ISO 9000 History

ISO 9000 is an important marketing tool and is recognized world wide. Maintained by the ISO (international standards organization), it is a family of ISO standards for quality management systems. ISO 9000 grew out of British standards institution's BS 5750. The ISO 9000 series are managed by several accreditation and certification bodies. Though the standard was first applied to manufacturing industries, it is now employed across a variety of other types of businesses.

Studies show that the history of industrialization has seen lots of standards on quality issues. For instance, during the two world wars, a high percentage of bullets and bombs went off in the factories themselves in the course of manufacturing. In an effort to curb such causalities, UK?s ministry of defense appointed inspectors in the factories to supervise the production process.

In 1959, the United States introduced Mil-Q-9858a, the first quality standard for military procurement. By 1962, NASA developed its quality system requirements for suppliers. Six years later, NATO accepted the AQAP (allied quality assurance procedures) specifications for the procurement of equipments. In 1969, UK and Canada introduced suppliers? quality assurance standards.

During the 1970s, British standards institution (BSI) published BS 9000 (the first UK standard for quality assurance) and BS 5179 (guidelines for quality assurance) norms. During the period, the BSI held meetings with industry to set a common standard. Consequently, in 1979, the institution developed BS 5750, a series of standards for use by manufacturing companies. They were enforced through assessments and audits.

In 1987, the BSI revised the standard to take in service providers and manufacturing industries also. In 1988, ISO adopted the BS 5750 standard without changes and published it globally under the name, ISO 9000.

In 1994, ISO revised the standard. In December 2000, the standard was again reorganized. The new ISO 9000 standard has many resemblances to its predecessors.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections

ISO 9000 Quality Assurance

ISO 9000 is a set of standards developed by the ISO (international organization for standardization) for quality assurance systems. It was first published in 1987 and the standards were modified in 1994. ISO 9000 serves as a true base for organizations to improve their quality assurance systems.

A quality assurance system involves the organizational structure, duties, procedures, processes, and materials for applying quality management. It is designed to help businesses assure their services and products, and please customer hopes by meeting their specifications. Quality assurance covers all activities of a product?s life cycle, including planning, controlling, measuring, testing and reporting, and improving quality levels.

ISO 9000 quality assurance models view an enterprise as a network of interconnected processes. For a quality system to be ISO-compliant, the processes should address areas known in the standard and should be documented and practiced as described. Documenting a process gives an organization the opportunity to understand, control, and improve its process network.

ISO quality assurance is a management activity that contains auditing and reporting actions. These two functions assist the manager to verify the efficiency of the quality system. ISO 9000 expresses quality assurance resources in general terms that can be used by any organization irrespective of the products or services provided. However, ISO 9000 does not explain how a business should apply these quality system elements.

Most companies first attempt to get certified to one of the quality assurance system models in the ISO 9000 series. For this, the company?s quality system and actions are audited by third party auditors for conformity to the standard and for effective operation. Upon successful certification, the company obtains a certificate from a certification body represented by the auditors.

ISO 9000 provides detailed information on ISO 9000, ISO 9000 Standards, ISO 9000 Software, ISO 9000 Consulting and more. ISO 9000 is affiliated with Home Inspections.

Six Sigma Vs ISO 9000

The debate over whether or not to choose Six Sigma over ISO 9000 is getting more interesting with each passing day. In an attempt to determine which of these is the better of the two, it is highly pertinent to discuss that in the context of applicability of them to industries. And there exists a huge amount of difference between the approaches of these two methodologies in tackling the issues.

Six Sigma - A Critical View

Six Sigma utilizes a multi-faceted approach to doing business with total improvement of the end product being the goal. In doing so, Six Sigma defines and analyzes the processes critically almost always focusing on process improvements. The statistical tools used in Six Sigma help not just in the adoption of processes but are also critical tools of Six Sigma implementation.

Process Development Stages

Let us examine the above statement as applicable to a process for easier understanding. While working on process improvement, the Black Belts break up the original sequence of different events that comprise the entire process and each event is further subdivided internally. This enables the "belts" to take an entirely different view of the process via the entire process as a whole. The powerful statistical tools employed at this stage of evaluation make the picture clearer and help the "belts" to arrive at decisions about the value additions those made to the process by different events.

