iso9000
DESCRIPTION
ManufacturingTRANSCRIPT
1.0 DEFINITION
ASQ (n.d.) define ISO 9000 series standards as a set of international standards on quality management
and assurance. The ISO 9000 series standards were developed to help companies effectively
document the quality system elements to be implemented to maintain an efficient quality system.
They are not limited to any of the industries and is applicable to all the industries. Hoyle (2009) define
ISO 9000 is set of interrelated ideas, principles and rules ad could therefore be considered as a system
like referring to the metric system or the imperial system of measurement.
The importance of ISO 9000 is the importance of quality. Many companies offer products and
services, but it is those companies who put out the best products and services efficiently that succeed.
With ISO 9000, an organization can identify the root of the problem, and therefore find a solution. By
improving efficiency, profit can be maximized.
As a broad range of companies implement the ISO 9000 standards, a supply chain with
integrity is created. Each company that participates in the process of developing, manufacturing, and
marketing a product knows that it is part of an internationally known, reliable system. Not only do
businesses recognize the importance of the ISO 9000, but also the customer realizes the importance of
quality. And because the consumer is most important to a company, ISO 9000 makes the customer its
focus.
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2.0 QUALITY MANAGEMENT PRINCIPLE
ISO states that there are 8 quality management principle in ISO 9000 series. The 8 principles are
customer focus, leadership, involvement of people, process approach, system approach to
management, continual improvement, factual approach to decision making, and mutually beneficial
supplier relationships. These principles can be used as a framework by senior management to guide
their organizations towards improved performance. The principles are derived from the collective
experience and knowledge of the international experts who participate in ISO Technical Committee
ISO/TC 176, Quality management and quality assurance, which is responsible for developing and
maintaining the ISO 9000 standards (ISO, 2012).
2.1 Principle 1 – Customer focus
The general definition for Principle 1 is organizations depend on their customers and therefore should
understand current and future customer needs, should meet customer requirements and strive to
exceed customer expectations (ISO, 2012).
The benefits of that can get is to increase revenue and market share obtained through flexible
and fast responses to market opportunities, increased effectiveness in the use of the organization’s
resources to enhance customer satisfaction and improved customer loyalty leading to repeat business
(ISO, 2012).
The steps that can be done to carry out this principle are researching and understanding
customer needs and expectations, ensuring that the objectives of the organization are linked to
customer needs and expectations, communicating customer needs and expectations throughout the
organization, measuring customer satisfaction and acting on the results, systematically managing
customer relationships, and ensuring a balanced approach between satisfying customers and other
interested parties (such as owners, employees, suppliers, financiers, local communities and society as
a whole) (ISO, 2012).
2.2 Principle 2 – Leadership
The general statement for Principle 2 is leaders establish unity of purpose and direction of the
organization and they should create and maintain the internal environment in which people can
become fully involved in achieving the organization’s objectives (ISO, 2012).
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The benefits that can obtained are people will understand and be motivated towards the
organization’s goals and objectives, activities are evaluated, aligned and implemented in a unified
way and miscommunication between levels of an organization will be minimized (ISO, 2012).
The steps that can used to achieve Principle 2 are considering the needs of all interested
parties including customers, owners, employees, suppliers, financiers, local communities and society
as a whole (ISO, 2012). Besides, establishing a clear vision of the organization’s future and setting
challenging goals and targets (ISO, 2012). In between, creating and sustaining shared values, fairness
and ethical role models at all levels of the organization. Other than that, establishing trust and
eliminating fear, providing people with the required resources, training and freedom to act with
responsibility and accountability, inspiring, and lastly is encouraging and recognizing people’s
contributions (ISO, 2012).
2.3 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 (ISO, 2012).
The benefits for involvement of people is to get motivated, committed and involved people
within the organization (ISO, 2012). Hence, innovation and creativity in furthering the organization’s
objectives. People also being accountable for their own performance and eager to participate in and
contribute to continual improvement (ISO, 2012).
For applying Principle 3, people need to understand the importance of their contribution and
role in the organization, identify constraints to their performance, and accept ownership of problems
and their responsibility for solving them (ISO, 2012). Besides, people have to evaluate their
performance against their personal goals and objectives, actively seeking opportunities to enhance
their competence, knowledge and experience. People are also free to share knowledge and experience
and openly discuss the problems and issues (ISO, 2012).
2.4 Principle 4 – Process approach
Process approach means a desired result is achieved more efficiently when activities and related
resources are managed as a process (ISO, 2012).
The benefits is to lower costs and shorter cycle times through effective use of resources,
improved, consistent and predictable results, and focused and prioritized improvement opportunities
(ISO, 2012).
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To achieve principle 4, systematically defining the activities necessary to obtain a desired
result, establishing clear responsibility and accountability for managing key activities, analysing and
measuring of the capability of key activities, and identifying the interfaces of key activities within and
between the functions of the organization are require (ISO, 2012). Focusing on the factors – such as
resources, methods, and materials that will also improve key activities of the organization. Evaluating
risks, consequences and impacts of activities on customers, suppliers and other interested parties
(ISO, 2012).
2.5 Principle 5 – System approach to management
System approach to management is to identify, understand and manage interrelated processes as a
system contributes to the organization’s effectiveness and efficiency in achieving its objectives(ISO,
2012).
The benefits of system approach to management are integration and alignment of the
processes that will best achieve the desired results, ability to focus effort on the key processes, and
providing confidence to interested parties as to the consistency, effectiveness and efficiency of the
organization (ISO, 2012).
In order to achieve this goal, it is necessarily to structure a system to achieve the
organization’s objectives in the most effective and efficient way (ISO, 2012). Besides, understanding
the interdependencies between the processes of the system, structured approaches that harmonize and
integrate processes, providing a better understanding of the roles and responsibilities necessary for
achieving common objectives and thereby reducing cross-functional barriers, understanding
organizational capabilities and establishing resource constraints prior to action, targeting and defining
how specific activities within a system should operate and lastly continually improving the system
through measurement and evaluation (ISO, 2012).
2.6 Principle 6 – Continual improvement
Continual improvement of the organization’s overall performance should be a permanent objective of
the organization (ISO, 2012).
Continual improvement can has the performance advantage through improved organizational
capabilities, alignment of improvement activities at all levels to an organization’s strategic intent, and
flexibility to react quickly to opportunities (ISO, 2012).
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The steps to implement this principle are employing a consistent organization-wide approach
to continual improvement of the organization’s performance, providing people with training in the
methods and tools of continual improvement, making continual improvement of products, processes
and systems an objective for every individual in the organization, establishing goals to guide, and
measures to track, continual improvement, and recognizing and acknowledging improvements (ISO,
2012).
2.7 Principle 7 – Factual approach to decision making
Factual approach to decision making shows that effective decisions are based on the analysis of data
and information (ISO, 2012).
