ISO 17025 is all about accreditation processes of laboratories, self-assessment of laboratories, customer assessments for laboratories as well as worldwide applicable guidelines for laboratories that carry out internal activities of testing, sampling and calibration.

Reasons behind Revision of ISO 17025

The working principles based on which ISO 17025 was revised to make it more aligned and compatible with other ISO standards so that organizations feel ease in integration. However the format much resembles to the new formats of ISO 17020, ISO 17034 and ISO 17065 for better understandings for the organizations that are ready to apply them in their current management cycle. Most significant benefit comes when a laboratory is ISO 9001 certified then technical requirements of ISO 17025 can easily be amalgamated with the guidelines by doing only minimal amendments necessary for each standard.

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Structure of Updated Version of ISO 17025

The structure of ISO 17025:2017 can be overviewed in the form of pointers below:

  • Scope
  • 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 17025:2017

  • In order to reduce prescriptive requirements and to subitute them with performance based on requirments, the application of risk based thinking has been introduced and applied.
  • Processes, procedures, documented information and responsibilities related to organizations exhibits much greater flexibility in the requirements.
  • Definition of the laboratory has been included.

What’s New in ISO 17025:2017?

Following are the major changings in new version of ISO 17025:2017:

Clause 03 – Terms and Definition

Some definitions of the terms have been introduced in updated version of ISO 17025:2017 which are inter and intra laboratory comparison, impartiality, proficiency testing, verification, decision rule, complaint and validation. Moreover, in 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, work force 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 or accreditation to the standard can give affirmation of capability of an association giving inspecting administrations which is again a new concept in updated version of ISO 17025.

Clause 04 – General Requirements

The concept of risk based reasoning is introduced all through the standard. While there are statements tending to dangers and room for improvements, the standard additionally recognizes particular prerequisites to utilize 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 reaches out to lab work force, including any board of trustees individuals, temporary workers, faculty of outside bodies, and people following up for the lab’s work. Privacy is to be kept up when data is gotten from sources other than the client (e.g., complainants or controllers), in which case the nature of the data is to be viewed as a secret to the research center and will not be imparted to the client, except if concurred by the source.

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 organizations themselves.

Clause 06 – Resource Requirements

ISO/IEC 17025:2017 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 work force who could impact the consequences of lab results are relied upon to be skilled and act unbiasedly. This applies not exclusively to staff who are directly engaged with testing, adjustment, as well as examining and testing exercises, yet in addition those in a roundabout way are a part of lab work, for example managerial and specialized work force. This may incorporate staff who perform upkeep or maintenance of equipment of lab or acquiring work force 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 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 precision of the results. Supplier evaluation must be ongoing process from time to time. Supplier and vendor selection criteria must be based on ISO accreditation / certification, raw materials’ pricings and quality of the material provided with bearable lead times.

Clause 07 – Process Requirements

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 in order to receive, analyze and evaluate the format of complaint. Every outcome of complaint must be ended up with an approach of improvement and it should be approved by an authority.