Updating Ims Program To Meet Iso 9001-2015
Updating Ims Program To Meet Iso 9001-2015
Thesis
CENTRIA UNIVERSITY OF APPLIED SCIENCES
Industrial management
April 2015
ABSTRACT
The purpose of this thesis was to improve and update the quality management system of
Pohjanmaan Metalli Oy by using IMS software. In addition to general improvement work,
objective was to develop the quality management system so that it can get an ISO 9001-
2015 quality certificate. The improvement and development of the quality management
system of a company were a methodical and long- spanned activity in both short and long
terms. The ISO 9001-2015 quality standard was presented the guidelines for improvement
of quality management system. On the other hand, IMS software may be utilized to the
extent that was purposeful in the terms of the organizations targets and needs.
In the theoretical part, the term of quality and quality management system was clarified
from different points of view and also IMS software was clarified based on process
illustration tool, a document management tool, processing tool for feedback and
evaluations, a separate section for an organisations indicators, a task management tool and
editor for creating manuals. Moreover, ISO 9001-2015 focused on the three enhancements
related to the context of the organisation, the introduction of risk based thinking and
elaboration of how to manage quality objectives.
In the practical part the quality project of Pohjanmaan Metalli Oy was reviewed from the
development plan to practical implementation and certification readiness throughout the
IMS software. According to the research the company has improved their external corporate
image, quality management system and development activities through the IMS software.
Moreover, this research developed their internal process to enhance their working
capability.
Key words
Quality Management, IMS, ISO 9001
CONCEPT DEFINITIONS
CONCEPT DEFINITIONS
PREFACE
1 INTRODUCTION 1
5 ABOUT ISO 21
5.1 ISO 9001 21
5.2 ISO 9001-2008 23
5.3 ISO 9001-2015 23
REFERENCES 49
1
1 INTRODUCTION
The objective of this thesis was to update the quality management system ISO 9001-2008 to
ISO 9001-2015 standard by using IMS system for Pohjanmaan Metalli Oy. Now the present
situation of Pohjanmaan Metalli Oy has IMS system, production control system according
to the EN-1090 standard. Quality management system was designed to the IMS system based
on production control system EN 1090-1 that can be easy to understand and it could be used
efficiently as a part of the business management system.
The thesis was commissioned by the company, which provides welding manufacturing
component, structural steel, design and sales. In this thesis, the target was to meet the ISO
9001-2015 requirements and update Integrated Management System software. All process
description should be based on ISO 9001-2015 requirements and information should be in
the IMS system. If the company has any limit, then it will be described what is the missing
and what should be done to fulfill the ISO 9001-2015 requirements.
For meeting the ISO 9001-2015, research work method will be used for quality management
system. Moreover, in this thesis IMS program was studied by company to update IMS
program. After that a self-evaluation was made. This thesis consists of two parts. The first
theoretical part of this thesis discusses the quality management system and integrated
management system software. Second part was practical work according to the ISO 9001-
2015 requirements in the Pohjanmaan Metalli Oy. Finally, conclusions are drawn in the
thesis.
2
The company employs over 10 professionals and the budgeted revenue for 2012 was
approximately EUR 2 million. The five shareholders are self-employed and four of them
work full time in the company. One shareholder is retired, but he is Chairman of the Board,
as well as a counselor. The company currently employs 10 people, four of them are
responsible for installation and other four employees do assembly work. In the office, there
are two full-time employees. Nine employees have welding qualifications, one has
experience in finishing line, one is an electrician and other one have good experience in saw
laser cutter machine. (Pohjanmaan Metalli Oy 2015.)
Pohjanmaan Metalli manufactures all metal and steel molding from special Finnish structural
products. The company continuously develops its products according to production control
system. Pohjanmaan Metalli OY also invests more in effective and environmentally strong
production technology. Generally the company works for structural steels products based on
customer needs such as stairs, building and so on. The company’s main export country is
Russia and also export to Asia. Pohjanmaan Metalli is situated in Ylivieska and it enables
fast delivery in Finland and also around the world because it is close to the port of Raahe.
(Pohjanmaan Metalli Oy 2015.)
The board of director is responsible for accounting and financial management. The CEO is
also responsible for the company’s accounting and provide necessary information for the
board of duties. Company’s mission is to produce quality structural products, security of
supply and customized products. In the recent years the company has invested heavily in
training activities and essential equipment to meet the current and future workloads.
