System Documentation Of ISO 9001 Standard

When considering what would be required to properly design, develop and document such a system to meet the requirements of ISO 9001, we find that there is very little difference between the approach needed to develop a system for this application, in comparison to approaches commonly used to develop systems which address manufacturing activities and other services. Proper design should begin with a review of the key processes used by the institution or organization, their ability to meet the customer needs established above and their overall degree of compliance with the requirements of the ISO 9001 standard.
System documentation required by the ISO 9001 standard, including a quality manual, and the six “system” procedures required by the ISO 9001 standard – the control of documents, the control of records, internal audits, the control of nonconformances, corrective action and preventative action all have a place in this system (as do the 19 types of records addressed in the ISO 9001 standard); they are just as relevant in this application as they are with their counterparts in other industries. Additional documentation, addressing the various activities performed by the organization will also be needed, as necessary to address the critical nature of the activities performed, as well as to ensure the customer needs defined above are met.
Read more on ISO 9001 Standard at http://www.iso9001-standard.us

What Is The Benefits Of ISO 9001 Certification

ISO 9001 certification is intended for any organization regardless of size, type or product including service. According to the ISO 9001 standard there a number of system requirements which an organisation needs to fulfill in order meet customer, regulatory and statutory requirements. Ensuring customer satisfaction through the quality management system is a key aim of the standard.
The ISO 9001 standard also includes elements that require monitoring and measurement of processes and continual improvement. In order to achieve certification an organization should have a documented quality management system and not a system of documents. The three main objectives of the documentation should be for communication of information, evidence of conformity and knowledge sharing.
Quality management system documentation may be in any form or type of medium such as paper, electronic or picture. A compliant quality management system will need to address key elements of the standard. There are five sections that outline the requirements of a compliant system, section 4 Quality Management System, section 5 Management Responsibility, section 6 Resource Management, section 7 Product Realisation and section 8 Measurement Analysis.
Read more on ISO 9001 Certification at http://www.iso9001-standard.us

ISO 9001 and occupational health and safety

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

Quality In ISO 9001 Standards

The Eight Dimensions of Quality

1. Performance

2. Reliability

3. Durability

4. Serviceability

5. Aesthetics

6. Features

7. Perceived Quality

8. Conformance to Standards

Terminology

Every product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:

1. Physical: length, weight, voltage, viscosity

2. Sensory: taste, appearance, color

3. Time Orientation: reliablility, durability, serviceablity.

Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

The Eight Dimensions of Quality1. Performance2. Reliability3. Durability4. Serviceability5. Aesthetics6. Features7. Perceived Quality8. Conformance to StandardsTerminologyEvery product possesses a number of elements that jointly describe what the user or consumer thinks of us as quality. These parameters are often called quality characteristics. Sometimes these are called critical-to-quality (CTQ) characteristics. Quality characteristics may be of several types:1. Physical: length, weight, voltage, viscosity2. Sensory: taste, appearance, color3. Time Orientation: reliablility, durability, serviceablity.Since variability can only be described in statistical terms, statistical methods play a central role in quality improvement efforts. In the application of statistical methods to quality engineering, it is fairly typical to classify data on quality characteristics as either attributes or variables data. Variables data are usually continuous measurements, such as length, voltage, or viscosity. Attributes data, on the other hand, are usually discrete data, often taking the form of counts. We will describe statistical-based quality engineering tools for dealing with both types of data.

Effects of ISO 9001 Implementation

Overall we can say that a company sought certification primarily to meet internal needs rather than as a response to external market forces. However the first action to be certified seems as a proactive response, we could not see a clear effort in the company to evaluate the actual results of this process.

Despite all, it has been stated that the certification has enabled them to achieve higher quality, productivity thus product reliability and increase in customer satisfaction. From the aspect of cost dimension it was declared that ISO 9001 implementations had moderately positive impacts on cost reductions by the increase in productivity and decreases in spoilage, rework and scrap. A factor affecting the occurrence of previous impacts is careful selection of the appropriate supplier.

Overall the most important impact of certification was stated to be the improvements in the brand image of the company from the viewpoint of their customers. This will also be very advantageous in the retention of existing customers and attraction of new ones. As a result of the synergy between the stated improvements company achieved a significant competitive advantage compared to competitors that are not certified.

Company has neither any application nor any action regarding TQM and quality costs.

Why is ISO 9001:2008 Certification Important?

Why is ISO 9001:2008 Certification Important?

First of all it provides a system for managers and organizations to achieve excellence and opens the door for American manufacturers and/or service organizations seeking a larger role in both international trade and with other American organizations. Many organizations require their suppliers to be certified or at a minimum to be working toward certification on ISO 9001:2008 to do business.

