ISO 17025 Technical Internal Audits: The Basics

The Testing and Calibration Laboratories are required to have a program of internal audits to assess whether their operations comply with ISO/IEC 17025 requirements on an ongoing basis. This involves auditing both management and technical activities to identify gaps, and to drive improvements.

A positive audit culture is essential to ensure that internal technical audits are effective. Management should encourage an open, fair, collaborative effort between technical auditors and auditees. There are ISO 17025 Auditor Training online courses available on web that specifically designed for those who want to learn auditing techniques based on ISO 17025:2017 as well as to know ISO 17025:2017 requirements in detail.

In this post, you will get information about an overview of the various technical audit techniques and the technical requirements that covered in three types of technical audits.

Are technical audits similar to management audits?

The same professional behaviour, general auditing skills, and good understanding of the ISO/IEC 17025:2017 standard is needed in both technical and management audits to ensure they are unbiased and meet their purpose. The Technical auditors are just like lead management auditors, need to be independent, impartial, observant, perceptive, and focused on assessing the compliance of processes, procedures and documented information against specific audit criteria.

What are the three types of audits?

There are three types of technical audits used to assess technical competence: witnessing, vertical, and horizontal.

a) Witnessing

Witnessing involves observing an auditee performing a particular activity, for example, a specific test method, and assessing the degree of compliance. The auditor must be provided with the documented test method against which compliance is assessed.

During the witnessing, the auditor would assess compliance with applicable clauses, but only as they relate to the specific witnessing. This means, for example, only the witnessed auditee’s training records would be assessed, for the specific activity.

b) Vertical audits

A vertical technical audit involves selecting a single report or reported result and assessing compliance with applicable clauses, but only for the specific laboratory activities to get to the point of reporting the specific result. The auditor would either work systematically backward, from the report to the registration of the particular sample (or sampling, if included), or forward from the sample registration.

c) Horizontal audits

Horizontal audits involve assessing compliance with applicable clauses, but across all test methods or activities within the scope of accreditation – For example, environmental controls or technical competency of personnel. A horizontal audit could involve one or all technical clauses. It would be performed on a sampling basis.

Performing a technical audit

The technical audit involves a process and performance-based approach using suitable techniques to collect and verify supplied information, observation of ISO 17025 documents, and record audit findings against technical audit criteria. The auditor must be able to assess whether the laboratory’s risk-based approach produces valid results for customers and meets ISO/IEC 17025:2017 requirements for technical competence.

Internal auditing techniques include the use of ISO 17025 audit checklist, document review, questioning and listening during interviews, and witnessing of activities.

Note that although certain audit techniques are more suitable for onsite audits, they can be adapted for remote audits. Whether remote or onsite, technical audits should be interactive to allow the auditor to engage with the auditees to develop an understanding of the critical technical issues at hand. The techniques should be chosen and combined based on the audit scope, objectives, and operational activities available for assessment.

What does ISO 17025:2017 require for laboratory measurement equipment and related procedures?

How can ISO 17025 help improve laboratory measurements? Present industry research and development depends heavily on precise measuring. To be able to meet that requirement, modern laboratories must use high-quality measuring equipment. Also, to obtain the correct measurement result, the laboratory must employ an organized approach in the measurement process.

The process approach to this topic clearly highlights the large number of activities that could influence a measurement result. For any test you wish to be accredited for, the starting point is to map the processes and activities related to the measurement test. Then, look at the risks and determine which controls should be put in place.

• Management of personnel competency
• Document control of procedures
• Effective technical records
• Suitable facilities and conditions
• Suitable calibrated equipment
• Certified reference materials
• Suitable reagents
• Suitable test method
• Validated methods
• Correct handling of samples

As the requirements of the ISO 17025:2017 standard state that laboratories must demonstrate their competence, practical work requires the proper use of laboratory equipment and commits to following controlled ISO 17025 procedures.

Laboratory equipment – Procedures and usage

The main tools for work in a laboratory are known as laboratory equipment. Laboratory equipment may include the main measurement instruments, measurement software, auxiliary measurement modules and equipment, reagents, consumables, and certified reference materials needed for the correct performance of the measurement procedure.

