Development of measurement methods and standard operating procedures

Tests that are necessary for practical application in laboratory activities, but are not currently covered by test method standards, can be difficult to develop. In the absence of standardised test methods, in order to meet customer requirements, the testing laboratory must define and develop its own “in-house” test method that will properly fulfil the requirements. We have a history of developing and validating reliable test methods. Our manager had a vision to achieve ISO 17025 certification. When we embarked on the process of reviewing available standardised test methods, we assessed their suitability for specific applications and legal requirements both in Ukraine and abroad, including manufacturers’ specifications, domestic regulations, European and international standards.

The idea that you can understand the uncertainty in every measurement and test, demonstrate operator competence and implement monitoring processes is a priority for us. Many of the test methods we have developed over the years have made their way into test standards and manuals and have been validated through multiple rounds of proficiency testing. Today, we routinely validate test methods for use by our customers and can do so relatively quickly. We understand how important a convenient and accurate test method can be to the process of ensuring that products are in compliance with established performance standards. We can help you identify a suitable test standard or develop a new test method to suit your needs.

One of the main aspects of our business is compliance with ISO 17025. ISO 17025:2017 specifies the requirements for verification and validation, and requires us to define how we carry out these measurements and tests, what control we have over the competence of personnel and equipment, and how we ensure that these measurements and tests will be used in the future. It is important to us that the ISO 17025 certification processes are carefully followed, as this affects the quality and accuracy of our results.

We also constantly update our methods in line with changes to the ISO 17025 standard. Our specialists regularly undergo ISO 17025 training and certification to keep up to date with the latest requirements and best practices in the industry. This allows us to maintain a high level of competence and provide our clients with the best possible solutions.

Thus, by implementing ISO 17025, we not only improve the quality of our services, but also strengthen the trust of our customers. It is important to remember that ISO 17025 certification is not only a requirement, but also a powerful tool for improving the efficiency and reliability of laboratory processes. Thanks to this standard, we can ensure the highest level of measurement accuracy and conformity, which is a key factor for the success of our customers in various industries.

Methodology verification

Each laboratory shall establish and maintain procedures for the verification of the test methods used. The verification of the test method should confirm that the output data of the methodology implemented in its own laboratory activities meet the requirements of the input data of this methodology. The results of test method verification, including identification of the test method, assessment of compliance with the selected criteria (selectivity (specificity), limit of detection (LOD), limit of quantification (LOQ), operating range, bias, precision: repeatability, reproducibility, measurement uncertainty, stability), date and person(s) performing the verification shall be documented in the testing laboratory.

Methodology validation

Each testing laboratory accredited in accordance with ISO/IEC 17025:2017 shall establish and maintain procedures for validation/verification of test methods. Validation of the design of a non-standardized test method should be carried out under specified operating conditions at the initial stage, before implementation in laboratory activities. Design validation of a non-standardized test method should ensure that the method meets the defined user needs and intended use and should include testing the test method used on a variety of matrices under actual or simulated conditions of use. Design validation should include software validation and risk analysis, if applicable. The results of the design validation of the non-standardized test method, including identification of the design, method(s), assessment of compliance with the established criteria (selectivity (specificity), limit of detection (LOD), limit of quantification (LOQ), operating range, bias, precision: repeatability, reproducibility, measurement uncertainty, stability), dates and person(s) performing the validation shall be documented in the testing laboratory.

Standard operating procedures (SOPs)

An SOP is a written document or set of instructions that describes all the steps of a specific procedure or process. The complexities of business operations, managing multiple channels, and integrating interconnected processes require strict SOPs. Every organization, from a small business to a multi-channel or multinational organization, needs to be supported by detailed SOPs that cover all aspects of their policies, procedures, and standards.

Developing SOPs is about systematizing business processes and documenting them clearly and concisely. A well-documented SOP defines the boundaries and steps of each business process, identifies the controls that need to be applied, and gives you peace of mind in terms of responsibility and accountability for each business process.

Writing a Standard Operating Procedure (SOP) is an important aspect of standardizing consistent processes and ensuring best practices for the smooth and efficient operation of an organization. It helps to eliminate uncertainty by predicting possible outcomes and training the right people to perform the right tasks. It’s more than just writing a simple process that tells you what to do, whereas an SOP tells you exactly how to do it. For any successful business, an SOP is a must. SOP:

  • Defines the tasks and roles required to achieve the desired result.
  • Contains detailed instructions on how to achieve this result step by step.
  • Defines the correct procedure and collects the relevant data.
  • Suggests possible solutions to foreseeable problems.
  • Provides an escalation matrix.
  • Establishes strategies for regular review.
  • A document for training new participants.

Why is LLC "CMLS" your partner in the preparation of manuals?

  • We have many templates that you can choose from to decide how your processes should be presented.
  • Include a detailed responsibility matrix.
  • Include detailed process analysis cycles.
  • We work with you to understand your processes and present them in a better and simpler format.

Here are some reasons why you might need an SOP:

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