Frequently Asked Questions

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Many organizations find that they do not have the time to undertake creation or upgrade of a quality management system (QMS). It’s generally not cost effective to hire a full-time employee to be responsible for the program, because once the system is created it is not a full-time position to maintain. Typically, an SME is only needed for creating a QMS, not maintaining it. Companies tend to be more successful if they involve as many different people in the process as possible, which ensures effective implementation and buy-in. 

ISO stands for International Organization for Standardization, located in Geneva, Switzerland. This organization is responsible for maintaining and publishing the ISO standards and guidelines. It is also the Greek word for equal.

ISO 9001 is an international standard defining quality management system requirements for all types of organizations in any industry. This standard provides the requirements for an organization to establish, implement, maintain, and improve a quality management system that will ensure its overall effectiveness in satisfying the defined requirements.

AS9100 is the international aerospace industry’s quality management system standard. It adds aerospace unique requirements to ISO 9001. Authored by SAE, AS9100 and related standards are available through www.sae.org. 

Since its initial publication in 1987, ISO has been adopted and accepted by most countries around the world, by most industries (automotive, telecommunication, aerospace, financial, education, healthcare, etc.) as either a required or voluntary standard for quality management systems, and by some government agencies (Department of Defense, FAA, FDA, etc.) as a flow-down to their suppliers. Since its initial issue, adoption and certification to this standard has seen exponential growth over the years. It has become the way that organizations do business and they way they assure suppliers can, as well. 

Certification is the process of having your quality management system reviewed and approved by a registrar or certification body to the ISO 9001 standard (or other industry standard).

A certification body or registrar is an organization that performs registration audits. They are typically approved by accreditation bodies to perform this service. 

You can find accredited certification bodies by searching the ANSI National Accreditation Board (ANAB) website at www.anab.org.

Certification costs vary depending on the number of employees, number of facilities, the quality management system standard, and the processes in place at a company. Costs typically include: documentation review, initial registration audit, report preparation, and surveillance audits.

Some of the benefits of a Quality Management System include: improved customer satisfaction, improved communication, reduced variation, increased predictability, increased market share, improved employee awareness, and reduced scrap and nonconformances.

Typically, training is required for personnel to understand the requirements of the Quality Management System. Additionally, companies may need to train their people on any new processes that have been defined during the course of implementation. Many choose to provide some formal training for their internal auditors. 

There are certified internal auditor courses available; however, there is no requirement that internal auditors be trained in one of these certified courses. Auditors simply must be qualified and competent to do internal audits.

Typical implementation takes anywhere from 6 to 18 months, to be ready for certification. The variation depends on the amount of time key employees can dedicate to the process, as well as company priorities.

The general steps for implementation include: gap analysis of current system, steering committee and management training, definition of company processes, development of quality manual if applicable, definition or documentation of processes (procedures and any related work instructions), quality management system implementation and related training, internal auditor training, conducting internal audits of entire system, conducting a full management review, and quality management system maintenance and improvement.

For the steering committee members, it will typically take about 2 to 8 hours per week of their time over the implementation period. For the main site coordinator this time may be more.

You need a copy of the applicable standard (i.e. ISO 9001, AS9100, IATF 16949, etc.) and a copy of ISO 9000. ISO 9000 (Fundamentals and Vocabulary) is a normative reference, which means that it is required. This provides employees with a consistent understanding of terminology.