chapter 1 management systems

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TMQU03 Quality Management and Engineering

Division of Quality Technology and Management, Linkping University1

1 QualityManagementSystems1.1 LearningobjectivesAfter studying this chapter, you will be able to:

Understand the purpose and benefits of a Quality Management System (QMS)in an organization

Explain how a QMS works Understand the issues related to implementing a QMS according to ISO

9001:2008

Understand the advantages and disadvantages of the ISO 9001:2008 standard1.2 ManagementSystemsA management system is an organizations policy, objectives and the work to achieve

these. Every employee must know the processes in his organization, his role in these

processes and in what direction the organization strives.

The quality policy gives the organizations general quality orientation and clarifies its

basic intentions. The quality policy should be used to generate measurable quality

objectives and should serve as a general framework for action. A quality objective is a

measurable objective to improve the performance of an organization. It is something

an organization aims for or tries to achieve. A plan is needed to reach these

objectives. A plan may include processes, routines for certain tasks, instructions,

performance measurements, skill requirements or any other means for controlling thework and actions within the organization.

An effective management system must be easy to use and update, understandable,

accessible and based on the company's own needs and prerequisites. The management

system needs to be documented to ensure a common understanding of quality policies

and procedures. The main objectives of documentation are:

Tool for information transmission and communication Provision of evidence that what was planned has actually been done. Knowledge sharing to disseminate and preserve the organizations

experiences.

However, it is important to emphasize that it is the policy, the quality objectives and

the actions to reach them, which constitute the QMS, not documentation.

Documentation is just a supporting tool.

Management systems can be designed with different purposes. A QMS concentrates

on increasing customer satisfaction and meeting or exceeding quality requirements.

Another example is an Environmental Management System (EMS). It concentrates on

minimizing the environmental impacts and on controlling activities that negatively

impact the environment.

To facilitate the work with different management systems the International

Organization for Standardization (ISO) has developed a series of voluntary standards

to provide guidelines to organizations on how to work with e.g. quality issues. Today


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there exist standards for management of such areas as quality, environment,

occupational health, safety and skills. The ISO standard for QMS is called ISO 9000

series.

1.3 ISO9001:2008The foundation of quality work in many organizations today is the standard ISO 9000.The standard was introduced 1987 and is under continuous improvement. The current

version is from 2008. The official definition of ISO 9000, which can be found on

ISO/TC 176 Committee homepage, is the following:

The ISO 9000 family of standards represents an international consensus on good

quality management practices. It consists of standards and guidelines relating to

QMSs and related supporting standards. ISO 9001:2008 is the standard that provides

a set of standardized requirements for a QMS, regardless of what the user

organization does, its size, or whether it is in the private, or public sector.

http://www.iso.org/iso/iso_9000_essentials

The termISO 9000 refers to a set of three standards:

ISO 9000, Principles and terminology ISO 9001, Requirements for certification ISO 9004, Guides for introducing quality management and improving quality.

Cannot be certified.

The most known and used standard is ISO 9001 since it contains requirements and is

often used for certification purposes. The requirements in ISO 9001 are expressed

generally to fit within many different organizations. They are supposed to be

adaptable to any organization, with more details specified in the organizations owndocuments.

ISO 9001 is based on eight management principles:

1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to management6. Continual improvement7. Factual approach to decision making8. Mutually beneficial supplier relationships

An organization that has developed a QMS according to ISO 9001 can obtain a

certificate proving it meets the requirements set by the standard. The certificate can be

issued by an independent accredited organization called certification body. In Sweden

there is a number of certification bodies accredited by SWEDAC (Swedish

governmental authority, every country in Europe has corresponding accreditation

body). Examples of accredited certification bodies in Sweden are Det Norske Veritas

(DNV), Intertek SEMKO Certification AB, Bureau Veritas, SFK Certification.

Certification bodies perform audits, which is a thorough review of organizations

documentation, procedures and processes. An ISO 9001 certificate does not say


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anything about the quality of the products or services; it just tells that an organization

has a basic system for managing quality designed according to ISO 9001.

1.4 EngagementandcommitmentthekeytosuccessISO 9000 offers organizations the capability to develop and implement an effective

and dynamic QMS with a customer focus, but the certification itself doesnt ensurethat an organization achieves sustained competitive advantages. The key to the

success is the willingness and the depth to which an organization desires to go in

satisfying the standards requirements or fulfilling their own improvement needs.

Requirement from customers is unfortunately the most common reason to introduce

ISO 9001 and organizations often lack motivation to effectively work with the QMS.

