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:

Measurement and calibration trace ability when it comes to standard
Core technical competency of lab staff
Regular and periodic lab equipment maintenance
Preciseness and Validity of testing methods done in the lab
Hassle free handling of lab equipment and items
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

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:

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 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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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!

Book A Call With An Expert Now

ISO 17025 Remarkable Corrective Actions Resolution

ISO/IEC 17025

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: Metro-logical 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

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

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!

Book A Call With An Expert Now

Invaluable ISO 17025 Accreditation Benefits to Laboratories

ISO/IEC 17025

What Is the ISO 17025 Accreditation Benefits?

Lab Operations Being More Credible

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

Measurement and calibration trace ability when it comes to standard
Core technical competency of lab staff
Regular and periodic lab equipment maintenance
Preciseness and Validity of testing methods done in the lab
Hassle free handling of lab equipment and items
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 guidelines of ISO 17025:2017 and having a sound technically competent staff by your side using high-quality lab equipment reduces the risk 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!