Module 2: Quality Systems
Imandi Aparna Devi
WHAT IS A QUALITY MANAGEMENT SYSTEM?
A quality management system (QMS) is a formalized system that defines and documents an
organization’s processes, procedures, and responsibilities for achieving quality policies,
practices, and objectives. It helps an organization coordinate and direct its activities to meet
customer and regulatory requirements, as well as continuously improve its effectiveness and
efficiency.
WHAT ARE THE BENEFITS OF A QMS?
Meeting customer requirements, which helps instill confidence in the organization, in turn leading to more customers, sales,
and repeat business
Meeting the organization's requirements, which ensures compliance with applicable regulations and provides products and
services in the most cost and resource-efficient manner, creating room for expansion, growth, and profit
These benefits offer additional advantages, including:
● Defining, improving, and controlling processes
● Reducing waste
● Preventing mistakes
● Lowering costs
● Facilitating and identifying training opportunities
● Engaging staff
● Setting organization wide direction
● Communicating a readiness to produce consistent results
WHAT ARE SOME QMS FRAMEWORKS?
Several frameworks exist to guide QMS development, including
● ISO 9001
● ISO 9000 series
● ISO 14000 series (environmental management systems)
● ISO 13485 (quality management systems for medical devices)
● ISO 19011 (auditing management systems)
● IATF 16949 (quality management systems for automotive-related products)
● AS 9100 (quality management systems for aviation, space, and defense)
Furthermore, several industries also have developed standards, built upon ISO 9001, that offer
specific direction regarding additional expectations that are uniquely associated with their
operations.
ISO 9001 is the most recognized and implemented quality management system standard in the
world. ISO 9001 specifies the requirements for a QMS that organizations can use to develop
their own programs.
WHAT ARE SOME QMS FRAMEWORKS?
The standard is structured around seven quality management principles.
Quality management principles are the guiding beliefs that, when used for organizational decision-
making, ensure long-term success from the perspective of customers, employees, and other
stakeholders.
The quality management principles demonstrate the depth of the organization’s commitment to
quality.
Well-formulated principles should be timeless, not dependent on temporary circumstances.
The ISO 9001:2015 principles are:
1. Customer focus
2. Leadership
3. Engagement of people
4. Process approach
5. Continuous improvement
6. Evidence-based decision making
7. Relationship management
ELEMENTS AND REQUIREMENTS OF A QMS
Each element of a QMS helps achieve the overall goal of meeting customer and
organizational requirements. A QMS should address an organization’s unique needs, but
many of the QMS systems have common expectations, including:
● Leadership
● Planning, commitment, and review
● The system spans the breadth of the organization
● Metrics and feedback
● Communication, education, and training
● Risk management
● Teamwork
● Compliance to requirements
● Continuous improvement
IMPLEMENTATION OF QMS
Every organization has its own culture, which influences which QMS methods are most efficient and effective.
Instead of developing a QMS by addressing each expectation described in a selected model, organizations should
outline the approaches currently in use for managing quality and meeting customer expectations.
A basic model for gathering customer expectations can be structured in the following four steps: plan your customer
data system, gather customer data, understand the data, and deploy (make use of) the data.
Next, map those approaches against the appropriate QMS framework or model. For each identified gap, the
organization should determine whether it would benefit from addressing the opportunity, and must clearly
understand the potential benefit before implementing any changes.
The QMS design should be influenced by the organization’s objectives, needs, products, and services. This structure
is based largely on the plan-do-check-act cycle and allows for continuous improvement to the product and QMS.
The basic steps to implementing a QMS are:
1. Design
2. Build
3. Deploy
4. Control
5. Measure
6. Review
7. Improve
QMS development, establishment, implementation, and monitoring should be accomplished under
the approach of applying the Juran Trilogy. The Juran Trilogy focuses on the three critical
processes of quality management—namely quality planning, quality control, and quality
improvement. By taking this approach, organizations can maximize their potential to operate in the
most strategic, efficient, and effective manner possible.
IMS
To manage quality and overall business performance, a company needs an integrated
management system (IMS), the structure of which is linked to actual business processes and
documentation systems.
An Integrated Management System (or “IMS”) can benefit your organization through
increased efficiency and effectiveness, and cost reductions while minimizing the disruption
caused by several external audits. It also shows your commitment to increased
performance, employee and customer satisfaction, and continuous improvement.
