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Invaluable ISO 17025 Accreditation Benefits to Laboratories

Invaluable ISO 17025 Accreditation Benefits to Laboratories

ISO/IEC 17025

Invaluable ISO 17025 Accreditation Benefits to Laboratories

There are numerous ISO 17025 accreditation benefits. One of the most vital and relevant ISO standards used for testing and calibration of samples in laboratories around the world is ISO 17025. Being accredited with ISO 17025:2017 gives a testing body the confidence to exhibit and prove that the accredited lab is considered to be precise when it comes to results validation, testing, and calibration.

What Is the ISO 17025 Accreditation Benefits?

The accreditation process is nothing but an attestation from a third party in complete relevance to a conformity assessment body that conveys full demonstration in a precise manner of its technical competence so that specific conformity tasks can be performed successfully and efficiently.

Lab Operations Being More Credible

Following factors can be assessed when it comes to lab operations:

  1. Measurement and calibration trace ability when it comes to standard
  2. Core technical competency of lab staff
  3. Regular and periodic lab equipment maintenance
  4. Preciseness and Validity of testing methods done in the lab
  5. Hassle free handling of lab equipment and items
  6. High-quality standard of testing conditions

Further time to time reassessment of lab operations is also carried out to monitor the lab progress.

What Benefits Does ISO 17025:2017 Brings for the Customer?

By following the guidelines of ISO 17025:2017 and having a sound technically competent staff by your side using high-quality lab equipment reduces the risk of allowing you to skip expensive retesting boosting your lab’s credibility worldwide.

Want to know how Sync Resource can help you out with ISO 17025:2017 Accreditation? Get in touch with us today!

What are the ISO 17025 Accreditation Benefits for US Laboratories?

Here is the way by which US-based laboratories can get the maximum benefit from being accredited with ISO 17025:2017:

Worldwide Reputation

By proper implementation and religiously following up the guidelines of ISO 17025:2017, one must be able to develop an X-factor to win an excellent reputation among market competitors.

Plus an upgraded better image in the views and eyes of auditors and regulatory departments boosts lab’s standing on national and international forums.

Cost Reduction

Getting accurate and precise results in one go will minimize lab’s operational cost because retesting will be avoided. Hence making control over lab operations in better shape.

Systematic Approach

Being ISO 17025:2017 accredited lab, one can run lab working through proper systematic approach keeping all systems protocols in place with all supporting documented information.

Improved Lab Testing Environment

Validity and appropriateness of test methods under prescribed lab environment result in more accurate outcomes every time helps you saving the expense on retesting and revalidating the samples.

Enhanced Customers’ Satisfaction Level

Providing every time accurate test results improves the lab’s reputation and increases the level of customers’ satisfaction on national and international platforms.

Documented Uncertainties

Uncertainty budget being recorded and proven.

Still Not Sure for ISO 17025:2017 Accreditation?

There are more ISO 17025 Accreditation Benefits:

ISO 17025:2017 accreditation technically enables testing labs to perform their work procedures in a better systematic way with full logical based thinking outcomes.

The healthy competition among accredited testing bodies develops a sense of making oneself more competent.

Moreover, various areas of improvements can be identified with the help of teamwork by implementing all the actions that are mutually decided    

Significant Changes in ISO 17025:2017 Being Jotted Down Here!

Let’s have a glance on the significant amendments being made in the updated version of ISO 17025.

1. Scope

The scope of ISO 17025 has been widened to touch horizons of sample testing, equipment calibration and sampling which will have relevance to calibration and testing techniques.

2. Better Process Approach

The process approach has been made more integrated with ISO 9001 (Quality Management System), ISO 15189 (Quality of Medical Lab) and ISO 17021 (Requirements for Audit and Certification Bodies).

3. Zoomed In Focus on Information Technologies

A robust focus on the usage of computer systems and technologies, having maintained electronic records and recording of outcomes and reports electronically rather than manually.

4. New Notions

Risk-Based thinking has been introduced as a new chapter in the updated version of ISO 17025.