(Pohjanmaan Metalli Oy 2015.)
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IMS Software allows to build a visual and maintenance operating system regardless of the
size of an organization. The functionalities of IMS Software support a wider range of
frameworks like as Quality Management System, Environment Management System, Health
and Safety Management Systems and European Foundation for Quality Management. The
following graph 1 demonstrates how IMS Software works for an organizations management
system. (IMS 2014 Update 6)
3.1 Processes
IMS software has a special section in a separate user-designed processes of drawing section,
which makes it possible to describe the entire operation of the organization's processes.
Processes are described hierarchically from the abstract level and proceeding toward the
concrete. None of the IMS process description is left separate but are closely integrated with
each other by the same hierarchical structure. Graph 2 provides a simple illustration of the
interface of the IMS process. (IMS 2014 Update 6)
There are three important entities in the processes section, for example process map, process
tree and the three page technique of the each process description. The system builds a
framework for process descriptions and this framework creates a uniform so that system can
be balanced process. Graph 3 presents the IMS support process.(IMS 2014 Update 6)
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The process descriptions can be linked with work instructions and forms, folders, metrics,
web pages, as well as, for example, transitions to other information systems. (IMS 2014
Update 6)
3.2 Documents
By the IMS software it is easy to create a documents for an organization. Moreover, most of
the documents directing the operations and records that are generated as a result of the
operations can be managed in section documents. In addition, documents are easy to find in
a hierarchical directory structure or using various comprehensive search functions. As seen
in the graph 4 bellow, planning and guidling business might be applied to control documents.
(IMS 2014 Update 6)
6
3.3 Indicators
3.4 Reports
Reports in IMS software provides a powerful tool for feedback and a systematic tool for
evaluation management. The system creates standard form templates such as questionnaires,
development proposals, deviations, complaints or reviews for logging, processing and
evaluating the effectiveness of the measures. The following graph 6 represents the customer
reclamation statistics in the IMS Software. (IMS 2014 Update 6)
8
In the IMS Software reports can be more comprehensive statistics to support decision-
making and proactive development of surveys and evaluations, responsive development
through feedback control. Moreover, reports can support achieving the goals and
performance of the development and monitoring. The Report depends on customer
reclamations. (IMS 2014 Update 6)
3.5 Manuals
In the IMS system, manuals can be used when management need to create the organization’s
code of professional standards, induction manual, sales manual, self-monitoring plan, and
description for self-evaluation. The manual can be response immediately that we can easily
share our manual between persons of different stage to maintain the management system.
The operations manual often acts as a door opening to the organization and the system. The
operations manual is intended for the use of staff and key stakeholders. There is also some
possibility to add links to other content in the management system. (IMS 2014 Update 6)
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These directions help defining quality-, environment- and safety systems. The idea is to
define a short, precise, concrete and business related operation description that includes
important factors about operation guidance, quality security, management of environmental
effects, and other factors that are essential in a healthy and functioning work place. The basis
for defining these systems is to support the expectations of customers, personnel, owners
and authorities. The idea is to collect quality-, health-, and environment- and safety matters
to one operation system that meets the standards of 9001:2008, ISO 14001 and OHSAS
18001, and take notice of EFQM or CAF -evaluation standards. (IMS 2014 Update 6)
10
Organizations operation system is based on flexible and responsible active operation and
management of processes that are planned in advance. The operation system is based on ISO
9001 and EFQM principles. In the experience from many years is the basis for IMS own
management system and developing customer solutions (quality management, safety process
and goal management models). IMS emphasizes the operation system's flexibility and the
ability to support the organization's effectiveness, when building customer solutions. (IMS
2014 Update 6)
The process of the organization is described at this point of the operations manual. Process
flowchart states the core and support the processes of the organizations. The actual process
descriptions are described in IMS solution's processes section. IMS solution is used to plan,
to implement and to communicate the organization’s process flowchart, process structure,
processes and part processes. The solution supports directly the so called three-page-
technique, which can easily be shaped according to the customer’s needs.
Documents, records, indicators, intranet and Internet links can be linked to process activities.
Links are showed in a small window at the left hand corner, and also in the stage description
procedures column and directions column at the right hand corner. Process links are also
showed on the front page of processes, and in the stage descriptions as button icons. The
idea is to combine the theoretical and visual information of a process. This way it is possible
to comprehend an entirety, a big picture of the process that is easy to understand.
