Quality Management System Course

History of quality
1. The Guild : - Was an association of artisans or merchants who controlled the practice
of thei craft in a particular town or area .
The earliest type of guild were formed for tradesmen.
Good flowing into Europe for the first time . For an example , a Carpenter might be a
member of the Joiners Guild.

2. Deming ( Dr. W. Edward Deming ) – The fishbone diagram

„ Quality is everyone’s responsability „
Eliminating the waste was his key message .
„ What could be measured , must be measured exactly „ – Dr. Walter A. Shewhart.

Deming’s 14 key principles :

1. Create constancy of purpose toward improvement of product and service ,

2. Adopt the new philosophy
3. Cease dependence on inspection to achieve quality
4. End the practice of awarding business on the basis of a price tag .
5. Improve constantly and forever the system of production and service.
6. Institute training on the job .
7. Institute leadership.
8. Drive out fear .
9. Break down barriers between departments .
10. Eliminate slogans , exhortations and targets .
a. Elimintane work standards ( quatas ) . Substitute with leadership.
b. Eliminate management by objective.
11. Eliminate barriers that rob the hourly worker of his right to pride of workmanship.
12. Remove barriers that rob people in management and engineering of their right to
pride and workmanship.
13. Institute a vigurous program of education and self-improvement.
14. Put everybody in the company to work to acomplish the transformation.

The Evolution of Quality

During the early days of manufacturing , an operative’s work was inspected and a decision
made whetherto accept or reject it .
Accompanying the creation of inspection functions , other problemes arose .
More technical problemes occured , requiring specialised skills , often not posessed by
production workers.
The inspectors lacked training.

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Inspectors were ordered to accepte defective goods to increse output.
Skilled workers were promoted into other roles , leaving less skilled workers to perform the
operational jobs , such asa manufacturing.
These changes led to the birth of separate inspection department with a chief-inspector.
Whith the creation of this new department , there come new services and issues .
E.g: standards , recordind of data and the accuaracy of measuring equipment.
The quality department evolved , in charge which was a „ quality control manager „ with
responsability for the inspection services and quality control engineering.

1920’s Statistical Theory .

In the 1920’ statistical theory began to be applied effectively to quality control and in 1924
Shewhart made the first sketch of a modern control chart.
Shewhart ,Demind , Dodge and Ronig’s work created the theory of statiscal process control
( SPC).
However , there was little use of these techniques in manufacturing companies until the late
1940’s.

Japanase Manufacturing.
Japan’s industrial system was virtually destroyed .
They had a reputation for cheap imitation products and a illiterate workforce.
The Japanese recognised the problems and set about solving them with the help of some notable
quality gurus -Juran , Deming and Friegebaum.
1950’s Quality Management System .
In the early 1950’s quality management practices developed rapidly in Japanese plants.
Become a major theme in Japanase management philosophy.
By 1960 qualiy control and mangament had become a national preocupation.
By the late 1960’s ,early 1970’s Japan’s import into the USA and Europe incredes significantly.

1960 International Conference .

In the 1969 the first international conference on quality control sponsored by Japan . America
and Europe was held in Tokyo.
In a paper given by Feigenbaum , the term „ total quality „ was used for the first time .

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Ishikawa gave a paper explaning how „ total quality control ” in Japan was different , meaning
„ company wide quality control ”.
Company wide quality management was common in Japanase companies by the late 1970’s.
The Quality Revolution .
The quality revolution in the west was slow to follow and did not begin untile the early 1980’s.
Companies introduced their own quality programmes and initiatives to counter the Japanese
success.
Total quality management (TQM) became the centre of these drives in most cases.
In a departament of Trade&Industry publications in 1982 it was stated that Britain’s world
trade share was declining and this was having a dramatic effect on the standard of living in the
country.
There was intense global competition and any country’s economic performance and reputation
for quality was made up of the reputations and performance of its individual companies and
product/services.
British Standard ( DB) 5750 .
The Bristish Standard (BS ) 5750 for quality system had been published in 1979.
In the 1983 the Nationa Quality Campaing was launched using BS 5750 as its main theme.
The aim was to bring to the attention of industry the importance of qualty for competitivenes
and survival in the world of market place.
The ISO 9001 .
Since then the International Standardisation Organisation (ISO ) 9000 has become the
Internatinally recognised standard for Quality Management Systems.
It comprises a number of standards that specify the requirements of the documentation ,
implementation and maintenance of a quality system.
Total Quality Management (TQM).
TQM is now part of a much wider concept that address overall organisational performance and
recognises the importance of processes.
There is also extensive research evidences that demonstrates the benefits of the approach.
What is Quality ?
Quality = the standard o something as meassured against other things or a similiar kind ( by
the oxford dictionary) .
Quality by the definition on IS) 8402 :
Quality = The totality of features and characteristics of a product or service that bear on
its ability to satisfy stated or implied needs.

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Calitatea = Totalitatea trasaturilor si caracteristicilor unui produs sau serviciu ce are
abilitatea de a satisface nevoile declarate sau implicite.