The benefits of factual approach to decision making is informed decisions, an increased
ability to demonstrate the effectiveness of past decisions through reference to factual records, and
increased ability to review, challenge and change opinions and decisions (ISO, 2012).
The steps to apply this principle are ensuring that data and information are sufficiently
accurate and reliable, making data accessible to those who need it, analysing data and information
using valid methods, and making decisions and taking action based on factual analysis, balanced with
experience and intuition (ISO, 2012).
2.8 Principle 8 – Mutually beneficial supplier relationships
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances
the ability of both to create value.
The benefits of this principle are increased ability to create value for both parties, flexibility
and speed of joint responses to changing, market or customer needs and expectations, and
optimization of costs and resources
Several steps can used to apply this principle: establishing relationships that balance short-
term gains with long-term considerations, pooling of expertise and resources with partners,
identifying and selecting key suppliers, clear and open communication, sharing information and future
plans, establishing joint development and improvement activities, and inspiring, encouraging and
recognizing improvements and achievements by suppliers.
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3.0 ISO 9000:2000 FAMILY
The ISO 9000 standards (Quality Management and Quality Assurance Standards) were first published
in 1987, revised for the first time in 1994, and revised for the second time in 2000. Standards are
reviewed every five years to ensure that they are current and satisfy the needs of users. The ISO 9000
+ 14000 News magazine enables the organization to keep abreast of information about standards (a
bimonthly publication which provides comprehensive coverage of international developments relating
to ISO’s management system standards, obtainable from ISO).
ISO 9000 is a starting point for understanding the standards, as it defines the fundamental
terms used in the ISO 9000 “family”, or set of standards relating to quality management. ISO 9001
specifies requirements for a quality management system whereby the ability can be demonstrated to
provide products that fulfil customer requirements as well as applicable regulatory requirements; it
also aims to enhance customer satisfaction. ISO 9004 provides you with guidance on continual
improvement of your quality management system so that the needs and expectations of all interested
parties are met. These interested parties include customers and end-users; directors and staff in the
organization; owners/ investors; suppliers and partners; and society at large.
The ISO 9000 series consists of four primary standards supported by several other documents.
The four primary standards are ISO 9000:2000, Quality management systems– Fundamentals and
vocabulary, ISO 9001:2000 Quality management systems – Requirements, ISO 9004:2000 Quality
management systems – Guidelines for performance improvements, and ISO/DIS 19011, Guidelines on
quality and/or environmental management systems auditing.
3.1 ISO 9000:2000, Quality management systems– Fundamentals and vocabulary
This standard describes the concepts of a quality management system (QMS) and defines the
fundamental terms used in the ISO 9000 family. The standard also includes the eight quality
management principles which were used to develop ISO 9001 and ISO 9004. This standard replaces
ISO 8402:1994 and ISO 9000-1:1994.
3.2 ISO 9001:2000, Quality management systems – Requirements
This standard specifies the requirements for a QMS, whereby an organization needs to assess and
demonstrate its ability to provide products that meet customer and applicable regulatory requirements,
and thereby enhance customer satisfaction (ISO, 2012). This standard replaces ISO 9001:1994, ISO
9002:1994 and ISO 9003:1994.
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3.3 ISO 9004:2000, Quality management systems – Guidelines for performance
Improvements
This standard provides guidance for continual improvement and can be used for performance
improvement of an organization. While ISO 9001 aims to give quality assurance to the manufacturing
processes for products and to enhance customer satisfaction, ISO 9004 takes in a broader perspective
of quality management and gives guidance for future improvement. This standard replaces ISO 9004-
1:1994. Guidelines for self-assessment have been included in Annex A of ISO 9004:2000. This annex
provides a simple, easy-to-use approach to determine the relative degree of maturity of an
organization’s QMS and to identify the main areas for improvement.
3.4 ISO/DIS 19011, Guidelines on quality and/or environmental management systems auditing
This future international standard, currently under development, provides guidance on conducting
internal or external quality and/or environmental management system audits to verify a system’s
ability to meet defined objectives. On its publication, anticipated for 2002, it will replace three
guidelines on auditing quality systems (ISO 10011-1, ISO 10011-2 and ISO 10011-3) and three
guidelines for auditing environmental management systems (ISO 14010, ISO 14011 and ISO 14012).
In addition to the above, the ISO 9000 family includes the following guidelines, technical reports
(TR) and technical specifications (TS):
ISO 10006:1997, Quality management–Guidelines to quality in project management
ISO 10007:1995, Quality management– Guidelines for configuration management
ISO 10012-1: 1992, Quality assurance requirements for measuring equipment –
Part 1: Metrological confirmation system for measuring equipment, and Part 2: Guidelines for control
of measuring processes
ISO/TR 10013:2001, Guidelines for quality management system documentation
ISO/TR 10014:1998, Guidelines for managing the economics of quality
ISO 10015:1999, Guidelines for training
ISO/TS 16949:1999, Quality systems –Automotive suppliers– Particular requirements for the
application of ISO 9001:1994
ISO /TR 10017:1999, Guidance on statistical techniques for ISO 9001:1994
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3.5 ISO 9001 and ISO 9004
ISO 9001 and ISO 9004 are a “consistent pair” of standards that relate modern quality management to
the processes and activities of an organization, and emphasize the promotion of continual
improvement and achievement of customer satisfaction. ISO 9001, which focuses on the effectiveness
of the quality management system in meeting customer requirements, is used for certification or for
contractual agreements between suppliers and buyers. On the other hand, ISO 9004 cannot be used for
certification as it does not prescribe requirements but provides guidance for the continual
improvement of an organization’s performance. ISO 9001 focuses on “effectiveness”, i.e. doing the
right things, whereas ISO 9004 emphasizes both “effectiveness” and “efficiency”, i.e. doing the right
thing in the right way.
8ISO 9002 and ISO 9003 were separate documents that were part of a series of standards for Quality
Management Systems, and were first introduced by the ISO organization (http://www.iso.org) in
1987. The standards gave requirements for creating a Quality Management System, often called a
QMS, based on documented procedures that defined separate areas of quality management. When
they were first introduced, a company would decide which of the standards they should be certified to:
ISO 9001 for design and production, ISO 9002 for production or ISO 9003 for inspection and testing,
depending on which type of industry the company was in or what the company did. Below is an
explanation of what the ISO 9002 & ISO 9003 standards were for, and what they included, but it is
important to know that a company can no longer be registered to either of these standards as of the
year 2000.
ISO 9002:1987, first published in 1987, described how to implement a Quality Management
System for the manufacture and delivery of products. There were 18 sections for which a documented
procedure needed to be written, and the mantra of the standard was “Document what you do, then do
what you document.” The standard was focused on industries that produced products rather than
service-based industries. However in 1987, ISO 9001 was identical to ISO 9002 with the addition of
requirements for design control and product service.
