What is ISO 17025 Transition?
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 the Revision of ISO 17025
The working principles based on which ISO 17025 Transition was revised to make it more aligned and compatible with other ISO standards so that organizations feel ease in integration.
However, the ISO 17025 Transition format much resembles 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.
The 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.
Structure of Updated Version of ISO 17025
The structure of ISO 17025:2017 can be overviewed in the form of pointers below:
Further having Annex mentioned below:
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 reaches out to 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 kept up when data is gotten from sources other than the client (e.g. complainants or controllers), in which case the nature of the information 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 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.
Does it feel like you are exploring a wormhole when researching standards used in calibration?You are not alone!
Here is a list of common international standards used in calibration.
This standard covers the general requirements for the competence of testing and calibration laboratories. Expect to see a revision to ISO 17025 to be released late 2017 early 2018. It is similar to ISO 9001 in general requirements but is very specific in the technical requirements necessary to be an ISO accredited calibration and/or testing laboratory.
You may find these articles helpful in understanding ISO 17025:
ISO 9001 or ISO 17025: How to choose a calibration company
As a calibration company we are sometimes asked which is better ISO 9001 or ISO 17025 certification. That really is the wrong question. Both of these International standards are excellent. The reason we said it is the wrong question is because they each have a particular focus. What is the difference between ISO 9001 and ISO 17025?...........
Compliant or ISO 17025 accredited: Is there a difference?
Recently I was having a conversation regarding quality and the often used phrase came up- ' All things being equal'. This got me thinking, when are all things equal?
In this particular conversation, it was regarding compliant versus accredited. I don't think it is immoral, illegal or unethical to use the term compliant when advertising a companies qualifications. That said, there is a significant difference between being compliant and being accredited......
'ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001.
This standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdfQuality Management Principles. Using ISO 9001:2015 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.
Get an overview of ISO 9001 in thispowerpointpresentation.
If you want to know more about the revision of ISO 9001:2015 see our revision page. '
Source: https://www.iso.org/iso-9001-quality-management.html
You may find these articles helpful in understanding ISO 9001 and calibration:
Where is calibration mentioned in ISO 9001:2015
The release of ISO 9001:2015 has many companies reevaluating how they do business. Why? While inherent in every business model, the concept of Risk-based thinking now requires a more articulated approach to measure inputs and outputs.So, where does calibration fit in Risk-based thinking and where is calibration mentioned in ISO 9001:2015?...........
ISO 9001:2015 - Is your calibration program ready?
Recently I was in a discussion with several Quality Managers regarding ISO 9001:2015 and the focus on Risk.
The discussion focused on what tools/techniques people would be using for Risk Assessment, Risk Management and Mitigation. The numbers of tools available is almost limitless and everyone had a good sense of where they were going to focus. There was keen focus on Process and Supplier Management......
This standard is specific to aerospace. Specifically Quality Management system requirements for Aviation, Space and Defense Organizations. As of September 15, 2017 the latest revision is AS 9100D. The general principles of ISO 9001 are covered within this standard. AS 9100 has a history looking specifically risk assessment and analysis. One key tool used is the FMEA- Failure Mode Effects Analysis. You will also see the term Nadcap in relation to AS 9100. Nadcap is the National Aerospace and Defense Contractors Accreditation Program. This is an industry-managed approach to conformity assessment using technical expertise from all parties involved.
You may find this article helpful in understanding AS 9100 and calibration:
AS 9100 and Calibration:It's time to get real!
It is critical that you support your airworthiness operations with a thorouhly vetted calibration prgram. What is your selection process for a calibration vendor? Do you require ISO17025 accreditation?........
Risk-based Thinking For Iso 17025 Requirements
Z540
The waters tend to get real muddy here. There are several versions of Z540. Z540-1 has been an American National Standard since 1994 and is rooted in MIL-STD 45662A. For a detailed discussion of Z540-1- Click Here.
Z540.3 focuses on False Accept and is based the the NASA 89% rule. NCSLI has published an interpretation that is very useful. Click Here to read it.
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You may find these articles helpful in understanding Z540 and calibration:
What you need to know about Z540 and calibration
As an17025 accredited provider of calibration services conflict arises when those unfamiliar with ANSI Z540.3 ask us to make decisions that must be made by the end user. As the end user of the calibration equipment you need to have an open dialogue with your calibration provider.......
Tur: What is it?
Risk-based Thinking For Iso 17025 Download
TAR, TUR, CMC, and TLAs
In the world of metrology, the three letter acronyms (TLAs) TAR,TUR,and CMCare routinely bantered about like exam scores. Bigger TARs and TURs with smaller CMCs led to the “Scope Wars” of the 90s and early 2000s..........
Was an ISO technical specification for the automotive supply chain. It is now managed by IATF- International Automotive Task Force. Similar to the general requirement to ISO 9001 it also specifically addresses calibration.IATF 16949 calls out the need for the use of ISO 17025 accredited calibration regardless if the calibrations are performed internally or externally.
You may find these articles helpful in understanding ISO/TS 16949 and calibration:
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What is the difference between Accreditation and Certification?
The recent changes to ISO 9001:2015 have caused some confusion about how to select a calibration provider.Does a calibration provider need ISO 9001 certification or ISO 17025 accreditation? Or both?........
CQI-9 Special Process Heat Treat System Assessment and Calibration
AIAG - Automotive Industry Action Group- released CQI-9 in March of 2006. The goal is to 'include a reduction of campaigns, spills, recalls and warranty claims related to heat treated components. The management system will emphasize continual improvement, defect prevention and the reduction of variation and waste in the supply chain.' This is achieved by performing a Heat Treat System Assessment- HTSA.
ISO 13485 - Medical Devices are specifically addressed in ISO 13485. It is common for the FDA to regulate medical devices that are available in the United States. The FDA 483 insection reports and warning letters are publicly available documents that call out significant violations of 21 CFR, parts 210 and 211.
You may find these articles helpful in understanding ISO 13485 and the FDA 483 inspection reports and letters and calibration:
Iso 17025 Risk Assessment Procedure
MIL-STD-45662A - This standard has been cancelled. The fundamental aspects of MIL-STD-45662A are found in ISO 17025, ISO 10012 and Z540.
You may find this article helpful in understanding the evolution of MIL-STD-45662A into ISO 17025:
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