Review In ISO 9000 Standards

If you have your own business and now you are looking for ISO 9000 certification for quality standards for business to make your business products more reliable to the customers. To be in the market for any business, it needs quality and for quality any business needs to follow quality standards, so ISO 9000 Standards developed many quality standards as per different -different business areas.
ISO 9000 Standards is a generic quality standard and can be applied to any organization but before applying it, a process starts with pre-assessment audits and passes through on-going maintenance. The process of implementing ISO 9001 includes identifying, collecting and organizing the information required for certification.
For implementing ISO 9000 standards, any organization needs to hire a consultant because detailed knowledge of ISO standards is essential before successfully applying it. A consultant will analyze your organization structure, your products and their standards and will make a complete plan as per ISO standards for your organization.To hire a consultant is easiest way because they have complete knowledge of ISO 9000 standards and they perform various activities like provides class room training to your business employee about ISO 9000 standards
An ISO consultant performs the various activities and explains the course objectives :
• understand the purpose of ISO 9000: 2005, ISO 9001: 2008, ISO 9004: 2000, ISO 19011: 2002 etc. standards and their interrelationship
• describe the purpose of Quality Management Systems and 8 Quality Management Principles
• Interpret the ISO 9001: 2008 in the context of audit
•Plan and conduct an audit in accordance with guidelines as per ISO 19011: 2002, gather objective evidence via various methods and determine conformity to the requirements of Quality Management Systems
• Develop understanding of Roles & Responsibilities of Lead Auditors
Hiring a Consultant is a better and easiest way to implement ISO 9000 in your organization.

Corrective and Preventive Actions In ISO 9001 Standard

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) andEngineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

Corrective and Preventive Actions In ISO 9001 Standard

Corrective and Preventive actions are used to adjust the manufacturing processes, quality system and product documentation to continuously improve product and service quality. This process never ends. Corrective and preventive actions are usually based on an engineering change request and engineering change order system. In general it is recommended that all feedback from internal and external sources be entered into the engineering change request system. This can include customer survey results, customer complaints, nonconforming material data, field failure data, work-in-process testing results, internal audit results, external audit results and suggestions from personnel. The inputs are then entered into the Engineering Change Request System. This system is used to queue workload for the engineering and quality problem solvers. The engineering manager or quality manager then reviews this bulk of requests for prioritization. The highest priority issues are assigned to personnel who create an engineering change order to correct the problem. Some engineering change requests will be denied and the denial will be justified in the ECR system before the item is closed. Other requests will generate an Engineering Change Order that includes an assignment to a project manager. The engineering change order will include complete details on how to correct the problem and when the change will take effect. This system is a closed loop system that will continuously improve quality. The status of the ECR and ECO systems should be used as input for the management review meetings.

The process of managing this data usually requires a database since priorities change on a daily basis and the amount of input can be very large, even at small companies. A database is also advised since the system can be used to generate automated reports that are used in the management reviews. Without constant supervision, engineering requests and change orders can pile up and start dragging down the company.

Corrective and preventive actions are listed separately in the standard to drive home the point that you can not have successful company that only corrects problems, you must prevent problems.

Corrective and preventive actions also go hand-in-hand with the requirement for continuous improvement. If the company is analyzing their mistakes, anticipating future mistakes and continuously improving, The quality of the product and services at the company will eventually be GREAT. The corrective and preventive actions system is the most critical element for an efficient quality system. Corrective and preventive actions are made using Engineering Change Requests (ECR) andEngineering Change Orders (ECO).

Any quality problem or suggestion should generate an ECR. This is the queue for engineering. If the engineering/quality manager decides that an action is required, then an ECO is created and assigned to someone with the resources to correct and prevent future problems.

ECOs should be generated by negative customer feedback, negative trend in product performance, observed areas for improvement, upgrades to documentation, or any other continuous improvement activities. Engineering change orders are the lifeblood of the organization and they must always be flowing to keep the organization strong and growing.