Consider the facts (source MORI/SGS-ICS) that with ISO 9001 certification:

• 83% realized improved management control
• 82% realized improved customer satisfaction
• 62% said it improved the ability to win work
• 61% stated a more motivated workforce
• 60% realized improved productivity
• 60% saw reduced waste
• 52% stated it improved marketing
• 50% had reduced costs
• 49% realized increased market share

ISO 9001 and occupational health and safety

ISO 9001 and occupational health and safety

Adopting ISO 9001 might lead to improvements in occupational health and safety in a variety of ways. In the process of formally documenting procedures, for example, managers can identify and eliminate hazardous practices and add safety precautions. Moreover, by fostering more focused attention to detail,ISO 9001 adoption can reveal new “win-win” opportunities to improve quality or efficiency and occupational health and safety that were previously obscured by indirect and distributed costs and benefits.

Additionally, processes that provide warning signals and prompt corrective action can forestall serious accidents. Finally, routine auditing and corrective action procedures required by ISO 9001 to address management system failures encourage root-cause analysis that can identify problematic work practices that might otherwise precipitate not only quality failures, but occupational health and safety concerns.

Departments charged with managing quality sometimes also manage health and safety, and companies are increasingly implementing integrated management systems that incorporate all these considerations. Occupational health and safety can be improved by applying the tools of continuous improvement associated with ISO 9001 certification. Employees who know how to identify root causes of quality problems, for example, also have the skills to identify root causes of safety problems.

The high rates of repetition and increased monitoring implicit in the emphasis of ISO 9001 on routinization and standardization of tasks can increase stress and repetitive motion injuries, potentially worsening the safety records of plants with quality program. Moreover, to the extent that the higher equipment utilization associated with ISO 9001 adoption translates into reduced employee downtime, employee fatigue, a major cause of injuries, might be expected to increase. Additionally, new quality management procedures implemented in association with ISO 9001 that add inspection tasks to work processes optimized for production can occasion poor ergonomic conditions that leave employees susceptible to injuries.

Process Approach In ISO 9001 Standards

Process Approach In ISO 9001 Standards

The ISO 9001 International Standard promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system, to enhance customer satisfaction by meeting customer requirements.

For an organization to function effectively, it has to determine and manage numerous linked activities. An activity or set of activities using resources, and managed in order to enable the transformation of inputs into outputs, can be considered as a process. Often the output from one process directly forms the input to the next.

The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management to produce the desired outcome, can be referred to as the “process approach”.

An advantage of the process approach is the ongoing control that it provides over the linkage between the individual processes within the system of processes, as well as over their combination and interaction.

When used within a quality management system, such an approach emphasizes the importance of

a) understanding and meeting requirements,

b) the need to consider processes in terms of added value,

c) obtaining results of process performance and effectiveness, and

d) continual improvement of processes based on objective measurement

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 9001 & ISO 14001 Standards and the environment

The ISO 14000 family of International Standards on environmental management is a relative newcomer to ISO’s portfolio – but enviroment-related standardization is far from being a new departure for ISO.

In fact, ISO has two-pronged approach to meeting the needs of business, industry, governments, non-governmental organizations and consumers in the field of the environment.

On the one hand, it offers a wideranging portfolio of standardized sampling, testing and analytical methods to deal with specific environmental challenges. It has developed more than 350 International Standards (out of a total more
than 12000) for the monitoring of such aspects as the quality of air, water and soil. These standards are means of providing business and government with scientifically valid data on the environmental effects of economic activity.

They also serve in a number of countries as the technical basis for environmental regulations.

ISO is leading a strategic approach by developing environmental management system standards that can be implemented in any type of organization in either public or private sectors (companies, administration, public utilities). To spearhead this strategic approach, ISO establish a new technical commitee, ISO /TC 207, Environmental management, in

1993. This followed ISO’s successful pioneering experience in management system standardization with the ISO 9000 series for quality management.

ISO’s direct involvement in environmental management stemmed from an intensive consultation process, carried out within the framework of a Strategic Advisory Group on Environment (SAGE),set up in 1991, in which 20 countrie, 11 international organizations and more than 100 environmental experts participated in defining the basic requirements of a new approach to environment-related standards.

This pioneering work was consolidated with ISO’s commitment to support the objective of “sustainable development” dicussed at the United Nations Conference on Environment and Development in Rio de Janeiro in 1992.

Today, delegations of business and government experts from 55 countries have participate actively within TC 207,

and another 16 countries have observer status. These delegations are chosen by the national standars institute concerned and they are required to bring to TC 207 a national consensus on issue being addressed by the commitee.

This national consensus is derived from a process of consultation with interested parties.

