This summer marked the deadline for implementation of ISO/IEC 17025: 2005 General Requirements for the Competence of Calibration and Testing Laboratories. This came after a two-year transitional period in which accreditation bodies recognized by the International Laboratory Accreditation Cooperation (ILAC) had been assessing laboratories to the requirements of the superseding standard, which replaces ISO 17025: 1999.
17025: 1999, the original 17025 standard, was amended because it shared some requirements with ISO 9001. When 9001: 1994 was reviewed and updated, thereby creating 9001: 2000, 17025 had to follow suit. “ISO Part 2 Directives stated that no standard could include management system requirements without referring to the latest edition of the pre-eminent ISO document on management systems-ISO 9000: 2000,” explains J.E.J. (Ned) Gravel, manager of training and quality at Ottawa, Ontario-based Canadian Association for Environmental Analytical Laboratories (CAEAL) and Canada’s accredited delegate who had a hand in drafting both incarnations of the 17025 standard. “We were told to go back to the table and align ISO/IEC 17025: 1999 with the management system wording in ISO 9000: 2000.”
Where 17025 and 9001 share commonalities is in Section 4 of 17025, Management Requirements, which encompasses much of the management system requirements that compose 9001. This was done in 1999, when 17025 was still on the drawing board, to create a laboratory competence standard that would garner wider acceptance than its predecessor, Guide 25, by incorporating the wording of 9001, a standard already well established in industry. The alignment of 17025: 2005 with 9001: 2000 mostly entails cosmetic changes to terminology found in Section 4. For example, the word client(s) was change to the word customer(s), and quality system was changed to management system.
But the core of the standard, Section 5, Technical Requirements, did see amendments that, though not cataclysmic, were more substantive. Found in Sections 5.2.2 and 5.9.2, respectively, the modifications deal with evaluating the effectiveness of laboratories’ training programs, and the tracking of quality control and quality assurance (QC/QA) trends. In 17025: 1999, clause 5.2.2 dealt with a laboratory’s obligation to document training program outcomes in support of personnel competence. The 2005 addition to this clause mandates that laboratories must demonstrate the effectiveness of that training through evaluation by an accreditation body. Of this amendment, Gravel states, “What we discovered when we were doing the alignment to 9001 was that we were asking labs to implement training programs to ensure competency of personnel, but we were not providing any guidance at all on how to ensure that what they were doing met the ISO 9000 definition of competence. So we said we’d evaluate the effectiveness of that.”
Clause 5.9.2 did not exist before the current revisions to 17025. It was, though, included in the 1999 standard as a note to 5.9-therefore not a requirement. The clause deals with the evaluation of a laboratory’s QC data by accreditation bodies, and the steps taken to correct problems in this area. “Most good laboratories were already tracking their quality control information,” says Gravel. “For example, you run a number of samples and quality control checks and things are either in control or they’re outside the warning limits or the control limits. Therefore, the laboratories have to do something. By taking the note and making it a requirement, we now require them to actually have something in place to track the trends in quality control in their laboratories.”
Benefits and the AssessmentThe benefits of 17025 accreditation are numerous. Not only do laboratories seek accreditation to sharpen overall business practices, helping them attain consistent production of technically valid data and an optimized management system, accreditation also tells potential clients that a laboratory is reliable and will produce internationally recognized test data. Furthermore, laboratories will find that many or all potential clients require 17025 accreditation.
Therefore, 17025 accreditation can be viewed as a tool to be leveraged to gain market share. Bill Hangartner Sr., president of Quality Calibration Service Inc. (West Allis, WI), points out there also is a marketing advantage in obtaining both 17025 and 9001 recognition: “Because there is generally a lack of understanding of what the standards are all about in the industry, our company is 9001: 2000 certified and also 17025 accredited.” This provides a clear-cut method for assuring potential clients of both the technical competency of the laboratory’s scope and an optimized management system.