ISO 9000: 1987 Version:

ISO 9000 : 1987 had the same structure asa the British Standard BS 5750.
Three models for quality management systems selection
Based on the scope of activities at the organisation.
ISO 9001 : 1987 Version:
Model for quality assurance and design , development , production installation and servicing.
ISO 9002 : 1987 Version :
Model for quality assurance and production installation and servicing .
Bassically the same material as ISO 9001 but without covering the creation of new products.
ISO 9003 : 1987 Version :
Model for quality assurance and final inspection and test covered only the final inspection of a
finished product with no concern for how the product was produced.
Influenced by existing US and others defence standards and military specifications.
Well suited to manufacturing the emphasis was placed on conformance with procedures rather
that the overall process management.
ISO 9000 :1994 Version :
Quality assurance via preventive actions by checking final product.
Continue to require evindence of compliance with documented procedures.
ISO 9002 : 2000 Version :
Combines the three standards 9001 & 9002 to 9003 into one called 9001.
Design development proceduress are required only for company that engages in creation of
new products.
Demands involment by upper executives.
ISO 9000: 2008 Version :
Uses the same numbering system as ISO 9001 : 200 to organize a standard .
No new requirements have been odded however same important clarifications and
modifications have been made.

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ISO 9000: 2015 Version :
The most noticeable change to the standard is its new structure. ISO 9001:2015 now follows
the same overall structure as other ISO management system standards (known as the High-
Level Structure), making it easier for anyone using multiple management systems.
Main changes in ISO 9001 for 2015 include updates to the requirements and guidance related
to risk management, change management, and supplier management. Additionally, the
standard has been revised to be more concise and easier to understand

What is ISO 9001 ?

ISO 9001 contains all the requirements which an organisation must address within the QMS if
they wish to be certified againts the standard.
The majority these requirements would be indentified by many as common sense topics which
they should want to address , in order to run their business well . Eg: sales , design , purchsing
, training , calibration and test equipments as well as control of records.
ISO 9001 is written by a committee and is designed for use in any type of organisation.
This means there are compromises in the wording standard and some interpretation is often
needed.
There are 8 sections in ISO 9001 :
1. Scope.
2. Reference
3. Terms and definitions
4. Quality management system
5. Management responsability
6. Resource management
7. Product realization
8. Meauserements , analysis and improvement.
The ISO 9001 keys to sucess :
In sections 4 ,5 ,6, 7 & 8 which contains requirements themselves and organisations whising
to be certified against ISO 9001 will need to demonstrate that they have all these requirements.
There are over 250 individual requirements in ISO 9001 that can be condensed into fove
key statements:
1. Determine the needs and expectations of the customers.
2. Establish policies , objectives and work environment necessary to motivate people to
satisfy these needs.
3. Design , resource and manage a system interrelated processes to implement the policy
and attain the objective.

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 4. Measure and analyze the effectiveness of each process in fulfilling its objectives.
5. Pursue the continued improvement in the system from a objective evalution of its
performance.
ISO 9001 : 2008 Approval .
ISO 9001 : 2008 registration gives an organisation a benefit an objectively evalueted enforced
QMS.
It is a tangible expression of an organisation’s commitment to quality that is internationally
understood and accepted.
ISO 9001 : 2008 registration is carried out by certification bodies ( registrars) , acredit
organisations that review the organisation’s quality manual and working practices to ensure
they meet standards.
It is important when an organisations is certified ISO 9001 , it is cleat which aspects the the
organisations are covered by the certificate.
This is addresed through the scope of registration and must be clearly indentify what is included
so as not to mislead.
It is a requirement that all elements of the ISO 9001 must be addresed by the organisation.
However , their are specific circumstances under which certain requirements of the standard
can be excluded , yet compliance with ISO 9001 still be claims.
Any excluded requirements does not affect the ability og the organisation to meet customer
and regulation requirements.
Any excluded requirement does not affect the ability of the organisation to provide conforming
products or services.
Any excluded requirement must only come from section 7 ( product realization ) of ISO 9001.
An example must be customer property . Clearly if a company never deals with such property
then the requirement would not be applicable .
The company’s quality manual mus also cleary indentify which specific requirements of the
ISO 9001 have beem excluded and a justification for the exclusion.
What ISO 9001 is not :

ISO 9001 is not a product standard -it contains no product requirements.

It is a series of generic requirements for QMS.
Approval of ISO 9001 does not guarantee the product or service quality . Customer focus
leadership , not standards produce satisfied customers.

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Where ISO 9001 Can Help ?

