In this article, you’ll find a snapshot of what documents you need to have to be compliant with the 2017 revision of ISO 17025. Clause 7 – Process Requirements This procedure must ensure that: The laboratory needs to have good communication with the customer. If changes are made, these amendments need to be tracked to previous versions or to the original observations. Be comfortable in your own knowledge before hiring a consultant (if you feel you need one) and certainly before engaging (e.g. Contract amendments undergo the same review. 7.1 Review of Requests, Tenders and Contracts. Ensure lab can provide for sample integrity. ISO 17025:2017 clause 7.5 states the requirements for technical records. 7.2.1 Selection and verification of methods. Appropriate methods of analysis are utilized depending on the laboratory. Initial the records so that they are traceable. If there are changes made to software configuration or modifications to commercial software, they need to be authorized and validated before used. Review includes requirements are adequately defined, documented and understood, whether the lab can do the work, the final contract is equally acceptable in the previous points, the appropriate method is selected, any subcontracting. The laboratory is required to use appropriate methods and... 7.3 Sampling. •Measurement Uncertainty What We Do •Measurement Uncertainty Calculations for at least the major testing areas. The lab must take precautions to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing and preparation for testing or calibration. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. Methods, procedures and, Determination of the performance characteristics of the method, A statement on the validity of the method, Environmental or transportation conditions, Diagrams or other equivalent means to identify the sampling location, Deviations, additions or exclusions from the sampling method and sampling plan, Have a system for the unambiguous identification of test or calibration items, Retain identification while the lab is responsible for the item, Accommodate a sub-division of an item or groups of items and the transfer of items, The lab should consult customers if there is any doubt about the suitability of an item for test of calibration, or if an item does not conform to the description provided. The laboratory is required to use appropriate methods and procedures for activities, and when necessary, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data. Retain all the files, including the original and amendments, including the date of alteration, altered aspects and personnel responsible for any alterations. By having your laboratory management system accredited to ISO/IEC 17025, … ISO 17025 PROCESS REQUIREMENTS 8 Process Requirements – cont. For laboratories aiming to be ISO 17025:2017 accredited, they must: Know the importance of handling customer complaints; Have a documented process to receive; Evaluate and make decisions on how to manage complaints. Any method deviation must be documented. Review includes requirements are adequately defined, documented and understood, whether the lab can do the work, the final contract is equally acceptable in the previous points, the appropriate method is selected, any subcontracting. For nonconformances, the procedure needs to include: Control of data and information is a critical component for laboratories in order for them to perform activities. 7.8.7 Reporting Opinions and Interpretations. REFER TO ISO/IEC 17025:2017 FOR DETAIL AND FOR CLARIFICATION NOTES. 7.4 Handling of Test or Calibration Items T, hank you for producing documents of this quality, ISO 17025 Internal Auditor Training Courses, copyright and intellectual property guidelines. Assessors are expected to know & have the standard, this worksheet is designed as guidance to prompt detailed recording of the process. Ensure sampling plan and method are available. R104 - General Requirements - ISO-IEC 17025-2017 Accreditation of Field Testing and Field Calibration Laboratories R105 - Requirements When Making Reference to A2LA Accredited Status R301 - General Requirements - Accreditation of ISO-IEC 17020 Inspection Bodies Copyright © 2020 ISO/IEC 17025 Resource Center - All Rights Reserved. Maintain records of complaints and corrective actions. Include the date. One of the key laboratory standards laid forth by ISO 17025 concerns document control and management. The laboratory must determine if the sampling methods address the factors to be controlled to ensure the validity of subsequent testing, and ensure that the sampling plan and method is available at the site where sampling is undertaken. The laboratory retains the following records of validation: ISO / IEC 17025:2017 requires all laboratories to have a sampling plan and method when carrying out sampling of substances, materials or products for subsequence testing or calibration. 