Those organizations devoting too much attention and placing too much value on the

certificate often fail to realize the full potential of the standard. A QMS designed

according to ISO 9000 differs considerably from organization to organization,

because it is influenced by different organizational and external conditions. The most

important organizational conditions are: maturity level of quality management,

internal motivation, implementation strategy, involvement of people. The external

conditions include certification audits and relationship with customers.

1.4.1 MotivestointroducemanagementsystemsMany organizations only certify to ISO 9000 because customers request it. They

certify without reflecting on whether or not ISO 9000 is in fact appropriate to their

business. Any improvement initiative needs a solid foundation to rest on. An

improvement can only be accomplished through change, and without the proper

motivation change will not happen. The internal motivation and design of ISO 9000

fitting the culture of the organization is therefore the most important prerequisite to

achieve positive effects from the QMS. The design of the QMS has to start from thereal needs of an organization. The focus should not rest on fulfilling the minimum

requirements, but on the areas that need to be improved. The objectives need to reflect

the expectations of customers as well as the organizations aims for future success. If

the commitment level is very low and too much value is placed on the certification,

the focus on real improvements is shifted away. The efforts are just limited to

fulfilling the auditors demands and setting defensive and easy to achieve objectives.

1.4.2 MaturitylevelofqualitymanagementOrganizations may have different maturity levels of quality management. For some

organizations, ISO 9000 may mean a radical change, for others it is just the usual way

of running the business. When starting to implement the standard, organizations may

to differing extents already comply with ISO 9001:2008 requirements. Seddon (1997),

known for his critical view of ISO 9000, discusses Toyota in one of his arguments

against the standard: Toyota tried ISO 9000 in its Shimoyama factory in 2000 and

promptly ceased its use for they found it to be of no value. Toyota is a company with

a high maturity level with quality management and with an image of a strong quality

organization. If Toyota already complies with the requirements and doesnt need to

strengthen its quality image with an ISO 9001 certificate, it is not surprising that the

standard is of no value for the company. It doesnt mean that ISO 9000 is of no value

for other organizations.


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1.4.3 TheorymeetspracticeImplementing an ISO 9001 management system means to create an alignment

between your practice and requirements in the standard. There are two strategies to

achieve this alignment. Organizations may standardize the practice or practice the

standard. The first strategy implies that the practice is not changed, but only described

in the language of the standard. The requirements of ISO 9001:2008 are general and

there is considerable freedom in interpreting them. Organizations may interpret the

requirements and the practice in such a way that they can claim that their existing

processes already comply with the standard. Practicing standards implies that

organizations reflect on a requirement and determine the best possible way of

fulfilling it in the context of their organization. Then the necessary changes in the

practice are implemented. These implementation strategies are not alternatives that

are totally free to choose, but rather should be fitted to the maturity level with quality

management and to the improvement needs of the organization. For mature

companies it is in many cases just enough to standardize the practice to fulfill the ISO

9001:2008 requirements. However, there is not only one single way of fulfilling arequirement and things can always be done better. Organizations that represent a low

level of quality management would be better off practicing the standard. They should

find a way to fulfill the requirements in the best possible way for the organization.

They should not confine themselves to the easiest way, but to the way that will

provide value for the organization.

1.4.4 InvolvementofallstaffFinally, an important organizational factor is the involvement of people. Management

system is the top managements responsibility. Top management needs to show

commitment and be involved in the quality work in order to demonstrate the

importance of quality work to other employees. Without the continuous support andcommitment from top management, the true importance of the initiative will be in

doubt and the energy behind it will be weakened.

A quality manager or other person with knowledge of quality management must work

as facilitator and drive the improvement work. Finally, all employees need to know

what the customer requirements are and be aware how their work contributes to their

fulfillment. Everybody needs to be involved in tackling and solving the existing

quality problems and identifying quality improvements. Staff may also need some

training in methods for finding improvements and solving problems. If you encourage

all staff to participate, they will be more motivated, as they get a chance to improve

their own situation.

1.4.5 TheauditorsroleOne needs to understand that certification bodies are not really independent as they

supposed to be. After all, they are paid for the certification services by the

organization they audit and they wish to continue being paid. The certification bodies

compete with each other about the customers to certify. Audits may increase

motivation and drive the quality work forward if they are performed in the correct

way. Audits should be perceived as an opportunity to receive advice, new ideas, and

help from outside and not as a checkpoint to be crossed in order to obtain the

certificate. Good auditors may make valuable input to the QMS in form of ideas and

suggestions for improvement and the transfer of experience from other organizations.