With this in mind, it is critical that the engineering change order system quick, simple and effective. I highly recommend the use of a database for managing ECRs and ECOs. This will give you a searchable history of changes to your products and is the best tool for continuous improvement.

Documentation Structure For ISO 14001 EMS

ISO 14001 Standard does not require an Environmental Manual. Despite this, almost all companies I worked with developed and used EMS Manuals. Many of our clients use a four-level structures, including records, as shown below:
Manual – level 1
Procedures – level 2
Instructions – level 3
EMS Records – level 4
While auditing EMS systems like the one above, I often asked clients about the position of their Environmental policy in this structure. If you start from an Environmental Manual, how would you know what standard this manual should cover? The Environmental policy defines it and therefore it may be included into the structure:
Policy – level 1
EMS Manual – level 2
ISO 14001 Procedures – level 3
Work Instructions – level 4
EMS Records – level 5

Documentation Structure For ISO 14001 EMS

ISO 14001 Standard does not require an Environmental Manual. Despite this, almost all companies I worked with developed and used EMS Manuals. Many of our clients use a four-level structures, including records, as shown below:
Manual – level 1
Procedures – level 2
Instructions – level 3
EMS Records – level 4
While auditing EMS systems like the one above, I often asked clients about the position of their Environmental policy in this structure. If you start from an Environmental Manual, how would you know what standard this manual should cover? The Environmental policy defines it and therefore it may be included into the structure:
Policy – level 1
EMS Manual – level 2
ISO 14001 Procedures – level 3
Work Instructions – level 4
EMS Records – level 5

ISO 14001 Standards Training DVD

ISO 14001 Standards Training DVD

ISO 14001:2004 Environmental Management System
This video is designed to provide the management with basic information on ISO 14000 Standards. The content is based on the revised ISO 14001:2004 Standards Environmental Management System.

The ISO 14001:2004 Standards Environmental Management System DVD will elaborate in details on:
a.Introduction to ISO 14001:2004 Standards Environmental Management System.
b.The history & origin of the standards.
c.Requirement of ISO 14001:2004 Standards.
d.Contents Of ISO 14001:2004 Standards.
e.ISO 14001:2004 Implementation Steps & Checklist.

ISO 14001 Standards Training DVD

ISO 14001 Standards Training DVD

ISO 14001:2004 Environmental Management System
This video is designed to provide the management with basic information on ISO 14000 Standards. The content is based on the revised ISO 14001:2004 Standards Environmental Management System.

The ISO 14001:2004 Standards Environmental Management System DVD will elaborate in details on:
a.Introduction to ISO 14001:2004 Standards Environmental Management System.
b.The history & origin of the standards.
c.Requirement of ISO 14001:2004 Standards.
d.Contents Of ISO 14001:2004 Standards.
e.ISO 14001:2004 Implementation Steps & Checklist.

ISO 9001 Standards Software

ISO 9001 Standards Software

Companies that need quality management systems realize that products like ISO 9001 software are important tools to insure their product safety, consistency and profitability. UsingISO 9001 software can help guarantee that any company can monitor productivity, customer satisfaction and product quality with reports that contain solid information.

This information is now vital to management in order for maximum efficiency in any industry. This is why ISO 9001 software is vital to any sized company. Continuous improvement means continuous profitability. Here are just a few reasons why:

o Companies increase sales because of better performance, quality, and delivery. This propels you ahead of your competition.

o ISO 9001 software helps retain employees and attract more highly qualified employees because they are assured of a controlled and consistent work environment.

o The experience of a more professional workplace boosts employee morale.

o Reduced operating costs dramatically increase your company’s productivity, leading to higher profitability.

o Customer satisfaction and higher profitability expand your market share and demand for your consistently higher product quality.

o When you’re compliant or certified to the appropriate standard, the businesses that work with you know that quality objectives, continuous improvement, and customer satisfaction are your goals.

Many companies require that their suppliers are ISO 9001 compliant; therefore, once you’re certified, your opportunities increase. ISO 9001 software has be utilized and has developed experience of helping manufacturing, service, and distribution organizations to be more efficient and more profitable through continuous improvement programs. We help you to implement the time-tested methods of continuous improvement to measure performance, analyze data, and apply the appropriate process changes. This includes using ISO 9001 software.