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Ultimate Guide to ISO 17025 Transition

Ultimate Guide to ISO 17025 Transition

ISO/IEC 17025

 

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:

  1. Scope
  2. Normative References
  3. Terms and Definitions
  4. General Requirements
  5. Structural Requirements
  6. Resource Requirements
  7. Process Requirements
  8. 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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What is Uncertainty of Measurement? – ISO 17025: A Beginners Guide

What is Uncertainty of Measurement? – ISO 17025: A Beginners Guide

ISO/IEC 17025

What is Uncertainty of Measurement? – ISO 17025: A Beginners Guide

Estimating the uncertainty of measurement certainly sounds like an oxymoron. You need to measure the uncertainty of measurement. Still with me? ISO 17025:2017 accounts for the uncertainty of measurement under the sub-clause 5.4.6, where it is prescribed for labs to understand, document, and apply procedures to estimate the uncertainty of measurement reasonably.

The essential requirements related to the uncertainty of measurement are stated below:

  • Labs must make use of appropriate steps to estimate the uncertainty of measurement.
  • Methods used that are statistical are not always to be used to estimate the uncertainty of measurement.
  • All the uncertainty components shall be identified and estimated to the closest match for each of the product testing.
  • Approximating the estimation of uncertainty in measurement will rely on knowing the methods used to perform the measurements
  • Validation data methodology can be used to determine the uncertainty of measurement.

The necessary part of measuring the uncertainty of measurement is to identify all sources of uncertainty of measurement. This consideration includes seeking every component, no matter how minor it is. If it’s contributing to the uncertainty of measurement and its estimation it needs to be considered.

Few Basic Concepts Relevant to Uncertainty of Measurement

Let’s brush up on some beginner’s guide terminology related to the uncertainty of measurement.

Measurement

Measurements are no more than numbers, usually acquired through apparatus such as scales, thermometers, stopwatches, or rulers.

Measuring an object will give us valuable information about what it is. A measurement is made up of two components – the value (a number) and the units related to a larger, defined measurement standard.

Measurand

It is the specific quantity subject to measurement.

Uncertainty of measurement

Uncertainty of measurement deals with the quality of measurement. As engineers will tell you, there’s no such thing as an exact value for a measurement, only the most probable value. Uncertainty of measurement is that doubt that happens with each measurement.

Error

Error is the difference between the measured value and the actual value. Error and Uncertainty of measurement are not interchangeable, no matter how closely they may look like one another. Error deals with flaws in the measuring process, but uncertainty is the doubt about result measurement.

Sources of Errors and Uncertainties

  • The measuring instruments
  • The item being measured
  • The Measurement Process
  • Calibration method
  • Operators’ skill and competencies
  • Sampling Issues
  • The Environment

ISO 17025 Corrective & Preventive Actions for continual improvement

General Kinds of Uncertainty in any Measurement

Random

Random uncertainty of measurement occurs when you get a different unexpected result after repeating a measurement.

Systematic

Systematic Uncertainty of Measurement occurs when a value consistently shows up as more or less than the actual value.  

Standard Uncertainty

Standard Uncertainty may be defined as the uncertainty of a measurement’s outcome, which may be expressed as a Standard Deviation.

Combined Standard Uncertainty

Combined Standard Uncertainty may be described as the result of a measurement that is estimated standard deviation equivalent to the positive square root of total variance obtained by adding all the uncertainty components.

Calibration

Calibration is a set of operational standards set up under specified conditions. The relation between quantities’ values indicated by the instrument used to measure or any values represented by reference material and corresponding values obtained by the standard.

Bias

The difference between the expected outcome of testing and the real accepted value obtained.

Validation

Validation is a process for proving the characteristics of the method’s capacity, which is appropriate for solving any analysis problem.

Reference Material

Reference material is a material or a substance used to calibrate a measuring apparatus or assessment of a measurement method or assign values to the material.

Essential Aspects to Estimate Uncertainty of Measurement

Following are the steps of the procedure for estimating the uncertainty of measurement:

The Measurand needs to be defined

Defining the measurand is essential in getting a proper estimate for uncertainty. The correlation between the measurand and input quantity should be established through the model equation.