In addition to vertical modelling, IMS solution supports also horizontal process network
definition. The horizontal linking of a process is done with its own symbol. This way
processes form a process network. (IMS 2014 Update 6)
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This section describes the indicators and measurements of the organization's success. ISO
9001 requires that customer satisfaction and processes are followed and measured.
Environment indicators can be related to process indicators, because environment effects are
formed in processes. If perspective is expanded to all business areas, also economical and
personnel related matters should be evaluated.
For example, customer related measurement tools could be surveys, customer satisfaction,
sales, reclaims, hit rates, reliabilities and permanence of customer relationships. Process
indicators could be for example error cost percentage, delivery reliability percentage and
usage level percentage. Economic indicators could be related to financial growth and
profitability. Personnel indicators could be work flexibility, customer feedback, training
costs and work atmosphere. (IMS 2014 Update 6)
3.7 Tasks
In the IMS Software, tasks allow several operating system, effective planning, monitoring
and responsibility throughout the organizations. Strategic planning is an essential part of any
kind of an organization but it is connected to development projects. Function modules and
systematic monitoring provide the necessary information for better management tools. Tasks
can be scheduled and may be projected into larger entities and subtasks. (IMS 2014 Update
6)
The functionalities of IMS Software can be utilized to the extent required by the
organization's needs and objectives. There are some several features of the IMS Software:
(IMS 2014 Update 6)
Quality management system might be paper based on, software based such as a data bank or
web pages. However, nowadays as IMS system is a part of a company’s management system
there have to be linkages for the boundaries between processes. There are several web pages
for example IMS program, IBM program and so on. There are many benefits for the quality
management system for example different link from many different websites can be added
in the IMS Software. IBM is world largest information technology company and it provides
hardware and software products for business server, storage products and custom design.
The business is changing more rapidly than ever. Nowadays business agility is the key to
sucess. Most of the times it depends on technology and a system that can react and change
quickly. However in the modern age designing an information technology system can meet
this diverse and often conflicting set of needs which is main challenge for all kinds of
companies. Many IBM application servers already provide support for IMS transation access
today. IMS outbound scenario is for intregration with business role engine and IBM provides
information for the operational decision manager to build IMS transaction. (Pohjanmaan
Metalli oy 2015)
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Pohjanmaan Metalli are uses IMS program because IMS system includes all elements of
mangement system in the same way. The functionalities of IMS software include process
illustration tool, document management tool, processing tool for feedback and evaluations,
a separate section form and the organisations indicators, task management tool and editor
for creating manuals. In the IMS Software documents are used for procedures related to
reviewing, approving, management system and information technology for specific work for
specific person. (Pohjanmaan Metalli oy 2015)
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As seen in the graph 8 above, Phojanmaan Metalli Oy has implemented IMS Software to
control all documents and standrads within the organisation. Also Pohjanmaan Metalli Oy
viewing the documents directly when new content is added to the document hierarchy. IMS
is used for all the number types that are supported by the current system implementation
such as routing analysis. Not only the routing analysis but also process diagrams are used
for measuring different factors such as customer satisfaction, product delivery, finance,
quality cost, the organizations monthly turnover, coverage percent, amount of customer
feedback, offers, profit and lost. IMS was established in Pohjanmaan Metalli in 2011. In
2014 they implemented Factory Production Plananing Control system based on EN 1090.
Currently, the production capacity is sufficient. At the present time, the production
technology is up to date by production control system SFS EN-1090 in the Pohjanmaan
Metalli oy . (Pohjanmaan Metalli oy 2015)
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Today quality is much more important than before. The quality of products and services has
to be accepted by customers. Thus, quality can be called as one of the main demanding parts
in the whole bargaining process. Undoubtedly, globalization influences the development of
quality meaning. Therefore, nowadays quality management includes four main activities of
managing the quality, which can be identified as follows: quality planning, quality control,
quality improvement and quality assurance. All these four activities are essential pillars of
quality management. They are related to each other and could not function separately. (Hoyle
2007)
Everyone hears the word quality almost on a daily basis. The meaning of the word is not as
clear-cut as one might at first imagine. Often, the word quality indicate tangible content such
as the maximum speed of the car which is an easily measurable thing. Some of the quality
attached to things again seem very abstract. These abstract things are often opinion and taste
issues, which cannot be measured, such as appearance. (Hokkanen & Strömberg, 2006, 18)
Generally, the quality of a product or service defines to the degree to which continuous
product or service meet the customer expectations. In the business sector, there are many
definitions for quality such as:
However nowadays a globally accepted definition of quality based on ISO 9001 is that:
” Quality is the degree to which a set of inherent characteristics fulfils requirements” (Tricker
2008)
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All four activities of quality management might be implemented in the real strategies of any
company with quality management systems that will be described in the next chapter.
