In virtually any undertaking, it helps to begin with a formula for success. If you’re opening a McDonald’s restaurant, you will benefit from a proven roadmap that is virtually guaranteed to lead to a profitable business. Quality management “formulas for success” don’t necessarily carry quite that same level of assurance, but there are a number of standards that can provide your business with that winning edge and vastly increase the likelihood that your QMS programs will deliver their intended results.
The American Society for Quality (ASQ) describes quality standards as “documents that provide requirements, specifications, guidelines, or characteristics that can be used consistently to ensure that materials, products, processes, and services are fit for their purpose.” Quality standards provide organizations with a shared vocabulary, formal definitions, and a common vision for what quality means and how it can be achieved.
Organizations that define and maintain standards
Internationally, there are numerous organizations that work together to define and curate standards. Two of the best-known are ISO (which is a global umbrella group) and ANSI (which is a US-based standards organization, and a member of ISO).
ISO has been defining standards for quite a long time. If you have ever used an old film camera, or its newer counterpart the digital SLR, you may be familiar with the “ISO” setting that designates film speed. In this case, ISO is referring to the “International Standards Organization”, and the ISO film speed setting is actually short for “ISO 6”, which was one of the earliest standards issued by that organization. Over the years, the film standard has been updated to keep up with changes in technology. (The latest version is ISO 6:1993.) That’s just one of many standards issued by ISO.
The International Standards Organization is actually a consortium of national standards organizations representing more than 145 countries around the world. The US member organization is ANSI, which stands for “American National Standards Institute”. Together, these groups define a wide range of different standards that affect a multitude of products and services around the world. When it comes to establishing quality standards in particular, the American Society for Quality also plays a prominent role in shaping the final outcome.
Let’s look at some of the quality management standards that everyone should be familiar with.
Even among the public at large, ISO 9001 is a fairly familiar term. Many of us have seen banners posted outside of production facilities that proudly proclaim a company’s ISO 9001 certification status. You may also have noticed similar claims posted on company websites. Many large organizations insist that their vendors be ISO 9001 certified.
ISO 9001 is a roadmap to success and is built around the eight quality management principles: customer focus, leadership, people involvement, process approach, a systematic approach to management, continuous improvement, a factual approach to decision-making, and mutually beneficial supplier relationships.
ISO 9001 standards provide a checklist of the all things a company needs to do in order to be successful in meeting its customers’ needs and expectations. “ISO 9000” refers to an entire group (or “family”) of standards pertaining to quality, including IS 9001. Another standard within that family is ISO 9004, which pertains to “Guidance to Achieve Sustained Success”, – more commonly known as “continuous improvement”. The latest revision of ISO 9001 happened in 2015 and is therefore referred to as ISO 9001:2015.
The ISO 14000 family of standards is aimed at helping companies to minimize the negative consequences of their operations on our natural environment. Its primary standard is ISO 14001, and although it is not necessarily positioned as a quality management standard per se, it certainly fits into the bigger picture of quality management programs and would fall within the scope of QMS at many organizations, – both from a process perspective and because it touches upon health and safety.
It’s also worthwhile to note that environmental responsibility has gained considerably more important for consumers in recent years. So although we normally think of quality primarily as an attribute of a company’s products or services, – the overall impact that a company has on the world around them is becoming an important factor in many consumers’ purchasing decisions.
To date, over 300,000 organizations globally have been certified for ISO 14001. That number is expected to continue growing in the coming years.
ISO 19011 lays out guidelines for auditing management systems, including general principles governing the process, evaluation of personnel involved in auditing, and overall management of audit procedures. This standard ISO 19011 also outlines systematic approaches to improving audit programs.
Like other ISO standards, 19011 addresses its subject matter in a comprehensive way, including the definition of overall objectives for an audit program, processes for performing audits, and guidance as to sound procedures for reviewing and interpreting the results.
In addition to these cross-industry standards, there are also a number of quality standards that apply to specific verticals, including medical devices, automotive, electronics, and more. Others pertain to specific domains such as IT Service Management. The following list is not intended as a comprehensive list of such industry-specific or domain-specific standards. Rather, it should serve as an example of the kind of specialized standards that exist to help quality managers in specific types of organizations design and implement programs successfully.
IEC and USNC/IEC pertain to electronics. The International Electrotechnical Commission (IEC) is an international organization, and the US National Committee of the IEC (USNC/IEC) is one of its member entities. The USNC/IEC is also a member organization of ANSI. Together these organizations collaborate to define standards for electronics, magnetics, electro-acoustics, multimedia, telecommunication, and energy production and distribution.
ISO 13485 applies to the manufacture of medical devices, as well as to associated services (such as servicing medical equipment, for example). This standard addresses factors that pertain to regulatory compliance under requirements established by the FDA and similar agencies.
IATF 16949 applies to the design and development, production, installation, and servicing of automotive products. Previously, it was referred to as “TS 16949”, but underwent a name change when it was last revised in 2016, and now falls under the auspices of the International Automotive Task Force (IATF).
These are just a few examples of industry-specific standards. There are other vertical standards, as well as domain-specific standards that may fall within the scope of quality management in many organizations. Standards have been defined for IT security (ISO 27001), occupational health and safety (ISO 45001), educational organization management (ISO 21001), and the aerospace industry (AS 9100, 9110, and 9120).
Whether your company is already certified in one of the standards, or is working to achieve certification, it helps to have good QMS technology in place to ensure consistent and accurate data collection, visibility to performance, and a common set of tools for employees. At Intellect, we provide highly configurable software for quality management that helps you achieve your objectives. To learn more about how Intellect can work for you, contact us today.