Quality Management Systems Guide
Quality Management Systems Guide
Risk, Software,
Quality and an
overview of
the proposed
Management changes to
ISO9001to be
released
Systems September
2015
Guide
Guiding your organization to excellence in all the
dimensions important to your business and customers
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Quality Management Systems
Guide
1. INTRODUCTION
Many challenges confront companies that are involved in the product/services delivery
industry. Periods of tremendous growth may be interrupted by economic downturn. Capital
assets are aging and costs to maintain and replace them are increasing. Changing workforce
demographics and the availability of resources are affecting the planning and execution of
certain projects.
Furthermore, quality management practices once thought to be valuable may have lost some
of their effectiveness. Therefore, an understanding of what constitutes a modern Quality
Management System (QMS) is not only required, it is essential.
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2. HOW DID IT ALL START?
From the time the ISO series of quality management standards were released in 1987, there
have been concerns that certification of a Quality Management System did not necessarily
assure stakeholders that conforming products or services would be delivered to the customer
on time. To a large extent these concerns continue today. In 1995 QS-9000 was introduced
with the thought that things would get better. This was followed by other sector-specific
standards, TL 9000 for Telecommunications, AS9100 for Aerospace, and ISO/TS 16949
replaced QS-9000. All of these had the common goal of delivering high quality products or
services on time, thereby achieving customer satisfaction. What many organizations miss or
do not understand is how they can realize true value from their certification.
Quality leadership from a national perspective has changed over the past five to six decades.
After the Second World War, Japan decided to make quality improvement a national
imperative as part of rebuilding their economy, and sought the help
of Shewhart, Deming and Juran, amongst others.
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These 14 points include key concepts such as:
Philip Crosby, the Guru of Quality Management, was a legend in the discipline of quality. A
noted quality professional, consultant, and author, he is widely recognized for promoting the
concept of "zero defects" and for defining quality as conformance to requirements.
Some of his concepts that set the stage for the current ISO family of standards include quality
as conformity to certain specifications set forth by management and not some vague concept
of "goodness." These specifications are not arbitrary either; they must be set according to
customer needs and wants.
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Quality management is not just a activity for the Quality Management department, it is a
philosophy embraced by everyone in an organization, championed by Executive management
and steered by the Quality Management Department.
Quality management systems have come a long way. The earliest systems emphasized
predictable outcomes of an industrial product production line, using simple statistics and
random sampling.
However, by the 20th century, labor inputs were typically the most costly inputs in most
industrialized societies, so the focus shifted to team cooperation and the dynamic forces at
work, especially the early signaling of problems via a continuous improvement cycle.
And now, in the 21st century, QMS tends to converge with sustainability and transparency
initiatives, as both investor and customer satisfaction and perceived quality are increasingly
tied to these factors.
1. Consensus: The views of all interests are taken into account: manufacturers, vendors
and users, consumer groups, testing laboratories, governments, engineering
professions and research organizations etc.
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2. Industry-wide: Global solutions to satisfy industries and customers worldwide.
Standards are revised periodically to remain relevant and current with advancements in
technology and global business conditions.
The focus of the ISO International Standards is to make sure that products and services are
safe, reliable and of good quality. In the business environment these standards are strategic
tools that help to reduce costs by minimizing waste and errors and increasing productivity. It
helps companies to access new markets, level the playing field for developing countries and
facilitate free and fair global trade.
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The key principles in developing a new standard are:
ISO has a number of management system standards, each focusing on different issues
affecting global business.
ISO 50001
– Energy Management
ISO 9001
– Quality Management
ISO 14000
– Environmental Management
ISO 22000
– Food Safety Management
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Our customers: We provide our customers with the best service possible based
on the understanding that we need their long-term loyalty and
support to flourish.
Our people: We treat our people with dignity and respect and are committed
to help them reach their full potential through development and
training. We also encourage them to participate in decisions that
influence their daily working lives.
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7. IMPLEMENTING YOUR QUALITY
MANAGEMENT SYSTEM
Employees
Suppliers
Shareholders
Society
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8. CORE STANDARDS
There are five sections in the standard that specify activities that need to be considered when
your organization implements a Quality Management System. The combined key factors are:
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9. RISK MANAGEMENT IN YOUR
ORGANIZATION
Risk management has become more and more critical in today’s business environment. You
can no longer count on taking measures to correct a problem after it happens. In today’s
instant information technology world the damage to your company’s reputation as a supplier of
quality products or services can be damaged beyond repair before you can take corrective
action. What can you do to reduce this potential? Risk Management Planning!
Risk Management process begins with identifying, assessing and prioritizing potential risks.