ISO 9003:1987, also released in 1987, provided requirements for a Quality Management
System exclusively for inspections and testing, and basically stripped away any requirements that
dealt with the manufacture or servicing of products. This standard was used almost exclusively by
warehouse and resale industries where the company itself did not manufacture the parts, but only
stocked and sold the product. These industries would be focused on ensuring that product they
purchased was properly inspected in order to meet the needs of customers they re-sold the product to.
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All three of the standards: ISO 9001, ISO 9002 & ISO 9003, were updated in 1994 with
minor changes, but the requirements were still focused on production-based industries. In 2000, ISO
9001 was updated from a “document everything” approach to a more process-based approach for
Quality Management Systems. This also made the standard more applicable to service-based
industries and added the ability of a company to exclude certain sections of the requirements, such as
design for companies that only build to customer design. By allowing the exclusions from some
requirements, the need for separate documents (ISO 9001, ISO 9002 & ISO 9003) was removed and
the ISO 9002 & ISO 9003 standards were rendered obsolete. From year 2000 onward, companies
could not have their Quality Management System certified to ISO 9002 or ISO 9003, and a company
could only certify an ISO 9001 Quality Management System.
3.7 Summary of ISO 9000:2000 Family
Table 3.1 simplifies the purpose for each standards of ISO 9000:2000 family.
Table 3.1: Summary of ISO 9000:2000 Family
Standards and guidelines Purpose
ISO 9000:2000, Quality management
systems - Fundamentals and vocabulary
Establishes a starting point for understanding the
standards and defines the fundamental terms and
definitions used in the ISO 9000 family which
required to avoid misunderstandings in their use.
ISO 9001:2000, Quality management
systems - Requirements
This is the requirement standard use assess the
ability to meet customer and applicable
regulatory requirements and thereby address
customer satisfaction. It is now the only
standard in the ISO 9000 family against which
third-party certification can be carried.
ISO 9004:2000, Quality management
systems - Guidelines for performance
improvements
This guideline standard provides guidance for
continual improvement of the quality
management system to benefit all parties
through sustained customer satisfaction.
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ISO 19011, Guidelines on Quality
and/or Environmental Management
Systems Auditing (currently under
development)
Provides the guidelines for verifying the
system's ability to achieve defined quality
objectives. This standard can be used internally
or for auditing the suppliers.
ISO 10005:1995, Quality management -
Guidelines for quality plans
Provides guidelines to assist in the preparation,
review, acceptance and revision of quality plans.
ISO 10006:1997, Quality management -
Guidelines to quality in project
management
Guidelines to help ensure the quality of both the
project processes and the project products.
ISO 10007:1995, Quality management -
Guidelines for configuration
management
Provides guidelines to ensure that a complex
product continues to function when components
are changed individually.
ISO/DIS 10012, Quality assurance
requirements for measuring equipment
- Part 1: Metrological confirmation
system for measuring equipment
Provides guidelines on the main features of a
calibration system to ensure that measurements
are made with the intended accuracy.
ISO 10012-2:1997, Quality assurance
for measuring equipment - Part
2: Guidelines for control of
measurement of processes
Provides supplementary guidance on the
application of statistical process control when
this is appropriate for achieving the objectives
of Part 1.
ISO 10013:1995, Guidelines for
developing quality manuals
Provides guidelines for the development, and
maintenance of quality manuals, tailored to your
specific needs.
ISO/TR 10014:1998, Guidelines for
managing the economics of quality
Provides guidance on how to achieve economic
benefits from the application of quality
management.
ISO 10015:1999, Quality management -
Guidelines for training
Provides guidance on the development,
implementation, maintenance and improvement
of strategies and systems for training that affects
the quality of products.
ISO/TS 16949:1999, Quality systems -
Automotive suppliers - Particular
requirements for the application of ISO
Sector specific guidance to the application of
ISO 9001 in the automotive industry.
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9001:1994
4.0 A BUSINESS MODEL OF A PROCESS-BASED QMS
ISO 9001 implement a model of a process based quality management system. However, the model
didn’t show a complete understanding and interactions to the organisations. Thus, a system model
called “reductionist thinking” is proposed by Hoyle (2009). These two process-based QMS models
are analysed and compared in the following.
4.1 Advantage of Process Approach
A major advantage of the process approach, when compared to other approaches, is in the
management and control of the interactions between these processes and the interfaces between the
functional hierarchies of the organization (ISO, 2008).
A process approach is also a powerful way of organizing and managing activities to create
value for the customer and other interested parties. Figure 4.2 shows an ISO 9001:2008 model of a
process based QMS.
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Figure 4.1: ISO 9001:2008 model of a process based QMS
Organizations are often structured into a hierarchy of functional units. Organizations are
usually managed vertically, with responsibility for the intended outputs being divided among
functional units. The end customer or other interested party is not always visible to all involved.
Consequently, problems that occur at the interface boundaries are often given less priority than the
short-term goals of the units. This leads to little or no improvement to the interested party, as actions
are usually focused on the functions, rather than on the intended output. The process approach
introduces horizontal management, crossing the barriers between different functional units and
unifying their focus to the main goals of the organization. It also improves the management of process
interface.
Figure 4.2: Example of a process sequence and its interactions
4.2 Implementing the Process Approach
Once the processes needed for the QMS and their sequences and interactions have been identified, it
is necessary to establish management responsibilities and accountabilities for the performance of
these processes. Many methodologies are available for managing and improving processes, but all
share some simple basic elements. A simple process management and improvement methodology
organized in a series of steps is described in the following
4.2.1 Step One: Establish the responsibilities for managing the process
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It is critical to have an overall process manager or process owner with end to end responsibility and
accountability for all aspects of process performance. The process manager needs to understand the
entire process and have the authority to effect changes in any part of it. The process manager plays the
duties for the following:
Forming the process management team, which includes representatives from each major part
of the process.
Ensuring the process operates in a controlled state of predictable performance.
Establishing process performance measures that adequately characterize the efficiency and
effectiveness of the process in meeting the needs of all customers and other interested parties.
Ensuring all aspects of process management and improvement are performed. This includes
creating documentation, tracking performance, and securing and allocating resources.
4.2.2 Step two: Define the process
The process manager and process management team need to carefully define the process so everyone
working within the process has a shared understanding of how it operates. How much documentation
is required depends on such attributes as the stability and education of the workforce and the
complexity and criticality of the process.
All process inputs and outputs are identified, along with the suppliers and customers, who
may be internal or external. The team also identifies process steps and flows. Many quality tools, such
as block diagrams and flowcharts, are available to support these activities. These first five steps (5.1.1
– 5.1.5) provide a basic methodology for process management. But the responsibilities of the process
manager and process management team do not end there. A significant benefit of process
management is its natural fit with process improvement. Once process performance has been
compared with customer requirements, process improvement is the natural next step.
