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Iso 9000

In an era of increasing globalism, the importance of manufacturing standardization has become more apparent. Organizations in different nations, with different cultures and even different measuring systems, must create products and components that match a common set of specifications. This way, bidding and pricing can be done with precision… when a customer orders 10 million widgets, the resulting product can be expected to have consistent quality even if the widgets are produced in five different plants in three different countries.

How can this be accomplished?  Individual inspection of each order in each facility in each country would be too expensive and therefore not cost effective. Instead, the required quality is accomplished through standardization of processes. Rather than inspecting the products themselves, companies can inspect the processes behind the products. Each process from engineering and manufacturing to purchasing and marketing can be measured by a commonly accepted set of standards, and a company interested in competing for business in a particular industry segment can gain credibility by becoming certified according to that set of standards.

That set of standards is ISO 9000.

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. For a manufacturer, some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) would include:

• a set of procedures that cover all key processes in the business;
• manufacturing processes to ensure they are producing quality product;
• keeping proper records;
• checking outgoing product for defects, with appropriate corrective action where necessary;
• regularly reviewing individual processes and the quality system itself for effectiveness; and
• facilitating continual improvement

History of ISO 9000

During WWII, major quality problems became apparent in many of Britain’s high-tech industries such as aircraft manufacturing, munitions, etc. (Bombs and ammunition from one manufacturer would explode in another maker’s factory while being fitted to a weapon system.) The solution adopted by government coordinators was to require factories to document each step in their manufacturing and to provide records verifying that these procedures were being followed. This standard, named BS 5750, became known as a management standard because it did not specify what to manufacture, but how to manage the manufacturing process. BS 5750 was adopted as an international standard by the International Standards Organisation in 1987, at the behest of the British government, and it became ISO 9000.

The 1987 version was known as ISO 9000:1987 and contained three models for quality management systems, designated as 9001:1987, 9002:1987, and 9003: :1987.
Subsequent versions in later years have been designated according to year, with the current version called ISO 9000:2000.

An organization that has been independently audited by ISO-approved auditors (and according to ISO auditing standards) and certified to be in conformance with ISO 9001 may refer to itself "ISO 9001 certified" or "ISO 9001 registered." (Note that Certification does not guarantee the quality of the end products – instead, it simply certifies that the accepted processes are being applied.

While these standards originated in manufacturing, they are now used in other types of organizations, including service organizations, marketing, government, even colleges and universities. In ISO parlance, a "product" can be a physical object, a set of services, or a software system. Service sectors now account for some 31% of the total.

The ISO 9000:2000 family includes:

Fundamentals and vocabulary: This standard discusses what quality management systems are and contains the core language of the entire ISO 9000 set of standards.

Requirements: This defines standards for organizations that design, develop, manufacture, install and/or service a product or provide any form of service. It includes a number of requirements an organization must fulfill in order to achieve customer satisfaction.

Guidelines for performance improvements: This covers the continual improvement process – that is, how to improve a mature system.

All previous standards in the ISO 9000 family, 9001, 9002 and 9003, have been integrated into the 9001 standard.

Summary of  ISO 9001:2000 in informal language

• The quality manual is a formal statement from management, closely linked to the business and marketing plan and to customer needs. The quality manual is understood and followed at all levels and by all employees. Each employee needs measurable objectives to work towards.
• Decisions about the quality system are made based on recorded data and the system is regularly audited and evaluated for conformance and effectiveness.
• You need a documented procedure to control quality documents in your company. Everyone must have access to up-to-date documents and be aware of how to use them.
• To maintain the quality system and produce conforming product, you need to provide suitable infrastructure, resources, information, equipment, measuring and monitoring devices, and environmental conditions.
• You need to map out all key processes in your company; control them by monitoring, measurement and analysis; and ensure that product quality objectives are met. If you can’t monitor a process by measurement, then make sure the process is well enough defined that you can make adjustments if the product does not meet user needs.
• For each product your company makes, you need to establish quality objectives; plan processes; and document and measure results to use as a tool for improvement. For each process, determine what kind of procedural documentation is required. (Note: “product” hardware, software, services, processed materials, or a combination of these.)