The next step in the process is to take action to minimize or eliminate the impact of negative
events.
Examples of common types of risk that management can control the impact of are:
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There are as many ways to eliminate or mitigate risk as there are risk factors. Here are 4 main
approaches:
Every company should implement a risk management plan, it is the responsible path to take in
maintaining a successful organization that protects its people, financial integrity and physical
assets.
Today’s electronic environment allows for all Quality Management System Documents, forms,
logs and records to be located in one place accessible by all who need them with no risk of
obsolete documents being used in the workplace.
You can link documents to their associated forms and logs, significantly increasing efficiency,
enhancing productivity and effectiveness of your Quality Management System.
Isocert SE is an example of QMS software – follow this link for a free Sample.
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11. THE EIGHT PRINCIPLES OF QUALITY
MANAGEMENT
Since Quality Management is becoming increasingly important to the leadership and
management of all organizations it is necessary for us to identify Quality Management as a
distinctive discipline of management and lay down universally understood and accepted rules
for this discipline.
The ISO technical committee working on the ISO 9000 standards had published a document
detailing the quality management principles and application guidelines and defines a Quality
Management Principle as follows:
Principle 2 - Leadership
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PRINCIPLE 1: CUSTOMER FOCUS
Organizations depend on their customers and therefore should understand current and future
customer needs, should meet customer requirements and strive to exceed customer
expectations.
i. Understand your customers’ needs and expectations for products, delivery, price,
dependability, etc.
ii. Ensure a balanced approach among customers and other stake holders (owners,
partners, people, suppliers, local communities and society at large) needs and
expectations.
iii. Communicate these needs and expectations throughout the organization.
iv. Measure customer satisfaction and act on results.
v. Manage customer relationships.
Key benefits:
Increased revenue and market share obtained through flexible and fast responses to
market opportunities.
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PRINCIPLE 2: LEADERSHIP
Leaders establish unity of purpose and direction of the organization. They should create and
maintain the internal environment in which people can become fully involved in achieving the
organization's objectives.
Key benefits:
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PRINCIPLE 3: INVOLVEMENT OF PEOPLE
People at all levels are the essence of an organization and their full involvement enables their
abilities to be used for the organization's benefit.
Key benefits:
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PRINCIPLE 4: PROCESS APPROACH
A desired result is achieved more efficiently when activities and related resources are
managed as a process.
ii. Identify and measure the inputs and outputs of the process.
iii. Identify the interfaces of the process with the functions of the organization.
v. Establish clear responsibility, authority, and accountability for managing the process.
vi. Identify internal and external customers, suppliers and other stake holders of the
process, and
vii. When designing processes, consider process steps, activities, flows, control
measures, training needs, equipment, methods, information, materials and other
resources to achieve the desired result.
Key benefits:
Lower costs and shorter cycle times through effective use of resources.
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PRINCIPLE 5: SYSTEM APPROACH TO MANAGEMENT
i. Define the system by identifying or developing the processes that affect a given
objective.
ii. Structure the system to achieve the objective in the most efficient way.
iv. Continually improve the system through measurement and evaluation, and
v. Estimate the resource requirements and establish resource constraints prior to action.
Key benefits:
Identifies all of the steps required to conduct business and meet the customer’s
requirements.
Provides an effective and efficient means of achieving the companies’ goals while
providing a better understanding to the employees of how to achieve common objectives.
ii. Apply the basic improvement concepts of incremental improvement and breakthrough
improvement.
iii. Use periodic assessments against established criteria of excellence to identify areas
for potential improvement.
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v. Promote prevention based activities.
vi. Provide every member of the organization with appropriate education and training, on
the methods and tools of continual improvement such as the Plan-Do-Check-Act cycle,
problem solving, process re-engineering, and process innovation.
Key benefits:
Performance advantage
through improved
organizational capabilities.
Alignment of improvement
activities at all levels to an
organization's strategic intent.
The Factual approach to decision making principle simply states that "Effective decisions are
based on the analysis of data and information."
The key steps in applying the Factual Approach to Decision Making are:
i. Take measurements and collect data and information relevant to the objective.
ii. Ensure that the data and information are sufficiently accurate, reliable and accessible.
v. Make decisions and take action based on the results of logical analysis balanced with
experience and intuition.
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Key benefits:
Informed decisions.
An increased ability to
demonstrate the effectiveness
of past decisions through
reference to factual records.
An organization and its suppliers are interdependent and a mutually beneficial relationship
enhances the ability of both to create value.
ii. Establish supplier relationships that balance short-term gains with long-term
considerations for the organization and society at large.
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Key benefits:
Increased ability to create value for both parties.