The process of becoming 17025 accredited is much like that of becoming 9001 certified, the difference being that calibration and testing laboratories deal with accreditation bodies recognized by ILAC rather than certification bodies. First, laboratories should purchase a copy of the 17025 standard, understand it and see if it is right for them. Then they need to contact an accreditation body that is an ILAC signatory. The laboratory should then seek a consultant, if necessary, and begin creating its management system. After this is complete, the assessment can be undertaken.
The quality manual is an essential part of the management system and needs to reflect all requirements of 17025. Roger Muse, vice president of ACLASS Accreditation Services (Arlington, VA), says that to achieve this it is imperative to keep a copy of the standard handy while composing the management system. “For example, 4.2.3 in the standard says, ‘Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improve its effectiveness.’ You need to have something in your quality manual that addresses that. Later, when we come and do the assessment, we’ll point to that and say, ‘Show us where you do this.’”
If the laboratory lacks the expertise needed to build its management system in-house, and it is appropriate to enlist the services of a consultant, be sure that the consultant understands the science to be accredited.
Muse states that a dangerous phenomenon facing laboratories today is a population of ISO 9001 creditors who also sell their services to labs seeking 17025 accreditation. While these consultants have a definite grasp on Section 4 of 17025, they will typically be at a loss when it comes to satisfying Section 5, Technical Requirements. “The most important thing when qualifying a consultant is the level of detail and knowledge in areas like proficiency testing, traceability and measurement uncertainty,” says Muse.
A similar pitfall waits for laboratories as they seek an accreditation body. Muse points out that there are some organizations offering 17025 accreditation that are not ILAC recognized. While some clients may accept such accreditation, many will not. An accreditation body is an ILAC signatory after it has signed the mutual recognition arrangement (MRA) of its corresponding regional cooperation. There are four regional cooperations operating under the ILAC umbrella: The European Accreditation Cooperation (EA), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), the Southern Africa Accreditation Cooperation (SADCA) and the Inter-American Accreditation Cooperation (IAAC). Signatories are peer-reviewed to ensure that they meet ILAC’s criteria for competence.
The time an assessment will take depends on the size of a laboratory’s staff and the breadth of its scope. On average, an assessment should not last more than a week, during which time the assessors will interview employees, observe laboratory procedure and review various records. When the assessment has been completed, the accreditation body’s report is reviewed and any noncompliances are explained, along with the requirements for completing corrective actions. After the corrective actions are received and approved by the accreditation body, the accreditation certificate is issued.
After accreditation, laboratories will undergo periodic reassessments and should expect some form of surveillance from their accreditation body. In the United States, accreditation bodies typically will perform reassessments every two years. “ISO/IEC 17011 allows for an accreditation body to determine frequency of reassessments with limitations the accreditation body must meet as a minimum. The American Association for Laboratory Accreditation (A2LA, Frederick, MD) performs a reassessment every two years, with typically no surveillance visits, except for the first anniversary date,” says Philip Smith, public affairs manager, A2LA.
ISO/IEC 17025: Into the FutureMuse says that a growing trend in 17025 accreditation is the tendency for 9001-certified manufacturers to seek 17025 accreditation for laboratories operating within their organizations. In particular, these are OEMs that manufacture equipment used by 17025-accredited laboratories. The standard dictates that such equipment must be periodically calibrated by another 17025 laboratory. By having their own laboratories become 17025 accredited, manufacturers of laboratory equipment can more fully serve their customers.
And in the coming years, Gravel forecasts that 17025 will continue to gain recognition around the world. “There were something like 500,000 plus organizations worldwide certified to ISO 9001 by 2002. I think ISO/IEC 17025 accreditation will surpass that figure by 2012.” Q
For more information about the companies mentioned in this article, visit their Web sites:
- A2LA, www.a2la.org
ACLASS Accreditation Services, www.aclasscorp.com
Quality Calibration Service Inc., www.qualitycalibration.com