Unit 6 Quality Management Systems

Introduction:

Previous unit gave you an insight on the concept of benchmarking, the various types of benchmarking
and their levels. It also talked about the process, reasons and benefits of benchmarking. In this unit,
you will study about ISO 9000 Quality Standard and ISO certifications. In this unit you will also learn
about the documentation of quality systems and implementation of ISO 9001:2000. Quality is the
basic requirement for business success and the survival of any business organization will depend on
its ability meet or exceed both stated and implied expectations of the customers. Thus quality
management has emerged as the most important strategic function for all business organizations. This
resulted in the development of various standards and guidelines. In order to fulfill customer needs and
expectations, all world class organizations create quality systems. This led to the concept of “Quality
Management Systems” which is popularly known as QMS. A Quality Management System is the
system which provides guidelines for the organization and its employees to identify the needs of
customer and to design, develop, produce and deliver the products or services to meet these needs.
Thus quality management systems ensure that an organization’s efforts are directed towards
achievement of high quality of products and services. 10.1 ISO 9000 ISO 9000 is a series of standards
dealing with quality management systems. The standards are published by the International
Organization. All industrialized countries are members and participate in writing the standards. Most
countries have adopted and published ISO 9000 as their own national standard. In the United States, it
has been issued as Q9000 with virtually the same text as the original standard.

A.1 ISO Standard Series and Some Other Standards:

The ISO Standard Series includes the following Systems Standards indicating their specific purposes:

ISO 9000: Quality Management and Quality Assurance Standards Guidelines for Selection and Use

ISO 9001: Model for Quality Assurance in Design/Development, Production Installation, and
Servicing.

ISO 9002: Model for Quality Assurance in Production and Installation.

ISO 9003: Model for Quality Assurance in Final Inspection and Test.

ISO 9004: Generic Guidelines for Quality Management and Systems.

ISO 9004-2: Guidelines for Services.

ISO 9000 Quality System Certification

Initially, ISO 9000 was used as the basis for specifying quality requirements in contractual
arrangements between a purchaser and supplier. Customers would perform on-site assessments of
their suppliers to ensure compliance. Third-party “registrars” are now being used to perform
independent ISO 9000 assessments. These certifying bodies are officially authorized by a national
accreditation group to carry out the audits and issue certificates. Registrars certify to customers that a
supplier is complying with all the applicable requirements of the standard.
A.2 Benefits of ISO Certification:

Some basic benefits of ISO 9000 Certification are summarized below:

Improved customer satisfaction

Greater quality awareness

Higher real and perceived quality

Positive cultural change

Competitive edge

Increased market share

Increased productivity

Reduced costs.

A.3 Limitation of ISO 9000 Certification:

Though ISO 9000 has proved to be very effective for software development organizations, however, it
also suffers from several limitations.

ISO 9000 does not automatically lead to Total Quality Management (TQM) i.e., continuous
improvement.

ISO 9000 does not provide any guideline for defining an appropriate process.

ISO 9000 certification process is not fool proof and thus variations in the certification norms may
exist.

A.4 ISO 9001 Requirements:

ISO 9001 has eight clauses. The first three clauses Scope, Normative Reference, and Terms and
Definitions are for information. The next five clauses Quality Management Systems, Management
Responsibility, Resource Management, Product and/or Service Realization, and Measurement,
Analysis and Improvement are requirements that an organization must meet. They are explained
below:

A4.1 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 achieve customer satisfaction. This is achieved by
continuous improvement of the system, rather than the product.

A4.2 Normative Reference:

ISO 9000:2000 Quality Management Systems – Fundamentals and vocabulary are normative
reference that provides applicable concepts and definitions.
A4.3 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

A4.4 Quality Management Systems (QMS)

(a) General Requirements: Organization shall establish, document, implement, and maintain a QMS
and continually improve its effectiveness. The organization shall:

Identify needed processes such as management activities, provision

of resources, product realization, and measurement.

Determine their sequence and interaction.

Determine criteria and methods for effective operation and control of

these processes.

Ensure the availability of resources and information necessary to

support and monitor these processes.

Monitor, measure, and analyze these processes.

Implement actions to achieve planned results and continuous

improvement of these processes.

