What is Quality?

Quality is the customer’s perception of how a good or service is fit for their purpose and how it
satisfies stated and implicit specifications.

Quality in an organization is best achieved by Management creating a Quality Management System

(QMS). A QMS is a formalized system that documents the company structure, management and
employee responsibilities, and the procedures required to deliver a quality product or service. Four
quality tools should be utilized when creating a QMS: Quality Manual, Standard Operating
Procedures (SOPs), work instructions and supporting documentation as flowcharts and quality
records. All four tools must be consistent, coherent and work together to increase the perceived
value of the good or service.

How do I manage Quality?

Quality Management is effectively managing your company QMS to achieve maximum customer
satisfaction at the lowest overall cost. Quality Management (QM) is a continuous process that
requires inputs of time, effort and commitment from all company resources.

Eight QM principles form the foundation for effective quality management:

1. Customer Focus - Understand your customer’s needs. Measure customer satisfaction.

Strive to exceed their expectations.
2. Leadership - Management establishes the strategy and leads the company toward
achieving its objectives. Management creates an environment that encourages staff to
continuously improve and work towards satisfying the customer.

3. People Involvement - Train your staff effectively. Teamwork and full employee
involvement makes quality a reality.

4. Continuous Improvement - Continue to make things better.

5. Process Approach - Understand and organize company resources and activities to

optimize how the organization operates.

6. Factual Approach to Decision Making - Make decisions based on the facts. Data must
be gathered, analyzed and assessed against the objectives.

7. System Approach to Management - Determine sequence and interaction of processes

and manage them as a system. Processes must meet customer requirements.

8. Mutually Beneficial Supplier Relationships - Work with your suppliers to produce a

win-win outcome.

9. What is ISO?
10. ISO or the International Organization for Standardization is a non-governmental
organization that was established in 1947. ISO includes a network of 180 national
standards bodies (as of 12/11) from the world’s leading industrial nations. One of the main
goals of ISO is to develop worldwide standardization by promoting adoption of
international quality standards. By doing so, barriers of trade are eliminated.
11. ISO has created 19,023 internal standards as of 12/11 in a variety of industries. Examples
of standards ISO has created include the standardized codes for country names, currencies
and languages, standardized format of worldwide telephone and banking cards, as well as
sizes and colors of road signs, and automobile bumper heights.
12. ISO includes 3,368 technical working bodies, in which some 50,000 experts from industry,
labor, government, and standardization bodies in all parts of the world develop and revise
standards. ISO has created standards for the automotive, manufacturing, mechanics,
packaging, and health care fields amongst many others.
13. Standards can be broadly sub-divided into three categories, namely product, process, and
management standards. The first refers to characteristics related to quality and safety for
 example. Process standards refer to the conditions under which products and services are
to be produced, packaged or refined. Management system standards assist organization to
manage their operations. They are often used to help create a framework that then allows
the organization to consistently achieve the requirements that are set out in product and
process standards.

What is the ISO Process Approach?

The ISO standards are structured around the Process Approach concept. Two of the eight quality
management principles are key to understanding this principle:

 Process Approach - Understand and organize company resources and activities to

optimize how the organization operates.
 System Approach to Management - Determine sequence and interaction of processes
and manage them as a system. Processes must meet customer requirements.

Therefore, when company resources and activities are optimally organized, and managed as a
system, the desired result is achieved more efficiently.

In order to effectively manage and improve your processes, use the Plan-Do-Check-Act or PDCA
cycle as a guide. First, you Plan by defining your key processes and establishing quality standards
for those processes. Next, you Do by implementing the plan. Thirdly, you Check by using
measurements to assess compliance with your plan, and finally, you Act by continuously improving
your product performance.

What are the Elements of a Quality Management System?

ISO standards are documented rules and guidelines for implementing a quality system into your
company. Specific technical specifications and/or other specific criteria may also be included
depending on the standard you select.

The ISO 9001 standard is a model of a quality system, describing the processes and resources
required for registration of a company's quality system. This ISO System diagram shows the
management system and processes that are part of the ISO quality management standard. A brief
summary of the key requirements is detailed below.

 QMS - Document processes necessary to ensure product or service is of high quality and
conforms to customer requirements.
 Management Responsibility - Provide a vision. Show commitment. Focus on the
customer. Define policy. Keep everyone informed.

 Resource Management - Assign the right person to the job. Create and maintain positive
workspace.

 Product Realization - Clearly understand customer, product, legal and design

requirements. Ensure specifications are followed. Check your suppliers.

 Measurement, Analysis & Improvement - Identify current and potential problems.

Monitor and measure customer satisfaction. Perform internal audits. Fix problems.

Why Implement a Quality Management System?

Implementing QMS in your company is a management decision that requires consideration of your
organization’s operations, strategy, staff and, most importantly, your customers.

ISO standards are now readily being applied by organizations in industries ranging from
manufacturers and labs to auto suppliers and pharmaceuticals. In many instances, the choice to
implement an ISO standard into a company is not only the result of a company seeking to improve
quality, efficiency, and profitability, but also as a result of ISO implementation being:

 Required by your Customers, especially internationally-focused businesses

 Required by overseas regulatory bodies for suppliers of quality-sensitive products, e.g.
medical devices

 Necessary to maintain market presence and a competitive advantage

For whatever reason your company decides to pursue or update its ISO certification, you need to
consider the benefits and costs involved with this process.

ISO Benefits

ISO standards are a guide that can help transform your company’s quality system into an effective
system that meets and exceeds customer expectations. Your company will start to realize these
benefits as you implement and adhere to the quality standards, and you will see the internal and
external benefits accrue over time.

Internally, processes will be aligned with customer expectations and company goals, therefore
forming a more organized operating environment for your management and employees. Product
and service quality will improve which decreases defects and waste. Process improvements will
help to motivate employees and increase staff involvement. Products and services will be
continually improved. All of these internal benefits will continually drive better financial results,
hence creating more value for your business.

As for the external benefits, ISO certification shows your customers and suppliers worldwide that
your company desires their confidence, satisfaction and continued business. Your company also
has the opportunity to increase its competitive advantage, retain and build its customer list, and
more easily respond to market opportunities around the world.

ISO Costs

Although the costs of implementation can be offset with increased sales, reduced defects and
improved productivity throughout the organization, the investment of implementing and
maintaining an ISO quality system needs to be considered.

Many factors should be considered when calculating your company’s ISO implementation costs.
The time, effort and money your organization puts into ISO registration depends on the number of
employees, locations, the ISO standard selected for registration and the current state of your
quality system and processes. Typical costs include:

 Management and employee time and effort

 Upgrading and creating documentation

 Training employees

 Registration fees

 Maintenance

As with implementation of any new tool, the key to minimizing costs is to arm yourself with
knowledge about the process, and then to design a sensible plan that has realistic objectives,
adequate resources and a practical time schedule. Having a leader or consultant to guide you
through the process and manage deadlines can also help you to control costs and achieve your
goals more quickly. In addition, if you have multiple locations or departments, costs can be
minimized by leveraging the information you learn and the resources you use as you move
through the implementation and maintenance process.