• You need to determine key points where each process requires monitoring and measurement, and ensure that all monitoring and measuring devices are properly maintained and calibrated.
• You need to have clear requirements for purchased product. Select suppliers appropriately and check that incoming product meets requirements.
• You need to determine the skills required for each job in your company, suitably train employees and evaluate the effectiveness of the training.
• You need to determine customer requirements and create systems for communicating with customers about product information, inquiries, contracts, orders, feedback and complaints.
• When developing new products, you need to plan the stages of development, with appropriate testing at each stage. You need to test and document whether the product meets design requirements, requirements and user needs.
• You need to regularly review performance through internal audits and meetings. Determine whether the quality system is working and what improvements can be made. Deal with past problems and potential problems. Keep records of these activities and the resulting decisions, and monitor their effectiveness. (Note: you need a documented procedure for internal audits.)
• You need documented procedures for dealing with actual and potential nonconformances (problems involving suppliers or customers, or internal problems). Make sure no one uses bad product, determine what to do with bad product, deal with the root cause of the problem and keep records to use as a tool to improve the system.

Certification – ISO does not itself certify organizations. Many countries have formed accreditation
bodies to authorize certification bodies, which audit organizations applying for ISO 9001 compliance certification. It is important to note that it is not possible to be certified to ISO 9000. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2000. Both the accreditation bodies and the certification bodies charge fees for their services. The various accreditation bodies have mutual agreements with each other to ensure that certificates issued by one of the Accredited Certification Bodies (CB) are accepted world-wide.

The applying organization is assessed based on an extensive sample of its sites, functions, products, services and processes; a list of problems ("action requests" or "non-compliances") is made known to the management. If there are no major problems on this list, the certification body will issue an ISO 9001 certificate for each geographical site it has visited, once it receives a satisfactory
improvement plan from the management showing how any problems will be resolved.

An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years. In contrast to the Capability Maturity Model there are no grades of competence within ISO 9001.

Auditing – Two types of auditing are required to become registered to the standard: auditing by an external certification body and audits by internal staff trained for this process (internal audits.) The aim is a continual process of review and assessment, to verify that the system is working as it's supposed to, find out where it can improve and to correct or prevent problems identified. It is considered healthier for internal auditors to audit outside their usual management line, so as to bring a degree of independence to their judgments.

Under the 1994 standard, the auditing process could be adequately addressed by performing "compliance auditing":

Tell me what you do (describe the business process)
Show me where it says that (reference the procedure manuals)
Prove that that is what happened (exhibit evidence in documented records)

How this led to preventive actions was not clear.

The 2000 standard uses the process approach. While auditors perform similar functions, they are expected to go beyond mere auditing for rote "compliance" by focusing on risk, status and importance. This means they are expected to make more judgments on what is effective, rather than merely adhering to what is formally prescribed. The difference from the previous standard can be explained thus:

Under the 1994 version, the question was broadly "Are you doing what the manual says you should be doing?"; whereas under the 2000 version, the question is more "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?”

The ISO 19011 standard for auditing applies to ISO 9000.

The ISO 9001 standard is generalized and abstract. Its parts must be carefully interpreted, to make sense within a particular organization. Developing software is not like making cheese or offering counseling services; yet the ISO 9001 guidelines, because they are business management guidelines, can be applied to each of these. Diverse organizations—police departments (US), professional soccer teams (Mexico) and city councils (UK)—have successfully implemented ISO
9001:2000 systems.

Over time, various industry sectors have wanted to standardize their interpretations of the guidelines within their own marketplace. This is partly to ensure that their versions of ISO 9000 have their specific requirements, but also to try and ensure that more appropriately trained and experienced auditors are sent to assess them.

