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Introduction to ISO 9000 Quality Management

The ISO 9000 family of standards relate to quality management systems and are designed to help organizations ensure they meet the needs of customers and other stakeholders (Poksinska et al, 2002. The standards are published by ISO, the International Organization for Standardization and available through National standards bodies.

The standard specifies six compulsory documents:

Control of Documents (4.2.3)
Control of Records (4.2.4)
Internal Audits (8.2.2)
Control of Nonconforming Product / Service (8.3)
Corrective Action (8.5.2)
Preventive Action (8.5.3)

In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).

Independent confirmation that organizations meet the requirements of ISO 9001 may be obtained from third party certification bodies. Over a million organizations worldwide ^[4] are independently certified making ISO 9001 one of the most widely used management tools in the world today.

The global adoption of ISO 9001 may be attributable to a number of factors. A number of major purchasers require their suppliers to hold ISO 9001 certification. In addition to several stakeholders' benefits, a number of studies have identified significant financial benefits for organizations certified to ISO 9001.

ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country.

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. Although commonly referred to as ISO 9000:2000 certification, the actual standard to which an organization's quality management can be certified is ISO 9001:2008. 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 worldwide.

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-compliance") is made known to the management. If there are no major problems on this list, or after it receives a satisfactory improvement plan from the management showing how any problems will be resolved, the certification body will issue an ISO 9001 certificate for each geographical site it has visited.

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. There are no grades of competence within ISO 9001: either a company is certified (meaning that it is committed to the method and model of quality management described in the standard), or it is not. In this respect, it contrasts with measurement-based quality systems such as the Capability Maturity Model.

Auditing

Two types of auditing are required to become registered to the standard: auditing by an external certification body (external audit) 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 this is what happened (exhibit evidence in documented records)

The 2000 standard uses a different approach. Auditors 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 specific "Will this process help you achieve your stated objectives? Is it a good process or is there a way to do it better?"

Effectiveness

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

Are the quality principles in ISO 9001:2000 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 an ISO 9001:2000 compliant quality management system?
Does it help to obtain ISO 9001:2000 certification?

Effectiveness of the ISO system being implemented depends on a number of factors, the most significant of which are:

Commitment of Senior Management to monitor, control, and improve quality. Organizations that implement an ISO system without this desire and commitment, often take the cheapest road to get a certificate on the wall and ignore problem areas uncovered in the audits.
How well the ISO system integrates into their business practices. Many organizations that implement ISO try to make their system fit into a cookie-cutter quality manual rather than create a manual that documents existing practices and only adds new processes to meet the ISO standard when necessary.
How well the ISO system focuses on improving the customer experience. The broadest definition of quality is "Whatever the customer perceives good quality to be". This means that you don't necessarily have to make a product that never fails, some customers will have a higher tolerance for product failures if they always receive shipments on-time, or some other dimension of customer service. Your ISO system should take into account all areas of the customer experience, the industry expectations, and seek to improve them on a continual basis. This means taking into account all processes that deal with the three stakeholders (your customers, your suppliers, and your organization), only then will you be able to sustain improvements in your customer experience.
How well the auditor finds and communicates areas of improvement. While ISO auditors may not provide consulting to the clients they audit, there is the potential for auditors to point out areas of improvement. Many auditors simply rely on submitting reports that indicate compliance or non-compliance with the appropriate section of the standard, however, to most executives, this is like speaking a foreign language. Auditors that can clearly identify and communicate areas of improvement in language and terms executive management understands allows the companies they audit to act on improvement initiatives. When management doesn't understand why they were non-compliant and the business implications, they simply ignore the reports and focus on what they do understand.