4.2.3 Step three: Identify customer requirements
Carefully gather, analyse and document customer needs, including how customers use the outputs of
the process. Communicate frequently with customers to understand needs from their viewpoint. To
the extent possible, define measurable customer needs and rank them in order of importance. Directly
validate needs and requirements with customers.
4.2.4 Step four: Establish measures of process performance
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Translate customer needs and requirements into measures of process performance. This is one of the
most important and difficult steps in process management.
Include customer satisfaction, in-process measures and measures of supplier performance in
process measures. Relate all important customer needs, such as on time performance, defect or error
rates, tolerance intervals, product reusability, and worker health and safety, to performance measures.
The process approach is therefore one of the strongest approaches for integrating management
system standards because each process must be managed and improved simultaneously for all process
performance measures. Directly linking process performance measures with customer needs is one of
the most powerful aspects of process management.
4.2.5 Step five: Compare process performance with customer requirements
Use the process performance measures to ensure your process is operating in a stable and predictable
manner. Compare the process performance measures with the needs and requirements of the
customers. Use a variety of statistical tools for analysing process measurement data to help quantify
process performance. Identify critical process improvement opportunities through gaps in process
performance.
4.2.6 Step six: Identify process improvement opportunities
Use gaps in process performance vs. customer needs to determine critical process improvement
opportunities. Analyse process performance measures for improvement opportunities related to
sources of such attributes as errors and defects, process simplification opportunities, process
bottlenecks and lack of adequate process controls.
Both process effectiveness and efficiency can improve as a result of process improvement
activities. Many tools exist to identify process improvement opportunities. Once process improvement
opportunities are identified, any of the many quality improvement methods can be used to improve
process performance. These quality improvement methods fit naturally into step seven of the process
management and improvement methodology. One quality improvement method that can be used at
this step is the plan, do, check, act (PDCA) cycle.
4.2.7 Step seven: Improve process performance
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Select the process improvement opportunity to pursue. This selection should take into account such
attributes as the criticality of certain improvement needs, difficulty of improvement opportunities, and
resources and expertise available.
Establish quality improvement teams to pursue specific improvement opportunities. These
teams are established by the process manager and process management team. The quality
improvement teams report to the process manager or the process management team and are typically
disbanded once their improvement project is completed.
5.0 QUALITY MANAGEMENT SYSTEM APPROACH
A system is defined in ISO 9000:2005 as a set of interrelated or interacting elements. But this
definition does not accord with others from relevant literature:
A set of components that work together for the overall objective of the whole (Bertalanffy 19683).
A set of variables that influence one another (Senge 19904)
A series of functions or activities within an organization that work together for the aim of the
organization (Deming 19945)
5.1 ISO 9001: 2005 System -Based Model
In ISO 9001:2008, there is a diagram (Figure 4.1) shows a model of a process based quality
management system (Hoyle, 2009, page 2).
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Figure 4.1: ISO 9001:2008 perception of a process based quality management system.
This model is often used in quality manuals in response to the requirement in ISO 9001 clause
4.1 to determine the interaction of processes (Hoyle, 2009, page 2). However, this shows a complete
misunderstanding of interactions for the diagram at best only shows a flow of product and
information.
The elements within the ellipse imply processes but in fact they are simply the headings of
sections 5, 6, 7 & 8 of the standard (Hoyle, 2009, page 2). Some of the requirements are deliberately
placed in section 8 because the only section where exclusions are permitted is section 7; hence
product measurement and nonconformity control, which would be part of product realization, are
included in section 8 and not section 7 (Hoyle, 2009, page 2). However, management responsibility is
not a process but a series of obligations (Hoyle, 2009, page 2). Separating measurement, analysis and
improvement implies that the output from product (Hoyle, 2009, page 3). Realization is not measured
as product measurement is addressed in section 8 of the standard not section 7 (Hoyle, 2009, page 3).
The continual improvement element that sits outside the ellipse implies it’s outside the system when it
is already addressed by the measurement analysis and improvement element (Hoyle, 2009, page 3).
The diagram omits other stakeholders upon which the delivery of outputs depend such as suppliers,
employees and investors (Hoyle, 2009, page 3). There is no indication of the influence of the business
environment mentioned in clause 0.1 of the standard (Hoyle, 2009, page 3).
5.2 Holistic Thinking System - Based Model
A better understanding model (system model) is created by Hoyle’s organisation (2009) on how they
work and imagine the models reflect reality but appearances can be deceiving. A system called
“reductionist thinking” are standards that encourage organizations to break the whole into parts then
manage the parts as if by doing so they are managing the whole (Hoyle, 2009, page 3). These types of
systems appear as systems of documentation that do not reflect the dynamic behaviour within
organizations enabling the management to handle the organization effectively. Instead of taking a part
of the organization, the whole of the organisation is taken and view it as a system of processes as
shown in Figure 4.2. A very different and more useful model compare to Figure 4.1.
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Figure 5.1: The organization viewed as a system of managed processes
This model displays several important characteristics:
The stakeholders sit inside the system boundary because they form part of the circle of influence.
The stakeholders – those parties that contribute to the organizations wealth creating capacity and
in return accrue certain benefits and share the risks (Hoyle, 2009, page 6). These parties can be
categorised as customers, investors, employees, suppliers and society (Hoyle, 2009, page 6).
Organizations satisfy customers by fulfilling their demands and thus there will be a “Fulfil
Demand Process”; for demands to be fulfilled they have firstly to be created and therefore there
will be a “Create Demand Process” (Hoyle, 2009, page 6). Both these processes need resources
and therefore there will be a “Resource Management Process” which feeds the Demand Creation
and Fulfilment Processes with capable resources when needed (Hoyle, 2009, page 6).. The
resources come from the other stakeholders and are provided by suppliers, employees and
investors (Hoyle, 2009, page 6).
All stakeholders are accounted in the model. These three processes need to be designed and
managed in such a way as to enable the organization to fulfil its purpose or what we commonly
refer to as mission and therefore there is a need for a “Manage Mission Process”;
Success depends on understanding stakeholder needs and expectations and responding to their
concerns and therefore intelligence and feedback is gathered by the Manage Mission Process,
promptly analysed and changes made to all processes to sustain success.
The model shows the relationship between the four key business processes. The
interconnections are channels along which product or information flow. They are not intended to
represent interactions as is the case with the model in Fig 4.1.
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5.3 Differences between Systems and Processes
There is therefore a distinct difference between systems and processes.
A process produces results through work being done in the process whereas a system
produces results through the interaction of processes
Processes produce outputs whereas systems create outcomes
Process owners manage activities to produce required outputs whereas system managers
manage interactions to produce desired outcomes
Rick Ross from the MIT Sloan School of Management identified some striking differences between
system diagrams and process diagrams that assist in clarifying these concepts. These are summarised
in Table 5.1.
