What is ISO 17025 Transition?
ISO 17025 is all about accreditation processes of laboratories. This includes self-assessment and customer assessments for laboratories as well as worldwide applicable guidelines for internal activities of testing, sampling, and calibration.
Reasons Behind the Revision of ISO 17025
The working principles based on which ISO 17025 Transition was revised to be more aligned and compatible with other ISO standards. However, the ISO 17025 Transition format much resembles the new formats of ISO 17020, ISO 17034 and ISO 17065 for clearer understanding for application in current management cycles.
The most significant benefit comes when a laboratory is ISO 9001 certified as technical requirements of ISO 17025 can easily be amalgamated with the guidelines by doing only minimal amendments necessary for each standard.
Structure of Updated Version of ISO 17025
The structure of ISO 17025:2017 can be over viewed in the form of pointers below:
- Normative References
- Terms and Definitions
- General Requirements
- Structural Requirements
- Resource Requirements
- Process Requirements
- Management Requirements
Further having Annex mentioned below:
- Annex A – Metrological Traceability (Informative)
- Annex B – Management System (Informative)
Summarized Highlighted Amendments in ISO 17025 Transition
To reduce prescriptive requirements and to substitute them with performance based on needs, the application of risk-based thinking has been introduced and applied.
Processes, procedures, documented information and responsibilities related to organizations exhibit much greater flexibility in the requirements.
Definition of the laboratory has been included.
What’s New in ISO 17025 Transition?
Following are the significant changing in the new version of ISO 17025
Clause 03 – Terms and Definition
Some definitions of the terms have been introduced in the updated version of ISO 17025:2017 which are inter and intra laboratory comparison, impartiality, proficiency testing, verification, decision rule, complaint, and validation.
Moreover, in the definition of laboratory there exists definitions of some other terms named as equipment calibration, sample testing, and sampling activities. An administration framework must be set up, the workforce must be skilled, equipment must be aligned and looked after appropriately with the help of maintenance strategies, testing methods must be approved, and the nature of examining must be guaranteed.
Utilization of our accreditation to the standard can give affirmation of capability of an association giving inspecting administrations which is again a new concept in an updated version of ISO 17025.
Clause 04 – General Requirements
The concept of risk-based reasoning is introduced all through the standard. While statements are tending to dangers and room for improvements, the standard additionally recognizes particular prerequisites to utilize a risk-based approach as for unprejudiced nature.
The updated standard also talks about how to deal with confidential data when required by law or approved by legally binding courses of action.
The necessity of confidentiality is addressed to include the lab workforce, including any board of trustees individuals, temporary workers, faculty of external bodies, and people following up for the lab’s work.
Privacy is to be practiced when data is retrieved from sources other than the client (e.g. complainants or controllers).
Clause 05 – Structural Requirements
Clause 5 characterizes fundamental necessities, including the status of the research facility, association and administration structure, recognizable proof of administration and its control, definition, and documentation of the scope of lab exercises, reporting techniques, and accessibility of staff in charge of actualizing and keeping up the uprightness of the administration framework.
There are negligible changes from the past variant of standard, mostly re-explaining and paraphrasing in relatively easier language making it more user-friendly to apply by the organizations themselves.
Clause 06 – Resource Requirements
ISO 17025 transition requires the laboratories to have well-trained staff, offices, maintenance frameworks, and competent administrations that should be able to oversee and play out its exercises.
All inner or outer workforce who could impact the consequences of lab results is relied upon to be skilled and act unbiased. This applies not exclusively to staff who are directly engaged with the testing, adjustment, as well as examining and testing exercises.
Besides, those in a roundabout way are a part of lab work, for example, managerial and specialized workforce. This may incorporate staff who perform upkeep or maintenance of equipment of lab or acquiring workforce who assess providers and request supplies from outside the labs.
Few lab prerequisites are rebuilt with little change to the expectation of the past variant of the standard. Wherever the laboratory performs sample testing (be it inside or outside the facility), it is mandatory to meet all the standards condition of the laboratory under which testing is being performed.
Moreover addition of controlling, monitoring and recording of the laboratory conditions must be ensured to avoid deviation in the precision of the results. Supplier evaluation must be an ongoing process from time to time.
Supplier and vendor selection criteria must be based on ISO accreditation/certification, raw materials’ pricing and quality of the material provided with bearable lead times.
Clause 07 – Process Requirements for ISO 17025 Transition
At the point when the lab completes testing of samples, materials, or items then that testing strategy is required to be accessible and executed. Records of testing information and results are to be held and retrievable.
A laboratory should have a defined methodology for the transportation, receipt, taking care of, stockpiling, maintenance, and transfer of testing samples. The lab must have a unique entry for every new object to be tested in the lab facility under standard conditions prescribed. Deviations from indicated lab conditions are required to be recorded at all times.
Laboratories must take into account uncertainty measurement while testing samples. The lab personnel staff must be able to count the contributions of external factors due to which lab results seems or are being deviated. For all non-conforming work, procedures should be taken into account.
For complaint handling, a documented process must exist to receive, analyze and evaluate the format of the complaint. Every outcome of the complaint must be ended up with an approach of improvement, and authority should approve it.
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