Bad auditors may act in their own interest (emotional, financial, or other personal


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interests) and not in the interests of the audited organization. Additionally, if the

audited organization is just interested in preserving the certificate, the efforts can be

limited to just satisfying the auditors requirements, not maintaining an effective

QMS. It is important that audits are used as a source for motivation and new ideas!

An auditor should be exchanged, if he/she does not provide value for the

organization!

1.4.6 ThecustomersroleThe pressure exerted by customers to achieve an ISO 9001 certificate is not the same

for every organization and the influence of customers on the QMS is different from

organization to organization. If you have a customer who is only interested that

suppliers show a certificate, the focus will be on a quick certification. Consequently,

organizations will prefer to standardize the practice instead of practicing the standard

and will limit their efforts to meet minimal requirements. On the contrary, customers,

who are interested in the actual quality management practices and want to develop

their suppliers, can make a valuable contribution to the effectiveness of the QMS.

1.4.7 AneverendingjourneyISO 9001 is just a framework that organizations need to fill with content themselves.

The QMS and its effects are not determined by the ISO 9000 requirements, but by the

organizational context and the way the system is implemented and operated.

Achieving an ISO 9001:2008 certificate is not the end of the journey. It just means

that a basic QMS is in place. It is a journey without an end! Organization need to use

the QMS and make continuous systematic improvements. Most of the payback on this

investment will show up in later years, when the organization becomes more and

more effective and competitive.

1.5 CoursebookRead more about ISO 9000 in your course book "Quality from Customer Needs to

Customer Satisfaction", chapter 20.


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1.6 Selfreviewquestions1. What is ISO 9001: 2008?2. What is the difference between ISO 9001 and ISO 9004?3. What is a Quality Management System?4. Which are the ISO 9001: 2008 management principles?5. How do you get a certificate?1.7 Assignments1. Why is it important to have an effective quality management QMS?2. What practices and working methods would you expect from an organization

that has an effective QMS?

3. QMS documentation must include a quality policy and quality objectives. Whatare quality policy and quality objectives, and what is the purpose of these?

4. One of the principles of quality management is to base decisions on facts. Thisprinciple appears in ISO 9001 under the title 8.2 Monitoring and Measurement.

What must an organization monitor and measure in order to take evidence-based

decisions? Give two examples.

5. ISO 9001:2008 demands that an organization conducts internal audits atplanned intervals. What is an internal audit?

6. How can you verify that the management system works, that the staff works inaccordance with the procedures and instructions and that the system leads to

continuous improvement?

7. What advice would you give organizations aiming to introduce ISO 9001:2008?Present three aspects.

8. Should all organizations implement a QMS according to ISO 9001: 2008? Whyor why not?

9. Researchers and practitioners can have completely different views on the valueof ISO 9000. The standard can be both perceived as an excellent cornerstone for

quality work and waste of time and money. How is it possible that there are

such different views on the value of ISO 9000?

10. What is an ISO 9001 certificate? How can you obtain an ISO 9001 certificate?Who may issue a certificate?


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1.8 Suggestedanswers1. Organizations need an effective QMS in order to:

ensure that customer requirements are met secure and develop the quality in the organization have consistent, repeatable processes and a common, understood system know more quickly if things are going wrong, and where reduce rework and frustration on spending money or time on the same

problems

fulfill the quality objectives facilitate continual improvement etc.

2. Some examples: clearly defined and standardized processes methods to find out customers requirements quality policy and quality objectives measurements of customer satisfaction continual improvement work internal and external audits taking care of nonconformities preventive and corrective actions management reviews etc.


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3. A quality policy is a comprehensive document, which formulates the directionfor the quality work. It shows commitment and gives an indication of the

importance an organization place upon quality. The policy should be

communicated and understood within all areas of the organization. Top

management should review the quality policy to ensure that is still appropriateto the organization.

The quality policy should set the framework to the quality objectives, which are

the targets sought or aimed by the organization. The quality objectives must be

SMART:

Specific Clear, understandable objectives that has a single aim or

purpose

Give direction as increase, decrease, improve, develop

Measurable

Can be measured quantitatively.

Units of: time, money, number, percent. So that we knowwhen we have reached them

AcceptableSet by those who shall meet the objectives, let everybody

participate. Demanding, but not frustrating.

RealisticLikely to be fulfilled with available resources. Objectives that

are not fulfilled are demoralizing.