Flexibility and speed of joint responses to changing market or customer needs and
expectations.
Optimisation of costs and resources.
W. Edwards Deming, saw it as part of the 'system' whereby feedback from the process and
customer were evaluated against organizational goals. The fact that it can be called a
management process does not mean that it needs to be executed by 'management'; but
rather merely that it makes decisions about the implementation of the delivery process and the
design of the delivery process itself.
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The whole QMS is owner driven.
Act Plan
•How to improve •What to do?
next time? •How to do it?
Check Do
• Did things happen •Do what was
according to plan? planned
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13. THE AUDIT
A Quality Audit is the process of systematically examining the quality management system of
an organization and is usually carried out by an internal or external quality auditor or an audit
team.
Quality audits are typically performed at predefined time intervals and ensure that an
organization has clearly defined internal system monitoring procedures linked to effective
action - audits examine a Quality Management System for correct implementation and
adequacy. This can help determine if the organization complies with the defined quality
system processes and can involve procedural or results-based assessment criteria.
For the benefit of the organization, quality auditing should not only report non-conformances
and corrective actions, but also highlight areas of good practice. In this way other departments
may share information and amend their working practices as a result, also contributing to
continual improvement.
1. Preparation – assign auditors, agree on audit program, gather and review all
documentation and develop a checklist.
2. Performance – open meeting, conduct audit, audit team meeting and closing of the
meeting.
3. Reporting – within fourteen days of the completion of an audit, an audit report should be
completed and issued to the auditee.
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14. THE CERTIFICATION
“ISO does not certify organizations itself. Numerous certification bodies exist, which audit
organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly
referred to as "ISO 9000" certification, the actual standard to which an organization's quality
management system can be certified is ISO 9001:2008. Many countries have
formed accreditation bodies to authorize ("accredit") the certification bodies. Both the
accreditation bodies and the certification bodies charge fees for their services. The various
accreditation bodies have mutual agreements with each other to ensure that certificates
issued by one of the Accredited Certification Bodies (CB) are accepted worldwide.
Certification bodies themselves operate under another quality standard, ISO/IEC 17021,] while
accreditation bodies operate under ISO/IEC 17011.”
1. System Certification
2. Product/Service Certification
3. Consignment Inspection
ISO/TC 176 monitors the use of the standards to determine how they can be improved to
meet user needs and expectations when the next revisions are due. They comprise of experts
from businesses and other organizations around the world. All ISO standards are reviewed
regularly for relevancy; changes are made when there is an established need to improve the
standard.
Based on input from the user community, ISO/TC 176 continues to evaluate and adopt new
concepts in the field of quality management for incorporation into ISO standards. This can
include specialised segment initiatives and supporting documents within the ISO family of
standards. Most ISO technical committees recognize the structure of ISO 9001 when new
management systems standards are developed for other or specific purposes.
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ISO9001:2015 WHAT IS COMING?
While the revision to the ISO Quality Standard is still out for comment and will not be
published until 2015 it is possible to see from the committee draft the direction the standard is
going.
The exclusions clause has been omitted due to the fact the committee is expressing
the requirements differently than in past revisions making the exclusions clause
redundant.
ISO 9001 is seeking to become more generic and applicable to companies providing
any type of product and greater acceptance in the area of service providers’ service.
To accomplish this the use of “goods and services” is replacing “product”
ISO 9001 specifies requirements “essential to the adoption of the process approach”
now required in clause 4.4
ISO 9001 is changing its high level structure to bring all Management System
standards into harmony, where in the past the basic structure of each standard differed
from the next causing confusion and difficulties for organizations and assessors alike.
Preventive Action is no longer in the standard but Risk Management has been added
to section 6 - Planning.
A “Revised QMS Guide” will be made available as soon as the new ISO Standards are made
available in 2015.
16. SUMMARY
ISO’s pledge to sustaining the ISO 9001 momentum through reviews, improvement and
streamlining of the standards guarantees that an organization’s confidence and involvement in
ISO 9001 today will continue to provide effective management solutions well into the future.
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Author: Tim Landerville, CEO Isocert Solutions LLC
Isocert Solutions was founded in 1990 in Sonoma County California by partner Tim
Landerville, Certified Lead Auditor, and has grown steadily since its inception. It maintains its
corporate office in Santa Rosa, California and others throughout the United States.
The company specializes in Enterprise-class software that is made for scalability, high
performance, quality management and robustness. Their software provides businesses with
logic support functionality, enabling enterprises to improve product quality, services and
productivity while providing efficiency gains. For more information please
see: http://isocertsolutions.com/ or call (707) 570-5669 to discuss how to become ISO 9001
certified.
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