85 % of business have under 250 employess

Around half of the business have under 50 employess
The value of investing in a QMS and how it can help the challenge small business face :
Problem :
Growing too fast : While growth is desirable , over expansion is a serious errror . Set
realistic goals and expand only as needs dictate.
Solution: With well defined process you will be able to indentify where the pinch points will
come from taking a new business and react accordingly.
Problem :
Failling to track yout finance : Look at business that fail and you will find that many of
them took on too much debt and failed to manage the cash flow.
Solution : Managing cash is critical in small business . Being close to customers and
delivering on their expectations should mean that payments are made on time and queries
delaying payment reduced.
Problem :
Lack of reserve capital : Be prepared for unexpected increseas in the costs of things like
utilities , materials and labour . Make sure you keep enough reserve cash to carry you through
tough times and seasonal slowdowns.
Solution : By measuring and monitoring your process performance and driving on
improvement in efficiency you will be able to keep costs to a minimum and be aware when
overruns in labour or material occur.
Problem :
Poor execution : Poor customer service and overall employee incompetence will quickly
sink your business . Make sure your employees place a premium on customer service .
Develop systems and processes for how to tasks should be accomplished and create internal
control to monitor them.
Solution : The core requirement of ISO 9001 is meeting customers expectations and
managing satisfaction . The regular audit of internal precess and management of satisfaction
will ensure that your focus on customers is maintained.
Problem :
A inadequate business plan : A well thought out business plan forces you to think the future
and the challanges you will face . It also force you to consider your financial needs , your
marketing and management plans , your competition , and you overall strategy.

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Solution: Having a plan is critical but it’s also important that the plan is communicated
throughout the business and everyone knows their role and its trained to do the job .
ISO 9001 pays particulat attention to this .
Problem :
Failling to change with the times : The ability to recognize opportunities and be flexible
enough to adapat is crucial to surviving and thriving . Learn how to wear multiple hats ,
respond nimbly , and develop new areas of expertise.
Solution : The focus on customers and requirements to continually improve will assist in
keeping you focused on changes in the market place . The system will also assist in ensuring
that the agreed change is carried out in a structure maner.
Problem :
Ineffective marketing : Customers can’t do business with you if they don’t know you’re
there . It doesn’t cost a lot to advertise and promote your business through online marketing ,
social media , e-mail , local search and more.
Solution : With quality at the forefront of you business , your proffesionalism will reflect
your reputation .
Problem :
Understanding the competition : Customer loyalty doesn’t just happen – you have to earn it
. Whatch your competition and stay one step ahead of them . If you don’t take care of your
customers , your competition will.
Solution : Measurement of customer satisfaction is a key part of ISO 9001 so you will be
able to indetify trends in retention and repeat purchase , two indicatoris of customers
satisfaction.
Benefits of the numbers :
75 % of businesses improve their levels of customer satisfaction and loyalty .
77% of businesses improve their operational performance .
74% of businesses aquaire new customers and retain existing clients.
44% of businesse achieve cost savings..

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 Writing your own QMS .
Clause 4.1. General Requirements
Clause 4.2. Documentation Requirements :
1. General Quality Manual ;
2. Control of documents ;
3. Control of records ;
QMS = A system managing structure , responsabilities , procedures , processes and
resources to implement the principles needed to achieve the quality objectives of an
organisation.
The QMS Objectives :
Cutomer focus : Actively reviewing customer needs through dialogue , making customers
aware of new products and services ; ensuring the organisation is aware of customer needs ;
corrective actions when the service fail to meet expectations.
Continual improvement : of products , services , working environment , staff development ,
and management and production processes.
Reduced waste : a reduction in waste products , repeated /corrective work and unnecessary
processes.
The main components of a QMS :
• The active and positive commitment of senior management
• Good two way communication throughout the organisation that encourges a culture of
innovation and improvement.
• Simple , efficent monitoring systems that enable all levels of management to indentify
bottlenecks and waste.
• Staff development that provides the corect level of compentence for each job , and
provides staff with opportunities to progress .
• Documentation that supports the above.
The benefits of a QMS :
• Improved customer satisfaction
• Improved quality of products and services
• Worker’s satisfaction and more commitment to the organisation.
• Better management and a more effective organisation
• Improved relations with suppliers
• Improved promotion of corporate image
The indirect benefitis of a QMS :
• Review business goals and asses how well the organisation is meeting those goals .
• Indetify processes that are unnecessary or inefficient and then remove them or improve
them.
• Review the organisational structure , clarifying managerial responsabilities .

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 • Improve internal communication and business and process interface.
• Improve staff morale by indentifying the importance of their output to the business and
by involving them in the review and improvement of their work
The risks of implementing a QMS :
• Short-term increase in production costs during training and implementation of the
QMS.
• Dissatisfaction of te staff because of new methodology . Eg: Resistance to change and
perceived risk of „ exposure ”
• Another set of rules and papers without actual results . Eg: Documents that reflect what
management think is happening , not what is happening.
• No improvement of quality level in the final product -additonal bureaucratic effort with
no gain .

What is ISO 9001 Clause 4 ?

Clause 4 defines what is required in a QMS . Under clause 4 there are two major categories.
1. General Requirements
2. Documentation requirements
The documentation requirements includes general provisions , the need for a quality
manual , control of documents and appropiate control of records.

