ISO 17025 is the equivalent of ISO 9000 for calibration and testing laboratories. It applies to any organization that wants to assure its customers of precision, accuracy and repeatability of results. This includes in-house laboratories for which assurance of results is at a premium.
The growth in use of Quality Systems generally has increased the need to ensure that laboratories that form part of larger organizations or offer other services can operate to a Quality System that is seen as compliant with ISO 9000 as well as with ISO 17025. Testing and calibration labs that comply with this standard will also operate in accordance with ISO 9000. Certification to ISO 9000 alone does not demonstrate the competence of the lab to produce technically valid data and results, whereas certification to ISO 17025 does provide that evidence.
QS 9000, the Automotive Quality Management System, and its successor, TS16949, have stipulated that first tier suppliers of calibration and test services be ISO 17025 certified, and that suppliers upstream of them be compliant.
What is ISO 17025?
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.
Overview of ISO 17025
ISO 17025 is one of the most popular quality standards for all laboratories; whether or not they do business with international customers.
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, QS-9001, 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.
ISO 17025 Success Factors
Research into what makes a ISO 17025 implementation a success has revealed 11 Critical Success Factors. They are, in order of importance: –
- Top management leadership & commitment
- 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-rehersal audit, final fixes, then formal Registration Audit by Accredited Registrar
- Continuous assessment, improvement, and re-registration of systems.
How SMC Cert can help with you ISO 17025 Implementation?
- Executive Overview Training for 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 System
- Calibration Models
- 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