ISO 9001 software also offers a suite of modules to enable you to manage the document management and ISO 9001 Compliance Management process. These modules enable complete transparent system measurement with targeted action items ensuring all persons are notified of tasks and carry them out in a prompt and efficient manner. ISO 9001 software provides training in there software and also bring extensive experience in implementing the ISO 9001 software in various environments.

ISO 9001 Standards – Design and Development

ISO 9001 Standards - Design and Development

Plan and control the product design and development. This planning must determine the:Identify problems and propose any necessary actions

- Stages of design and development

- Appropriate review, verification, and validation activities for each stage

- Responsibility and authority for design and development

The interfaces between the different involved groups must be managed to ensure effective communication and the clear assignment of responsibility. Update, as appropriate, the planning output during design and development.

NOTE: Design and development review, verification, and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as deemed suitable for the product and the organization.

Determine product requirement inputs and maintain records. The inputs must include:

- Functional and performance requirements

- Applicable statutory and regulatory requirements

- Applicable information derived from similar designs

- Requirements essential for design and development

Review these inputs for adequacy. Resolve any incomplete, ambiguous, or conflicting requirements.

Document the outputs of the design and development process in a form suitable for verification against the inputs to the process. The outputs must:

- Meet design and development input requirements

- Provide information for purchasing, production, and service

- Contain or reference product acceptance criteria

- Define essential characteristics for safe and proper use

- Be approved before their release

Perform systematic reviews of design and development at suitable stages in accordance with planned arrangements to:

- Evaluate the ability of the results to meet requirements

- The reviews must include representatives of the functions concerned with the stage being reviewed. Maintain the results of reviews and subsequent follow-up actions.

Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.

Organizations may be able to demonstrate conformity without the need for extensive documentation.

To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective

evidence” as “data supporting the existence or variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”

Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)

Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.

Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

Understand Quality Management

Quality Management may be defined as the process through which organizations apply statistical process control mechanisms in order to improve the quality and standards of goods and services that are manufactured. Closely related to Quality Management is tqm, also known as total quality management. This is basically a management strategy that is applied in businesses in order to create awareness of high quality in most organizational processes. Quality Management features three main components including quality assurance, quality improvement and quality control. Quality management is focused not only on the quality of products and services but also on continuous improvement of quality standards.

Most methods that are now being used for Quality Management, quality system and quality manufacturing system take into consideration the need for high quality as an essential attribute in services and products that are manufactured by companies and organizations.Quality Management usually involves the successful improvement of quality of services and products. This is usually done through quality training processes where one can also acquire lessons on quality process and process management. One tool that is used for ensuring auditing quality in Quality Management is the MasterControlQAAD(TM) software. Besides using tools to carry out Quality Management successfully, one can also consider applying project management. This will help ensure continuous quality improvement.

The other way through which organizations can improve quality of process and service output is by using six sigma. This is basically a business management strategy that helps identify and remove defects and variations in the manufacturing process. It also helps guarantee Quality Management. It works by using a set of high quality business management and overall management methods to ensure quality and guarantee Quality Management. Most products and services to which Quality Management is applied are certified with iso certificates. Some of the iso certificates that guarantee that a product or service has undertaken Quality Management, change management and process improvement is iso 9001.

iso 9001 and iso 14001:2004 set down specific guidelines for environmental management systems and Quality Management. Other guidelines can be found in other generic process management philosophies such as the lean management that follows iso 9000 quality improvement standards aimed at guaranteeing total quality to its quality systems. The other mode through which organizations guarantee Quality Management is by use of a quality plan that meets iso 14000 and iso 14001 iso certification requirements. The other iso certification that guarantees product quality in Quality Management include iso 9001 2000.

