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Dave K. Banerjea

Metrology

Seven Tips for Calibration Accreditation

Before you start, be informed. Then be methodical.

Published: Monday, April 14, 2014 - 15:47

Story update 4/24/2014: We bumped up the cost of accreditation based on comments that the original article was on the low side. We also added references to ILAC as well as additional accreditation bodies that operate in the United States (ACLASS, NVLAP, L.A.B.)

Getting calibration accreditation is a big investment. You will invest both time and money determining the standards to which you must comply, getting the appropriate training, possibly hiring a consultant, making changes to your process and, finally, documenting the process. Here are seven tips to help ensure the success of your calibration system accreditation effort.

Don’t underestimate the task

The amount of time and money it takes for you to prepare for accreditation depends on your current quality system, the size of your company, and the particular type of accreditation you’re seeking, but you can expect it to take at least three to six months to get accredited. Once you are accredited, you will need to spend some hours to keep your quality manual up to date to maintain accreditation.

There are direct costs, too. You should expect to spend at least $8,000 to achieve the initial accreditation, including application fees and assessor expenses. After accreditation, you'll need to pay at least $3,500 annually to maintain the accreditation.

Get the appropriate accreditation

Most people are familiar with the ISO 9001:2008 standard, and many companies are required to comply with it. Although complying with the standard is often a must for manufacturing companies, calibration laboratories may also need to comply with and be accredited to ISO/IEC 17025—“General Requirements for the Competence of Calibration and Testing Laboratories.”

ISO 9001 fulfills the management requirements of the ISO 17025 standard, which leaves the technical requirements to be addressed in order to complete the accreditation to ISO 17025.

One important consideration is that ISO 9001 alone does not evaluate the technical competence of a calibration or testing lab. This means that the evaluation of a supplier against ISO 9001 does not ensure for your customers that the test, inspection, or calibration data are accurate and reliable.

ISO/IEC 17025 accreditation is available for both freestanding commercial laboratories and in-house laboratories that are part of a larger facility. Compliance with ISO/IEC 17025 solidifies your calibration and testing laboratory as a serious competitor.

ISO/IEC 17025 more directly addresses quality requirements for calibration and testing labs than does IS0 9001. Laboratories can receive ISO/IEC 17025 accreditation through an accreditation body that is signatory to the International Laboratory Accreditation Cooperation (ILAC) mutual recognition arrangement. In the United States, some of these accreditation bodies include the ANSI-ASQ National Accreditation Board (ACLASS), L.A.B, A2LA and NVLAP. The ANSI Z540.1-1994 standard is now superseded by ANS/ISO/IEC 17025:2005 for part 1 and ANSI/NCSL Z540.3-2006 for part 2). This standard and all ISO standards are available for purchase at American National Standards Institute (ANSI), the ISO member body for the United States. It is essentially the same standard as ISO/IEC 17025 but has some extra requirements taken from the now-defunct MILSTD-45662 for calibration systems. All accreditation bodies describe the general requirements for ISO/IEC 17025 accreditation on their web sites and many have checklists and guidance documents.

Accreditation bodies describe the general requirements for ISO/IEC 17025 accreditation on their web sites and many have checklists and guidance documents. Here is an example of one published by ACLASS and another published by A2LA that describe the general requirements for ISO/IEC 17025 accreditation. Other accreditation bodies should be able to point you to their checklists.

Another standard to be aware of is ISO 10012:2003—“Measurement management systems—Requirements for measurement processes and measuring equipment.” Appendix A on setting and adjusting calibration intervals is the most useful section of this document for establishing a calibration system at your company.

Document, document, document

ISO/IEC 17025, Clause 5.2 requires that a laboratory have a quality manual and that it “shall state the laboratory’s policies and operational procedures established in order to meet the requirements.” The manual and other quality-related documentation must include:
• A quality policy statement
• The laboratory’s organizational structure
• Procedures for document control
• Job descriptions of key staff
• Procedures that document how the lab achieves traceability
• Descriptions of the types of tests a laboratory can perform, references to the test procedures, and procedures for handling
• A procedure to ensure that it can properly perform new tests
• Procedures to ensure calibration of test equipment and verification of standards
• Procedures for dealing with complaints and protecting customer confidentiality
• Procedures for audit and review

Get appropriate training

The standards all require that calibration lab technicians have appropriate training and that you document that fact. According to Greg Gogates, an auditor with Fasor Technical Services in Landsdale, Pennsylvania, some companies try to claim that the training records are part of an employee’s private records and are therefore unavailable. Gogates says, however, that if he cannot verify the training, he cannot certify the laboratory.