Not all measurement equipment ensures success in the laboratory. The laboratory must provide proof that it uses uniquely identified and calibrated equipment, that this equipment is in the correct state and that it is regularly tested and maintained and, of course, that it provides skilled personnel to operate that equipment.

Valid use of laboratory equipment is influenced by the place where the measurement is performed. Measurement can be done on the laboratory premises, where environmental conditions are controlled and it is easier to maintain repeatability for any consecutive measurement. But, in some cases, measurements must be performed onsite, where environmental conditions vary and may influence the validity of the measurement.

Things that you should know about the ISO 17025:2017 Documentation for Various Laboratories

One such rule for ISO/IEC 17025 for that includes a list of ISO 17025:2017 requirements for testing laboratories. Testing laboratories need to be accredited to ISO/IEC 17025 to demonstrate their technical expertise and to ensure the accuracy of test results.

As we all know, ISO/IEC 17025 is one of the most important standards for all types of workplaces, universities and research institutes that perform experiments and calculations. ISO/IEC 17025 incorporates management and technical requirements that enable the testing or calibration laboratory to claim its technical competence. To have ISO 17025 accreditation by regulatory bodies proves that results are consistent and accurate and are produced using industry-standard standards.

Due to the use of unmaintained and uncalibrated instruments, Environment/Chemical Testing Laboratory factors, and to the skill level of the laboratory technician performing the tests are these variations. One reason for this variation is the production of potency reports to increase sales. This is usually done through the process of converting samples and test results.

The main purpose of any laboratory involved in analyzing the evaluation to obtain reliable results as possible, in a very short time. This means that regardless of the lab type, high quality and reliable analytical results. There is a need to efficiently manage resources such as personnel, test equipment and equipment, chemicals and reagents, laboratory environment and any other person involved in the production of results and data.

When you choose to provide laboratory testing or calibration, customer there may be a need to ensure that the supplier may issue relevant results. There are many aspects such as personnel competence, equipment reliability, validation and validation of testing methods, sample measurement procedures and calibration tracking at national and international standards that participate in laboratory technology.

So, For ISO/IEC 17025:2017 accreditation consultancy; Global Manager Group which has NABL 17025 Accredited Calibration lab provides facility Ready-to-Use ISO 17025 Documents to accreditation procedures in the calibration laboratory, Environment/Chemical Testing Laboratory as well as Civil Testing Laboratory across the globe. Also over 30 calibration laboratories globally are already accredited under guidance of GMG.

Based on good quality laboratory practices, Global Manager Group provides complete set of lab accreditation documentation kit with sample ISO 17025:2017 Manual, Quality Procedures, Exhibits, Work Instructions, and Sample Formats as well as ISO 17025:2017 Audit checklist for quick accreditation application for various such as Civil Material Testing Lab, Calibration Lab, Environmental Testing Lab, Chemical Testing Lab, Petroleum Testing Lab and Metal Testing Lab.

A global standard – ISO/IEC 17025 is for continuous improvement and maintenance. The laboratory complies with ISO/IEC 17025 benefits in the following ways:

• Improves the reliability of laboratory test results
• May develop technical capacity in case of consideration and/or legal issues
• The efficiency of lab increases , laboratory gains strong competitive advantage, and spending is reduced, customer complaints are reduced
• The Regulation facilitates tracking of ratings and calculations of good performance, sets the technical capacity of staff, maintains inspection equipment records, verifies the accuracy of test results, the accuracy and accuracy of test and calibration methods, the handling and flow of test materials, and the quality of the testing environment.

To get ISO 17025:2017 Consultancy for Accreditation for laboratories you can directly visit here – https://www.globalmanagergroup.com/Services/iso-17025-2017-consultancy-accreditation

What are the Technical Requirements for Seeking ISO 17025 Certification?

ISO/IEC 17025:2017 standard is applicable to all entities engaged in Calibration, Sampling or Testing Laboratories. Standard applies to all small, medium, large, government or privately owned laboratories and other entities engaged in activities of testing and calibration.

ISO 17025 Standard is mostly used by universities, research laboratories, industries, product certifying organizations and inspection bodies. It is mandatory for entities seeking ISO 17025 Certification to get their measuring equipment calibrated in an ISO 17025 certified laboratory.

