains how the requirements
of ISO 9001:2000 are planned to be fulfilled by the organisation taking into
consideration the type of product/service offered, complexity of processing methods,
the competence of operating personnel, and a number of sites where the Quality
Management System is implemented. The manual also contains general information
about the organization:

i. Establishment and evolution over the years.

ii. The position in the supply chain.
iii. The suppliers and customers in the chain.
iv. The site-related details.
v. Quality policy and related objectives.
vi. Organisation chart.
vii. Applicable statutory and regulatory requirements.
viii. The structure of QMS documentation.
ix. The site map from external and internal points of view.
x. Roles and responsibilities.
xi. Details of external resources utilized.

The manual gives reference to or contains all the elements of the QMS
documentation. It acts as a reference document for training of new team members
of the organization, communicating the QMS overview to National and
International customers, and as a supporting document during any statutory and
regulatory interaction. The manual is required to be reviewed periodically by the
top management in management review meetings. The relevant inputs to be
reviewed in the meeting are required to be collected from different processes
constituting the Quality Management System

2. Mandatory Procedures: The following documented procedures are as follows:

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 i. Control of documents: This procedure contains information related to approval
of documents, re-approval of documents, identification of changes,
identification of current revision status, availability of relevant versions at
points of use, legibility, documents of external origin, and management of
obsolete documents. • A master list of documents is prepared which gives details
like document name, document number, issue date, current revision number and
date, and information about the preparation, review, and approval of the
documents.
ii. Control of records: This procedure defines controls needed for the
identification, storage, protection, retrieval, retention time, and disposal of
records. A master list of records is prepared which gives details like - record
name, associated format number and issue date, version of record (soft/hard),
record originating process, etc.
iii. Internal audits: This procedure contains the responsibility and requirements
for planning and conducting audits, and for reporting results and records. It also
contains the details of the competence of the internal audit team members.
iv. Control of non-conforming product: This procedure contains information
about the identification and assessment of potentially nonconforming end
products to determine their proper handling and review of the corrections
carried out. It also specifies the records required to be maintained.
v. Corrective action: This procedure contains information related to review of
non-conformities (including customer complaints), review of trends in
monitoring results, determination of causes of non-conformities, evaluating the
need for the action, determining and implementing the actions needed,
recording the results and reviewing corrective actions taken.
vi. Preventive action: This procedure contains information related to review of
potential non-conformities (including customer complaints), review of trends in
monitoring results, determination of causes of potential nonconformities,
evaluating the need for the action, determining and implementing the actions
needed, recording the results and reviewing corrective actions taken

3. Standard Operating Procedures: The following SOPs are generally maintained:

i. Procedure for training

ii. Procedure for maintenance
iii. Procedure for identification and traceability
iv. Procedure for handling potentially non-conforming product
v. Procedure for purchase
vi. Procedure for verification of purchased product
vii. Procedure for raw material stores
viii. Procedure for finished goods stores
ix. Procedure for dispatch
x. Procedure for handling customer complaints

4. Process Definition Documents: These documents define the identified processes in

the following terms to ensure that the process approach is followed:

i. Process ID (Name and number)

ii. Process purpose and scope

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 iii. Process objectives • Process owner
iv. Process organisation
v. Process resources
vi. Process input methods and outputs
vii. Process tracking
viii. Process documents and records
ix. Process Effectiveness

5. Work Instructions: These documents provide instructional guidance to operational

personnel for carrying out micro-activities outlined in different SOPs. The details of the
contents depend on the competence of the operating personnel, the complexity of the
process, and the nature of the product/service. These documents should be accessible
to the operating personnel preferably near their work area. These documents should be
available in the (local) language, that the operational workforce understands. These
documents are to be drafted with the help of the operational personnel and may contain
a pictorial presentation of work activities so that non-conformities are avoided.