In order to meet supplier quality in Quality Management systems, there are several iso training sessions that are offered. These meet iso standards. An organization that is in need of Quality Management for its products and services may also consider using a quality manual for its day to day Quality Management plans. Such a manual will usually have guidelines for iso quality. However, when applying the guidelines in the manual, regard must be had to quality audit measures aimed at guaranteeing Quality Management for the organization. Quality Management also involves knowledge of as9100 and iso 13485 that are commonly applicable in supplier management.

Quality Management programs that are iso certified help offer quality policy to existing iso 9001 certifications and quality management system that meet iso 9000 and ts16949 requirements. Quality companies that are aimed at ensuring Quality Management for the products and services that they manufacture also use quality management software that guarantees managing quality. In order to enhance Quality Management, the software guarantees quality procedures through its high rate of functionality. Besides such software, an organization can adopt quality assurance training and also offer quality consulting to its members in order to guarantee Quality Management to its products and services.

There are also several quality project management plans, which meet iso standards such as iso 9002 that are available today. Such plans are usually developed with a view to developing flexible, affordable and scalable management solutions to companies that seek to uphold Quality Management for their products and services. Such plans feature quality management systems that offer quality control management and quality assurance management through quality a management plan. Other quality objectives that can be obtained through iso 9001 training thus meeting iso 9000 certification use project management skills to improve Quality Management for the manufactured products and services.

Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in aquality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Integrating Management Systems Within The ISO Standards

Today’s free market economies increasingly encourage diverse sources of supply and provide opportunities for expanding markets. Fair competition needs to be based on identifiable, clearly defined common references that are recognised from one country to the next. A standard, internationally recognised, developed by consensus among trading partners, serves as the language of trade. The International Organisation for Standardisation (ISO) has developed around 8′700, mostly technical related standards on this basis. Standards Series such as ISO 9000, ISO 14000 and what is to be known as ISO 18000 and ISO 26000 are Management related. These standards contain generic guidelines for Management Systems in the area of Quality, Environment, Occupational Health & Safety and Human Resources.

ISO is a word derived from the Greek isos, meaning “equal”. ISO Standards are developed and updated by the International Organisation for Standardisation which has around 150 member bodies. A member body of ISO is the national body “most representative of standardisation in its country”.(eg. Germany – DIN, USA – ANSI, Australia – SAA).
More than 50 countries, as well as the European Community have adopted ISO 9000 which is recognised internationally as a benchmark for measuring quality in a trade context. Since its first issue in 1987, approximately 430′000 companies have been using ISO 9000. Being a standard coming from an organisation that is usually involved in the development of technical standards, ISO 9000 is often regarded as a document that belongs in the hands of a technician exposed to production line quality control. At a closer look, however, ISO 9000 Standard Series provide guidance in the development and application of Management Systems as well as Quality Control in Manufacturing and Administration.

ISO has been developing a number of Management System Guidelines for various aspects of business. The most recent are the ISO 14000 Environmental Management System Guidelines. This is an international standard that will affect business in the near future. ISO 14000 has been designed to integrate with ISO 9000. However, apart from international standards there are local standards a company has to comply with. To remain compliant with local standards, further manuals and/or procedures are required (eg. lifting procedure in a warehouse to satisfy Work Safety requirements). A company may have several Manuals describing its Management Systems (eg. Human Resources, Quality, Security, Health/Safety, Finances). An overall link between the systems is often missing which makes the monitoring and the assessment of effectiveness difficult. Double handling of information, contradicting instructions, high maintenance costs, administrative excess and lack of overall transparency are common results.
ISO 9000 Standard Series for Quality (of) Management Systems provide generic guidance for the development of an overall Management System, ISO 14000 provides guidance for Environmental Management, etc. Transparency and monitoring of all business activities can be achieved by integrating all systems into one.
Complaints that ISO 9000 is paralysing operations and, that it does not reflect reality are usually a result of not clearly understanding how the standard can be properly structured to address the needs of a company. ISO 9000 can be structured by focusing on “best practice” process rather than the standard, by fitting the standard to the process and not the process to the standard. Having recognised this, ISO has been working on a new structure for ISO 9000, called “Vision 2000″, taking a process orientated approach to ensure that “best practice” as well as several standards can be addressed within one system. Focusing on process allows the development of a practical “working document”, providing an effective management tool. Having learned from the past, the trend to Process Orientated Management Systems started about three years ago in Europe and is finding increasing approval from certification bodies.Every company has its own culture and key individuals.
The business environment influences processes in certain ways (eg. employee market, laws, infrastructure, client, etc.)
To ensure competitiveness a company needs to ensure adequate flexibility in their system to effectively respond to changes in the business environment.
An effective system is a lean system that incorporates all necessary functions, controls of activities and “best practice” without being caught up in detail.
An effective system must also be flexible enough to enable the proper controls on outsourcing and sub-contracting of activities (eg. production, administration, service, etc.)