4.1 General Requirements :

The organisation shall establish document ,implement and maintain QMS and continually
improve its effectiveness in accordance with requirements of this International Standard.
The organisation shall :
a) Determine the process needed for the QMS and thei application troughout the
organisation.
b) Determine the sequence and interaction of these processes
c) Determine criteria and methods needed to ensure that both operation and control of
these processes are effective.
d) Ensure the availability of resources and information necessary to sport the operation
and monitoring of these processes.
e) Monitor measures where applicable and analyse these processes
f) Implement actions necessary to achieve planned results and continous improvement of
these processes.
These processes shall be managed by the organisation in accordance with the requirements of
this International Standard.
Where a organisation choose to outsource any process that affects product conformity to
requirements , the organisations shall ensure control over such processes . The type and extent
of control to be applied to these outsoureced processes shall be defined within the QMS.

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4.2 Documentation requirements .
4.2.1. General .
a) Documented statements of a quality policy and quality objectives .
b) A quality manual
c) Documented procedures and records required by this International Standard.
d) Documents , including records determined by the organisation to be necessary to ensure
the effective planing , operatiom and control of its processes.

4.2.2. Quality Manual.

a) The scope of the QMS includind of and a justification for any exclusions.
b) The documented procedures established for the QMS or reference to them
c) A description of the interaction between the processes of the QMS.
4.2.3. Control of documents.
Documentes required by the QMS shall be controlled . Records are a special type of document
and shall be controlled according to the requirements given in 4.2.4.
A documented procedure shall be established to define the controls needed :
a) To approve documentes for adequacy prior to use .
b) To review and update as neccesary an re-approve documentes .
c) To ensure that changes and the current revision status of documents are indetified.
d) To ensure that relevant versions of the applicable documents are points of use.
e) To ensure that documentes of external origin determined by the organsiation to be
necessary for the planning and operation of the QMS are indentified and their
distribution controlled .
f) To prevent the unitended use of absolute documents and to apply suitable
indentification to them if they are retained for any purpose.
4.2.4. Control of records.
• Records established to provide evidence of conformity to requirements and of the
effective operation of the QMS shall be controlled.
• The organisation shall establish a documented procedure to define the controls needed
for the indentification , storage , protection , retrieval, retention and disposition of
records . Records shall remain legible , readly indentificable and retrievable.

Quality Managemen System.

Clause 4.2.
Clause 4.1
Documentation requirements
General

Requirements General Quality Control of Control of

Manual Documents Records

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 QMS Implementation.
5.Management responsability.
5.1. Management commitment.
The standard recognizes that a effective quality program requires involvment and commitment
of the organisation’s top management.
Therefore the standard assigns top management the following responsabilities:
• Overseeing the creation of the QMS.
• Communicating the importance of the meeting requirements , including customer ,
legal and regulatory requirements.
• Establishing the quality policy and quality objectives .
• Communicating with parties responsible for product and service quality.
• Providing adequate resources for the operation of the QMS.
• Reviewing the operation of the QMS.

5.2. Customer Focus.

Top management must ensure that customer requirements are understood and met with the
goal of improving customer satisfaction .
5.3. Quality Policy.
The quality policy indentifies the main goals of the QMS . The quality policy must be :
• Appropiate to the organisation’s purpuse;
• Include a commitment to met customer , legal and regulatory requirements.
• Create a background for establishing quality objectives.
• Communicated throughout the organisation
• Review for ongoing suitability to the needs of the organisation and ist customers.
5.4. Planning
5.4.1. Quality objectives.
Establish measureable quality objectives that support the quality policy and communicate them
troughout the organisation.
5.4.2. QMS Planning.
Plan the QMS so that the quality objetives are met and so the system continues to work as it is
changed to incorporate improvements.
5.5.Responsabilities.
5.5.1.Reponsabilities and authority.
Effective work on a cleat understanding of each persons responsability and authority .
Therefore responsability and authority must be defined and communicated.

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5.5.2 Management representative.
Top management must appoint a manager to have ongoing operational responsability for the
QMS . This person is refearred to as the Management Representative. This duties of the
Management Representative include :
• Ensuring that the processes needed for the QMS are established , implemented and
maintained.
• Reporting on the performance of the QMS and any improvements needed.
• Promoting awarness of cusotmer requirements throughout the organisation.
5.5.3. Internal communication.
Top management needs to set up an effective system of communication to ensure effective
operation of the QMS.
5.6. Management Review.
5.61. General.
Top management is required to regularly certain aspects of the QMS to make sure that the goals
are being achieved and to look for ways to improve the QMS . The review must cover suitability
, adequacy , and effectiveness of the QMS. The review also includes assessing opportunities
for improvement needed changes to the QMS , quality policy and quality objectives . Records
of these review must be kept.
5.6.2. Review Input.
The meeting must address the following areas :
• Internal audit results
• Customer feedback
• How well processes have been working
• Status of previously indentifed problemes
• Intems indentifed for follow-up in previous management reviews .
• Planned processes or product changes that could affect quality.
• Recomandations for improvement generated through the operation of the QMS.
5.6.3. Review Output.
These reviews result in decisions and actions related to :
• Improving the QMS.
• Improving the product.
• The need for aditional resources , including human resources.

