Process Requirements of ISO 17025September 4, 2019 2019-12-19 10:42
Process Requirements of ISO 17025
Process Requirements of ISO 17025
ISO 17025 has process requirements for some aspects involved in a laboratory’s systems.
Clause 7- Process Requirements has 11 subclauses:
- 1 Review of Requests, Tenders, and Contracts
- 2 Selection, Verification, and Validation of Methods
- 3 Sampling
- 4 Handling of Test and Calibration Items
- 5 Technical Records
- 6 Evaluation of Measurement Uncertainty
- 7 Ensuring the Validity of Results
- 8 Reporting of Results
- 9 Complaints
- 10 Nonconforming Work
- 11 Control of Data and Information Management
7.1 Review of Requests, Tenders, and Contracts
Your laboratory must have a procedure for the review of requests, tenders, and contracts. This procedure guarantees the:
- Identification, comprehension, and documentation of requirements;
- Selection of appropriate procedures or methods in fulfilling the customer’s requirements;
- The laboratory’s resources and capacity to meet the requirements;
- The laboratory’s compliance with the requirements of 6.6 when using external provides.
The laboratory must:
– have good communication with the customer;
– meet the customer’s needs;
– notify the customer if their methods are outdated or inappropriate;
– inform the customer if their request cannot be accomplished because it would compromise the laboratory’s integrity.
7.2 Selection, Verification, and Validation of Methods
7.2.1 Selection and verification of methods
The laboratory must utilize proper methods and procedures for activities. This also applies to the measurement uncertainty’s evaluation and statistical techniques for the analysis of data. The laboratory must update methods, procedures, and supporting documentation. These should be available to all personnel.
ISO 17025:2017 requires a laboratory to stay updated with appropriate methods when customers do not provide a method. The laboratory must select the best and latest valid version. It must also notify the customer about the chosen method.
The laboratory must verify that the selected method has been published either regionally, nationally, or internationally. The method may also come from another reputable technical organization such as scientific journals. The laboratory must verify that it can execute the method it chooses.
ISO 17025 Section 7.2 requires a laboratory to keep records of verification. Competent personnel must manage the method development, if necessary. Periodic reviews must take place for method developments.
7.2.2 Validation of Methods
ISO/IEC 17025 requires laboratories to validate the methods that they use. This includes standard, non-standard, and laboratory-developed methods. Validate these methods to meet the given application’s needs. In the case of changes to a validated method, understand the influence of the changes.
The laboratory keeps the following records of validation:
- The validation of the procedure used
- Specification of the requirements
- Determination of the performance characteristics of the method
- Obtained results
- A statement on the method’s validity
ISO/IEC 17025:2017 requires all laboratories to have a sampling plan and method when carrying out a sampling of products, materials, or substances, for testing or calibration. The laboratory must determine if the sampling methods address the factors to be controlled. This ensures the validity of subsequent testing and the availability of the sampling plan and method at the sampling site. Sampling must use proper statistical methods.
Sampling methods must describe:
- The sampling plan
- The selection of samples or sites
- The preparation and treatment of samples
When the laboratory is sampling, they must preserve the appropriate records of samples. These records must cover, when appropriate:
- References to the sampling method
- Personnel doing the sample
- The sampling’s date and time
- Data to identify and describe the sample
- Diagrams or other equivalent means to identify the sampling location
- Deviations, additions, or exclusions from the sampling plan and sampling method
- Environmental or transportation conditions
7.4 Handling of Test and Calibration Items
The laboratory must have a procedure for transportation, receipt, handling, storage, protection, disposal, retention, or return of test or calibration items. This covers all important provisions to protect the test or calibration item’s integrity. This protects the interest of the laboratory and customer. The laboratory must take precautions to prevent loss, deterioration, damage, and contamination to the item during preparation, handling, transporting and storing for testing or calibration.