Examples of such employee training would include courses taken on calibration and testing methods, operator training provided by instrument and equipment manufacturers, and technical courses on subjects such as measurement uncertainty analysis and measurement systems analysis.

Most manufacturers of calibration equipment and software offer training for customers who will be using their equipment or software. Because proper training is becoming such an important part of the accreditation process, you may want to make this one of the criteria for purchasing a piece of equipment or software.

Many accreditation bodies offer training including the ANSI-ASQ National Accreditation Board (ACLASS), L.A.B and A2LA. These courses include ISO 17025 Lead Assessor, Internal Auditor for 17025 and Measurement Uncertainty, a critical concept for calibration labs.

Another resource is the National Conference of Standards Laboratories (NCSL). They sponsor an annual conference and have several publications and videotapes that can help you manage a calibration laboratory. You can reach them at 1800 30th Street, Suite 305B, Boulder, Colorado, 80301–1032. Their phone number is (303) 440–3339 and their website address is here.

Prepare for your audit

The auditing agency will give you ample notice as to when your audit will occur. Make sure you are ready when the auditor arrives at your facility. It is important, says Gogates, to have someone available who is familiar with your lab and can answer any questions.

Another thing you can do to prepare for your audit is to get a copy of the checklist that an assessor might use.

Understand and explain uncertainty

To be certified, it is important that calibration labs understand the sources of measurement uncertainties in their processes and how to calculate those uncertainties.

Measurement uncertainty represents the estimate of the variability of measurement for any specific test or calibration. Exact uncertainty contributors and contributions may vary from day to day in a laboratory, so this is why it is considered an “estimate.” Calculating the uncertainty will typically include factors such as instrument precision or accuracy, reported reference standards, measurement uncertainties, equipment resolution, and repeatability. Some calibration management software solutions, such as GAGEtrak, perform these uncertainty calculations.

One guide you can use to do this is ANSI/NCSL Z540-2-1997 (R2012)—“New National Standard for Expression of Uncertainty in Measurement.” This is the U.S. version of the “ISO Guide to the Expression of Uncertainty in Measurement” (GUM) and is available from the NCSL.

Another resource to help you understand measurement uncertainty is the web page titled “The NIST Reference on Constants, Units, and Uncertainty.” On this page is information about ordering NIST Technical Note 1297 (TN 1297), which is a summary of the ISO GUM. Single copies of the printed version are available free from NIST. It is also available online in PDF format.

Document the software you use

Many calibration laboratories use software developed in-house to control their processes and keep track of instruments. Many of these are Excel spreadsheet-based programs. Although these programs work well, to be accredited you need to supply documentation that specifies the calculations that the program performs.

The documentation must also show how the program protects the integrity of the data. For example, if the program automatically gathers data from an instrument through a serial bus or an instrumentation bus such as the GPIB, the documentation must show how the data are handled to ensure data integrity.

Using a commercially available calibration management software package makes software documentation easier. Normally, the software vendor can provide all the documentation necessary to satisfy the auditor. CyberMetrics, for example, can supply you with an optional validation kit for validating that GAGEtrak calibration management software works as expected.

Validation is accomplished by providing known inputs to the software, such as calibration measurements and calibration dates, and then assessing that the outputs are correct (e.g., calculations, due dates), that records are preserved, and so forth. If security is a concern, then the system should be challenged to ensure that it protects against unauthorized access, that audit logs are maintained, and that electronic signatures are secure. This type of validation is primarily aimed at FDA and government-regulated organizations that must comply with Part 11 of Title 21 of the “Code of Federal Regulations—Electronic records—Electronic signatures” (21 CFR Part 11).

Dave K. Banerjea is president and CEO of CyberMetrics Corp., a Quality Digest Daily content partner.

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Dave K. Banerjea

Dave K. Banerjea is president and CEO of CyberMetrics Corp., developer and worldwide distributor of GAGEtrak calibration management, FaciliWorks CMMS maintenance management, and SUPPLIERtrak supplier quality assurance software.