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What is a steering team ?
A team led by top management that will coordinate and lead the implementation project.
The ISO Steering Team will :
• Indentify what procedures need to be developed and indentify people to work on the
procedure ; they make up a „ Task Team ” for that procedure.
• Lead each team
• Assign start dates and completion dates for each team , and put together a Gant Chart
for the project . Not all teams will be active at one time.
• Meet on a schedule basis to evaluate progress , answer questions from the teams and
evaluate resource needs for the implementation.
• Review and Approve procedures as they are completed.
Roll Out :
1. Train employees in the basics of ISO 9001 .
2. Task Teams hold team meetings to :
• Review procedure templates and current processes
• Review Gap Analysis results
• Edit procedure template for the organisation.
• Submit the edited procedure to the ISO Steering Team for approval .
• Take any necessary action to implement the new procedure.
3. The ISO Steering Team will review the procedures m they will approve or sugest
changes.
4. The new QMS will be used for several months while records are collected and
improvements made.

Tips and Tricks.

1. Establish commitment.
Implementation tasks takes time and resources . Make sure you have commitment before
starting the projet.
Tips:
• Know why you implementing ISO 9001 . It is because a client or a market is asking for
you ro register ? It is for the internal benefits ?
• Is the motivation coming from the executive management .
• Keep the reasons for implementation visible during your project to retain commitment
and stay focused on the end goal.
• Assign an ISO Steering Team . This team should be made up of management from the
different areas of the company.Include de Management Representative and people that
have the authority to devote resources of the project and remove road blocks.
Common setbacks :
• Assignig responsability for implementation to one person or department.

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 • The ISO 9001 QMS is a Management System
• It is not a quality control program and cannot be implemented by Quality Assurance
alone .
• Losing commitment during the project
• During implementation other projects come up that compete for people’s time and
resources . Ask decisions makers if ISO implementation is still a goal.

2. Prepare an implementation.
A good project plan si a key of a succesful project.
Tips :
• Conduct a Gap Analysis. Compare your current system to the requirements of the
standard . Determine what is already in place , and what needs to be implemented .
From this you can prepare a task ist for each of the sections of the standard .
• Have an ISO Steering Team create „ Point Teams ” for each of the sections that apply
to your organisation.
• Determine team membership and the timeline for each team. Use information from the
Gap Analysis and tasks list to determine the appropiate people for the team and estimate
the timeline.
Common setbacks :
• Proceeding without a plan . Without a plan projects tend to run indefinetily without
sowing measurable progress . By having a plan you have a specific deadlines to meet.
You can show progress as you meet the deadlines and take action if you are not meeting
deadlines,
• Not having the ISO Steering Team approve and support the plan. The ISO Steering
team will be watching the timeline , coordonating and implementing the plan . They
should have input and approval of the plan , or better yet , prepares the plan.

3. Kick-off the Project in a Big Way.

Let everyone in the company know you have started your project , Hold the basic ISO 9001
training for all employees.
Tips:
• Include some sort of celebration in the kick-off . Eg: a lunch for employees , a picnic ,
a prize or a cake.
• Use this training and celebration to inform employees of the Plan and Timeline.
• Tell emplyees how they will be involved and how they will be affected by the project.
• Communicate why this will be good for the company and good for the employees.
Common setbacks :
• No kick-off . Employees that are working on the project are aware but others in the
company are not . When the new procedures that are implemented ,employees dont’t

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 know why and there is little support for the ISO project. Non-conformances are
common place in this environment.
• Training on ISO 9001 but no information on why the company is doing this or how
employees will be involved. This can result in the employees thinking another
management program , how long will this one last ?

4. Design and document the QMS.

Use information from Gap Analysis and Project Plan . Use people currently involved in each
processes to make changes to the existing processes and bring it into compliance with the
standard .
Tips :
• Use the ISO Steering Team and Point Teams for the Design and Documentation . The
ISO steering team meets in regulary basis. During those meetings the team reviews the
timeline , reviews what the Point Teams are working on , removes roadblocks , resolves
conflicts and reassigns resources as needed to keep the project on track.
• The Point Teams meet on an as needed basis according to the timeline . When the Point
Team meet ,they address the tasks on their task list.
• Spread out the Point Teams on the timeline so you don’t have too many meetings at
one time . For example , you may want to have the document control team meet early
in the project to establish a system to collect and control the documentes that will be
generated but the internal Audit team would meet later in the process because sudits
will not begin until the system is complete.
• Keep the Point Team on schedule . Review their task list at the ISO Steering meetings
, watch for problemes and delayes , and give them help as soon as problemes arise.
• Have each member of the Steering Team lead several Point Teams . Each Point Team
should have a ISO Steering Team member for a leader. This allows you to coordinate
the work of different teams.
Common setbacks:
• Poor team make-up. Make sure to include people involved in the process. For example
, use purchasing staff for the purchasing team.
• Not meeting timelines . Establish realiste timelines for the plan ; teams should be able
to meet them with small changes . If the teams are not expected to meet deadlines ,
other tasks will take precedence ; the project will drag on and lose energy.
• Misinterpretation of the standard . If you don;t understand what is required by the
standard you may waste time and resources doing things that are not required , frustrate
team members , and miss importand requirements of the standard.
• No central point of collection and control of the new documentes . If the document
control system si not developed early on in the project you create confusion on what
documents are final , what has been approved , what is the final revision , where is the
electronic file , eas it distributed .
• Not establishing documents templates early on in the process. If you don’t format and
distribute document templates for procedures and work instructions you will not get

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 consistent documents .You will need to go back at the end of your project and redo
documentation.
• Lack of communication during the project . Remember , employees that are not Point
Team members may not hearing much about what is going on with the project .
Employees may think the projectfaded away. Communicate with newsletters , bulletin
boards or meetings.