With an integrated management system, your management systems work together, with
each function aligned behind a single goal: improving the performance of the entire
organization. Instead of silos, you have a coordinated effort which is greater than the sum of
its parts and is not only more efficient but more effective. An integrated system provides a
clear, uniform image of your entire organization, how they impact each other, and the
associated risks. Efficiency is gained from less duplication, and it becomes easier to adopt
new systems in the future.
In Other Words
An integrated management system (IMS) is a management system, which integrates all
relevant components of a business into one coherent system so as to enable the
optimal achievement of its business objectives.
The integrated approach requires combining all the internal business management
practices into one system.
For the different systems to be properly integrated, rather than simply being separate
systems joined together, there have to be effective linkages so that the boundaries
between processes are seamless.
The fundamental components of the system include the organisation, resources and
processes. Therefore, people, equipment and business culture are part of the system
as well as the documented policies and practices.
What can be integrated?
Any system, which is required by the effective running of a business, can
be integrated either totally or partially under a unified management
structure. In essence any system, which has an impact on overall
business performance should be part of the integrated management
system.
Benefits of an IMS
1. Improving Performance
2. Eliminating Redundancies
3. Accountability
4. Establishing Consistency
5. Reducing Bureaucracy
6. Cost Reduction
7. Optimize Processes and Resources
8. Reducing Maintenance
9. Integrated Audits
10. Facilitating Decision Making
To ensure this is done effectively, the steps listed below should be
followed:
● Define the Business Model and Primary Functions
● Analyse business processes using flow charts, standards and
failure mode analysis techniques
● Formulate operational policies which will govern the processes
and their inter-linkages
● Develop internal business procedures to control each business
process which define who does what and where, when and how
● Implement the new and improved practices, if required
● Identify optimum documentation needs by linkage to the control
procedures
● Document the system
How should systems be integrated?
There are several approaches, which can be taken, depending on an
organisation's current position. However, all systems should eventually share the
following processes:
● Management review
● Document development and control
● Monitoring, analysis and review
● Internal audit
● Training
● Continual improvement (Corrective and Preventive Actions)
What is required to ensure effective integrated management systems?
To ensure effective systems, the following functions must be performed:
Risk Assessment- this should address customer perceptions, health & safety risks, environmental
concerns & impacts and process failure modes. By having a common approach it will be easier to
compare risks occurring in different parts of the business.
Norms & Regulations Management - to capture norms and regulations with respect to product
specifications, environment and health & safety and their impacts on the business.
Continual Improvement Management - this should focus on specific improvement programmes related
to quality, health & safety and environment.
Stakeholders Awareness - this should address needs of both customers, staff and general public with
respect to quality, health & safety and environment
What is the best approach to take?
Whether an organisation has an existing formal system or not, it is best to adopt the business process
approach to management system development. The benefits are that one coherent system can be
built which serves business needs and does not tie the organisation to a particular standard. The
standards are used to assist identify tasks and processes. This approach starts by looking at the
business as a whole and establishing its objectives, mission and core processes which deliver the
objectives and achieve this mission.
What types of systems can be integrated?
All systems relevant to the business, whether certifiable or otherwise, can be
included. These could include: Quality (ISO 9001); Environment (ISO 14001);
Occupational Health & Safety (ISO 45001 & BS 8800); Food Safety & Hazard
Analysis Critical Control Points (HACCP); Ethical Trading Practices (SA
8000); Social & Ethical Accounting, Auditing and Reporting (AA 1000);
Investor in People (IIP); Law Society Practice Management Standard
(LEXCEL), European Directives and CE Markings; Information Security (BS
7799); Quality System Requirements for Automotive Industry Suppliers
(ISO/TS 16949 & QS 9000); Quality System Requirements for
Telecommunications Industry Suppliers (TL 9000); and Business Excellence
Model (BEM).
Why should management systems be integrated?
Integration is designed to:
● Ensure focus on business goals & objectives
● Harmonise and optimise practices
● Reduce risks to the business and increase profitability
● Balance conflicting objectives
● Eliminate conflicting responsibilities and relationships
● Create consistency
● Reduce duplication and therefore costs
● Improve communications
● Facilitate training and development
BENCHMARKING