ISO 9000 Standards – Conducting Management Reviews

ISO 9000 Standards – Conducting Management Reviews

The ISO 9000 standards requires that top management conduct

management reviews.

The term review is defined in ISO 9001 as an activity

undertaken to ensure the suitability, adequacy, effective-

ness and efficiency of the subject matter to achieve

established objectives. The addition of the term manage-

ment means that the management review can be

perceived as a review of management rather than a

review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 such as design

review and nonconformity review clearly indicate it is design and non-

conformity that is being reviewed. If the system was to be reviewed then the

action should be called a system review. It is no doubt unintentional in the

standard but, if the management system is perceived as the way in which the

organization’s objectives are achieved, a review of management is in fact a

review of the way achievement of objectives is being managed because the

organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless

they believe it is essential to running the business. The way to do this is to treat

it as a business performance review. This is simpler than it may appear. If the

quality policy is now accepted as corporate policy and the quality objectives

are accepted as corporate objectives, any review of the management system

becomes a performance review and no different to any other executive

meeting. The problem with the former management reviews was that they

allowed discussion on the means for achieving objectives to take place in other

management meetings leaving the management review to a review of errors,

mistakes and documentation that no one was interested in anyway. The

management system is the means for achieving objectives therefore it makes

sense to review the means when reviewing the ends so that actions are linked to

results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not

the quality manager, not the operational manager – but top management – those

who direct and control the organization at the highest level. In many ISO 9000

registered organizations, the management review is a chore, an event held once

each year, on a Friday afternoon before a national holiday – perhaps a cynical

view but nonetheless often true. The reason the event has such a low priority

is that management have not understood what the review is all about. Tell

them it’s about reviewing nonconformities, customer complaints and internal

audit records and you will be lucky if anyone turns up. The quality manager

produces all the statistics so the others managers are free of any burden. By

careful tactics, these managers may come away with no actions, having

delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management

reviews, management would need to demonstrate that it planned for the

reviews, prepared input material in the form of performance results, metrics

and explanations, decided what to do about the results and accepted action to

bring about improvement.

The ISO 9000 standards requires that top management conduct management reviews.

The term review is defined in ISO 9000 Standards as an activity undertaken to ensure the suitability, adequacy, effectiveness and efficiency of the subject matter to achieve established objectives. The addition of the term management means that the management review can be perceived as a review of management rather than a review by management, although both meanings are conveyed in the standard.

The rationale for this is that the examples given in ISO 9000 Standards such as design review and nonconformity review clearly indicate it is design and non-conformity that is being reviewed. If the system was to be reviewed then the action should be called a system review. It is no doubt unintentional in the standard but, if the management system is perceived as the way in which the organization’s objectives are achieved, a review of management is in fact a review of the way achievement of objectives is being managed because the organization exists to achieve objectives and so both meanings are correct.

Top management will not regard the management review as important unless they believe it is essential to running the business. The way to do this is to treat it as a business performance review. This is simpler than it may appear. If the quality policy is now accepted as corporate policy and the quality objectives are accepted as corporate objectives, any review of the management system becomes a performance review and no different to any other executive meeting. The problem with the former management reviews was that they allowed discussion on the means for achieving objectives to take place in other management meetings leaving the management review to a review of errors, mistakes and documentation that no one was interested in anyway. The management system is the means for achieving objectives therefore it makes sense to review the means when reviewing the ends so that actions are linked to results and commitment secured for all related changes in one transaction.