Time limitedThe time by which each objective will be accomplished should

be stated

Quality objectives are often set in the following areas: customer satisfaction poor quality costs customer complaints process outcomes on time deliveries market position

4. The organization must monitor and measure: Customer satisfaction. Collect information on customer perception as to

whether the organization has met customer requirements. Have the

organization delivered what customers expected? How is the company

doing compared to competitors? Do customers have unspoken desires or

needs that can be satisfied?

Management system performance. Does the QMS still meet the ISO9001 requirements and the needs of the organization? Does the QMS

continuously improve? Internal audits are a tool for checking this.

Process performance to demonstrate the ability of the processes toachieve planned results

Product performance. Do important characteristics of products/servicesstill meet the requirements?


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5. Internal audits are a kind of self-assessment. An organization should performinternal audits within planned intervals to control if the QMS:

still meets the ISO 9001 requirements, conforms to the plannedarrangements and fulfills the needs of the organization

is effectively implemented and maintained

Internal audits are often performed by selected employees from the

organization. Internal auditors need education and training on:

the ISO 9001 standard how it can be applied in this particular organization how to define and find nonconformities and suggest possible

improvements

Also consultants can be hired to perform internal audits.

Organizations need to plan an audit program that will cover different areas oforganization considering the status and importance of the processes, as well as

the results of previous audits. Also audit criteria, scope, frequency and

methods for auditing need to be defined and documented.

By auditing an organization has the opportunity to identify areas that need to

be improved. Audits also allow employees to learn about other departments.

This is significant in empowering employees and giving them a chance to look

at the larger picture and see how all the pieces of the organization work

together.

6.

This is done in internal and external audits and in the management review.Internal audits are explained in assignment 5.

External audits are performed by third party, usually by independent

certification bodies or customers. An external party is examining the elements

of QMS in order to evaluate how well these elements comply with QMS

requirements. Elements include responsibilities, authorities, relationships,

functions, procedures, processes, and resources. An external audit consists of

two parts:

adequacy audit: evaluation whether the documented procedures comply

with the standards requirements

compliance audit: evaluation whether the documented procedures are

followed by the employees

If the auditor discovers that the documented procedures do not meet the

requirements or the actual working methods differ from documented

procedures, a nonconformity report is written. External audits focus primarily

on checking compliance. The internal audits can however focus on other

things such as identifying opportunities for improvement.

A management review is an opportunity for top management to review the

performance of their organizations management system. Typically,

management reviews are held as regularly scheduled events with topmanagement collecting, analyzing and reviewing performance data such as


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audit results, customer feedback, process performance, product conformity

and any follow-up actions from previous reviews, corrective actions and

preventive actions. As result the review should assess opportunities for

improvement and the need for changes to the QMS, including the quality

policy and quality objectives.

7. A few advices: Do not implement the system just because the customers require it. Think

about what is important for the company. The effort and money spent on

the introduction must pay back

Practice the standard in the important areas, standardize practice only ifthe areas are well developed or not significant

Involve everybody in the implementation work Always think about that the system should provide value for the

organization, not for the auditors

Choose a good and demanding certification body. Change the auditor ifthe audits are not providing value

Involve the customer in the implementation process Keep your management system simple and easy to maintain. Keep the

documentation short and understandable for everyone.

8. No, not all organizations should implement ISO 9001:2008. ISO 9001 is abasic QMS, which is good to have. Especially it is valuable for companies

with low maturity level of quality management. For companies with high

maturity level of quality management it might be an unnecessary burden.

Costs and benefits should be valued. For some companies other quality

improvement strategies are more suitable.

9. ISO 9000 was designed to provide guidelines on quality management forevery kind of organization. The standard is very general and may be

interpreted in many different ways. Consequently, ISO 9001 implemented in

so many diverse business environments may result in many different QMSs.

The most important thing to understand about ISO 9000 is that not the

standard itself, but the way organizations implement it, constitutes the QMS.The benefits achieved from ISO 9001 depend on the level of ambition and

commitment to achieve business excellence. The primary drivers for setting

objectives dont come from ISO 9000 itself, but are influenced by the

organizations position in the supply chain, market position, or simply the

ambition to improve the organizations performance. Organizations

implementing ISO 9000 may also have different maturity levels of quality

management. For some organizations, ISO 9000 may mean a radical change;

for others, it is just the usual way of running the business.


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10.ISO 9001:2008 certificate is an official document which can be issued by anaccredited certification body. In Sweden, these certification bodies are

organizations accredited by Swedac. Certification bodies have the authority to

perform audits. Audits examine the elements of a QMS in order to evaluate

how well these elements comply with ISO 9001 requirements. If therequirements are fulfilled, a certificate is issued. Certification bodies are not

allowed to provide consultancy services!

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