Table 5.1 Comparison of system and process diagrams
Process diagrams System diagrams
Show flow of activities in a straight line Show cause & effect in a circle
The labels are verbs and tasks The labels are nouns and variables
The arrows indicate sequence The arrows indicate influence or causality
A change in one activity does not necessarily
affect other activities
A change in one element produces a change in
all variables
Tends to represent a static picture Always represents a dynamic picture
5.4 Type of Social System
Gharajedaghi identified three types of social systems each being a product of their age: mechanistic
view, biological view, and sociocultural view.
A mechanistic system is mindless, it has no purpose of its own except to create profit for its
owner. No parts must deviate and it’s a reactive system with no choice. This type of social system was
prevalent in the 19c when entrepreneurs organised labour to create and operate the machines of the
industrial revolution. The perception that the primary purpose of a business is to make a profit for
their master emanates from this period in our history and is still prevalent today. When other types of
systems enter into the market place, parts are attracted to better working conditions and exercise their
only choice which is to leave.
A biological system is uniminded with a purpose of its own, dictated by an executive. Its
growth is the measure of success, profit the means to achieve it and although the system has a choice
the parts don’t. The parts either conform or are replaced. This is representative of the typical 20c
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command and control structures having a board of directors dictating purpose and direction and a
work force implementing the strategies and policies of the directors. These organizations can provide
security for the less ambitious parts but those more ambitious either set up their own mechanistic or
biological systems, find other sympathetic biological systems or join a sociocultural system.
A sociocultural system is multi minded, with a choice of ends and mean. The parts share
values and work by consensus. The culture is the DNA that integrates the parts into the whole. This
type of social system is not yet common but is growing in popularity as our society moves away from
deference with its automatic respect for authority towards consensus management and mutual
responsibility
6.0 IMPLEMENTATION OF ISO9000
An ISO 9000 quality management system can be implemented by following the steps detailed as
follows:
6.1 Evaluate the organization’s need/goals for implementing a QMS
Need may arise from repeated customer complaints; frequent warranty returns; delayed deliveries;
high inventories; frequent production hold-ups; and high level of rework or rejection of products or
services.
At this stage, identify the goals which you would like to achieve through a QMS, such as
customer satisfaction, increased market share, improved communications and morale in the
organization, greater efficiency and profitability, etc.
Another objective in implementing a QMS may be a demonstration of compliance through
third party certification, which may be requested by an important client or required for enlisting as a
supplier to large companies, e.g., original equipment manufacturers (OEMs).
6.2 Obtain information about the ISO 9000 family
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The persons identified for initiating the development of an ISO 9000 QMS need to understand the
requirements of ISO 9001:2000 as read with ISO 9000:2000 and ISO 9004:2000.
Supporting information such as quality management principles, frequently asked questions
(FAQs), guidance on clause 1.2 (application) of ISO 9001:2000, guidance on documentation
requirements of ISO 9001:2000 and other brochures are available free of charge on the ISO web site
at http://www.iso.org.
6.3 Appoint a consultant, if necessary
If, within the organization, for those who do not have adequate competence to develop a QMS, they
may require to appoint a consultant. Before doing so, it is good to check his/her background;
knowledge about the product realization processes of the organization; and experience in helping
other organizations to achieve their stated goals, including certification.
Carry out a cost-benefit analysis of hiring a consultant and agree the scope of his/her work in writing.
It is also possible to appoint a consultant only for the training of key staff; the latter can then carry out
further training and development of the system.
6.4 Awareness and training
Raise awareness about QMS requirements amongst all personnel performing activities that affect
quality. Plan for and provide specific training on how to develop Quality Manuals; on procedures; on
QMS planning; on how to identify and implement improvement processes; and on how to audit
compliance with the QMS, etc.
The Institute of Quality Assurance (IQA), the American Society for Quality (ASQ) and the
International Auditor and Training Certification Association (IATCA) can provide lists of training
organizations.
6.5 Gap analysis
Evaluate gaps between your existing quality management system and the QMS requirements of ISO
9001. Prepare how to bridge these gaps, including by planning for any additional resources required.
Gap analysis may be carried out through self assessment or by the external consultant.
6.6 Product realization processes
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Review clause 7 of ISO 9001:2000 relating to “Product realization” to determine how the
requirements apply or do not apply to your company’s QMS. The processes covered by this clause
include: customer-related processes, design and development, purchasing, production and service
provision, and control of measuring and monitoring devices.
Note that if the company is not responsible for preparing the design of the product, they can
exclude the requirement for “design and development” from the QMS and explain the reasons for
doing so in the Quality Manual.
6.7 Staffing
Decide on the responsibilities of the persons who will be involved in developing and documenting the
QMS, including the appointment of a management representative who will oversee the
implementation of the QMS. Establishing a project Steering Committee may also prove useful to
oversee progress and provide resources wherever required.
6.8 Planning a time frame
Prepare a complete plan to close the gaps identified in Step 6.5 to develop the QMS processes. In the
plan, include activities to be performed, resources required, responsibilities and an estimated
completion time for each activity. Clauses 4.1 and 7.1 of ISO 9001:2000 provide information that
should be used when developing the plan. The total time required for each phase (planning,
documentation, implementation and evaluation) depends on the extent of the gaps in your existing
QMS.
6.9 Draft a Quality Manual
In the Quality Manual,
Include how the QMS applies to the products, processes, locations and departments of the
organization;
Exclude any requirement with justification for doing so as decided in step 6.6 above
Refer to or include documented procedures for QMS
Describe the interaction between the processes of the QMS, e.g., the interaction between product
realization processes and other management, measurement and improvement processes
Draft the quality policy and quality objectives for the organization.
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The staff concerned in the organization should review the Quality Manual and the documented
procedures so that their comments and suggestions can be taken into account before the Quality
Manual and procedures are approved for issue and use. The effective date of implementation should
also be decided.
6.10 Carry out internal audits
During the phase of implementation of some three to six months after the documentation has been
written, the trained auditors should carry out one or two internal audits covering all activities for the
QMS, and concerned management should take corrective action on the audit findings without delay.
Wherever required, revise the manuals, procedures and objectives. After each internal audit, the top
management should review the effectiveness of the system and provide necessary resources for
corrective actions and improvements.
6.11 Apply for certification
On satisfactory completion of Step 10, and if your company decides to obtain third party certification,
you can make an application for certification to an accredited certification body. The certification
audit process is explained section VII.
6.12 Conduct periodic evaluations
After certification, the organization should periodically conduct internal audits to review the
effectiveness of the QMS and see how it can be “continually improved”. The organization should
evaluate periodically if the purpose and goals (e Step 6.1) for which the QMS was developed are
being achieved, including its continual improvement.
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7.0 ISO 9001
ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the
family that can be certified to (although this is not a requirement). It can be used by any of the
organization, whether it is large scale or small scale, regardless of its field of activity. In fact ISO
9001:2008 is implemented by over one million companies and organizations in over 170 countries
(ISO, n.d.).