1. The TickIT guidelines are an interpretation of ISO 9000 produced by the UK Board of Trade to suit the processes of the information technology industry, especially software development.
2. AS 9000 is the Aerospace Basic Quality System Standard, an interpretation developed by major aerospace manufacturers. The current version is AS 9100.
3. PS 9000 is an application of the standard for Pharmaceutical Packaging Materials.
4. QS 9000 is an interpretation agreed upon by major automotive manufacturers (GM, Ford, Chrysler). It includes techniques such as FMEA (failure mode and effects analysis) and APQP       (Advanced Product Quality Planning). QS 9000 is now replaced by ISOTS 16949.
5. ISOTS 16949:2002 is an interpretation agreed upon by major automotive manufacturers (American and European manufacturers); latest version is based on ISO 9001:2000. The emphasis on a
6. process approach is stronger than in ISO 9001:2000. ISOTS 16949:2002 contains the full text of ISO 9001:2000 and automotive industry-specific requirements.

• TL 9000 is the Telecom Quality Management and Measurement System Standard, an interpretation developed by the telecom consortium, QuEST Forum. The current version is 4.0 and unlike ISO 9001 or the above sector standards, TL 9000 includes standardized product measurements that can be benchmarked.
• ISO 13485:2003 is the medical industry's equivalent of ISO 9001:2000. Whereas the standards it replaces were interpretations of how to apply ISO 9001 and ISO 9002 to medical devices, ISO 13485:2003 is a stand-alone standard. Compliance with ISO 13485 does not necessarily mean compliance with IS0 9001:2000.

Debate on the effectiveness of ISO 9000

The debate on the effectiveness of ISO 9000 commonly centers on the following questions:

• Are the quality principles in ISO 9000:2000 of value? (Note that the version date is important: in the 2000 version ISO attempted to address many concerns and criticisms of ISO 9000:1994.)
• Does it help to implement ISO 9000:2000?
• Does it help to obtain ISO 9000:2000 certification?

Advantages

It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade, and Barnes, who says "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Barnes also cites a survey by Lloyd's Register Quality Assurance that indicated ISO 9000 increased net profit, and another by Deloitte-Touche that reported that the costs of registration were recovered in three years. According to the Providence Business News, implementing ISO often gives the following advantages:

   1. Create a more efficient, effective operation
   2. Increase customer satisfaction and retention
   3. Reduce audits
   4. Enhance marketing
   5. Improve employee motivation, awareness, and morale
   6. Promote international trade

However, a broad statistical study of 800 Spanish companies found that ISO registration in itself creates little improvement because companies interested in ISO have usually already made some type of commitment to quality and were performing just as well before registration.

Problems

A common criticism of ISO 9000 is the amount of money, time and paperwork required for registration. According to Barnes, "Opponents claim that it is only for documentation. Proponents believe that if a company has documented its quality systems, then most of the paperwork has already been completed."

According to Seddon, ISO 9000 promotes specification, control, and procedures rather than understanding and improvement. Wade argues that ISO 9000 is effective as a guideline, but that promoting it as a standard "helps to mislead companies into thinking that certification means better quality, … [undermining] the need for an organization to set its own quality standards." Paraphrased, Wade's argument is that total, blind reliance on the specifications of ISO 9000 does not guarantee a successful quality system.

The standard is seen as especially prone to failure when a company is interested in certification before quality. Certifications are in fact often based on customer contractual
requirements rather than a desire to actually improve quality. "If you just want the certificate on the wall, chances are, you will create a paper system that doesn't have much to do with the way you actually run your business," said ISO's Roger Frost. Certification by an independent auditor is often seen as the problem area, and according to Barnes, "has become a vehicle to increase consulting services." In fact, ISO itself advises that ISO 9000 can be implemented without certification, simply for the quality benefits that can be achieved.

Summary

A good overview for effective use of ISO 9000 is provided by Barnes:

"Good business judgment is needed to determine its proper role for a company... Is certification itself important to the marketing plans of the company? If not, do not rush to certification... Even without certification, companies should utilize the ISO 9000 model as a benchmark to assess the adequacy of its quality programs."

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