This principle obviously goes beyond standardizing the processes and setting the pathway for being vigilant about adherence to the Six Sigma methodology. Useless values which have lost meaning make way for more meaningful events and eventually more robust and comprehensive processes. In a Six Sigma environment, customer demands will assume a key role in driving the processes towards aligning all activities with the vision of the leader of the company. The approach is "how to" rather than "what to" deliver.

The ISO 9000 Approach

The ISO approach towards quality management concentrates on standardization of the activities of production. The eight quality principles of ISO 9000, along with its twenty-four requirements outline business processes. The emphasis here is on the control of events in each aspect of doing business by documenting evidence and reports. The eight principles of ISO 9000 include prioritizing customer data, purchasing and quality systems, among other critical aspects. ISO 9000 recognizes each process, whose end goals are the same, as an independent entity. Documented quality requirements typically decide, based on set rules, whether or not a particular process adhered to that standard.

Document and Process Control

Maintenance of quality is achieved by adhering to key process and document control. Operating procedures and process control documents restrict deviations outside the concepts of what you should be doing in every process. What-you-should-be-doing is given emphasis under standard conditions rather than dealing with process improvement.

Stalwarts in industry are examining the possibility of merging the best practices of the two. Several industry leaders have already acknowledged the benefits of using both methodologies to compliment each other. Another view is that, as Six Sigma implementation is what you do within your company (unlike the certification in ISO) the company does not get recognition for achieving successful Six Sigma implementation. However, as long as the culmination of a business activity is defined by both methodologies as retaining and improving the customer base along with maximizing the bottom line, rejection of one in favor of other will be hard to justify.

Tony Jacowski is a quality analyst for The MBA Journal. Aveta Solution's Six Sigma Online offers online six sigma training and certification classes for lean six sigma, black belts, green belts, and yellow belts

Preparing For ISO 9001 2000 Registration

The steps need to be taken to prepare an organization for ISO 9001 2000 registration:

Whilst the following text is not exhaustive in its content it should give you a reasonable idea of what’s involved in setting up an ISO 9001 2000 registration within an organization.

First and most importantly you should either purchase a copy of the ISO 9001 2000 standard or read a copy at your local library.

At first glance many of the terms referred to in the standard sound quite confusing but if you study the content of this web site you will soon become familiar with the terminology used.

Now that you are a little more familiar with the ISO 9001 2000 Quality Management Standard and its terminology you should start to analyze the current practices of your organization to those documented within the ISO 9001 2000 standard,This process is known as a gap analysis audit. You can either carry this process out yourselves or employ the skills of an ISO 9001 2000 consultant to carry out the task for you.

It is very important to get this audit right as the results will be used to set the direction of your organization on its route to full ISO 9001 2000 registration. In short if this audit is wrong or incomplete your organization will happily steam along in the wrong direction, wasting resources as it goes, until someone tells you otherwise. If I were to give one piece of advice here it would be to recommend using a professional, a small amount of money spent at this stage could save you unnecessary expenditure if you were to get it wrong.

As the gap analysis audit on your organization progresses you will be able to identify the processes which are already documented, and those that are not. It will be useful to your organization to compile a list of documents that you will need for the Quality Management System as you complete the gap analysis audit, there is no sense in doing the same job twice.

It is important to remember that just because a process is documented does not necessarily mean it is compliant with the requirements of the ISO 9001 2000 standard. Almost certainly your organization will have to tweak existing processes and or instigate new ones in order to comply with the documented requirements of the ISO 9001 2000 standard.

For this purpose you may decide to bring together a team of employees and have them review the processes and suggest improvements which will make the process compliant with ISO 9001 2000. Alternatively you may wish to employ an ISO 9001 2000 consultant to carry out this task for you. Whilst a consultant may initially seem expensive he or she will have the experience to complete the task expediently and cost effectively.

Now that the organizations processes and any short falls against the ISO 9001 2000 standard have been identified they have to be documented in a within a controlled document control system. Whilst there is not a definitive, prescribed method to document an ISO 9001 2000 Quality Management System there are, as with most things, easy and hard ways of doing this. If you are unsure how to do this there is an example procedure here or once again you can employ a consultant to complete this task expediently.

Design and implement the Quality Management System to comply with the requirements of ISO 9001 2000.

This will typically require:

Establishing a quality policy and measurable quality objectives.