This standard is based on a number of quality management principles including a strong
customer focus, the motivation and implication of top management, the process approach and
continual improvement (ISO, n.d.). These principles are explained in more detail in the following.
Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services,
which in turn brings many business benefits (ISO, n.d.).
7.1 ISO 9001: 6 Mandatory Procedures
These ISO 9001 mandatory procedures are specified by ISO 9001 requires “documented procedures”
for the listed six activities: Document control procedure (4.2.3), Records procedure (4.2.4) , Internal
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audit procedure (8.2.2), Control of non-conformance procedure (8.3), Corrective action procedure
(8.5.2), and Preventive action procedure (8.5.3).
7.1.1 ISO 9001: Control of documents (4.2.3)
A robust document control process invariably lies at the heart of any compliant quality management
system; almost every aspect of auditing and compliance verification is determined through the
scrutiny of documented evidence (ISO Navigator, 2013). With this in mind, it becomes apparent that
the on-going maintenance of an efficient document management system must not be overlooked (ISO
Navigator, 2013).
The organization must control all documentation, generated by the QMS, by implementing a
document control procedure that defines the controls needed to; approve, review, update, identify
changes, identify revision status, etc (ISO Navigator, 2013).. The document control procedure should
define the scope, purpose, method and responsibilities required to implement these parameters (ISO
Navigator, 2013).
In order to comply with the document control clause, it is essential that all personnel
understand what type of documents should be controlled and more importantly, how this control
should be exercised (ISO Navigator, 2013). To get the most out of the document control procedure, it
must communicate the steps necessary to ensure that staff and other users of the organization’s
documentation understand what they must do in order to manage that information effectively and
efficiently (ISO Navigator, 2013).
Departmental managers should always be responsible for promoting good document and
record management practices in their area whilst supporting overall compliance to the document
control procedure (ISO Navigator, 2013). Individuals and their line managers should be responsible
for the documents and records that they create, as well as being responsible for their retention and
disposal in line with legislative requirements and organizational procedures and practices (ISO
Navigator, 2013).
The documentation must specifically state this in the procedure and on the documents
themselves, which are ‘For Reference Only’ and are not updated if don’t want to control external
documents. For multi-site/corporate certifications the auditor will expect to see that system
documentation and changes are centrally managed (usually performed at the headquarters location)
with further control of documents at the local level, as applicable (ISO Navigator, 2013).
7.1.2 ISO 9001: Control of records (4.2.4)
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The organization must implement a documented procedure to define the controls needed for the
identification, storage, protection, retrieval, retention and disposition of records and that these records
must remain legible and identifiable throughout their retention period (ISO Navigator, 2013). Records
prove the efficacy of the QMS. The records procedure will be as follow:-
Records prove compliance against requirements
Develop and implement the control of records procedure
Maintain the legibility and accessibility of QMS documents and records
Implementing a document management system could mean keeping certain records that the
organization might not be already keeping (ISO Navigator, 2013). Some of these records may seem a
little confusing until the organisation become more familiar with the quality standard (ISO Navigator,
2013).
The following clauses of ISO 9001 contain the instruction 'see 4.2.4' which means that the
organisation must retain these 21 records (ISO Navigator, 2013):
5.6.1 Management review minutes
6.2.2 Records of education, training, skills and experience
7.1 Evidence that the realization processes and product fulfil requirements
7.2.2 Records of sales activities
7.3.2 Design and development inputs
7.3.4 Design and development reviews and any related actions
7.3.5 Design and development verification and any related actions
7.3.6 Design and development validation and any related actions
7.3.7 Design and development changes and any related actions
7.4.1 Results of supplier evaluations and any actions arising
7.5.2 Records to demonstrate the validation of special processes
7.5.3 Records of product identification where traceability is required
7.5.4 Customer property that is lost, damaged or found to be unsuitable
7.6 Basis used for calibration where no standards exist
7.6 Validity of the previous results when equipment is out of calibration
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product
8.3 Records of the product non-conformities and any subsequent actions
8.5.2 Results of corrective action
8.5.3 Results of preventive action
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7.1.3 ISO 9001: Internal audit (8.2.2)
The purpose of the ISO 9001 internal audit is to assess the effectiveness of the quality management
system and the organization's overall performance (ISO Navigator, 2013). The internal audits
demonstrate compliance with the ‘planned arrangements’, e.g. QMS manual, procedures or process
maps and that the planned arrangements are implemented and maintained (ISO Navigator, 2013).
The auditor’s role is to gauge how well this system is functioning by gathering of objective
evidence of conformance and performance (ISO Navigator, 2013). The auditee will often be a
processes owner; they are the experts of that process and as such will provide an invaluable insight
into the mechanics of the process (ISO Navigator, 2013).
The auditor will verify that processes are documented, implemented and understood (ISO
Navigator, 2013). They will also seek confirmation that each process complies with the necessary
requirements, that the process is effective and demonstrates continual improvement (ISO Navigator,
2013).
The ISO 9001 internal audit checklist is just one of the many tools which are available from
the auditor’s toolbox that help ensure the audit addresses the necessary requirements (ISO Navigator,
2013). It stands as a reference point before, during and after the audit process and if developed for a
specific audit, and used correctly will provide the following advantages (ISO Navigator, 2013):
Ensures the audit is conducted systematically
Promotes audit planning
Ensures a consistent audit approach
Actively supports the organization’s audit process
Provides a repository for notes collected during the audit process
Ensures uniformity in the performance of different auditors
Provides reference to objective evidence
7.1.4 ISO 9001: Control of non-conformances (8.3)
Records of each non-conformance and how it was dealt with must kept no matter how a non-
conformance is resolve (ISO Navigator, 2013). It is easier to spot negative trends and examine the
root cause, and eliminate the cause of the problems by keeping records of the non-conformities and
doing data analysis (ISO Navigator, 2013). This, in turn, should result in fewer defective products and
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more satisfied customers (ISO Navigator, 2013). Few other processes require as rigid adherence to
procedures as controlling non-conforming products. There can be no room for deviation (ISO
Navigator, 2013).
If a manufactured product is inspected and found to be out of specification, it is most likely to
be deemed non-conforming product (ISO Navigator, 2013). It is necessary bring it back into
specification. The re-verification after remedial work might involve testing as well as inspection. Re-
verification is equivalent to re-inspection and records could include a signature of approval or a more
formal test report (ISO Navigator, 2013). The reason is not just to verify that the defect has been
removed, but also to assure that fresh defects have not been introduced by the rework (ISO Navigator,
2013). Records would be as appropriate for the re-inspection or re-testing performed. Here is the
listed non-conformance procedure (ISO Navigator, 2013):-
1. Develop a procedure to control non-conforming products
2. Define how non-conforming products are identified
3. Define how non-conforming products are dealt with
4. Remove or correcting non-conformities
5. Prevent the delivery or use of non-conforming products
6. Verify how non-conforming products were corrected
7. Provide evidence that corrected product(s) now conform
8. Keep records that catalogue non-conforming products
7.1.5 Corrective action (8.5.2)
A corrective action should be considered as a reactive response to a problem since it is taken when a
non-conformance is detected or upon receipt of a customer complaint or other event (ISO Navigator,
2013).