5. Run the System for three months.

Once the system is complete , follow documented procedure , conduct internal audits and
management reviews and make improvements to the system.
Tips:
• Start off with an additional training for all employees . Summarize the new quality
systeme emphasizing their responsabilities .Review the timeline for running the system
and conducting audits.
• Schedule internal audits so you can audit the entire system 2 times before the
registration audit . This allows you to find non-conformances and fix them before your
registrar comes in.
• Keep corrective work actions on schedule .
• Hold management review at least once before your audit ( required ) . More is better.
Common setbacks:
• Lack of communication with employees . Employees that have not been involved in the
design and documentation of the quality system will not be as aware of the requirements
of the quality system. Training and communication are critical to get tehm involved.
• Lack of follow through on corrective actions . The new system will generate numerous
corecive actions . If they are not investigated and completed , your system will not be
ready for a registration audit.
• Ineffective management review . Management must take a close look at data from the
quality system , evaluate it and take action.

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 What is the PDCA Cycle ?

• The plan -do-check-act (PDCA ) cycle is the foundation of all ISO management
standards.
• The cycle ensures development , continuous improvement and control of the
management system in question.
• It is a simple tool that ensure constant monitoring of your organisation’s effectiveness.

Plan

Act Do

Check

Plan – Establishing the architecture of your QMS is covered in clause 4.1. of the standard.
Do – Implementing the plans and using the QMS.
Check – Review if the results are satisfactory at appropiate intervals againts ISO 9001
requirements.
Act – Improving the QMS or acting at the challenges and issues found in the reviews.

Plan – Mangement Responsability .

The PDCA cycle starts with management as it is up to them to indentify appropiate process
and relevant area of focus.
Process indentification.
• Appropiate process indetification is essential to a practical system and the key to start
with two processes ( Management and Operations ) and then decide if sub-processes
are necessary rather than working „ bottom up ”.
• Each process has to also have an „owner” that is responsible for the activities relate to
the success criteria for the process.

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Planning and review :
In order to succesfuly plan your quality system before implementation , a quality manual and
a number of documents outlinig procedures are required . The areas of documentation are :
• Document control
• Records control
• Internal Audits
• Non-conforming product
• Corrective actions
• Preventive actions

• Additonal procedures may be required if without them , the process might end up
having variable or unpredictible results such as those caused by inexperienced staff ,
complicated parameters or other risks.
• The QMS is after all , a system for minimazing business risks.
Fundamental direction :
Owners or managers of your organisation should establish the fundamental direction of the
QMS using the Quality Policy . There are several aspects that have to be though through while
designing the Quality Policy :
• Strategy : Should follow from the Quality Policy and the business environment.
• Process Criteria : should be aligned to the strategy
• Customer focus : system process have to be design to ensure customer satisfaction
• Resources : human technological and environmental resources have to be put in place .
The QMS requires that each company establish a way their staff are competent.

• Having established the system , it has to be used to see that it works in the way it
was intended . It will be necessary to use the procedures , forms , equipment and
instructions in the way it was planned .
• Dont’t worry if some of the steps don’t apply to you , ISO 9001 certification is
designed for every type of organisation , you just work on the aspects that are
relevant to you .

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 Do- Implementation and Use.

Fundamental direction :
The direction from your management and the assigned resources should make this part of the
process fairly easy to implement . It is important to plan and define the process all along the
supply chain , this might include :
• Sales
• Purchasing
• Research and development
• Manufacturing
• Delivery

Check – Review of Results .

• At appropiate intervals , the results of the QMS should be reviewed .

• The intervals will be short when the system si new but can be longer once the QMS
becomes mature,
• The reporting of results against the process success criteria should be regular and be used
by management to ensure that the business in on track.
• Records should be designed to facilitate prompt recording and the early detection of
problemes.
• Dont’t worry if your organisation has some problemes , every organisation has them , but
a successfull one will indentify these at a early stage and deal with them in a effective
manner.
• A key milestone in evaluating the QMS is the management review , a meeting which
assesses whether the QMS has successed in meeting :
- Strategic objectives
- Process success criteria
- ISO 9001 requirements.
• Reviewing perceived customer satisfaction is a key metric that has to be rewiewed . It is
recognised that the handling of complaints it is not enough ; customers may just move their
business to a competitor.
• Probably the most important characteristic of a successfull QMS is internal audits.
• It is expected that an organisation that does not do internal audots is very likely to have
their certification revoked ( If they have ISO 9001 certification ) as their system is probably
out of control.