The requirement emphasizes that top management conduct the review – not the quality manager, not the operational manager – but top management – those who direct and control the organization at the highest level. In many ISO 9000 registered organizations, the management review is a chore, an event held once each year, on a Friday afternoon before a national holiday – perhaps a cynical view but nonetheless often true. The reason the event has such a low priority is that management have not understood what the review is all about. Tell them it’s about reviewing nonconformities, customer complaints and internal audit records and you will be lucky if anyone turns up. The quality manager produces all the statistics so the others managers are free of any burden. By careful tactics, these managers may come away with no actions, having delegated any in their quarter to the quality manager.

In order to provide evidence of its commitment to conducting management reviews, management would need to demonstrate that it planned for the reviews, prepared input material in the form of performance results, metrics and explanations, decided what to do about the results and accepted action to bring about improvement.

Documents That Ensure Effective Planning, Operation And Control

Documents That Ensure Effective Planning, Operation And Control

The ISO 9000 standard requires management system documentation to include documents required by the organization to ensure the effective planning, operation and control of its processes.
The documents required for effective planning, operation and control of the processes would include several different types of documents. Some will be
product and process specific and others will be common to all processes. Rather than stipulate the documents that are needed, ISO 9000 Standards now provides for the organization to decide what it needs for the effective operation and control of its processes. This phrase is the key to determining the documents that are needed.
There are three types of controlled documents, namely:
- Policies and practices (these include process descriptions, control procedures, guides, operating procedures and internal standards)
- Documents derived from these policies and practices, such as drawings,
specifications, plans, work instructions, technical procedures and reports
- External documents referenced in either of the above
There will always be exceptions to this model but in general the majority of
documents used in a management system can be classified in this way.
Derived documents are those that are derived by executing processes;
for example, audit reports result from using the audit process, drawings result from using the design process, procurement specifications result from using the procurement process. There are, however, two types of derived document:
prescriptive and descriptive documents. Prescriptive documents are those that prescribe requirements, instructions, guidance etc. and may be subject to change. They have issue status and approval status, and are implemented in doing work. Descriptive documents result from doing work and are not
implemented. They may have issue and approval status. Specifications, plans, purchase orders, drawings are all prescriptive whereas audit reports, test reports, inspection records are all descriptive. This distinction is only necessary because the controls required will be different for each class of documents.

Document Review In ISO 9000 Standards

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.

Previously the implication was that the review was a

check by potential users that the document was fit

for purpose before it was offered for approval. It

could be construed that for a document to receive

approval it must be checked and therefore ‘review

and approval’ in this context are one and the same

and the requirement is in this instance enhanced

rather than relaxed.

A review is another look at something. Therefore

document review is a task that is carried out at any

time following the issue of a document.

This requirement responds to the Continual Improvement principle.

Reviews may be necessary when:

- Taking remedial action (i.e. Correcting an error)

- Taking corrective action (i.e. Preventing an error recurring)

- Taking preventive action (i.e. Preventing the occurrence of an error)

- Taking maintenance action (i.e. Keeping information current)

- Validating a document for use (i.e. When selecting documents for use in

connection with a project, product, contract or other application)

- Taking improvement action (i.e. Making beneficial change to the

information)

Reviews may be random or periodic. Random reviews are reactive and arise

from an error or a change that is either planned or unplanned. Periodic reviews

are proactive and could be scheduled once each year to review the policies,

processes, products, procedures, specification etc. for continued suitability. In

this way obsolete documents are culled from the system. However, if the

system is being properly maintained there should be no outdated information

available in the user domain. Whenever a new process or a modified process

in installed the redundant elements including documentation and equipment

should be disposed of.

Document Review In ISO 9000 Standards

The ISO 9000 Standard requires that documents be reviewed.