(b) Documentation: General documentation includes a quality policy, a quality manual, required
documented procedures, documents needed to ensure effective planning, operation and control of
processes and various records required. A quality manual shall be established and maintained and it
must contain information related cope of QMS, documented procedures and description of
interactions among QMS processes. All the documents required by QMS shall be controlled and this
includes approval of documents prior to their use, review, updation and re-approve as necessary,
identifying current revision status, and prompt removal of obsolete documents. Records must be
established and maintained to provide evidence of conformity to requirements and effective operation
of QMS. Records must be legible, readily identifiable and retrievable.

A4.5 Management Responsibility

(a) Management commitment: Top management should be committed for continuous

improvement and it shall demonstrate through the evidence by communicating the needs. to
meet customer, legal, and regulatory expectations, establishing a quality policy, ensuring
Notes that quality objectives are achieved, conducting management reviews, and ensuring that
the resources needed are available.
(b) Customer focus: Top management shall also ensure that customer requirements are
determined and met with the aim of enhancing customer satisfaction.
(c) Quality policy: Management must ensure that quality policy of the organization is appropriate
to its mission, define its commitment to comply with requirements and for continuous
improvement of the QMS, provides for establishing and reviewing quality objectives.
(d) Planning: Top management is responsible for establishing quality objectives and these
objectives shall be measurable and be in line with quality policy of the organization. Top
 management shall also ensure that the planning of the QMS is accomplished in order to meet
the requirements of QMS.
(e) Responsibility, authority and communication: Top management must ensure that
responsibilities and authorities are defined and communicated within the organization.
Responsibilities can be defined in job descriptions, procedures, and work instructions.
Authority and interrelationships can be defined in organization charts. Top management shall
also appoint a management representative, who regardless of his other duties, shall be
responsible for ensuring that the processes needed for the QMS system are established,
implemented and maintained. Top management shall also ensure that appropriate
communication channels are established within the organization and communication takes
place regarding the QMS.
(f) Management review: Top management shall review the QMS at planned intervals to ensure
its continuing suitability, adequacy and effectiveness. The input to review shall include
information on results of audits, customer feedback, status of corrective performance, follow
up actions from previous reviews and recommendations for improvement.

A4.6 Resource Management

(a) Provisions of resources: Organization must determine and allocate resources needed to
implement and maintain QMS and improve its effectiveness, and to enhance customer
satisfaction. This includes all resources like people, infrastructure, work environment,
information, suppliers, natural resources, and financial resources.
(b) Human resources: All the employees involved in any task which affects product quality
shall be competent and organization shall determine competence necessary for performing
work. It shall provide training to develop those competencies.
(c) Infrastructure: The organization shall determine, provide and maintain the infrastructure
needed to achieve conformity to product requirements. This includes buildings, workspace,
and associated utilities, process equipment, and supporting services.
(d) Work environment: The organization shall determine and manage work environment
needed to achieve conformity to product requirements.

A4.7 Product Realization

(a) Planning of product realization: Organization shall plan and develop processes needed for
product realization. Organization shall determine quality objectives and requirements of the
product, the need to establish processes, documents, and provide resources, validating
activities and criteria for product acceptance, and the records needed to provide evidence for
the product realization.
(b) Customer related processes: Organization shall also determine requirements specified by
customers, related delivery and post delivery services. It shall also determine any statutory
requirements related to product. It is also necessary to review the requirements related to
product. Organization shall determine and implement effective management for
communicating with customers in relation to product, and customer complaints.
(c) Design and development: Organization shall plan and control the design and development
activities of the product. Inputs relating to product requirements shall be determined and
records maintained. 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. At suitable, stage, systematic reviews of design and development shall be performed
in accordance with the planned arrangements. 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. 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. Design and
development changes shall be identified and records maintained.
(d) Purchasing: The organization shall ensure that the purchased product conformed to
specified purchase requirements. Purchasing information shall describe product to be
purchased and its requirements. The organization shall establish and implement the inspection
to ensure the purchased product meets the specified purchase requirements.
(e) Production and service provision: The organization shall plan and carry out production
and service provision under controlled condition. The organization shall validate any
processes of production or service provision where the resulting output cannot be verified by
subsequent monitoring or measurement.
(f) 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. All
measuring instruments shall be calibrated at specified intervals

A4.8 Measurement, Analysis and Improvement

Organization shall plan and implement the monitoring, analysis, and improvement processes
needed to demonstrate conformity of the product, conformity to QMS and for continuous
improvement. Organization must monitor and measure customer satisfaction to ensure that it
has met customer requirements. Organization shall conduct internal audits at planned
intervals to check whether QMS conforms to planned arrangements and it is effectively
implemented. Organization shall apply suitable methods for monitoring. Organization shall
ensure that product which does not conform to product requirements is identified and
controlled to prevent its unintended use or delivery. Organization shall also determine,
collect, and analyze appropriate data to demonstrate the suitability and effectiveness of the
QMS and to evaluate where continuous improvement of effectiveness of the QMS can be
made. Organization shall continuously 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. It shall also take action to eliminate the cause of
non-conformities in order to prevent recurrence.