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 Act- Continuous Improvement

• Improvement is another name to dealing with challanges of the organisation.

• Challenges can be tackled with corrective actions or , preferably with preventive actions.
• All corrective actions needs to be recorded and preventive actions designed for recurring
problemes.
As a check list , the following questions should be asked :
- Customer focus : Have you found out what the customer’s current and future need an
expectations are at a strategic level ?
- Quality policy : Does it really suit your organisation and reflect your customer’s
expectations, your vision and your mission – and the requirements of the standard ?
- Objectives : Are all objectives measurable and linked to both the processes and to the
strategies ?
- Plan the system : Have all responsabilities been indentified and communicated ? Does
everyone know what they need to do to contribute to the success of the business – and
the QMS ?
- Review at regular intervals : Are the results of the QMS being reviewed and
compared against planned results ? Is action been taken to improve areas results where
results are not quite as good as planned ?
- Principles : Management should review the 8 principles and how well the system
delivers against these.

8.5.1. Continual Improvement .

Continual improvement can be initiated through the use of quality policy , quality objective ,
audit results , analysis of data , corrective and preventive actions and management review .
This requirement covers both the reactive and proactive action of improvement .
Clause 8.5.1.
Continual improvement draws together various aspects of the QMS :
- Quality policy
- Quality objectives
- Audit results
- Data analysis
- Corrective actions
- Preventive actions
- Management review

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 ISO 9001 requires continual improvement of the effectiveness of the QMS . Continual
improvement is driven by the objectives set by top management . As a minimum , quality
objectives should address :
- The improvement of internal efficenty
- Individual customer requirements
- The level of performance that your industry expects
There is no requirement that the organisation should set objectives for improvement of all its
process at any one time . It would be unrealistic to expect an organisation to make progress in
all potential improvements simultaneously.
Each improvement will require the commitmnet of resources , which should be prioritesed by
top management , especially if investement is required .
How to indentify what need improving ?
Inputs for improvement opportunities are obtained from :
- Customer satisfaction
- Customer complaints and feedback
- Market research and analysis
- Inputs from employees , suppliers , and other interesed parties
- Internal and external audits of the quality system
- Records of product or process non-conformance
- Data from process and product characteristics and their trends.
Opportunities for improvement may also be indentified on a special project basis. The
following are example of such projects :
- Non value added use of floor space
- Excessive inspection/testing
- Excessive handling and storage
- Excessive failures and costs to quality
- Machine set-up change over times.
The Principle of Continual Improvement .
• The organisation shall establish document implement and maintain QMS and
continually improve its effectiveness in accordance with the requirements of
international standard . The organization shall :
- Indetify the processes needed for QMS and their application throughout the
organisation,
- Determine the sequence and interaction of these processes .
- Determine the criteria and methods needed that both the operation and control of these
processes are effective.
- Ensure the availability of the resources and information necessary to support the
operation of the processes.
- Monitor , measure and analysis these processes.

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 - The organisation shall continually improve the effectiveness of the QMS trough the
use of the quality policy , quality objectives , audit results , analysis of data , corrective
and preventive actions and management review.
- Continual improvement requires management support . Top management shall provide
evidence of its commitment to the development and implementation of the QMS and
continually improving its effectiveness.
- Continual improvement of the effectiveness of the QMS must be included in the qualty
policy.
- Also management review which must be carried out and planned intervals must include
the assessments of opportunities for improvement and the need for changes to the QMS
, including quality policy and quality objectives.
- As to the requirements of the process , measurement , analysis and improvement , the
organisation shall plan and implement the monitoring , measurement , analysis and
improvement of the product , to ensure conformity of the QMS and to continually
improve the effectiveness of the QMS.
- This shall include determination of applicable methods , includind statistical
techniques and the extent of their use .
- Management should continually seek to improve the efficency and effectiveness of the
processes of the organisation , rather that wait for a problem to reveal opportunitiess
for improvement.
- Improvements can range from small steps ongoing continual improvement to strategic
breaktrough improvement projects.
- The organisation should have a process in place to indentify and manage improvement
activities of these procesess.

Process for Continual Improvement.

We have looked at the PDCA cycle and the continual improvement process should be
incorporated into it and involve the following steps :
a) Reason for improvement : a process problem should be indentified and a area of
improvement selected , nothing the reason for working on it.
b) Current situation : the effectiveness and efficienty of the existing process should be
evaluated . Data to discover what types of problemes occur must often should be
collected and analysed . A specific problem should be selected and an objective for
improvement should be set.
c) Analysis : the root causes of the problem should be indentified and verified .
d) Indentification of possible solutions : alternative solutions should be explored . The
best solution should be selected and implemented.
Ex : The one that will eliminate the root causes of the problem and prevent the problem
from recurring.
e) Evaluation of effects : it should be confirm that the problem and its root causes have
been eliminated or their effects decreased , that the solution has worked and the
objective for improvement has been meet.
f) Implementation and standardization of the new solotion : the old process should be
replaced with the improved process , thereby preventing the problem and its root causes
from recurring.