From its beginning, it was recognized that ISO/TC 207 should have close cooperation with ISO/TC 176, Quality management and quality assurance, in the areas of management systems, auditing and related terminology. Active efforts are under way to ensure compatibility of ISO environmental management and quality management standards, for the benefit of all organizations wishing to implement them.

Improve your performance management with new version of ISO 9001

A quality management system enables you to manage your business processes effectively:

it is much more than a set of rules and procedures. When properly implemented and maintained, a QMS addresses the needs of your organisation and delivers tangible business benefits.

The new version of ISO 9001 has recently been published. One of the main aims of ISO 9001:2008 is to facilitate integration with other standards. Although there are no new requirements as such, there are some key clarifications to be taken into account.

There are three main objectives to the new standard:

Detail, clarify, improve the understanding of ISO 9001:2000 (previous version)

Improve compatibility with ISO 14001:2004 Simplify the way in which ISO 9001 can be integrated with other management system standards (such as OHSAS 18001)

There are no new requirements in the new standard:

The title, scope, and structure of the standard are unchanged

The process approach is confirmed

Compatibility with the latest revision of ISO 14001:2004 is maintained and improved upon

Preservation of the quality management principles included in ISO 9000:2000

There are five main areas to note. The relevant sections of the standard are noted in brackets.

1. A reinforcement of the notion of product conformity

2. Compatibility with other standards is evolving

3. A better understanding of outsourced processes

4. An editorial clarification of some requirements – for instance;

A reinforcement of the notion of product conformity2.3.4.

An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolving

• (6.4) work environment, including an explanatory note on work environment giving examples,

to help meet product conformity requirements

• (8.2.1) measurement of customer satisfaction, including a note broadening the scope beyond

satisfaction surveys to include other channels such as customer feedback5.

• (Introduction) the notion of risk

• (5.5.2) appointment of a management représentative

• (6.2.2) assessing the effectiveness of achieving compétence

• (8.5.2 et 3) assessing the effectiveness of corrective and preventive actions?

Some additional explanations regarding the requirements of the standard;An editorial clarification of some requirements – for instance;A better understanding of outsourced processesCompatibility with other standards is evolvingA reinforcement of the notion of product conformity

ISO 9001 Standards Certification

ISO 9001 Standards Certification

When an organization chooses not to pursue ISO 9001 certification or not to retain the ISO 9001 certificate, it should make no difference to the way the organization is managed. It’s similar to the man who chooses not to take the course examination. He still has the knowledge he has acquired whether or not he takes the exam and gets a certificate. What he cannot do is demonstrate to others that he has reached a certain level of education without having to prove it every time. People who know him don’t care that he didn’t take the exam. It is only those who don’t know him that he will have difficulty convincing.

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

Step by Step: Leading your company to Successful ISO 9001:2008 Registration

1. ISO 9000 Introduction, a Process approach.

2. Gap Analysis: Schedule the Gap Analysis, Conduction and ISO 9001 Gap Analysis.

3. Prepare a Project Plan: The Team approach, Steering Team, Task Teams.

4. Train employees on ISO 9001: Mamagement Overview, Employee awareness, Keeping them informed.

5. Document your system: How much Documentation do you need, Importance of Documentation control

6. Implement the QMS in your Organization:Training on new procedures, Training of internal auditors.

7. Audit your QMS: Train internal Auditors, Conduct Internal Audits.

8. ISO 9001:2008 Registration Audit: Selecting a Registrar and then go ahead with registration.

Structure Of ISO 9001

ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
Clause 1 Scope
Clause 2 Normative reference
Clause 3 Terms and definitions
Clause 4 Quality management system
Clause 5 Management responsibility
Clause 6 Resource management
Clause 7 Product realization
Clause 8 Measurement, analysis and improvement
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ISO 9001 And ISO 14001 Information Site

ISO 9001 And ISO 14001 Information Site:

http://iso9001-procedure.blogspot.com/
http://iso-14001-ems.blogspot.com/
http://iso14001qualitymanual.blogspot.com/
http://iso14001requirements.blogspot.com/
http://iso14001certification.blogspot.com/
http://iso14001qualitysystem.blogspot.com/
http://environmentsystem.blogspot.com/
http://iso14000series.blogspot.com/
http://iso9000standard.blogspot.com/
http://six-sigma-qc.blogspot.com/
http://iso9001-documents.blogspot.com/
http://iso9001-training.blogspot.com/
http://quality-assurance-system.blogspot.com/
http://iso14001standard.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9001-certification.blogspot.com/
http://iso9000series.blogspot.com/
http://iso9001standards.blogspot.com/
http://iso9000certification.blogspot.com/
http://isotemplate.blogspot.com/
http://iso9001training.blogspot.com/
http://qualitymanualsystem.blogspot.com/

