Getting 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.
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1. Don’t underestimate the task.
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Getting accredited isn’t easy. Of course, the amount of time and money
it takes for you to prepare for accreditation depends on your current quality system
and the particular type of accreditation you’re seeking, but you can expect it to
take at least 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 $5,000
to achieve the initial accreditation, including application fees and assessor expenses.
After accreditation, you’ll need to pay at least $1,000 annually to maintain the
accreditation.
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2. Get the appropriate accreditation.
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Most people are familiar with the ISO 9001:2000 standards, and many
companies are required to comply with those standards. While complying with the
standards is often a must for manufacturing companies, calibration laboratories
may also need to comply with and be accredited to ISO/IEC Guide 251990, "General
Requirements for the Competence of Calibration and Testing Laboratories." The latest
edition of QS-9000, for example, requires that calibration labs have ISO/IEC Guide
25 accreditation, and the next revision of ISO 9001:2000 will probably require that
both internal and external calibration labs have ISO/IEC Guide 25 accreditation.
ISO/IEC Guide 25 more directly addresses quality requirements for calibration
and testing labs than does IS0 9000. Laboratories in the United States can receive
ISO 25 accreditation through either the National Voluntary Laboratory Accreditation
Program (NVLAP), or the American Association for Laboratory Accreditation (A2LA),
both of Gaithersburg, MD. In the U.S., the standard carries the designation ANSI
Z540.1-1994 and is available from the American National Standards Institute. It
is essentially the same standard as ISO/IEC Guide 25, but has some extra requirements
taken from the now-defunct MILSTD-45662 for calibration systems.
Another standard to be aware of is ISO 10012-1:1992, "Quality assurance
for measuring equipment. Guidelines for control of measurement processes." Appendix
A on setting and adjusting calibration intervals is the most useful section of this
document.
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3. Document, document, document.
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ISO/IEC Guide 25, Section 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.
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4. Get appropriate training. |
The standards all require that cal lab technicians have appropriate
training and that you document that fact. According to Greg Gogates, an auditor
with Fasor Technical Services Inc., Landsdale, PA, 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.
Most manufacturers of calibration equipment and software offer training
for customers who will be using their equipment or software. As 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.
Several industry organizations also offer training. The American Association
for Laboratory Accreditation (A2LA) offers classes on ISO/IEC Guide 25, quality-system
documentation, calibration-laboratory practices, and measurement uncertainty. You
can reach the A2LA at 5301 Buckeystown Pike, Suite 350, Frederick, MD, 21704-8307.
Their phone number is 301-644-3248, and their Web site is http://www.a2la.org.
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, CO 80301-1032. Their phone number is 303-440-3339,
and their Web address is http://www.ncslinternational.org/
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5. Prepare for your audit.
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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. If you’re being audited by the A2LA
for compliance to ISO/IEC Guide 25, get the checklist found at http://www.a2la.org/a2la/assessor.htm.
It lists all the criteria that the A2LA assessor will check when auditing your laboratory.
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6. Understand and explain uncertainty calculations. |
To be certified, it is important for calibration labs to understand
the sources of measurement uncertainties in their processes and how to calculate
those uncertainties. One guide you can use to do this is ANSI/NCSL Z540-2-1997,
"New National Standard for Expression of Uncertainty in Measurement." This is the
American version of the ISO Guide to the Expression of Uncertainty in Measurement
(GUM) and is available from the National Conference of Standards Laboratories.
Another resource to help you understand measurement uncertainty is
the Web page titled The NIST Reference on Constants, Units, and Uncertainty at
http://www.physics.nist.gov/cuu/Uncertainty/bibliography.html. On this page
is information on ordering NIST Technical Note 1297 (TN 1297), which is a summary
of the ISO GUM. Single copies of the printed version are available free of charge
from NIST. It is also available online in Acrobat.pdf format.
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7. Document the software you use.
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Many calibration laboratories use software developed in-house to control
their processes and keep track of instruments. Many of these are Excel (Microsoft
Corp., Redmond, WA) spreadsheet-based programs. While 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
of the documentation necessary to satisfy the auditor. CyberMetrics, for example,
can supply you with an optional "validation guide and test database" for validating
that GAGEtrak works as expected. Also available is a programmer documentation and
source-code kit, which you can use to validate the program at the source-code level
and to customize the software to your exact needs.
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