Technical Requirements for seeking ISO 17025 Certification are:

1. General
This clause tells concerning factors contribute to the correctness and responsibility of the tests and/or calibrations performed by laboratory.

2. Personnel
This clause guides on a way to make sure that all laboratory personnel UN agency will impact tests and calibration results are adequately qualified.

3. Accommodation and environmental conditions
This clause describes the policy and procedure on accommodation and environmental conditions, like to facilitate correct performance of the tests and/or calibrations.

4. Test and calibration strategies and technique validation
This clause guides on policy and procedure of choice of strategies, Laboratory developed strategies, No-standard strategies, validation of methods, estimation of uncertainty of activity, management of information.

5. Equipment
This clause describes the policy and procedure on sampling, activity and equipment needed for proper performance of the tests and/or calibrations. The intention to form certain that the instruments are appropriate for playacting hand-picked tests and/or calibrations and are well characterized, tag and maintained.

6. Measurement Traceability
This clause describes the procedure on system for choosing, using, calibrating, checking, dominant and maintaining activity standards, reference materials used as activity standards, and measurement and equipment use perform tests and calibrations.

7. Sampling
This clause guides on choice, sampling arrange, withdrawal and preparation of sample or samples from substance, material or product to yield the desired info.

8. Handling of test and calibration items
This clause describes a way to make sure that sample integrity is maintained throughout transport, storage, and retention and people samples are disposed of safely.

9. Assuring the quality of test and calibration results
This clause guides on procedures for watching the validity of tests and calibrations through proficiency testing program or ILC , activity of uncertainty , regular use of certified reference materials associate degreed/or internal control mistreatment secondary reference materials and/or replicate tests and/or retesting and/or co-relation of results for various characteristics of an item.

10. Reporting the results
This clause guides on however results of every check, calibrations or series of tests or calibrations distributed by the laboratory shall be according accurately, clearly, unambiguously and objectively and in accordance with any specific directions within the check or calibration strategies.

An Overview on ISO 17025:2017 Management and Technical Requirements

ISO 17025:2017 is the international standard for testing and calibration laboratories. It’s a set of requirements those laboratories use to show that they operate a quality management system and that they’re technically competent to do the work that they do.

The ISO/IEC 17025:2017 standard itself comprises five elements that are Scope, Normative References, Terms and Definitions, Management Requirements and Technical Requirements. The two main sections in ISO/IEC 17025 are Management Requirements under clause number 4 and Technical Requirements under clause number 5.

Management requirements are primarily related to the operation and effectiveness of the quality management system within the laboratory. Technical requirements include factors which determine the correctness and reliability of the tests and calibrations performed in laboratory.

Management System Requirements (Clause 4)

4.1 – Organization
4.2 – Quality System
4.3 – Document control:
4.4 – Review of requests, tenders and contracts
4.5 – Subcontracting of tests and calibrations
4.6 – Purchasing services and supplies
4.7 – Service to the client
4.8 – Complaints
4.9 – Control of Non-conforming testing and/or calibration work
4.10 – Improvements
4.11 – Corrective actions
4.12 – Preventive action
4.13 – Control of records
4.14 – Internal audits
4.15 – Management reviews

Technical System Requirements (Clause 5)

5.1 – General
5.2 – Personnel
5.3 – Accommodation and environmental conditions
5.4 – Test and calibration methods and method validation
5.5 – Equipment
5.6 – Measurement traceability
5.7 – Sampling
5.8 – Handling test and calibration items
5.9 – Assuring the quality of test and calibration results
5.10 – Reporting results

ISO/IEC 17025:2017 standard is designed to help you establish the correct management and technical requirements to achieve accurate results. ISO 17025 accreditation confirms that you have the correct quality systems in place to manage everything from administration to technical operations. And you can achieve all of this by ISO/IEC 17025:2017 training.

ISO 17025 auditor training help you demonstrate to customers, regulatory authorities and accreditation bodies that your laboratory complies with ISO/IEC 17025:2017 requirements – starting with an introduction to laboratory accreditation, to implementing and auditing your own system to maintain compliance.