Identification of Sources of the uncertainty of measurement

Some of the more common sources for uncertainty of measurement include:

  • Unclear defining criteria of the measurement
  • Sampling method
  • The way the sample is being transported and stored
  • Sample preparation method
  • Internal Lab conditions and external environmental conditions under which the measurement has been carried out
  • Lab operators
  • Any change in the testing procedures
  • Equipment that is used to get measurement done
  • Reference material used

Stepwise Method to Estimate Uncertainty of Measurement According to ISO 17025

Following is the eight-step approach to estimate the uncertainty of measurement:

  •  Decide what the measurement will allow you to conclude. If possible, estimate the actual output for the measurement and determine what calculations may be necessary to give you the desired outcome.
  • Conduct the measurements, nothing the results.
  • Draw an estimate of each input quantity’s uncertainty that provides a feed to the final desired result.
  • Determine what errors may have affected the measuring process and if those errors are independent of each other. If the errors are dependent, you may be required to perform more calculations for error-correction.
  • Calculate the outcome of your measurement exercise.
  • Evaluate the combined standard uncertainty from all the individual aspects.
  • Denote uncertainty with uncertainty interval and state level of confidence.
  • Mention measurement results along with uncertainty and state how the measurement is done and the uncertainty of measurement.

How to Minimize Uncertainty in Measurement?

Here are a few simple stepwise techniques that can be used to minimize uncertainty in measurement:

  • Calibrating the Measuring Instrument: It is crucial to perform a calibration on measuring instruments before measuring anything with a reference standard or agent.
  • Do Corrections: Make corrections that can affect your measurement practice. For example: if you find zero error in your measuring instrument, you should make your measurement outcome likewise after removing zero error.
  • Sync your Measurements to National Standards: Make your measurement outcomes traceable and in sync with the national standards.
  • Measuring Instrument: Choose the best of the best measuring instrument and make the maximum use of the lab’s calibration facilities.
  • Repeat Measurement Process: Check the accuracy and precision of measurement by repeating them repeatedly. Multiple iterations may be able to rule out errors or spot systematic errors.
  • Remove base reference numbers and assumed measurements. Rely on the physical measures and not those obtained from secondary sources.
  • Be aware of the fact that during multiple calibration chains, the uncertainty increases after each step.

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What is Estimation of Uncertainty of Measurement Procedure? – ISO 17025

What is Estimation of Uncertainty of Measurement Procedure? – ISO 17025

ISO/IEC 17025

So just what is the estimation of uncertainty of measurement? I am so happy you asked. While the term might take you back to the old acronym ‘WAG’ (Wild Ass Guess) the International Organization for Standardization ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories” has emphasized the mandatory requirement for all testing & calibration laboratories to apply procedures for close ‘estimation of uncertainty measurement’. It is compulsory for testing & calibration laboratories when submitting final test /calibration results; labs should also attach an enclosed statement about the best closest estimated uncertainty of measurement, keeping it most relevant to the validity of results. All the general requirements for the estimation of uncertainty of measurement and reporting has been mentioned in ISO 17025.

Definition of Uncertainty in ‘Estimation of Uncertainty of Measurement’ as Defined by ISO

Uncertainty – is defined by ISO (International Vocabulary of Basic and General Terms in Metrology) as the parameter, associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement. Got that? (Redundant question!)

Responsible Functions of Testing Bodies

Let’s start with the responsibility of functions:

Quality Assurance: QA is responsible for maintaining and performing the activities defined in the estimation of uncertainty in the measurement procedure.

Lab Operations: All Lab operators are responsible for ensuring that all the specified requirements should be followed by all means.

Other Supporting Functions: All other relevant functions are responsible for ensuring that all the requirements specified in the procedure has been fulfilled or not.

Why Calculate Uncertainty of Measurement?

The ultimate use of estimating uncertainties in measurement is to:

  • Be able to exhibit about the accuracy of test results that have been performed in the lab by lab operators.
  • Allow the consumer of data to be able to interpret data in the report properly.

While estimating the uncertainties, it is important to take into account all possible contributors that can affect your lab testing activity and on the uncertainty of measurement.

  • After measuring uncertainty in measurement, one can get a realistic comparison of outcomes from different testing/calibration bodies.
  • Measuring uncertainty in measurement often helps to avoid repetitive testing/calibration procedures, thus saving time and cost.
  • While evaluating uncertainties in measurement, one always count all the factors that can impact or contribute towards uncertainties in measurement, leading to improvement of the procedures, making testing/calibration bodies more precise.