However, the foundation of any quality management system is based on eight main quality
management principles. These principles explain the main sense of quality management and
cover the meaning of requirements of most of the standards and quality management systems
(International Organization of Standardization 2014). Within the principles an organization
could find the most significant reasons of achieving the highest quality. (Hoyle 2007)
All European organizations, both in the public and private sectors, are facing
new challenges. The increasing pressure to compete on a global stage with
limited resources means we all have to work together to secure our future
prosperity, and that of generations to come. The EFQM Excellence Model
provides a framework that encourages the cooperation, collaboration and
innovation that we will need to ensure this goal is achieved. ( Rompuy 2010 )
Continual improvement is a set of recurring activities that are carried out in order to enhance
performance. Continual improvements can be achieved by carrying out audits, self-
assessments, and management reviews. Continual improvements can also be realized by
collecting data, analyzing information, setting objectives, and implementing corrective and
preventive actions. (SFS 2012).
Continuous improvement is a one kind of method that can focus on increasing the
effectiveness and efficiency throughout the organization to meet its policy and objectives.
By using Deming method (PDCD) cycle every organization can meet their objectives and
policy. The graph 10 illustrates the PDCA cycle for continuous improvement.
Every effective organization needs to have the PDCA cycle for continuous improvement.
Continual improvement is also a part of total quality management philosophy. Moreover, it
leads to better results such as price, productivity, time, delivery, responsibilities, profit and
customer and employee satisfaction. (Deming 1993)
Customer focus is normally a strong contributor to overall of a business and also includes
delivering customer value where business needs and potential markets. It involves ensuring
that a company needs to focus on customer satisfaction first because customer focus is an
essential part of any successful business. (Howard 2010)
The definition of quality control is the part of quality management focused on fulfilling
requirements (ISO 2001). In other terms it means the functional techniques and activities
that are used to fulfil the requirements for quality. Quality control ensures the maintenance
of standards of the quality of goods and service and the process of making sure that products
or service are ready to consistently high standards. The following graph 11 presents the five
elements of quality control of an organization. ( Tricker 2008 )
The process of quality control part covers mostly fulfilling requirements and regulating
future performance of a product or service. Quality control might be applied to different
parts of the operational processes. It is used in the beginning steps of manufacturing, the
intermediate stage of the developing of a product or even in final measuring of the
performance of a produced product. Wherever quality control is applied the main issue is to
prevent changes and to increase the level of predictability. Operations under control and a
high level of predictability are the key of success of any business. (Hoyle 2007)
Quality assurance is focused on providing the confidence of the future fulfillment of all
requirements. There are always some restrictions and requirements to maintain quality and
these have to be completed in order to gain the result. A customer or a manager are not able
to handle or observe all actions by themselves, thus they have to trust a company that the
requirements are met. Eventually, creating quality assurance is understood as recording,
organizing reviews and documenting the processes and results. However, these activities can
be mentioned also as quality control tools as well as quality assurance parts. Nevertheless,
from the customer’s point of view the standards mainly show an assurance and provide
confidence about the quality. Thus, those standards that are used to assure a customer in
quality are mostly described as the main example of quality assurance. Therefore, quality
assurance is the key feature of the standards and the most visible part by customers. (Juran
& Gryna 1993)
This part of quality management is based on the defining quality objectives and all
components to achieve those objectives (Bergman & Klefsjö 2010). Quality planning could
be divided in two ways – strategic and operational. Strategic is considered as the setting
process of long-term goals that explain vision, mission and the values of the business. This
way of quality planning is more theoretical and leads to analyzing all the external and
internal sides of the business. However, the operational way of quality planning is considered
as more realistic and, primarily a more systemic way. It mainly consists of creating product
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goals that contains for example estimated demand, figures of productivity, etc. Both ways
could not be separated due to the mutual supplement structure. (Hoyle 2007)
In the aspect of any company, quality planning could be seen as e.g. creating of a quality
system team that is responsible for coordinating the quality planning within all departments.