The organization should first contain the problem and then determine its root cause in order to
take appropriate corrective action to prevent the problem’s recurrence (ISO Navigator, 2013).
Develop a procedure to control corrective actions in order to correct non-conformities by (ISO
Navigator, 2013):
1. Recording corrective actions
2. Performing an initial review
3. Determining causes
4. Determining the need to take action
5. Implementing action where required
6. Preventing recurrence
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7. Evaluating effectiveness
8. Recording the results using the forms provided
9. Examining the effectiveness of corrective actions
In response to a symptom, evaluate the need for initiating the problem solving process (ISO
Navigator, 2013). If necessary, provide an emergency response action to protect the customer and
initiate the process. Application criteria (ISO Navigator, 2013):
1. The symptoms has been defined and quantified
2. The customers who experienced the problem or symptom are identified
3. Measurements taken to quantify the problem or symptom
4. Performance gap
5. The cause is unknown
6. Symptom complexity exceeds the ability of one person to resolve
Establish an investigation team with (ISO Navigator, 2013):-
1. Process and/or product knowledge
2. Allocated time
3. Authority to solve the problem and implement corrective actions
4. Skill in the required technical disciplines
5. A designated Team Leader
The corrective action procedure must explain how the team (ISO Navigator, 2013):
Review non-conformance and customer complaints
Decide the cause of the problem
Decide an appropriate course of action to stop the problem recurring
Put the plan into action
Ensure that the action has solved the problem
7.1.6 ISO 9001: Preventive action (8.5.3)
Preventive action should be considered as a proactive undertaking (ISO Navigator, 2013). For
example, if we anticipate a potential problem and take action to eliminate the causes and prevent the
occurrence of that problem, this is considered to be preventive action (ISO Navigator, 2013). Develop
a procedure to control preventive actions in order to prevent potential non-conformities from
occurring by (ISO Navigator, 2013):
1. Reporting potential non-conformities using the forms provided
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2. Investigating the causes
3. Determining their potential effects
4. Determining whether action is necessary
5. Developing and implementing suitable responses to eliminate the causes
6. Recording the results of preventive actions
7. Verifying and documenting the effectiveness of preventive actions
7.2 Management Responsibilities
The ISO 9000 standard contains high expectations for top management leadership and involvement to
provide guidance to the overall quality management system (Dawson, 2015). In fact, nearly 15% of
the standard’s text is devoted to the subject of top management responsibility (Dawson, 2015).
Clearly, the designers of the standard have realized the imperative for the perspective and authority
that top management must bring to ensure effective operation of the system (Dawson, 2015).
Because of this, it can be expected that ISO registrars will approach the auditing of the
standard with a heightened focus on the function of management in the system (Dawson, 2015). The
auditors will be looking for objective evidence that management has a regular discipline of
involvement and leadership as prescribed by the standard (Dawson, 2015). This evidence must be
more than merely words of support for quality (Dawson, 2015). The activities outlined in the
requirements are all demonstrable, and records of such activities will be carefully reviewed (Dawson,
2015).
This extra focus on the role of management is explained in the opening text of the
Management Responsibility requirements section: “Top management shall provide evidence of its
commitment to the development and implementation of the quality management system and
continually improve its effectiveness…” (ref. 5.1, ISO 9000).
The ISO 9000 standard lists six distinct requirements for top management. By “top management”
the standard refers to the individual at the top of the organization (e.g. CEO, President, and Chairman)
and his/her direct reports (Dawson, 2015). Depending upon the size and structure of the organization,
one or two layers of management below this top group may be included in this scope. In summary, the
requirements for this leadership group are (Dawson, 2015):
Consistent commitment to making the quality management system effective as
demonstrated by regular communications, establishment of a quality policy and quality
objectives, management reviews and resource provision (ref. 5.1).
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Ensuring customer focus throughout the organization as demonstrated by clearly
determining and consistently meeting customer requirements resulting in improved customer
satisfaction (ref. 5.2).
Establishment and communication of a quality policy that articulates management’s
intention that the company complies with all requirements (customer, regulatory, etc.) and
will continually strive to improve the overall quality management system’s effectiveness (ref.
5.3).
Ongoing planning of measurable product quality and process quality objectives to be sure
they are established and met throughout the organization, even when changes to the quality
management system are made (ref. 5.4).
Defining and communicating responsibility and authority for everyone affecting the quality
management system, including a designated management representative who has the authority
to ensure the system is established and maintained and is responsible to report the system’s
performance to top management (ref. 5.5). This requirement also includes the need to
establish effective communication processes within the organization regarding the
effectiveness of the quality management system.
Conducting a regular management review of the quality management system to ensure that
it remains suitable, adequate and effective to satisfy the company’s quality policy and
accomplish the organization’s quality objectives (ref. 5.6).
A management team responsible for preparing their organization for ISO 9000 registration will
need to give focus and attention to the planning and implementation of the specific requirements for
top management and the oversight of the development of the organization’s overall quality
management system (Dawson, 2015).
7.3 ISO 9001: 2008 – Product Realization Requirements
The organization shall plan and develop the processes needed for product realization. The focus is on
controls governing the making of product to meet customer requirements and all the QMS processes
that, directly or indirectly, make this happen (ISO 9001 Training, n.d.).
Product realization is the term used to describe the work that the organization goes through to
develop, manufacture, and deliver the finished goods or services. An effective Quality Management
System (QMS) includes a comprehensive approach to getting from the product concept to the finished
product. This approach, sometimes called a quality plan, includes the following (ISO 9001 Training,
n.d.):-
product requirements and quality objectives,
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creation of the processes, documents, and resources needed for product realization,
required verification, monitoring, inspection, and test activities,
The records to be kept.
Product realization processes may include - customer related processes (sales and marketing);
design and development; production; shipping; receiving; packaging; measurement and monitoring of
product and processes, etc., whether performed onsite or off-site (ISO 9001 Training, n.d.). Some of
the support processes that come to bear on product realization include- document control; record
control; human resources; infrastructure provision and maintenance; IT; purchasing and materials
management; laboratory services and control of monitoring and measuring devices, business planning
and etc. (ISO 9001 Training, n.d.).
The output of product realization planning may be implemented in many different ways. It
does not necessarily have to be all in one document, but may sometimes include several documents
(drawings; machine set-up; inspection criteria; process sheets; etc.) (ISO 9001 Training, n.d.). These
must be readily available to those performing realization processes.