General Principles of Measuring Uncertainties of Measurement

  1. Know More About Measurand: The main objective of doing measurement is to know the value of measurand (anything which is being measured). It is important for measurement to begin with an appropriate set of specification of the measurand, a proper method of measurement, and the specific detail of the measurement procedure.
  2. Perfectly Perfect: No measurement process or testing /calibration can be called perfectly perfect! Also, those imperfections help uncertainties to rise ultimately leading to an error of measurement in the final result. The result of any measurement being carried out has some certain quantity of uncertainties, which are important to get identified.
  3. Components of Uncertainties: Random and Systematic components always exist in case of errors. However, uncertainties arise from more random factors and imperfect calibration for systematic errors.
  4. Random errors: Random errors usually arises from variations being made randomly. Every time a measurement is being done, random factors impact uncertainties in different ways, varying in every measurement cycle coming from various sources each time the measurement is being taken.
  5. Systematic errors: Systematic errors arise from other systematic effects. However, these can be reduced to a much extent firstly by identifying them and then by eliminating (preferably) or reducing them.
  6. Components of Uncertainty of Measurement: All the components of the uncertainty of measurement should be evaluated using proper methods, and each is expressed as Standard Deviation and also referred to as Standard Uncertainty.
  7. Standard Components of Uncertainties: All the standard components of uncertainties combined to produce an overall uncertainty value, which is often referred to as Combined Standard Uncertainty.

Where Does Uncertainty in Measurement Come From?

There can be many possible sources of uncertainties in testing/calibration and measurements existing in testing/calibration labs, which can be stated as:

  • If the requirement of the test/calibration is not being defined clearly, then ambiguities may lead to uncertainties in measurement
  • Even if the requirements of the test/calibration is known even then, it is not possible to fulfill the required conditions for the testing/calibration bodies
  • Improper sampling methods may lead to uncertainties
  • Especially in analog instruments, personal bias can end up having uncertainty in measurement
  • The mistake in the values of constants and other parameters used in data evaluation
  • Errors in instrument scale
  • Variations in repeated observations can still be observed even if the test /calibration is being performed in the same conditions

Calibration is characterized as follows:

  • Repeated measurements can be made
  • Uncertainty of reference instruments is provided at each stage down the calibration chain, starting with the national standard, and
  • Customers are aware of the need for a statement of uncertainty to ensure that the instrument meets their requirements.

Basic Calculations

The measurement uncertainty calculation is:

Expanded Uncertainty = (combined Standard Uncertainty) * K

 Where K is the coverage factor.

estimation of uncertainty of measurement

Estimation of Uncertainty of Measurement

The combined Standard Uncertainty is an RSS (Root Sum Square) calculation:

U1 is the calibrator’s accuracy-related uncertainty.

U2 is the combination of two DUT related uncertainty components:

  1. S1: The standard deviation of the mean within a sequence of actual measurements (a Type A uncertainty)
  2. S2: The resolution (or sensitivity) of the DUT (a Type B uncertainty)

U3, U4, U5, U6, U7, U8, U9, and U10 are optional uncertainty components.

Uncertainty is an unpreventable part of any measurement, and it begins to matter when results are close to a specified limit.  A proper evaluation of uncertainty is good professional testing/calibration body practice and can provide laboratories and customers with valuable information about the quality and reliability of the result.

Although common practice in calibration, there is some way to go with an expression of uncertainty in testing/calibration; however, there is growing activity in the area and, in time, estimation of uncertainty measurement will be common. No more WAGs!

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ISO 17025 Remarkable Corrective Actions Resolution

ISO 17025 Remarkable Corrective Actions Resolution

ISO/IEC 17025

The International Standards Organization has outlined a series of qualifications that pertain to quality assurance of products and services. ISO 17025 deals specifically with Laboratory Management Systems. If a company is seeking ISO 17025 accreditation, they need to conform to the rules set forward by the ISO committee. Before a business can determine whether it should start on the path of accreditation or not, however, the structure of the ISO program should be evaluated.