These professionals are representing such functions as planning and establishing quality
management policies gradually to all parts of the business. The quality system team is also
continually working with other three parts of quality management. However, the main
function is firstly to involve all the departments to the quality management policy of the
organization. (Harrington & Mathers 1997)
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5 ABOUT ISO
ISO 9001 is a standard focused on quality management system and also the world’s most
popular quality management system standard and is all about keeping customers satisfied.
ISO 9001 is the only part of the ISO 9000 family against which an organization can become
certified. As a result, ISO 9001 contains all of the requirements which an organization must
address within their QMS if organization’s wish to be certified against the Standard. It is
very important to evaluate and enforce quality management system. It specifies the
requirements to successfully implement a quality management system in order to monitor
and improve the performance of an organization, regardless of the size or the industry,
whether that means driving down costs, increasing productivity or improving customer
satisfaction. Another way we can say to meet the requirements of this standard will provide
quality management systems that will be of real benefit to an organization to help manage
the business effectively and put in place the best practice methodology. ISO 9001 specially
focuses on quality management system. Quality management system standrads of the ISO
9001 series are based on eight quality management systems such as. (ISO 2015)
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach to Management
Continual Improvement
Factual Approach to Decision Making and
Mutually Beneficial Supplier Relationships.
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The graph 12 demostrates the structure of the ISO 9001 family of standrads.
ISO 9001-2008 was a process based approach to promote quality management. For an
organization, it is essential to identify and manage numerous linked activities. Process
approach is an activity using resource and managed in order to enable the transformation of
input into output. Also process can be defined as a set of inter related activities. There are
main eight section of ISO 9001-2008. (ISO 2008)
Scope
Normative References
Terms and Definitions
Quality Management System
Resource Management
Product realization
Measurement, Analysis and Improvement
Graph 13 below shows the model of a process based quality management system
ISO 9001-2015 is a risk based thinking approach to quality management. The approach of
risks and opportunities, which emphasizes identifying potential problems as well as
opportunities for improvement, needs to be applied to the quality management system
processes. For risk based thinking there are no requirements for processes, procedure,
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records, evidence and formal risk management. There are some changes from ISO 9001-
2008 to ISO 9001-2015. For example. (ISO 2015)
GRAPH 14. Comparing the latest version of ISO 9001: 2015 with ISO 9001:2008 (ISO
2015)
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ISO 9001-2015 is a new high level structure that every company will feature in all
management systems. This revised standard should maintain the current focus on effective
process management to produce desired outcomes and technology since the last major
revision in 2000. The quality manager of Pohjanmaan Metalli Oy was helped to meet new
requirements of ISO 9001-2015 in the company. Moreover, information was collected from
ISO webpage, ISO CD version and also ISO 9001-2015 revision training webinar. In the
present situation Pohjanmaan Metalli has a factory production planning control system, as a
result most of the requirements of ISO 9001 they have. There are some missing requirements
the fact that they do not have any kind of a quality management system and process structure
and customer property. (Pohjanmaan Metalli Oy 2015)
The selected suppliers and customer satisfaction was evaluated based on their ability to meet
the requirements. Requirement are very important to any organisation, and select suppliers
based on their criteria. Some companies use a questionnaire form with new suppliers.
Another common method is to place a few trial orders to make an assessment. If one cannot
fulfil the customer’s needs without a particular supplier, then it is a good idea to include a
risk assessment in the evaluation – go through the “what if” scenarios and develop backup
plans. This thesis will help to find out what one needs to know about transitioning to the new
ISO 9001:2015 Quality Management Systems (QMS) standard. What can be changes from
ISO 9001:2008 to ISO 9001:2015 and how these will affect an organization will be discussed
more so that transition arrangements in Pohjanmaan Metalli Oy. (Pohjanmaan Metalli Oy
2015)
The quality management planning should take into account the context of the organization
so that products and services meet the needs and expectations of interested parties. The
organization shall determine the internal and external factors. The quality management
system design should take into account the context of the organization, so that products and
services meet needs and expectations of the interested parties. (ISO 2015)
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The organization should determine the internal and external factors that are relevant to its
purpose, strategic direction and the organizational ability to achieve the desired result of its
quality management system. Organization should focus on
a) The external issues arising from legal, technological, competitive, market, and social
economic environment.
