ISO 9000, AS 9100, TS 16949, ISO 13485 and ISO 17025 are five common quality standards. As ISO standards as a whole become increasingly focused on competence, consistency and impartiality, these five stand to become more subject to future revision.
The Future of ISO
As industries evolve, so do the standards that have informed them. This is particularly true for ISO standards, which routinely undergo revisions. Craig S. Morr, director, Quality & Safety, at NSF International (Ann Arbor, MI), says that as all ISO standards change, they are eventually headed in the same direction.“Most of the ISO standards are moving toward more of a standardized format,” he explains. “The reason is to align all systems together so that a quality system can exist and handle many different standards.
“The other part of that is moving toward more competence, impartiality and consistency,” Morr continues. “[ISO is] trying to make standards where organizations and businesses who operate off of them practice those three tenants so openly in their process.”
This is just good business, and it helps remove international trade barriers, Morr notes. When businesses across the globe recognize the same quality standards, they are on a more level playing field.
Jeff Rodgers, senior lead auditor with RMS LLC (Detroit, MI), says this is exemplified in how ISO 9001, a now universal quality management standard, has been revised and changed over the years. 9001 has moved away from the prescriptive, documentation-heavy side of standardization and embraced measurement and increasingly subjective definitions.
Rodgers says its revisions have enabled companies in any industry to adopt it, making it a prime model for other ISO revisions and an indicator of how they will change in the future.
By using what Rodgers and the ISO community call the process approach-or measuring tasks within a company alongside coordinated goals-organizations can examine the efficiency of their processes more closely by identifying “the weakest link” in a set of sequential activities. “Because the 9001 standard went to the process approach, all the requirements ever imposed on an organization go into each one of those processes,” Rodgers says.
Rodgers envisions that 9001 will continue to set the tone for how ISO standards are formed. When it was revised in 2008, no new requirements were added, but rumor has it that some of the wording changes were aligned closely to ISO 14001, an environmental standard that is set to be revised in 2013, Rodgers says. While there is no hard evidence, he says this would not be surprising as ISO standards on the whole are evolving in order to be more harmonious.
ISO 9001
ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its competence to regularly meeting customer and regulatory requirements. It seeks to improve customer satisfaction by applying processes for continuous improvement and by ensuring conformity to regulatory requirements. These requirements are general and are intended to be universal.ISO 9001 was last revised in 2008.
ISO 17025
ISO/IEC 17025 is the primary standard used by testing and calibration laboratories. It was originally issued by the International Organization for Standardization in 1999. While it is similar to ISO 9000, 17025 incorporates the concept of competence. It applies directly to testing and calibration results.17025 specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It includes testing and calibration performed using standard methods, nonstandard methods and laboratory-developed methods.
It is appropriate for all organizations performing tests and/or calibrations, such as first-, second- and third-party laboratories.
Management requirements and technical requirements comprise ISO 17025’s two main sections. Management requirements are related to the quality management system within the laboratory, while technical requirements have factors that apply to the tests and calibrations performed in the laboratory.
“Since the early ’90s, there has been a big push in the industry from regulatory bodies-they pushed labs to get 17025 accreditation,” says Rodgers. “It has done wonders. The competency of our calibrations, our tests and our inspection results produced were very high.”
ISO 17025 was published in 1999; it replaced ISO Guide 25. ISO 17025 was reissued in 2005 with wording that better reflected the quality system words of the 2000 version of ISO 9001.
The most significant changes included more emphasis on the responsibilities of senior management, and specific requirements for continual improvement of the management system itself, particularly in regard to communication with the customer.
The result was an improvement in competence for test inspection and calibration for both internal and commercial labs, Rodgers says. “There is now more accurate and precise reporting of calibration test and inspection,” he notes.
ISO 17025 vs. ISO 9001
While these two standards share similarities, they are not interchangeable. ISO 9001 applies to an entire organization. It is useful as a management evaluation tool, but this standard does not have enough technical content to provide an assurance that test, inspection or calibration data are accurate and reliable.Laboratories that do not manufacture products and perform calibration or testing as primary functions will normally need to meet the accreditation requirements of ISO/IEC 17025 and not necessarily the certification requirements of ISO 9001.
It is becoming more common for companies offering more than laboratory services to be certified to ISO 9001 while the laboratory within the organization is accredited to ISO/IEC 17025. Ideally, the company would achieve ISO 9001 certification through an accredited certification body and ISO/IEC 17025 through an International Laboratory Accreditation Cooperation (ILAC)-recognized accreditation body.
AS 9100
AS 9100 was developed using ISO 9001 and AS 9000. It builds on these requirements to produce a global standard that meets the requirements of aerospace companies. It was the first standard available for use across the global aerospace community, and it adds the additional requirements necessary to address both civil and military aviation and aerospace needs.AS 9100 was released in October 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries. AS 9100 replaces the earlier AS 9000 and fully ISO 9000, while adding additional requirements relating to quality and safety.
Revision C of the standard was released in 2009.
TS 16949
TS 16949, in conjunction with ISO 9001, identifies the quality management system requirements for the design and development, production, and installation and service of automotive-related products. ISO/TS 16949 can be applied throughout the automotive supply chain. It is applicable to sites of the organization where customer-specified parts are manufactured.The standard was last revised in 2009.
ISO 13485
ISO 13485 specifies requirements for a quality management system for the medical device industry. Organizations use this standard to demonstrate the ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements.The standard was designed to give consistent medical device regulatory requirements for quality management systems. This means it includes some requirements for medical devices and excludes some of the requirements of ISO 9001 that are not suitable as regulatory requirements. Because of these exclusions, organizations whose quality management systems match this standard cannot claim conformity to ISO 9001 unless their quality management systems conform to all the requirements of ISO 9001.
ISO 13485 has not been revised since it was introduced in 2003.Q