Structure of ISO 17025

There are a series of headings to review for ISO 17025. Among these are:

  • Scope: This heading covers the requirements (both scientific and technical) that a lab must display to demonstrate that it operates at the quality standards set forth by accreditation.
  • Normative References: Outlines a non-ambiguous framework for discussion of ISO 17025.
  • Terminologies and Definitions: The specific phrases and words that will be used to discuss laboratory Management Systems.
  • General Requirements: Requirements that the management system must have that encompass standard operating procedures and interface.
  • Structural Requirements: Infrastructure necessary to attain ISO 17025 accreditation.
  • Resource Requirements: Resources that a laboratory seeking ISO 17025 accreditation should have access to.
  • Process Requirements: Internal lab procedures should follow the guidelines set forward in this section.
  • Management Requirements: The management and running of the lab should use this section as a general guideline.

In addition to these clauses, two Annexes are also attached, viz.:

  • Annex A: Metrological Traceability (Informative)
  • Annex B: Management System (Informative)

To ensure that results delivered are accurate and precise, testing and calibration labs work within strictly defined guidelines for these specific tasks:

  • Documentation of results into a readable format
  • Sample analysis
  • Sample testing
  • Sample labeling
  • Sample identification

ISO 17025 requires a continuous review of processes. This review happens both during the audit process as well as after accreditation. The ISO 17025 methodology comes with a clause that focuses on corrective and preventative actions. The clause in detail states:

Clause 8.7 “Corrective Action” 8.7.1: Procedure for implementing Corrective Action: Selection and implementation of Corrective Action Selection and implementation of the most suitable Corrective Action. Document and implement any changes as a result of Corrective Action 8.7.2: Effectively addressing Nonconformities, Cause Analysis – Investigation of the root cause 8.7.3: Recording and Monitoring, Monitoring of Corrective Action

Steps in Addressing Corrective Actions

When corrective actions are prescribed to a laboratory, implementation of these corrective actions is done as follows:

  • Root Cause Analysis: A problem can’t be solved unless the root cause of the issue is located. A cross-functional team is best suited to examining every aspect of the matter in detail to determine where the problem exists within the procedure.
  • Examination of non-conformity: Non-conformity is a precursor to a problem arising within a process. The Corrective Actions unit should address any non-conformity that has occurred or has the possibility of re-occurring.
  • Determining Corrective Actions and Implementation: The most suitable corrective actions that will ensure the quality of the process would be selected from the potential actions, under the supervision of management. The chosen works will then be implemented to bring about change.
  • Monitoring of Actions: The team is required to observe and record what happens after the measures have been applied. If the discrepancy re-occurs, the process must be redone.
  • Additional Auditing: Determine whether internal audits are higher in quantity, or create any further non-conformity.
  • Record-Keeping: Meticulous recording of problems and actions taken to alleviate them allows for analysis of the methods undertaken both quantitatively and qualitatively. A review of records will make it easier to determine whether suggested activities are likely to work or not based on previous implementations.
  • Evaluation of Corrective Actions: Quality assurance departments are required to revisit the activities performed periodically to determine their long-term success. Management teams can use these periodic reports in the future for both internal and external audits.

The Vital Role of Continuous Improvement

ISO 17025 is an iterative process seeking to ensure that a laboratory raises the quality of methods with each audit. Daily improvement is facilitated by embedding a continuous improvement cycle and using Six Sigma Quality Management within the institution. Additionally, the current level of the institution’s Quality Management Service can be referenced. Additional benefits of a continuous improvement cycle include:

  • Reduction in customer complaints due to a higher quality of service, which leads to better customer response times.
  • Making it easier to gain ISO accreditation or re-accreditation.
  • Reduction in non-conformities that impact the efficiency and effectiveness of the system.
  • Delivering continual betterment through corrective actions.
  • Overview and verification of how effective the implemented corrective actions have been in both the short and long term.
  • Examining other opportunities the business has for improvement.
  • Checks on the efficiency of the company’s QMS.
  • Be updated with the current advances and changes to the company’s processes to match those developments.

Are you interested in gaining ISO accreditation for your company? We’d be happy to answer any questions you may have regarding the process. Contact us today!

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ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO IEC 17025 Laboratory Requirements: Calibration and Testing

ISO/IEC 17025, Uncategorized

Laboratory accreditation for testing and calibration falls under the ISO IEC 17025 standard. Any laboratory that wants to demonstrate their conformity to the highest levels of quality for their results would be well-advised to seek ISO IEC 17025 accreditation. The accreditation was designed alongside eighteen liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC).

