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All About Flex: ISO 9001 Basics

ISO 9001 is an internationally recognized standard that specifies requirements for a business’s or organization’s quality management system. Companies achieving ISO 9001 certification are audited to review compliance for systems to assure products or services are delivered with a consistent quality level and meet agreed upon specifications.

The ISO 9001 standards embody the following seven quality management principles:

• QMP 1 – Customer focus
• QMP 2 – Leadership
• QMP 3 – Engagement of people
• QMP 4 – Process approach
• QMP 5 – Improvement
• QMP 6 – Evidence-based decision making
• QMP 7 – Relationship management 

To achieve ISO9001 certification a company must undergo a rigorous audit by an accredited third-party registrar. Once certified, the company is then required to satisfactorily complete a recertification audit every three years. Companies will also have internal systems established for conducting “unofficial” audits at higher frequency levels. Although recurring internal audits of the quality system is an ISO 9001 requirement, the frequency is not specified.

The ISO governing body regularly reviews and updates its requirements, generally every 5 years. When a company is certified as ISO compliant, the standard awarded will have the revision year in its designation.

The following are the past revisions of ISO9001:

• ISO9001:1987
• ISO9001:1994
• ISO9001:2000
• ISO9001:2008
• ISO9001:2015

Companies may continue to operate under the 2008 certification until 2018, when they will be required to adopt the newer standards of ISO2001:2015.

Background

ISO is an international organization for setting standards. ISO means “equal” in Greek. It began in 1947 and is headquarter in Geneva, Switzerland. There are over 160 countries that recognize ISO and over 20 rotating organizations that provide governance and guidance. There are 250 technical committees that develop the ISO standards covering a wide array of industries. Over twenty thousand standards are in existence.

ISO 9000 was developed in Great Britain where the British Standards Institute (BSI) developed quality assurance standards for the electronics industry. The first standard was published in 1971 by BSI and was known as BS 9000. There were several iterations throughout the 1970s to create a common industry standard. This effort produced BS 5750, which evolved to become ISO 9000.

The British Standards Institute convinced ISO to adopt this standard in the mid-1980s. The result was the first ISO quality standard known as ISO 9000:1987. Three variations of standards exist under ISO 9000:

• ISO 9001
• ISO 9002
• ISO 9003

ISO 9001 is applicable to organizations offering design development, production and servicing. This includes introducing new products. ISO 9002 is similar but is for organizations that don’t offer design and development. ISO 9003 covers only inspection and testing of a final product.

The ISO 9001:2000 revision made ISO 9002 and ISO 9003 standards obsolete. With this change, companies could only achieve ISO 9001 certification.

The 2000 and 2008 revisions reflected a philosophical change in regard to quality systems standards. Previous to 2000, the standards emphasized documentation and adherence to procedures. In 2000 the emphasis started to swing toward management and management processes. The intention was that pre-2000 organizations were highly focused on following procedures. After 2000, the focus was more on monitoring the effectiveness of processes. It was believed the document-heavy organizations pre-2000 were not flexible enough to adapt to changing conditions and requirements.

Today, ISO 9001 is the most widely recognized standard in the world with over 1,300,000 organizations certified to this standard. Many companies will require their supplier base to be certified to ISO 9001 as a condition of doing business.

Additional Resources

1. The British Assessment Bureau
2. www.iso.org
3. www.sis.pitt.edu
4. www.iso9001help.co.uk
5. asq.org

Dave Becker is vice president of sales and marketing at All Flex Flexible Circuits LLC.