ISO 9000 Quality Control

Sunday, March 14, 2010

ISO 9000 Standards Video Clip On Youtube

ISO 9000 Standards - ISO 9000 Standard Software
The term ISO9000 Standards refers to a set of quality management standards. ISO9000 currently includes three quality standards: ISO 9000:2005, ISO 9001:2000, and ISO 9004:2000. ISO 9001:2000 presents requirements, while ISO 9000:2005 and ISO 9004:2000 present guidelines. All of these are process standards (not product standards).

ISO 9001 Standard 's purpose is to facilitate international trade by providing a single set of standards that people everywhere would recognize and respect.

The ISO 9001 Standards apply to all kinds of organizations in all kinds of areas. Some of these areas include manufacturing, processing, servicing, printing, forestry, electronics, steel, computing, legal services, financial services, accounting, trucking, banking, retailing, drilling, recycling, aerospace, construction, exploration, textiles, pharmaceuticals, oil and gas, pulp and paper, petrochemicals, publishing, shipping, energy, telecommunications, plastics, metals, research, health care, hospitality, utilities, pest control, aviation, machine tools, food processing, agriculture, government, education, recreation, fabrication, sanitation, software development, consumer products, transportation, design, instrumentation, tourism, communications, biotechnology, chemicals, engineering, farming, entertainment, horticulture, consulting, insurance, and so on.

Friday, January 1, 2010

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.)

Establishing Quality Policy In ISO 9000 Standards

Establishing Quality Policy In ISO 9000 Standards

The standard requires that top management establish

the quality policy.

ISO 9001 defines a quality policy as the overall

intentions and direction of an organization related to

quality as formally expressed by top management. It

also suggests that the policy be consistent with the

overall policy of the organization and provide a

framework for setting quality objectives. Further-

more ISO 9001 advises that the eight quality manage-

ment principles be used as a basis for forming the quality policy. The quality

policy can therefore be considered as the values, beliefs and rules that guide

actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the

organization. A rule may be ‘confidentiality’ and expressed as Company

information shall not be shared with those outside the organization. Both these are

also beliefs because it might be believed that deceiving people only leads to

failure in the long run. It might also be believed that disclosing confidential

information fuels the competition and will drive the organization out of

business. Both values guide actions, decisions and behaviours and hence may

be termed policies. They are not objectives because they are not achieved – they

are demonstrated by the manner in which actions and decisions are taken and

the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this

requirement is an understanding of why a quality policy is needed, what is

required to establish a quality policy and where it fits in relation to other

policies.

Defining the purpose or mission of the business is one thing but without

some guiding policies, the fulfilment of this mission may not happen unless

effort is guided in a common direction. If every manager chooses his or her

direction, and policies, the full potential of the organization would not be

realized. A shared vision is required that incorporates shared values and

shared policies.

The purpose of corporate policies is to influence the short and long-term

actions and decisions and to influence the direction in which the mission will

be fulfilled. If there were policies related to the organization’s customers, they

could be fulfilled at the expense of employees, shareholders and society. If

there were policies related to profit, without other policies being defined, profit

is positioned as a boundary condition to all actions and decisions. Clearly this

may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies

exist to channel actions and decisions along a path that will fulfil the

organization’s purpose and mission. A goal of the organization may be the

attainment of ISO 9001 certification and thus a quality policy of meeting the

requirements of ISO 9001 would be consistent with such a goal, but goals are not

the same as purpose as indicated in the box to the right. Clearly no organization

would have ISO 9000 certification as its purpose because certification is not a

reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do

not channel actions and decisions. They become the focus of ridicule when the

organization’s fortunes change. There has to be a clear link from mission to

policy.

Policies are not expressed as vague statements or emphatic statements using

the words may, should or shall, but clear intentions by use of the words ‘we will’

– thus expressing a commitment or by the words ‘we are, we do, we don’t, we

have’ expressing shared beliefs. Very short statements tend to become slogans

which people chant but rarely understand the impact on what they do. Their

virtue is that they rarely become outdated. Long statements confuse people

because they contain too much for them to remember. Their virtue is that they

not only define what the company stands for but how it will keep its

promises.

In the ISO 9001 definition of quality policy it is suggested that the eight

quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the

quality policy the intention to identify and satisfy the needs and expectations

of customers and other interested parties and the associated strategy by which

this will be achieved, this requirement would be fulfilled. The inclusion of the

strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

The standard requires that top management establish the quality policy.

ISO 9001 defines a quality policy as the overall intentions and direction of an organization related to quality as formally expressed by top management. It also suggests that the policy be consistent with the overall policy of the organization and provide a framework for setting quality objectives. Furthermore ISO 9001 advises that the eight quality management principles be used as a basis for forming the quality policy. The quality policy can therefore be considered as the values, beliefs and rules that guide actions, decisions and behaviours. A value may be ‘integrity’ and expressed as:

We will be open and honest in our dealings with those inside and outside the organization. A rule may be ‘confidentiality’ and expressed as Company information shall not be shared with those outside the organization. Both these are also beliefs because it might be believed that deceiving people only leads to failure in the long run. It might also be believed that disclosing confidential information fuels the competition and will drive the organization out of business. Both values guide actions, decisions and behaviours and hence may be termed policies. They are not objectives because they are not achieved – they are demonstrated by the manner in which actions and decisions are taken and the way your organization behaves towards others.

The detail of quality policy will be addressed later. What is important in this requirement is an understanding of why a quality policy is needed, what is required to establish a quality policy and where it fits in relation to other policies.

Defining the purpose or mission of the business is one thing but without some guiding policies, the fulfilment of this mission may not happen unless effort is guided in a common direction. If every manager chooses his or her direction, and policies, the full potential of the organization would not be realized. A shared vision is required that incorporates shared values and shared policies.