b) The internal issues related to values, culture knowledge and performance of the
organization. (ISO 2015)
The organization must be familiar with the interested parties that are relevant to the quality
management system. The organization need to understand how they can meet customer
requirements and customer satisfaction. This interested parties can be direct customers, final
customer, suppliers and distributors. Moreover, the organization should monitor and review
the information about these interested parties and their relevant requirements. (ISO 2015)
An organization shall classify the limits and scope of organization. Responsible person
should be defined for products, services and processes. Business environment and
stakeholder requirements have been taken into consideration. The quality management
system should be reserved and suitability must be determined. (ISO 2015)
a) the operating environment and the requirements of the stakeholders is taken into
consideration.
c) if any part of the standard does not apply, then it must be justified
d) the extent of the quality management system and is not applicable to matters must be
documented as information available in stakeholders. (ISO 2015)
The company’s has IMS Software to control all document. Pohjanmaan Metalli has continual
improvement process for quality management system. The management ensure that
companies has enough resource to support the operation and monitoring. (Quality Manager
2015)
c) to determining the risks to which the client will flow if the undesirable products are
delivered or the processes of interaction does not work.
The following graph 15 presents the quality management system in the Pohjanmaan
Metalli Oy.
f) monitoring, analyzing and making the necessary changes in processes, products and
services, intended for the production.
Phojanmaan Metalli Oy follow the PDCA cycle and continual improvement process to
meet quality management system requirements. (Pohjanmaan Metalli 2014).
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The company always focus on continual improvement process to monitor and measure. The
management apply process based approach for effective measurement. The manager of the
company is responsible for dicision making process.(Quality manager 2015)
6.2 Leadership
Company use electronic device such as mobile phones and email to communicate with
customer. Moreover, it is a small company so it is easy to communicate with employees and
always communicate with each other face to face depends on meeting or work instruction.
Moreover. Companies has plan and process for annual management review with our
customers' based on future prospects and goals, as well as developments in the field.
Moreover, the management of company makes its own development plan for high quality
product. (Pohjanmaan Metalli Oy 2015).
A set of self‐assessment the ISO 9001: 2015 Standard was used to assess the adoption status
of quality management practices. This document will describe the development of a scale
for measuring top management commitment towards continual quality performance
improvement in Pohjanmaan Metalli oy. (Quality Manager 2015)
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Top management should ensure that the quality policy (ISO 2015)
The company's mission is to produce high quality steel structures based on customer's need.
The company's objective and strategy is to develop the quality of products, reliability and
profitability. (Pohjanmaan Metalli Oy 2015).
Self-evaluation and review are based on an organized and structured process of collecting,
analyzing and interpreting information about all aspects of the work and standard. The
authority of company have good mission and quality policy to develop the company. (IMS
2015)
Top management should ensure that responsibilities and authorities are defined and
communicated within the organization. Top management is responsible for the
establishment, maintenance and development of the operating system. Management need to
appoint a member of the organization’s management who, irrespective of other
responsibilities, should have responsibility and authority that includes (ISO 2015)
a) ensuring the process needed for the quality management system are established,
implemented and maintained
b) reporting to top management on the performance of the quality management system and
any need for improvement and
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IWS is responsible for the process, quality manager is responsible for the management of
the quality management system. Sales manager is responsible to fulfil customer needs.
(Pohjanmaan Metalli Oy 2015).
An organisation should more recognize its strengths and weaknesses, identify the
opportunities and threats it faces and identify potential strategic alliances. (IMS 2015)
6.3 Planning
The organization should establish the risks and opportunities management procedures
proportionate to the potential impact of the goods, services and customer satisfaction.
Procedures should be combined into the processes and their effectiveness should be
evaluated. (ISO 2015)
The quality management system is integrated into the customer satisfaction as well as goods
and services with the threat of the risks and opportunities for the identification of
management procedures. (Pohjanmaan Metalli Oy 2015).
The organization should retain documented information on the quality objectives and the
organization will determine (ISO 2015)
6.4 Support
6.4.1 Resources
The organization will determine and provide the resources needed for the establishment,
implementation, maintenance and continual improvement of the quality management
system. The organization should determine what the existing internal, resources, capabilities
and limitations are and which goods and services should be sourced externally. (ISO 2015)
The organization will determine, provide and maintain the infrastructure necessary for its
operations and assure the conformity of goods and service and customer satisfaction.
Moreover, maintaining the process environment necessary for its operations and assuring
conformity of goods and service and customer devices can include measuring and
measurement methods such as surveys. (ISO 2015)
Management should make sure that the employees are aware of the link between product
quality and costs. They need more focus on work environment and supporting system.