Managing processes In ISO 9001 Standard

Managing processes In ISO 9001 Standard

The standard requires the organization to manage the identified processes in accordance with the requirements of ISO 9001. The first stage in managing a process is to establish what it is you are trying to achieve, what requirements you need to satisfy, what goals you are aiming at; then establish how you will measure your achievements. The next stage is to define the process you will employ to deliver the results. Managing the process then involves managing all the inherent
characteristics of the process in such a manner that the requirements of customers and interested parties are fulfilled by the process outcomes. This means:
Managing the process inputs
Managing the work
Managing the physical resources
Managing the financial resources
Managing the human resources
Managing the constraints
Managing the outputs

Process management is therefore much more than managing activities and therefore when describing processes, one needs more than a flow chart of activities. The chart is a diagrammatical representation of a process but only one aspect. One can also add numerical data to the charts to indicate resources, cycle times, delays, costs etc. but the intangible factors of the human environment cannot be reduced to numerical data to add to the charts.

The notes to clause 4.1 of ISO 9001 need some explanation. It is stated that the processes needed for the management system include management activities, provision of resources, product realization and measurement. This note could cause confusion because it suggests that these are the processes that are needed for the management system. It would be unwise to use this as the model and far better to identify the processes from observing how the business operates. The term provision of resources should be Resource Management, which is the
collection of processes covering financial, human and physical resources.

Product realization is also a collection of processes such as design, production, service delivery, etc. Measurement is not a single process but a sub-process within each process. Grouping all the measurement processes together serves no useful purpose except it matches the standard – a purpose of little value in managing the organization.

The second note refers to outsourcing processes although it is difficult to imagine that management activities, product realization or measurement would be outsourced in its entirety. It is likely that market research; design, product verification, equipment calibration and other specialized services may be outsourced. While outsourcing comes under purchasing, it is correct to point out that the organization should control any outsourced processes. The supplier of the process is usually referred to as a subcontractor because they provide services to the organization’s requirements not their own. Control of subcontractors is covered by clause 7.4 but in meeting clause 7.4.3, you need to treat suppliers and subcontractors differently.

Continual improvement in the quality management In ISO 9001

Continual improvement in the quality management system and its processes In ISO 9001

The standard requires the organization to continually improve the effectiveness of the quality management system in accordance with the requirements of ISO 9001 and to implement action necessary to achieve planned results andcontinual improvement of the identified processes.

ISO 9000 defines continual improvement as a recurring activity to increase the ability to fulfil requirements. As the organization’s objectives are its requirements, continually improving the effectiveness of the management system means continually increasing the ability of the organization to fulfil its objectives.

This requirement responds to the Continual Improvement principle. If the management system is enabling the organization to accomplish its objectives when that is its purpose, why improve? The need for improvement arises out of a need to become more effective at what you do, more efficient in the utilization of resources so that the organization becomes best in its class. The purpose of measuring process performance is to establish whether or not the objectives are being achieved and if not to take action on the difference. If the performance targets are being achieved, opportunities may well exist to raise standards and increase efficiency and effectiveness.

If the performance of a process parameter is currently meeting the standard that has been established, there are several improvement actions you can take:
Raise the standard e.g. if the norm for the sales ratio of orders won to all orders bid is 60%, an improvement programme could be developed for raising the standard to 75% or higher
Increase efficiency e.g. if the time to process an order is within limits, identify and eliminate wasted resources Increase effectiveness e.g. if you bid against all customer requests, by only bidding for those you know you can win you improve your hit rate

You can call all these actions improvement actions because they clearly improve performance. However, we need to distinguish between being better at what we do now and doing new things. Some may argue that improving efficiency is being better at what we do now, and so it is – but if in order to improve efficiency we have to be innovative we are truly reaching new standards. Forty years ago, supervisors in industry would cut an eraser in half in the name of efficiency rather than hand out two erasers. Clearly this was a lack of trust disguised as efficiency improvement and it had quite the opposite effect. In fact they were not only increasing waste but also creating a hostile environment.

Each of the improvement actions is dealt with later in the book and the subject of continual improvement addressed again under Quality planning in Chapter 5. There are several steps to undertaking continual improvement (Juran, J. M., 1995)12 .
1 Determine current performance
2 Establish the need for change
3 Obtain commitment and define the improvement objectives
4 Organize diagnostic resources
5 Carry out research and analysis to discover the cause of current
performance
6 Define and test solutions that will accomplish the improvement
objectives
7 Product improvement plans which specify how and by whom the changes
will be implemented
8 Identify and overcome any resistance to change
9 Implement the change10 Put in place controls to hold new levels of performance and repeat step one.