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 g) Evaluation of the effectiveness and efficiency of the process with the improvement
action completed : the effectiveness and efficiency of the improvement project should
be evaluated and consideration should be given for using it solution elsewhere in the
organisation.

To summarise:

• Continuual improvement : This is clearly definded in ISO 9001 Clause 8.51. „

Continual Improvement ” . Normally a Continual Improvement project its initiated by
the top management , particulary if there is cross functional involvement . A project
team is ussualy formalized and supported with resources to carry out the improvement
project.
• Corrective Action : This is clearly specified in ISO 9001 Clause 8.5.2. „ Corrective
Actions ” . Whenever nonconformity is encountered in QMS , the problem must be
resolved without undue delay according to the corrective action procedure established
in QMS .It is a requirement that the corrective action should be effective in eliminating
the root causes of the nonconformity to prevent its recurrence.
• Preventive Actions : This requirement is defined in ISO 9001 Clause 8.5.3.
„Preventive Actions ” . Through the analysis of data on processes , products ,suppliers
, customer feedback , audit , etc , potential nonconformities could be indentified and
preventive actions taken. Preventive actions shall be taken accordind to the established
procedure in QMS and it is a requirement to review the effectiveness of such actions
taken.

Kaizen .
Kai = Change ; Zen = Good . „Simple means change for better ”.

• In English Kaizen is typically applied for implemeting continuous improvement .

• Kaizen is an approach to activity organisation based on common sense , self -discipline
, order and economy.
• Kaizen method is a strong contribuitor and fundamental part of a lean production
process model in lean manufacturing.
• It is also appplicable to lean software development.
Lean manufacturing is a methodology that focuses on minimazing waste with
manufacturing systems while simultaneously maximazing productivity.
The history of Kaizen begin after WW2 when Toyota first implemented quality cycles in its
productuon process.
Masaaki Imai founded in 1985 the Kaizen Institute Consulting Group.

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The Kaizen method follows ten specific principles , which are described below :
1. Improve everything continuously
2. Abolish old ,traditional concepts
3. Accept no excuses and make things happen
4. Say no to the status quo of implementing new methods and assuming they will work.
5. If something is wrong , correct it.
6. Empower everyone to take part in problem solving .
7. Get information on opinions from multiple people.
8. Before making decisions ask „ Why ” five times to get to the root cause.
9. Be economical . Save money through small improvement and spend that money on
further improvements.
10. Remember that improvement has no limits . Never stop trying to improve.

The 5W and 1H of Kaizen :

Who ?
1. Who does it ?
2. Who is doing it ?
3. Who should be doing it ?
4. Who else can do it ?
5. Who else should do it ?
What ?
1. What to do ?
2. What is being done ?
3. What should be done ?
4. What else can be done ?
5. What else should be done ?
Where ?
1. Where to do it ?
2. Where is it done ?
3. Where should it be done ?
4. Where else can it be done ?
5. Where else should it be done ?
When ?
1. When to do it ?
2. When is it done ?
3. When should it be done ?
4. What other time can it be done ?
5. What other time should it be done ?

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Why ?
1. Why does he do it ?
2. Why do it ?
3. Why do it there ?
4. Why do it then ?
5. Why do it that way ?
How ?
1. How to do it ?
2. How is it done ?
3. How should it be done ?
4. Can this method be used in other areas ?
5. Is there any way to do it ?

The Seven Waste ( Muda ) .

Kaizen method strives toward perfection by eliminating waste ( muda ) in the workplace.
The goal of Kaizen is production whitout waste by increasing standardized activities and
process.
Industrial engineer Taiichi Oho the father of the Toyoto Production system noticed that there
is an 80% loss in every process and the value of the process is less than 20%.
After analyzing manufacturing processes , Taiichi Oho was able to indetify which steps add
value and which ones do not .
As a result he developed a better way for organisation to indetify waste with his „ Seven Waste
” model . These wastes include :
1. Delay : waiting or time spent in a queue with no value added . A large part of an
individual product’s life is spent waiting to be worked on .
2. Producing more that you need : Over production ussualy hides and/or generates all
the others . It leads to excess inventory , which then requires the expenditure of
resources and storage space and preservation.
3. Over proccesing or undertaking non-value added activity : Over processing occurs
when work is performed on a piece that what is required by the customer.
4. Transportation : Each time a product is moved , it stands the risk of being damaged ,
lost , delayed , etc as well as being a cost for non added value.
5. Unnecessary movement or motion : Motion refers to the damage that the production
process inflicts on the entity that creates the product . This may be either over time (
wear and tear for equipment and repetitive strain injuries for workers) or during sicrete
events ( accidents that damage equipment and/or injure workers ) .
6. Inventory : Whether it is in the form of raw materials , work-in-progress , or finished
good , represents a capital outlay that has not yet produced an income , either by the
producer of for the customer.

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 7. Production of defects : Defects cause extra costs for reworking the part and can
sometimes result in doubling the cost of a simple product.

Learning outcomes :
1. Definition of quality.
2. The History of quality management
3. The various QMS styles.
4. The sections needed in a QMS.
5. How to create your own QMS
6. How to implement a QMS.

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