(Quality Manager 2015)
6.4.2 Competence
a) determine the important competence for personal performing work affecting to product
requirements
The company has good system for the right person for right job based on employee’s
experience. Sometimes, company provide necessary training to employees to achieve
competence. There are some documents in the IMS Software of Pohjanmaan Metalli Oy that
are provide information about employee’s education, training, skills and experience.
(Pohjanmaan Metalli Oy 2015)
6.4.3 Awareness
a) Quality policy
b) Quality objectives
6.4.4 Communication
The organization shall determine the associated quality of management of internal and
external communications. (ISO 2015)
a) where to communicate
b) when to comminucate
c) to whom comminucate
As a small company it is easy to communicate with employees and the manager always
communicates with workers when they need to cmmunicate. (Quality Manager 2015)
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Documents and records have been replaced by documented information. The quality
management system documentation should include (ISO 2015)
b) a quality manual
d) control of documents
e) control of records
f) a description of the interaction between the processes of the quality management system
Pohjanmaan Metalli control all document by IMS system. All these document are checked
twice a year. (Pohjanmaan Metalli Oy 2015)
Documents and records are used to support effective and efficient operation of the processes
of the organization so company maintain their documentation by IMS software. (Quality
Manager 2015)
6.5 Operation
The organizational will plan and develop the processes needed for operational planning and
control. Operational planning and control should be consistent with the requirements of the
other processes of the quality management system. In operational planning and control, the
organization should determine (ISO 2015)
Pohjanmaan Metalli oy has product development process for control of product. The
development process includes the level of automation, manual process, outsource process,
and particular machine, verification, validation, inspection and test activities to the products.
(Pohjanmaan Metalli Oy 2015)
Organization needs to carry out the process of interaction with the customer and to determine
the needs of customers. The organization should (ISO 2015)
a) implement the process of interacting with the customer and find out the needs of
customers.
Pohjanmaan Metalli always concentrate customer needs based on contracts because all
customer needs are not same. The company do not use any client assets in production line.
(Pohjanmaan Metalli Oy 2015)
Management will define customer related process to ensure consideration of customer need
for products and service. Company has good customer feedback system about product and
service from customer. (IMS 2015)
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The organization should plan and control the design and development of product. During the
design and development planning, the organization needs to determine (ISO 2015)
b) the review, verification and validation that are appropriate to each design and
development stage
Pohjanmaan Metalli do not have their own design and development. They always buy from
other companies. (Pohjanmaan Metalli Oy 2015)
b) Process Control division of responsibilities between the organization and the supplier.
The organization shall establish and apply the evaluation criteria and have to select and re-
evaluate suppliers based on their ability to produce the requirements of goods and services.
(ISO 2015)
Always company need to evaluate and select suppliers based on their ability to supply
product in accordance with the customer requirements. Their aim is to develop the
procurement work. (Quality Manager 2015)
An organization needs to take into account the development stages of the process and the
control of the following: (ISO 2015)
The organization will need to determine the development of the control of the following:
The organization needs to establish some specific process such as defined criteria for the
review and approval of the process, approval of equipment and qualification of personal, use
of specific methods and procedures and requirements for records and revalidation. FPC
manual will cover all of these requirements. (ISO 2015)
The management activities will include for example verification and validation considered
in production and service provision. They always need to focus more on revalidation and
FPC manual. (IMS 2015)
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An organization needs to take into account the identified risks and determine the following:
(ISO 2015)
a) what needs to be monitored and measured to demonstrate the conformity of initial product
The graph 19 provides a simple illustration of monitoring, measuring and evaluation of the
quality management system.
An organization needs to monitor the customer related information in terms of what extent
the requirements will be met. If necessary, the organization should obtain the information
such as customer feedback, the customer views and understanding of the organization and
the processes of goods and services. (ISO 2015)
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Pohjanmaan Metalli use the fishbone method for problem solving method. Moreover, they
a have time of delivery measurement system, process flow and customer satisfaction
measurement system. (Pohjanmaan Metalli Oy 2015)
Management will concern about collection of customer-related data for analysis, in order to
obtain information for improvements. Moreover the organization analyze data is to assess
its performance and identify areas for improvement. (IMS 2015)
The organization should manage internal audits at planned intervals to determine whether
the quality management system
b) should be planned, taking into consideration the status and importance of the process.