Who Does the ISO IEC 17025 Apply To?

Accreditation should be a priority for labs that do testing, sampling, or equipment calibrations. Whether the lab is government-run or private doesn’t make a difference. While many labs believe they already run at peak efficiency, implementing ISO IEC 17025 usually reveals a lot of gaps in their processes and management methodologies. Among the perks of achieving ISO IEC 17025 accreditation are:

  • Quality control systems can anticipate problems and deal with preventative actions.
  • Methods of testing have specific accuracies, precision, and limits of detection.
  • The institution starts using globally published and accepted standards for their testing methodologies and calibration of instruments.
  • The accreditation similarly outlines an acceptable set of methods that the lab can use.

The Benefits that ISO IEC 17025 Brings to Institutions

Accreditation can take a lot of time, but the sheer benefits that it offers to an institution are second to none. An accredited lab is one that is afforded respect in their dealings with their business clientele. By starting on the path of ISO IEC 17025 accreditation, an institution removes any doubt that a client may have regarding their operation and methodologies. In the business of laboratory testing, trust is the most important thing for clients. The accreditation encourages trust in a laboratory because the accreditation shows that the company conforms to professional, accepted standards that are approved globally.

Clients will no longer have to worry about retesting leading to different results. The generated results from the labs’ test would be accurate and precise. This peace of mind is critical to a client’s decision to return for future business. Not only does ISO IEC 17025 affect the way a client sees the institution, but how other companies in the industry view them as well.

Institutions that are certified as ISO IEC 17025 compliant tend to be seen in a better light by other labs, both certified and uncertified. Cooperation and sharing of results will be a lot easier with other labs because of this accreditation. The partner labs will have peace of mind that their results will not end up in unauthorized hands. Since this accreditation is accepted globally, international boundaries don’t matter to this level of trust. A certified institution is accorded the same respect anywhere in the world they choose to do business.

How Long does ISO IEC 17025 Accreditation Take

Accreditation doesn’t have a specific timeline. There is no set number of days or weeks that can be applied to every organization. Accreditation depends on a handful of critical practices that may vary, depending on the institution. These are:

  • Number of locations where testing /calibration is done
  • How complex the testing methodologies and equipment calibrations are
  • How many employees the business employs
  • The number of tests or calibrations that are within the institution’s scope of operations

The 2017 Update to ISO IEC 17025

In 2017, the ISO IEC 17025 received a series of updates. Rapid progress in the technology and within the market’s demands made revamping the process of accreditation necessary to deal with these changes. The changes sought to incorporate developments within the realms of IT and technical methodologies while updating the accreditation’s vocabulary to meet the demands of the modern world. The new amendments integrated changes to the ISO 9001 standard, hoping to bring about further integration of both standards.

Significant Changes in the 2017 Amendment

With the ISO IEC 17025:2017 amendment, the industry saw the accreditation change some areas significantly, including:

  • Accreditation Scope: All of a laboratory’s sampling techniques, equipment calibration, and testing will now be covered under the new scope of the accreditation.
  • Alignment between ISO IEC 17000 and ISO IEC 17025: The accreditation was redesigned to bring about a closer alignment between the two standards.
  • Improved Approach to Processes: The accreditation system has been developed to synchronize more closely with existing accreditation systems, including ISO 15189 (Quality of Medical Laboratories), IEC 17000 (Standard of Conformity Assessment Activities), and ISO 9001 (Quality Management System).
  • Reduction in Paperwork: A broader focus on IT and software reduces the amount of paperwork a business needs to perform to conform to the accreditation’s standard.
  • Risk-Based Considerations: A section has been added to the accreditation that allows for closer integration with ISO 9001:2015.
  • Synchronization of Terms: Terminology and vocabulary have been updated to reflect standard conformity assessments.

Display of Accreditation

Once a lab has successfully achieved ISO IEC 17025, they can proudly display the certificate wherever they see fit. Additionally, they can include the accreditation in all their marketing materials, not limited to the company’s website and brochures. Accreditation puts the clients’ minds at ease since it allows them to trust the institution as an internationally recognized organization for their work.

Are you trying to get ISO IEC 17025 accreditation for your institution? Contact us today, and we can work through any questions you might have about the process or the application.

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