7.3.1 Customer-related Processes
First is determination of requirements related to the product. The Standard requires the
organization to determine product requirements. These requirements can come from the customer,
may be mandated by laws or regulations, and include generally accepted standards within your
industry or market. Requirements are established by standard contracts or oral agreements that the
sales department uses in discussions with customers, and other sources.
Second is the review of requirements related to the product. After gathering preliminary
product requirements, these requirements need to be reviewed to be sure that the customer
understands them and that the organization is meeting these requirements. This review must ensure:
the requirements are known and understood, any changes from the original contract or discussions is
understood, the organization has the ability to meet the requirements, and records are kept of this
review. Routine orders for items described in a catalogue of products are considered reviewed when
the relevant product information is reviewed.
Third is customer communication. Put in place effective customer communications
channels, to allow dialogue regarding: product information, questions about contracts, order handling,
changes, and receiving customer feedback, including complaints.
7.3.2 Design and Development Planning
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Control of design and development changes is to identify, document, review, and approve all design
changes before carrying them out. Evaluate the impact of the changes on the present design of the
product (Simply Quality, 2001). Keep records of the review.
To effectively plan the design and development process, the organization must (Simply Quality,
2001):
Clearly define the stages involved in the design and development process.
Identify how the review and verification of the design will take place.
Describe clear responsibility and authority for the people doing this work.
See that design information flows effectively among the various groups having a role in
designing, selling, managing, manufacturing, and servicing the products.
Keep design and development plans up to date.
Design and development inputs is to determine the product requirements, including(Simply
Quality, 2001):
what it does and how well it must perform,
legal and regulatory requirements,
pertinent information from similar designs,
other pertinent requirements.
Design and development outputs is the output of design and development which must
include sufficient information to verify that design output meets design input requirements (Simply
Quality, 2001). In addition, it must (Simply Quality, 2001):-
include the information need to purchase component materials, manufacture the product, and
service the product.
specify how to determine if the product has acceptable performance,
highlight safety and usage considerations.
Design and development review is the review the design and development work products to
(Simply Quality, 2001): -
determine if the design meets the design input requirements,
identify and problems with the design,
propose solutions to identified design problems,
Include representatives from each function concerned with the design and development stage
being reviewed. Keep records of the reviews.
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Design and development verification is to verify, according to the plan, that the design
output meets design input requirements (Simply Quality, 2001). Record the results of these
verification activities during this phase.
Design and development validation is to validate the operation of the resulting product
under actual operating conditions (Simply Quality, 2001). If the product has multiple uses, validate
operation for each intended use (Simply Quality, 2001). The methods for validation defined in the
design output should be followed (Simply Quality, 2001). Whenever possible, the validation of a
product or service should be performed prior to delivery to the customer. Record the results of these
validation activities (Simply Quality, 2001).
7.4 ISO 9001:2008 – Measurement, Analysis and Improvements
The organization shall plan and implement the monitoring, measurement, analysis and improvement
processes needed:
a) To demonstrate conformity to product requirements,
b) To ensure conformity of the quality management system, and
c) To continually improve the effectiveness of the quality management system.
This shall include determination of applicable methods, including statistical techniques, and the extent
of their use.
Planning of measurement and data analyses processes must consider the methods and
resources (time, manpower, computer, software, statistical tool, etc.) needed to collect, organize and
analyse product and QMS performance data (ISO 9001 Training, n.d.). Measurement involves
physically measuring product characteristics or process parameters against acceptance criteria at
predefined intervals and sampling sizes, using predefined measurement devices (ISO 9001 Training,
n.d.). The measurement results may not always be fully recorded (ISO 9001 Training, n.d.).
The organizations cross-functional knowledge of customer requirements; product;
technology; manufacturing processes and etc. are used to determine what statistical methods to use
for each process and to what extent to use them must include in the quality plan (ISO 9001 Training,
n.d.). Next, statistical methods to verify product characteristics and process parameters include -
process capability studies; control charts; Pareto analysis; variation analysis (ISO 9001 Training,
n.d.). After that, define and implement appropriate training and competency requirements for all
personnel using statistical methods, tools and analysis (ISO 9001 Training, n.d.).
Monitoring usually involves conducting ongoing periodic checks to determine whether
product characteristics or process parameters are within acceptable limits (ISO 9001 Training, n.d.).
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Monitoring can be done manually or by automation (computers or electronic sensors, etc). The
frequency of monitoring may vary on the risk and reliability of product and processes (ISO 9001
Training, n.d.). Monitoring is also useful in determining the scope and frequency of product and
process measurement. The results of monitoring may or may not be recorded (ISO 9001 Training,
n.d.).
8.0 REFERENCES
American Society for Quality (ASQ). (n.d.). Quality Glossary – I. Retrieved on 23rd May 2015, from
http://asq.org/glossary/i.html
ISO. (2008). ISO 9000 Introduction and Support Package: Guidance on the Concept and Use of the
Process Approach for management systems. Retrieved on 23rd May 2015, from http://www
iso.org/iso/04_concept_and_use_of_the_process_approach_for_management_systems.pdf
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Hooper, J.H. (2015). The Process Approach to QMS In ISO 9001 and ISO 9004. Retrieved on 23rd
May 2015, from http://asq.org/quality-progress/2001/12/standards-outlook/the-process-approach-
to-qms-in-iso-9001-and.html
ISO Central Secretariat. (2012). Quality management principles. Retrieved on 23rd May 2015, from
http://www.iso.org/iso/qmp_2012.pdf
Hoyle. (2009). SYSTEMS AND PROCESSES – IS THERE A DIFFERENCE? Retrieved on 23rd May
2015, from http://www.thecqi.org/Documents/community/South%20Western/Wessex%20Br
anch/Systems%20and%20Processes%20article%20by%20David%20Hoyle%20Oct09%20(2).
ISO Navigator. (2013). ISO 9001: Mandatory procedures. Retrieved on 23rd May 2015, from
http://www.iso9001help.co.uk/mandatory.html
Dawson, S. (2015). Management Responsibility in ISO 9001:2008. Retrieved on 23rd May 2015, from
https://www.thecoresolution.com/5-0-management-responsibility/
ISO 9001 Training Sitemap. (n.d.). ISO 9001 Training – Understanding ISO 9001:2008
Requirements for Quality Management Systems. Retrieved on 23rd May 2015, from http://www.
askartsolutions.com/iso9001training/Planning-of-Product-Realization.html
Simply Quality. (n.d.). 7 Product Realization Requirements. Retrieved on 23rd May 2015, from
http://www.simplyquality.org/2000%20Summary/req_7-0.html
International World Trade Centre (UNCTAD/WTO). (November 2001). An Introduction to ISO
9000: 2000. Retrieved on 23rd May 2015, from http://legacy.intracen.org/tdc/Export%20Quality%
20Bulletins/eq70eng.pdf
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