Previously the implication was that the review was a

check by potential users that the document was fit

for purpose before it was offered for approval. It

could be construed that for a document to receive

approval it must be checked and therefore ‘review

and approval’ in this context are one and the same

and the requirement is in this instance enhanced

rather than relaxed.

A review is another look at something. Therefore

document review is a task that is carried out at any

time following the issue of a document.

This requirement responds to the Continual Improvement principle.

Reviews may be necessary when:

- Taking remedial action (i.e. Correcting an error)

- Taking corrective action (i.e. Preventing an error recurring)

- Taking preventive action (i.e. Preventing the occurrence of an error)

- Taking maintenance action (i.e. Keeping information current)

- Validating a document for use (i.e. When selecting documents for use in

connection with a project, product, contract or other application)

- Taking improvement action (i.e. Making beneficial change to the

information)

Reviews may be random or periodic. Random reviews are reactive and arise

from an error or a change that is either planned or unplanned. Periodic reviews

are proactive and could be scheduled once each year to review the policies,

processes, products, procedures, specification etc. for continued suitability. In

this way obsolete documents are culled from the system. However, if the

system is being properly maintained there should be no outdated information

available in the user domain. Whenever a new process or a modified process

in installed the redundant elements including documentation and equipment

should be disposed of.

The characteristics of quality Classification of products and services

If we group products and services (entities) by type, category, class and grade

we can use the subdivision to make comparisons on an equitable basis. But

when we compare entities we must be careful not to claim one is of better

quality than the other unless they are of the same grade. Entities of the same

type have at least one attribute in common. Entities of the same grade have

been designed for the same functional use and therefore comparisons are valid.

Comparisons on quality between entities of different grades, classes, categories

or types are invalid because they have been designed for a different use or

purpose.

Let us look at some examples to illustrate the point. Food is a type of entity.

Transport is another entity. Putting aside the fact that in the food industry the

terms class and grade are used to denote the condition of post-production

product, comparisons between types is like comparing fruit and trucks – there

are no common attributes. Comparisons between categories are like comparing

fruit and vegetables. Comparisons between classes are like comparing apples

and oranges. Comparisons between grades is like comparing eating apples and

cooking apples.

Now let us take another example. Transport is a type of entity. There are

different categories of transport such as airliners, ships, automobiles and trains;

they are all modes of transport but each has many different attributes.

Differences between categories of transport are therefore differences in modes of

transport. Within each category there are differences in class. For manufactured

products, differences between classes imply differences in purpose. Luxury cars,

large family cars, small family cars, vans, trucks, four-wheel drive vehicles etc.

fall within the same category of transport but each was designed for a different

purpose. Family cars are in a different class to luxury cars; they were not

designed for the same purpose. It is therefore inappropriate to compare a

Cadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo.

Entities designed for the same purpose but having different specifications are

of different grades. A Ford Mondeo GTX is a different grade to a Mondeo LX.

They were both designed for the same purpose but differ in their performance

and features.

Now let us take an example from the service industry: accommodation. There

are various categories, such as rented, leased and purchased. In the rented

category there are hotels, inns, guesthouses, apartments etc. It would be inappropriate

to compare hotels with guesthouses or apartments with inns. They are

each in a different class. Hotels are a class of accommodation within which are

grades such as 5 star, 4 star, 3 star etc., indicating the facilities offered.

You can legitimately compare the quality of entities if comparing entities of

the same grade. If a low-grade service meets the needs for which it was

designed, it is of the requisite quality. If a high-grade product or service fails to

meet the requirements for which it was designed, it is of poor quality,

regardless of it still meeting the requirements for the lower grade. There is a

market for such differences in products and services but should customer

expectations change then what was once acceptable for a particular grade may

no longer be acceptable and regrading may have to occur.