A5 Documentation ISO 9000 documentation includes the following functions:

The quality policy is a formal statement from management, closely linked to the business and
marketing plan and to customer needs. The quality policy is understood and followed at all levels
and by all employees. Each employee needs measurable objectives to work Notes towards.
Decisions about the quality system are made based on recorded data and the system is regularly
audited and evaluated for conformance and effectiveness.

Records should show how and where raw materials and products were processed, to allow
products and problems to be traced to the source.

ISO 9000 documentation includes procedures to control quality documents in your company.
Everyone must have access to up-to-date documents and be aware of how to use them.
To maintain the quality system and produce conforming product, ISO 9000 documentation must
provide suitable infrastructure, resources, information, equipment, measuring and monitoring
devices, and environmental conditions.

You need to map out all key processes in your company; control them by monitoring,
measurement and analysis; and ensure that product quality objectives are met. If you can’t
monitor a process by measurement, then make sure the process is well enough defined that you
can make adjustments if the product does not meet user needs.

For each product your company makes, you need to establish quality objectives; plan processes;
and document and measure results to use as a tool for improvement. For each process, determine
what kind of procedural documentation is required (note: a “product” is hardware, software,
services, processed materials, or a combination of these).

You need to determine key points where each process requires monitoring and measurement, and
ensure that all monitoring and measuring devices are properly maintained and calibrated.

You need to have clear requirements for purchased product.

You need to determine customer requirements and create systems for communicating with
customers about product information, inquiries, contracts, orders, feedback and complaints.

When developing new products, you need to plan the stages of development, with appropriate
testing at each stage. You need to test and document whether the product meets design
requirements, regulatory requirements and user needs.

A6 Implementation:

The steps involved in implementing ISO 9001: 2000 are explained below:

1. Top Management Commitment: The first and most important requirement for implementing
ISO 9000 is full commitment from top management. CEO and Board of Directors must be
committed to provide all the necessary resources for successful implementation.

2. Appointment of Management Representative: Top management must appoint a management

representative to coordinate the implementation and maintenance of QMS.

3. Awareness Building: All members of the organization must have awareness about QMS and its
potential benefits. This can be achieved through awareness building training programs.

4. Appointing an Implementation Team: After building awareness among the employees about
ISO 9000, an implementation team should be constituted. The team shall be drawn from all the
levels and all functional areas.

5. Training: The implementation team, supervisors, and an internal audit team shall undergo
necessary training outside the organization about ISO 9000 and later these employees can conduct
in-house training.

6. Time Schedule: There must be a definite time schedule for implementation and registration for
ISO 9000. Hence organization must define deadlines for different stages of implementation.
7. Select Element Owners: Each system element must have an owner and each owner can select a
team to assist in the process.

8. Reviewing the Present System: A thorough is needed on the current quality system in place.
This can help in conducting gap analysis.

9. Writing the Documents: This step involves preparation of documents like quality manual and
procedure manuals. Documentation process shall involve all the employees related to the task
concerned.

10. Installing the New System: Once a quality manual is prepared and standard procedures are
laid down, they must be integrated into day-to-day works of the organization.

11. Internal Audit: An internal audit shall be conducted for the new quality system. This ensures
that new system is working effectively.

12. Management Review: Management review is used to determine effectiveness of the system in
achieving the stated quality goals. Any revisions if required can be incorporated based on review.
13. Pre-assessment: Pre-assessment can be carried out to ensure that organization is ready for
registration.

14. Registration: This is the last step in implementation and it involves submitting an application
to registration. Registrar’s office shall conduct an audit and if these auditors are satisfied then
certification is issued

A6.1 Internal Audit :

Internal audit is the most important requirement for successful implementation of ISO 9001. After
the organization has established its quality polices, procedures and they are put into practice,
checks must be made to ensure that they are being strictly followed and yielding the expected
results. This is achieved through an internal audit conducted by a team of trained auditors.
Internal helps in determining actual performance and its conformance to QMS, helps in taking
any corrective actions, follow up actions for any previous non-conformances, and provide
opportunity for continuous improvement