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Achieving ISO 17025 Certification
Achieving ISO 17025 Certification
Achieving ISO 17025 Certification
STEPS
Benny R. Smith
Inchworm Solutions
Santa Rosa, CA
Summary: The increasing popularity of ISO 17025 as a means of insuring product quality
has spawned a flurry of demand for compliance. This paper presents an approach for
achieving compliance through internal auditing and careful selection and application of
process controls.
THE 10 STEPS
1.
2.
3.
4.
5.
Otherwise, list non-conformities and relate each to a specific clause of ISO 17025.
6.
7.
Go to step 2.
8.
9.
Whereas ISO 9001 is a general standard that can be applied to any organization, ISO 17025 is
designed for testing and calibration laboratories. It includes all of the requirements of ISO
9001:1994. Future revisions will incorporate the requirements of ISO 9001:2000.
ISO 17025 (1999) is a process-control standard that contains all of the requirements that insure
that testing and calibration laboratories have a quality system, are technically competent and are
able to generate valid measurements. The Standard can be applied anywhere that testing and/or
calibration is done.
Although ISO 17025 seems to be designed for accreditation of high-level calibration labs, nothing
in the standard prevents its use in other organizations where the measurement discipline may be
oriented toward manufacturing and the calibration of general purpose instrumentation. The
American Association for Laboratory Accreditation (A2LA) instructs applicants for ISO 17025
certification to evaluate how the criteria [of ISO 17025] apply to your laboratory; identify
clauses that do not apply, or apply only to a limited extent, and identify the reasons for their nonapplicability.
THE CHECKLIST
An effective audit requires a clear, concise checklist that accurately reflects the requirements of
the standard. Non-conformities generated by such a checklist will be unambiguous. Once the
checklist is created, provide a copy to everyone in the organization so that they know exactly
what is expected for compliance.
Sections 4.0 and 5.0 of the Summary of ISO 17025 (Appendix) can be used as a first-draft
checklist. Section 4.0 deals with management requirements and section 5.0 deals with technical
requirements. Several paragraphs in those sections deserve special attention.
Section 4.0: Management Requirements
4.2.1 Documentation
Strive for just enough documentation supported by a lean, efficient retrieval system. Overdocumenting leads to confusion and needless busy-work.
4.3 Document Control
Review and approval are essential to the credibility of your documentation. Authorization and
control of revisions is necessary to prevent processes and documentation from diverging from
one another. Auditors will expect to see proof that only the latest revisions of process documents
are in use.
4.10 Corrective Action
Everyone makes mistakes. It is important to acknowledge this fact by having a system that
identifies and analyzes mistakes and discrepancies, and changes the process to prevent
recurrence. It is important to show that you never repeat a mistake.
Appendix
FOREWORD
This edition of ISO 17025 cancels and replaces ISO/IEC Guide 25: 1990.
INTRODUCTION
ISO 17025 applies to testing and calibration laboratories (not defined).
Accreditation bodies should use this standard to accredit the competence of testing and
calibration laboratories.
Complying with ISO 17025 requires compliance with ISO 9001 or 9002 as well.
Certification to ISO 9000 does not remove the need for testing and calibration labs to comply with
this standard. ISO 17025 covers several technical competence requirements that are not
covered by ISO 9001/9002.
1. SCOPE
ISO17025 specifies the competence required to carry out tests and/or calibrations.
It applies to all organizations performing tests and/or calibrations, including testing or calibration
that is part of inspection or product certification.
The NOTES given in the standard do not contain requirements and are not part of the standard.
They provide clarification, examples, and guidance only.
2. NORMATIVE REFERENCES
(A list of documents whose provisions form part of the provisions of ISO 17025.)
4.8 Complaints
Have a procedure for resolving complaints.
Record all complaints and actions taken.
5.2 Personnel
Only competent, qualified personnel can execute procedures.
Formulate goals for the education, training, and skills of personnel.
Identify training needs and provide training.
Keep records of authorization, competence, qualifications, training, and experience of personnel.
Maintain job descriptions for all personnel involved in tests or calibrations..
5.5 Equipment
Provide equipment that is capable of achieving the required accuracy.
Calibrate equipment before use.
Only authorized personnel will operate equipment.
Maintain a calibration record for each piece of equipment.
Protect and maintain equipment.
Remove defective or questionable equipment from use.
Examine the effect of having used defective or questionable equipment.
Update software to reflect changes in equipment parameters or correction factors.
Calibration status will be displayed on all equipment.
Prevent unauthorized adjustment of equipment.
5.7 Sampling
If sampling is employed, the sampling plan must be statistically justified.
Document requests by the client for deviations from the sampling plan.
Follow procedures for sampling and record the results.