8.2 Management System Documentation. Suggestions on how to implement the novelties • Regarding impartiality (4.1) This includes all provisions necessary to protect the integrity of the test or calibration item, and to protect the integrity of the test or calibration item, and the interest of the lab and customer. If, required by the customer, the lab must include a disclaimer in the report indicating which results may be affected by the deviation. The laboratory shall have a procedure for monitoring the validity of results. When you are keeping records, you need to include the date and identify, As an ISO/IEC 17025:2017 accredited laboratory, it is important to understand where, 7.8.3 Specific Requirements for Test Reports, 7.8.4 Specific Requirements for Calibration Certificates, 7.8.5 Reporting Sampling- Specific Requirements, When a statement of conformity is provided, the lab needs to document the decision rule employed and take into account the level of, Who is responsible and authorized for the management of nonconforming work, Establish actions based upon the risk level, An evaluation of the significance of the nonconforming work including an impact analysis, The decision to be taken for the nonconformity, Who is responsible for authorizing the resumption of work. Lab is to inform client if client-specified method is not appropriate. ISO 17025 is based on ISO 9001 with a particular focus on testing and calibration bodies (of course). Evaluate the significance of nonconforming work. 8.3 Control of Management System Documentation All documents must be controlled. ISO/IEC 17025:2017 requirements are relatively simple. ISO/IEC 17025:2017 ISO/IEC 17025:2005 Clause Title Clause Title 4.1 Impartiality 4.1.4/4.1.5 Organization 4.2 Confidentiality 4.1.5 c) Organization Identification of changes New harmonized text has been included, so these are completely new clauses. As a lab, you need to ensure that technical records for all of the lab’s activities contain results, a report, and information in order to facilitate, if possible, identification of components affecting the measurement results and its associated measurement uncertainty, and enable the repetition of the lab activities under conditions as close as possible to the original. For any test you wish to be accredited for, the starting point is to map the processes and activities related to the measurement test. The validation of the methods needs to be as extensive as necessary to meet the needs of the given application. ANAB is the longest established provider of accreditation based on ISO standards for forensic agencies in the United States. Process Requirements are the heart of the ISO 17025:2017 standard, describing the activities to ensure that results are based on … Quality is signing your name to the results! The laboratory must retain records of nonconforming work, and if the lab believes nonconformities may take place again, the lab needs to take corrective action. This includes non-standard methods, laboratory-developed methods and standard methods. As a lab, you need to ensure that technical records for all of the lab’s activities contain results, a report, and information in order to facilitate, if possible, identification of components affecting the measurement results and its associated measurement uncertainty, and enable the repetition of the lab activities under conditions as close as possible to the original. Labs need to ensure that amendments meet the requirements. Mandatory documents for ISO 17025:2017. Reference methods are preferred. When a laboratory information management system is managed and maintained off-site or through external providers, the lab needs to ensure that the provider or operator of the system complies with all applicable requirements. 7.8.2 Common Requirements for Reports. Clause 7.10 emphasizes that labs must have a procedure that must be implemented when activities or results do not conform to its own procedures or the agreed requirements made by the customer. Ensure correlation of sample characteristics. Important Note to Users of this Site:  Although this site is intended to be a useful information resource for those seeking to implement and maintain effective laboratory quality management systems, the www.isoiec17025.com  Web Site is not affiliated with and does not act on behalf of the International Organization for Standardization (ISO), which is the organization that develops and issues international standards, including the ISO 17025 standard. The following article is meant to provide information and open the discussion around this topic. We began providing accreditation of forensic testing agencies in 1982, and moved to a foundation based on ISO/IEC 17025 in 1999. As an ISO/IEC 17025:2017 accredited lab, ensuring the validity of results should be a top priority. Unfortunately, there are differences between these ‘common’ areas in ISO/IEC 17025 and ISO 9001, so laboratories who also operate ISO 9001 systems will need to review the detail of these aspects to ensure compliance. Option B: ISO 9001 Management System option. When a statement of conformity is provided, the lab needs to document the decision rule employed and take into account the level of risk associated with it. 7.9 Complaints Based on ISO/IEC 17025:2017 and requirements in ANAB AR 3125. The lab must communicate what method they are using with the customer. ISO/IEC 17025 requires laboratories to validate methods that they use. Ensure deficiencies are recorded and client informed. It is applicable to all organizations performing tests and/or calibrations. 7.5 Technical Records An ISO 17025:2017 checklist is a tool used to determine a laboratory’s competency in testing and calibration according to the requirements set by the ISO 17025:2017 standard. 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