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What Is Quality Management System

A quality management system (QMS) is a set of processes and procedures implemented by an organization to ensure quality in the delivery of products and services. ISO 9001 provides requirements for a QMS to help organizations ensure consistency in meeting customer and regulatory requirements. It outlines key clauses including management responsibility, resource management, product realization, and measurement/analysis/improvement to establish processes for quality planning, assurance, control, and improvement. The standard is applicable to organizations of any type or size looking to implement or certify a QMS.

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171 views4 pages

What Is Quality Management System

A quality management system (QMS) is a set of processes and procedures implemented by an organization to ensure quality in the delivery of products and services. ISO 9001 provides requirements for a QMS to help organizations ensure consistency in meeting customer and regulatory requirements. It outlines key clauses including management responsibility, resource management, product realization, and measurement/analysis/improvement to establish processes for quality planning, assurance, control, and improvement. The standard is applicable to organizations of any type or size looking to implement or certify a QMS.

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Alias
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We take content rights seriously. If you suspect this is your content, claim it here.
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What is Quality Management System?

Quality management system is defined as a set of interrelated or interacting elements to


establish policy and objectives for an organization and to achieve those objectives with regard
to quality.
 

ISO 9001 applies to all types and sizes of organizations that wish to: 

 Establish, implement, maintain and improve an QMS;


 Assure conformity with the organization’s stated quality policy;
 Demonstrate conformity to others;
 Seek certification/registration of its QMS by an accredited third party certification body;
and
 Make a self-determination and self-declaration of conformity with this International
Standard.

Key clauses of ISO 9001:2008 


Clause 4: Quality management system
Clause 5: Management responsibility
Clause6: Resource management
Clause 7: Product realization
Clause 8: Measurement, analysis and improvement
 
Each of these key activities is listed below.
 

Clause 4: Quality management system 


The organization shall establish, document, implement and maintain a QMS and continually
improve   its effectiveness in accordance with the requirements of ISO 9001 by:
 

 Determining the processes needed for the QMS and their application throughout the
organization;
 Determining the sequence and interaction of these processes;
 Determining criteria and methods needed to ensure that both the operation and control
of these processes are effective;
 Providing resources and information necessary to support the operation and monitoring
of these processes;
 Monitoring, measuring and analyzing these processes; and
 Implementing actions necessary to achieve planned results and continual improvement
of these processes.
 
This clause also includes requirements related to the QMS documentation that includes: the
quality policy and objectives, the quality manual, procedures, records, documents to ensure
effective planning, operation and control of processes and other documentation specified by
national or regional regulations. It also provides requirements on how to control these
documents and records.
 

Clause 5: Management responsibility 


Top management shall demonstrate an ongoing commitment to the development and
implementation of the QMS and continually improving its effectiveness by:

 Communicating to the organization the importance of meeting customer as well as


statutory and regulatory requirements;
 Establishing the quality policy;
 Ensuring that quality objectives are established;
 Conducting management reviews; and
 Ensuring the availability of resources.
 

Clause 6: Resouce management 


The day-to-day management of an effective quality management system relies on using the
appropriate resources for each task. These include competent staff with relevant (and
demonstrable) training and supporting services, awareness and communication.
 
To achieve conformity to product requirements it is important to provide and maintain an
appropriate infrastructure.
 
This clause also includes the managing of the work environment, which must be managed by
the organization in order to achieve conformity to product requirements. 
 

Clause 7: Product realization 


This clause describes all processes related to product realization, starting from planning of
product realization, customer related processes, design and development to the end product
and after sales services. In detail this clause includes:

 Planning of product realization: During this stage the organization must plan and develop
all processes necessary for product realization;
 Customer-related processes: It is important to manage processes related to customers
in order to make sure the organization is determining and meeting their requirements;
 Design and development: The design and development process must include design
and development planning,     inputs, outputs, review, verification, validation and control
of design and development changes;
 Purchasing: It is important to establish documented procedures to ensure that
purchased product conforms to specified purchase requirements;
 Production and service provision: This sub-clause includes the control and validation of
production and service provision. The identification and traceability, customer property
and preservation of product are also part of this sub-clause.
 Control of monitoring and measuring devices: The requirements for what needs to be
measured and the acceptance criteria may come from the customer, regulatory, industry
or the organization itself. Monitoring and measurement must be carried out in
consistency with the requirements. 
 

Clause 8: Measurement, analysis and improvement 


Once the quality management system is implemented, permanent monitoring, measurement,
analysis and improvement is required, to:

 Demonstrate conformity to the product;


 Ensure conformity of the QMS; and
 Continually improve the effectiveness of the QMS.

An organization can continually improve the effectiveness of its management system through
the use of the quality policy, objectives, audit results, analysis of data, corrective and preventive
actions.
 
Continual improvement can be defined as all the actions taken throughout the organization to
increase effectiveness (reaching objectives) and efficiency (an optimal cost/benefit ration) of
quality processes to bring increased benefits to the organization and its stakeholders.
 

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