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ISO 17025 was developed so that testing & calibration laboratories were
recognized for their capabilities & areas of competence. All
measurements and decisions should be based on accurate, repeatable,
verifiable, cost effective, timely, and believable measurements, opinions,
and recommendations. ISO 17025 helps assures this happens first
time, every time, and on-time.
Without these assurances, the data, opinion, and recommendations are
immediately suspect, questionable, risky, and of greatly reduced value and
usability.
Customers should ensure that all data and opinions upon which they rely
can be traced back through an unbroken chain of data based on ISO 17025.
ISO 17025 is one of the most popular quality standards for all
laboratories; whether or not they do business with international
customers. Currently, there are over 300 laboratories certified to ISO
17025 in Canada.
In 1891, British physicist Lord Kelvin wrote,
“When
you can measure what you are speaking about,
and express it in numbers,
you know something about it.”
Mikel Harry, a noted Six Sigma authority, extends this thought as,
“We don't know
what we don’t know; we can’t act on what we don’t know; we won’t know
until we search; we won’t search for what we don’t question; we don’t
question what we don’t measure.”
Both imply that if you failed to quantify the results of what you were
doing, in a way, it means that you might not understand what you were
really doing.
Hence, organizations that are unable to track their processes, their
products, or their raw materials are unable to fully manage their
businesses.
All other quality initiatives (eg. ISO 9001, ISO/TS-16949, Six
Sigma, TQM, DOE, QFD, etc.) depend on reliable measurements, comparisons,
and recommendations based on international standards.
ISO 17025 controls all aspects of how laboratories conduct their
business (ie. who, what, when, where, how, how much, & why) of
measurement, testing, certifying, recommending, & reporting.
Research into what makes a ISO 17025
implementation a success has revealed 11 Critical Success Factors. They
are, in order of importance:
- Leadership & commitment, preferably by Top
management but at least by somebody.
- A simple, comprehensive implementation plan
- Training & support for everyone involved or
affected by the implementation project
- Buy-in and voluntary support & commitment from
a critical mass of people (>1
person, building to 25% of employees)
- Early successes that clearly prove that ISO
17025 will benefit customers, suppliers, management, and especially
workers
- Adequate resources and time to achieve all
that needs to be done
- Rapid and effective communication, feedback,
and recognition on efforts made, results achieved, and work to be done
- Expert, pre-experienced advise, coaching,
cheerleading, pre-warnings, and technical expertise on ISO 17025
implementation.
- Auditing, training, and remedial assistance to
achieve consistent compliance to minimum requirements.
- Dress-rehearsal audit, final fixes, then formal
Registration Audit by Accredited Registrar
- Continuous assessment, improvement, and
re-registration of systems.
Top of Page
Sometimes, it helps to get a clear view of today so we can better
understand where we need to go in the future. PQA has prepared an
ISO 17025 Self-Assessment Survey which you can use to assess your
lab's current capabilities. In 31 questions, we cover most of the
requirements of ISO 17025 that typically impact on customers, employees,
and accreditation. Self-scoring is provided. Discussion of
your answers among the Sr. management team will probably be beneficial to
deciding when and how to proceed.
How can
PQA help your ISO 17025 Implementation ?
PQA's personnel were involved in
their first study of measurement repeatability & reproducibility in
1984, inter-laboratory calibration in 1985, ISO 9001 (Guide 25 )
implementation in 1987. Since then, we have helped hundreds of
organizations with gaining effective compliance to International
Quality Standards through:
- Executive Overview Training for ISO 17025
- Gap Assessment to ISO 17025
- Project Planning, Scheduling, & Management
- Worker Training
- Generic Templates for Policies, Procedures, Process Maps, and
Documentation Systems
- Statistical Data Analysis of 7 Characteristics of a Metrology
Systems
- Repeatability
- Reproducibility
- Linearity
- Bias
- Hysteresis
- Accuracy
- Granularity (Resolution)
- Calibration Models & DOE on Measurement System Capabilities
- Inter-Lab Calibrations
- Reducing measurement system sensitivity to Operator,
Environmental, Common cause, and Special Causes
- Developing Customized tests and measurement criteria.
- Process Auditing
- Error Reduction Investigations & Program Implementations
- Management Reviews for Accountability, Cost Reduction, and
Independent (Third Party) Verification
- Dress rehearsal audit prior to official registration
accreditation audit
You are the expert in your lab, and in the analysis of your
customer's samples. We are the experts in the implementation of
ISO 17025.
While it is possible to achieve, what would you say to a customer
who was considering testing their own samples instead of using your
services? What about implementing ISO 17025 on your own, without
the expert guidance & assistance from PQA? Is there any
difference between these two cases?
For more information on how PQA can help you achieve ISO 17025,
please e-mail PQA at dwhitred@pqa.net
or discuss your specific situation with Don Whitred, one of PQA's Senior Consultants,
at 519-667-1720.
ISO 17025 FAQ
If you have some questions about ISO 17025, send them to PQA, and
we'll attempt to answer the question for you.
Frequently Asked Questions for ISO 17025
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ISO 13485 Medical Devices