The purpose of corporate policies is to influence the short and long-term actions and decisions and to influence the direction in which the mission will be fulfilled. If there were policies related to the organization’s customers, they could be fulfilled at the expense of employees, shareholders and society. If there were policies related to profit, without other policies being defined, profit is positioned as a boundary condition to all actions and decisions. Clearly this may not direct the organization towards its mission.

As stated above, the quality policy is the corporate policy and such policies exist to channel actions and decisions along a path that will fulfil the organization’s purpose and mission. A goal of the organization may be the attainment of ISO 9001 certification and thus a quality policy of meeting the requirements of ISO 9001 would be consistent with such a goal, but goals are not the same as purpose as indicated in the box to the right. Clearly no organization would have ISO 9000 certification as its purpose because certification is not a reason for existence – an objective maybe but not a purpose.

Policies expressed as short catchy phrases such as “to be the best” really do not channel actions and decisions. They become the focus of ridicule when the organization’s fortunes change. There has to be a clear link from mission to policy.

Policies are not expressed as vague statements or emphatic statements using the words may, should or shall, but clear intentions by use of the words ‘we will’ – thus expressing a commitment or by the words ‘we are, we do, we don’t, we have’ expressing shared beliefs. Very short statements tend to become slogans which people chant but rarely understand the impact on what they do. Their virtue is that they rarely become outdated. Long statements confuse people because they contain too much for them to remember. Their virtue is that they not only define what the company stands for but how it will keep its promises.

In the ISO 9001 definition of quality policy it is suggested that the eight quality management principles be used as a basis for establishing the policy.

One of these principles is the Customer Focus principle. By including in the quality policy the intention to identify and satisfy the needs and expectations of customers and other interested parties and the associated strategy by which this will be achieved, this requirement would be fulfilled. The inclusion of the strategy is important because the policy should guide action and decision.

Omitting the strategy may not ensure uniformity of approach and direction.

Reasons a Company Becomes Certified in ISO 9001 Standards

ISO 9000 certification or registration can be an expensive process. A company must consider the reasons and promised benefits for going through this process. If a company decides to seek certification, they should consider making sure their suppliers are certified or at least compliant to the ISO 9000 standards.

Major reasons
In the early 1990s, companies seemed to be jumping on the certification bandwagon without seriously considering the rationale for doing so. Often they did so because competitors or “everybody else” is getting registered. Today companies seriously look at the reasons and benefits for becoming registered.

The major reasons that company leadership or management decides to seek ISO 9000 certification are to gain continued or increased business and to maintain effective operations.

Improved business
A company can maintain a relationship with customers, as well as get increased business through complying to the ISO 900 standards or becoming certified. This comes from satisfying customer demands, the desire for European business, and to advertise.

Finally, some companies want to become certified, so they can advertise that fact and give the impression of being better than their competitors.

You have seen ads with a logo stating the company is certified at some ISO 9000 level. It apparently gives those companies a leg up on competitors not registered.

Again, this seemed more important in the 1990s, but you don’t see that many companies using ISO 9000 certification as an advertising tool.

ISO 9000 is supposed to make sure your business is run in an orderly manner that will assure continued success.

One would think that a goal such as being run effectively and able to deliver goods consistently and reliably would also be desirable for a company’s own operation. Surprisingly, many companies do not consider that as a goal.

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

IMPLEMENTATION GUIDANCE FOR ISO 9001:2008

This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period between ISO 9001:2000 and ISO 9001:2008.

While the changes between ISO 9001:2000 and ISO 9001:2008 are expected to have a limited impact on users, some arrangements regarding implementation are needed.

Note: To reflect the limited scope of the changes the term “implementation” is now being used to make a clear distinction with the former “transition” from ISO 9001:1994 to ISO 9001:2000, when there were significant changes throughout the standard.

A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2000, given in Annex B to ISO 9001:2008.

ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard.

Certification to ISO 9001:2008 is not an “upgrade”, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 No new requirements were introduced in this edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS In order to assist organizations to have a full understanding of the new ISO 9001:2008, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development.

Prior to the commencement of a revision (or amendment) to a management system standard, ISO/Guide 72:2001 Guidelines for the justification and development of management system standards recommends that a “Justification Study” is prepared to present a case for the proposed project and that it outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2008 user needs were identified from the following:

- the results of a formal “Systematic Review” on ISO 9001:2000 that was performed by the members of ISO/TC 176/SC2 during 2003-2004

- feedback from the ISO/TC 176/Working Group on “Interpretations”

- the results of an extensive worldwide “User Feedback Survey on ISO 9001 and ISO 9004″ by ISO/TC 176/SC 2/WG 18 and similar national surveys.

The Justification Study identified the need for an amendment, provided that the impact on users would be limited and that changes would only be introduced when there were clear benefits to users.

The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO14001:2004.

A tool for assessing the impacts versus benefits for proposed changes was created to assist the drafters of the amendment in deciding which changes should be included, and to assist in the verification of drafts against the identified user needs. The following decision making principles were applied:

1) No changes with high impact would be incorporated into the standard;

2) Changes with medium impact would only be incorporated when they provided a correspondingly medium or high benefit to users of the standard;

3) Even where a change was low impact, it had to be justified by the benefits it delivered to users, before being incorporated.

The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories:

- No changes or minimum changes on user documents, including records

- No changes or minimum changes to existing processes of the organization

- No additional training required or minimal training required

- No effects on current certifications

The benefits identified for the ISO 9001:2008 edition fall into the following categories:

- Provides clarity

- Increases compatibility with ISO 14001.

- Maintains consistency with ISO 9000 family of standards.

- Improves translatability.

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.