Where manufacturing processes are prone to uncontrollable variation it is

not uncommon to grade products as a method of selection. The product that is

free of imperfections would be the highest grade and would therefore

command the highest price. Any product with imperfections would be

downgraded and sold at a correspondingly lower price. Examples of such

practice arise in the fruit and vegetables trade and the ceramics, glass and

textile industries. In the electronic component industry, grading is a common

practice to select devices that operate between certain temperature ranges. In

ideal conditions all devices would meet the higher specification but due to

manufacturing variation only a few may actually reach full performance. The

remainder of the devices has a degraded performance but still offer all the

functions of the top-grade component at lower temperatures. To say that these

differences are not differences in quality would be misleading, because the

products were all designed to fulfil the higher specification. As there is a

market for such products it is expedient to exploit it. There is a range over

which product quality can vary and still create satisfied customers. Outside the

lower end of this range the product is considered to be of poor quality.

The Characteristics Of Quality Classification

If we group products and services (entities) by type, category, class and grade

we can use the subdivision to make comparisons on an equitable basis. But

when we compare entities we must be careful not to claim one is of better

quality than the other unless they are of the same grade. Entities of the same

type have at least one attribute in common. Entities of the same grade have

been designed for the same functional use and therefore comparisons are valid.

Comparisons on quality between entities of different grades, classes, categories

or types are invalid because they have been designed for a different use or

purpose.

Let us look at some examples to illustrate the point. Food is a type of entity.

Transport is another entity. Putting aside the fact that in the food industry the

terms class and grade are used to denote the condition of post-production

product, comparisons between types is like comparing fruit and trucks – there

are no common attributes. Comparisons between categories are like comparing

fruit and vegetables. Comparisons between classes are like comparing apples

and oranges. Comparisons between grades is like comparing eating apples and

cooking apples.

Now let us take another example. Transport is a type of entity. There are

different categories of transport such as airliners, ships, automobiles and trains;

they are all modes of transport but each has many different attributes.

Differences between categories of transport are therefore differences in modes of

transport. Within each category there are differences in class. For manufactured

products, differences between classes imply differences in purpose. Luxury cars,

large family cars, small family cars, vans, trucks, four-wheel drive vehicles etc.

fall within the same category of transport but each was designed for a different

purpose. Family cars are in a different class to luxury cars; they were not

designed for the same purpose. It is therefore inappropriate to compare a

Cadillac with a Chevrolet or a Rolls Royce Silver Shadow with a Ford Mondeo.

Entities designed for the same purpose but having different specifications are

of different grades. A Ford Mondeo GTX is a different grade to a Mondeo LX.

They were both designed for the same purpose but differ in their performance

and features.

Now let us take an example from the service industry: accommodation. There

are various categories, such as rented, leased and purchased. In the rented

category there are hotels, inns, guesthouses, apartments etc. It would be inappropriate

to compare hotels with guesthouses or apartments with inns. They are

each in a different class. Hotels are a class of accommodation within which are

grades such as 5 star, 4 star, 3 star etc., indicating the facilities offered.

You can legitimately compare the quality of entities if comparing entities of

the same grade. If a low-grade service meets the needs for which it was

designed, it is of the requisite quality. If a high-grade product or service fails to

meet the requirements for which it was designed, it is of poor quality,

regardless of it still meeting the requirements for the lower grade. There is a

market for such differences in products and services but should customer

expectations change then what was once acceptable for a particular grade may

no longer be acceptable and regrading may have to occur.

Where manufacturing processes are prone to uncontrollable variation it is

not uncommon to grade products as a method of selection. The product that is

free of imperfections would be the highest grade and would therefore

command the highest price. Any product with imperfections would be

downgraded and sold at a correspondingly lower price. Examples of such

practice arise in the fruit and vegetables trade and the ceramics, glass and

textile industries. In the electronic component industry, grading is a common

practice to select devices that operate between certain temperature ranges. In

ideal conditions all devices would meet the higher specification but due to

manufacturing variation only a few may actually reach full performance. The

remainder of the devices has a degraded performance but still offer all the

functions of the top-grade component at lower temperatures. To say that these

differences are not differences in quality would be misleading, because the

products were all designed to fulfil the higher specification. As there is a

market for such products it is expedient to exploit it. There is a range over

which product quality can vary and still create satisfied customers. Outside the

lower end of this range the product is considered to be of poor quality.