d) need to define audit criteria, scope, frequency and methods. (ISO 2015)
CEO is responsible for internal audit. CEO is responsible for taking corrective action for
continual improvement. Manager should define where should be more audit for companies’
internal process. (Pohjanmaan Metalli Oy 2015)
Internal audit should be based on companies own experience. Management should focus on
their external and internal audit. The company can use a questionnaire for effective internal
audit. (IMS 2015)
The risk must be reflected in the output data, processing and management decisions. Top
management should determine about internal meeting, review key performance quality,
quality policy, quality objectives, results of audit, customer feedback, preventive and
corrective action, recommendation for continual improvement. (ISO 2015)
42
Once a year Pohjanmaan Metalli has a management review system and audits can be held
software based which helps to maintain quality. (Pohjanmaan Metalli Oy 2015)
Top management review activity should be evaluated to improve the effectiveness and
efficiency of organizational processes. (Quality Manager 2015)
6.7 Improvement
To meet these requirements, an organization has some documents such as what kind of
changes needed in the management, deviation and deviation of reports. (Pohjanmaan Metalli
Oy 2015)
The organization will need to more focus on how they control nonconformity products and
take corrective action to meet the requirements. For that the management will concern to
take preventive action for improving the cost of poor quality. (Quality Manager 2015)
The organization needs to continually improve the effectiveness of the quality management
system through the use of the quality policy, quality objectives, audit results, the analysis of
data, corrective and preventive actions and management review. A documented procedure
should be established to define requirements for (ISO 2015)
To update the IMS program, I used practical and theoretical method. I collected information
from the ISO webpage and seminars about what kinds of change can be in ISO 9001 revision
version. For updating the IMS and implementing the ISO 9001-2015, I prepared some new
documents such as quality policy, quality management system and customer satisfaction
measurement system through the IMS program. Then all of these new requirements were
added in IMS system to meet ISO 9001-2015. (Pohjanmaan Metalli Oy 2015)
45
ISO 9001-2015 is a risk based analysis process. The new ISO 9001 revision version will
provide maximum benefit to the organization if it approaches ISO 9001 implementation in
a practical way. ISO 9001-2015 creates an idea that positive risk (opportunities) should be
managing the same way as negative risk. ISO 9001 revision version certification is not just
suitable for a large company or organization but also a small company or organization will
benefit from it by saving time and cost, improving performance and improving customer
relationship. In this thesis, the target was to meet and update ISO 9001-2015 by using IMS
software. Most of the requirements were meet in this thesis but some of the requirements
were not meet because the new requirement will not publish from ISO until September 2015.
We implemented ISO 9001-2015 English and Finnish version in the IMS software in
Pohjanmaan Metalli Oy. After that we wrote all of new requirements of ISO 9001-2015
version. Then we checked IMS software if it meets all the new requirements or not. From
this thesis company got information how to make their own quality policy, customer related
documents and how to measure customer satisfaction. The graph 21 presents the quality
policy the Pohjanmaan Metalli Oy.
46
For customer related document and measure customer document, companies need to make
a plan of what is measurements which will be done in various stage and various department
such as what kind of tools and satisfaction techniques can be apply in the company. The
company can use different kind of measurement tools like as control chart, hypothesis
testing, and process capabilities and so on.
In my view ISO 9001-2015 will have a positive impact as it is clearer and better than the
previous standard because in ISO 9001-2015 the focus on risk management where the
previous standard ISO 9001-2008 v had only preventive action. However, in this case the
new requirements will be of great value for the small business that had previously not
47
properly managed the external and internal risk to their very existence. In fact, I got much
new knowledge and experience. I had no previous experience in quality management
systems and ISO standards. Although the work was challenging but it was interesting.
However I think, I acquired much practical experience that will help in the future. I hope
that my work will help the company and they will get good foundation for the quality
management system.
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REFERENCES
Juran, M. Gryna, M.1993. Quality assurance. Quality Planning and analysis 634-649.
Van Rompuy, Herman. Etterbeek, Belgium, 31 Oct. 1947. President of the European
Council 2009–2014.
Tiri Anne, 2015. Quality manager.1 March 2015. Pohjanmaan Metalli Oy. Ylivieska,
Finland.
Kano, M.2001. The Kano Model. How to Delight Your Customer 22-26.
Moen, R. & Clifford, N. 2013. Evolution of the PDCA Cycle. Www-document. Available:
http://pkpinc.com/files/NA01MoenNormanFullpaper.pdf. Modified 11.4.2014 . Accessed
28 December 2013.