6. Miscellaneous Documents: The following important miscellaneous documents are

required to be maintained.

i. Statutory and regulatory requirements

ii. Documents of external origin
iii. Quality policy
iv. Quality objectives
v. List of available resources
vi. List of role-wise necessary competence
vii. Customer requirements
viii. Technical documents (research articles etc.)

7. Formats and Records: The following records are required to be maintained in pre-
determined formats as evidence of activities carried out as per the defined quality
management system:
i. Current competence of all concerned
ii. Calibration of measuring and monitoring instruments
iii. Outcome of internal audits
iv. Output of management review
v. Corrective actions
vi. Training and effectiveness of training given
vii. Product design input determination
viii. Product design review
ix. Product design verification
x. Product design validation
xi. Product design change review
xii. Corrections of non-conforming product
xiii. Verification of purchased product
xiv. Identification of products where traceability is a requirement
xv. Release of the end product
xvi. Receipt and the issue of material/products in stores
xvii. Maintenance (breakdown and preventive)

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 xviii. Quality objective tracking
xix. Document change control
xx. Document distribution

Environmental Management System

• An environmental management system (EMS) is a framework that organizations use to
manage and reduce their environmental impact.
• It involves developing and implementing policies, procedures, and practices to ensure
compliance with environmental regulations and promote sustainability.
• helps organizations identify and assess environmental risks, set environmental
objectives, and establish processes for monitoring and improving environmental
performance.
• It includes elements such as environmental planning, implementation, evaluation, and
corrective action.
• By implementing an EMS, organizations can minimize their environmental footprint,
enhance their environmental reputation, and contribute to a more sustainable future.
• An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling
an organization of any size or type to:

1. identify and control the environmental impact of its activities, products or services,
2. to improve its environmental performance continually
3. to implement a systematic approach to setting environmental objectives and targets,
to achieving these, and to demonstrating that they have been achieved.

https://indiafreenotes.com/environmental-management-system-ems/

ISO – 14000, 14001

An EMS meeting the requirements of ISO 14001:2004 is a management tool enabling an

organization of any size or type to identify and control the environmental impact of its
activities, products, or services, improve its environmental performance continually, and
implement a systematic approach to setting environmental objectives and targets, to achieving
these, and to demonstrating that they have been achieved.

General requirements

1. Environmental policy
2. Planning
3. Implementation and operation
4. Checking and corrective action
5. Management review

Benefits:
1. Facilitate trade and remove trade barriers
2. improve the environmental performance of planet Earth
3. Build consensus that there is a need for environment management and a common
terminology for EMS.

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ISO 14000 Standard

ISO 14000 is a family of standards related to environmental management that exists to help
organizations:

1. minimize how their operations (processes, etc) negatively affect the environment (i.e.
cause adverse changes to air, water, or land)
2. comply with applicable laws, regulations, and other environmentally oriented
requirements and
3. continually improve in the above.

• ISO 14000 is a series of international standards that focuses on environmental management.

• It provides organizations with guidelines and frameworks to help them address
environmental challenges and improve their environmental performance.
• The ISO 14000 series covers various aspects of environmental management, including
environmental auditing, life cycle assessment, environmental labelling, and environmental
performance evaluation.
• These standards are designed to promote sustainable practices, reduce environmental
impact, and ensure compliance with applicable regulations.
• ISO 14000 provides a globally recognized framework for organizations to demonstrate
their commitment to environmental responsibility.

ISO 14001 standard

ISO 14001 is a globally recognized standard within the ISO 14000 series that focuses on
environmental management systems (EMS).
It provides a framework for organizations to establish, implement, maintain, and improve their
environmental performance.
ISO 14001 helps organizations identify and manage environmental risks, comply with
applicable environmental regulations, and continuously improve their environmental
performance.
By adopting this standard, organizations demonstrate their commitment to environmental
sustainability and responsible practices.
ISO 14001 certification can enhance an organization's reputation, build trust with stakeholders,
and contribute to a more sustainable future.