What is ISO 17025 Transition?
ISO 17025 is the International Standard for Testing and Calibration Laboratory accreditation and the highest level of recognition for any lab across the globe.
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 overviewed 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.
Impartiality and Confidentiality are very critical for Laboratory operation and reporting accurate results. The updated standard also talks about how to deal with risk associated with impartiality and confidentiality as it applies to various situations including workforce relationships, customer feedback, external stakeholders’ needs, systems requirements, temporary workers, and so on.
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, equipment/instruments, work environment and competent administrations that should be able to oversee and play out its exercises.
All Lab Technicians ( permanent/ temporary) who could impact the consequences of lab results are relied upon to be skilled and impartial. This applies to staff who are directly engaged with the testing, calibration, and sample collection, as well as those indirectly part of lab work, for example, managerial and support team like Purchasing, HR.
Instead of SI system Traceability Metrological Traceability is introduced to assure comparability of measurement results both nationally and internationally.
Externally provided products and services need to be defined along with criteria for qualification, selection, evaluation and re-evaluation. This includes critical to quality products, services and processes.
Clause 07 – Process Requirements for ISO 17025 Transition
Process requirements are similar to the Technical Requirement Clause 5 of ISO 17025:2005 standard. Defining the Decision Rule for customer requirements for conformity statement is most critical in this clause.
A laboratory should have a defined methodology for the transportation, receipt, taking care of, stockpiling, maintenance, and transfer of testing and calibration items. The lab must have a unique entry for every new object to be tested/calibrated in the lab facility under standard conditions prescribed. Deviations from indicated lab conditions are required to be recorded at all times.
Requirement for measurement uncertainty remains the same. Laboratories must take into account uncertainty measurement while testing /calibrating items. These budgets should identify all contributors and also repeatability and reproducibility ( Technical competency of various Technicians). For all non-conforming work, Technical/Quality Manager should be informed and testing/calibration stopped till a further decision is made.
Control of Data and Information Management requires all the Laboratory using any off the shelf software( MS Office Suite) or modified off-shelf software, for the collection, processing, recording, reporting, storage, or retrieval of data to be validated for functionality, including the proper functioning of interfaces within the laboratory information management systems or prior to use
Clause 08 – Management Requirements for ISO 17025 Transition
Laboratories that have existing ISO 9001 standard now will be able to select from 2 options, Option A and Option B.
Lab having existing ISO 9001 is Option B and Lab without any existing standard needs to select Option A. Management requirements have new additional requirements of identification of Risk and opportunities for all processes of Lab as well as a revision to Management review input.
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