Documenting a quality manual, describing your Quality Management System.

Documenting procedures which describe the processes in your organization.

Creating a document issue, withdrawal and re-issue of documents system.

Documenting test and inspection methods.

Documenting a corrective and preventive action process.

Identification of training needs and necessary job skills.

Calibrating and controlling measuring and test equipment.

Measuring and monitoring customer satisfaction.

Measuring process, and product conformity.

Training employees on the operation of the quality management system.

Planning, conducting and following up internal Quality Management System audits.

Continual improvement of the Quality Management System.

As each process in your organization is revised, documented and implemented you need to ensure that your employees are trained accordingly in the operation of the revised process and that their documented training records are updated. All employees must have had at least basic ISO 9001 2000 training so that they can demonstrate that they understand what is required of them. You can either attempt this training your self or employ a consultant trainer to do this task for you.

You must generate and keep documented records of employee training in accordance with your new processes procedures which, of course must be compliant with ISO 9001 2000.

These records will be used as evidence to prove to your ISO assessor that you are operating your Quality Management System in accordance with your documented procedures and ISO 9001 2000. Driso's Easy ISO 9001 2000® software will record, control all of your organisations training records in an ISO 9001 2000 compliant format.

As your processes evolve you must start internal quality management system audits so as to satisfy your organization that it is in fact operating its processes in accordance with its own documented procedures and the requirements of ISO 9001 2000.

Your ISO 9001 2000 auditor will look at the records generated by your internal audits. ISO 9001 2000 relies on Quality Management System audits to provide assurance that the organization is meeting the requirements of the ISO 9001 2000 standard.

An audit includes an inspection of the documents and records that make up your quality system. Most importantly it is an inspection of the way the people in the organization work and the knowledge they have about the operation of the quality management system. management reviews must be carried out by the top management in your organization to ensure that your Quality Management System is working effectively and that it is geared to produce continual improvement of your products or service.

Registration requirements vary slightly between the various certification bodies but it is usual to have a Pre-Assessment. A pre-assessment is a mock audit similar in duration to a full registration audit which your organization neither passes nor fails. The important feature of a pre-assessment is that it will provide a full list of any short falls between the requirements of the ISO 9001 2000 standard and your Quality Management System.

As a senior lead auditor I would always advise an organization to opt for a pre-assessment.

You now need to select a registration agency.

There are many registration agencies to choose from and in theory they are similar inthe services they provide, chiefly because they all have to abide by the same to EN standards, EN45011 and EN45012. In practice they offer different service levels, response times and re-assessment periods. So my advice would be to choose your registration body very carefully.

Finally the day has arrived for your registration rudit. This is where an auditor from the chosen certification body visits your organization and carries out a comprehensive audit of your organization.

When the auditor identifies a discrepancy or non-conformance between the work that is being performed and the requirements of ISO 9001 and how you say you operate your processes the discrepancy or non-conformance will be written up. There is no specific number of non-conformances that have to be raised for your organization to either pass or fail. It depends on how serious each point raised is or if a number of minor issues are all raised against one clause of ISO 9001 2000, say for example design.

For example: If only a few minor non-conformances are found during the registration audit, the registration body will issue a certificate of registration to ISO 9001 2000 stating that your organization complies with the requirements of the ISO 9001 standard. If however a major non-conformance is raised this results in your organisation being told that you must correct the non-conformance(s) and re-apply for another registration audit. This is why I would always recommend that you have a consultant carry out a Pre-Assessment audit on your business, re-applying for a complete re-assessment from a registration body can be a very expensive business.

Once a certificate of registration is issued it typically expires after three years, however some registration bodies certificates never expire. All registration bodies typically require Quality Management System surveillance audits of your organization at six months intervals to maintain the validity of the certificate.

At this point, you deserve to celebrate your accomplishments! However, once the certificate is issued you need to continue to monitor your own Quality Management System to ensure you continue to comply with the requirements of ISO 9001 2000.

Driso provide ISO 9001 2000 consultancy, auditing, software, and training Services. They also supply Easy ISO 9001 2000® software for initially setting up an ISO 9001 2000 compliant Quality Management System or improving upon an existing one.

To contact Driso Consultancy Services visit the web site below and see what they can do for you and your business. Contact: http://www.driso.co.uk for more details.