The laboratory must:
- Develop handling instructions
- Have a system for the definite identification of test or calibration items
- Keep identification while the laboratory handles the item
- Guarantee that items do not get confused
- Accommodate a sub-division of an item or groups of items
- Handle the transfer of items
- Record any deviations
The laboratory must consult customers if there is any doubt about an item’s suitability for a test or calibration. This also applies to any doubt if an item does not conform to the description provided. If the customer requires, the laboratory must include a disclaimer in the report stating which results may be affected by the deviation. If applicable, the laboratory must record what environment items need to be stored in.
7.5 Technical Records
ISO 17025:2017 clause 7.5 indicates the requirements for technical records. A laboratory must ensure that technical records for all activities include results, a report, and information. This facilitates, if possible, identification of components affecting the measurement results and its associated measurement uncertainty. This should also allow the repetition of laboratory activities under conditions close to the original. When preserving records, include the date and identify responsible personnel. Records should cover the original observations, as well as data and calculations. Record those at the time of creation. If changes are made, monitor these amendments to original observations or previous versions. Keep all the files, including the original and alterations, the date of alteration, altered aspects, and personnel responsible for any amendments.
7.6 Evaluation of Measurement Uncertainty
An ISO/IEC 17025:2017 accredited laboratory must understand where measurement uncertainty is coming from. The laboratory must identify the contributions to the uncertainties. When you are evaluating for uncertainty, consider all significant contributions, even those coming from sampling. For calibrations, the laboratory must evaluate its equipment for uncertainty. Evaluate measurement uncertainty when performing testing. If the test method excludes rigorous evaluation of measurement uncertainty, the laboratory should make estimates of uncertainty, which is based upon practical experience or understanding theoretical principles.
7.7 Ensuring the Validity of Results
The laboratory must have a procedure for monitoring the validity of results. An ISO/IEC 17025:2017 accredited lab must prioritize ensuring the validity of results. Use statistical techniques to identify trends. The laboratory must develop a procedure for checking the validity of their results. Understand if the system or process may be inefficient. In this case, take preventive action. Proficiency testing is addressed in 7.7.2. If you are looking to be accredited to ISO 17025, you also need to become ISO/IEC 17043:2010 certified.
7.8 Reporting of Results
ISO/IEC 17025:2017 clause 7.8 is divided into several subclauses:
- 8.1 General
- 8.2 Common Requirements for Reports
- 8.3 Specific Requirements for Test Reports
- 8.4 Specific Requirements for Calibration Certificates
- 8.5 Reporting Sampling- Specific Requirements
- 8.6 Reporting Statements of Conformity
- 8.7 Reporting Opinions and Interpretations
- 8.8 Amendments to Reports
7.8.1 General. Reporting results must follow the standard’s requirements if your laboratory wants to become ISO/IEC 17025 accredited. Review and authorize the results before release. Report the results in an accurate, concise, and clear, manner. Include any agreed information with the customer. Add necessary details for interpretation of the results, as well as all information required by the methods used.
7.8.2 Common Requirements for Reports. This identifies what needs to be provided in the results. When developing a report, identify who was responsible for testing and calibration. Carefully record dates.
7.8.3 Specific Requirements for Test Reports
7.8.4 Specific Requirements for Calibration Certificates
7.8.5 Reporting Sampling- Specific Requirements.
These subclauses add extra requirements to 7.8.2. These are more specific requirements for the interpretation of the test results, calibration certificates, and reporting sampling.
7.8.6 Reporting Statements of Conformity
When there’s a given statement of conformity, the laboratory must document the decision rule employed. Next, the laboratory must also consider the level of risk associated with the decision rule. Finally, it must provide a statement of conformity that states which parts, standards, and specifications, are met or not, and what decision rule was applied.
7.8.7 Reporting Opinions and Interpretations
If opinions and interpretations are expressed, the laboratory must guarantee that only authorized personnel will discharge the respective statement. The laboratory must document the basis upon which these statements are made. It must also clarify if any interpretations or opinions are based upon the results from tests or calibrations. Maintain both written and verbal records if opinions or interpretations are communicated to the customer.
7.8.8. Amendments to Reports
Identify changes if an issued report needs amendments or re-issuing. Issue the modification in the form of a document or data transfer. Add the statement “Amendment to Report, serial number (or another identification method)”. The laboratory must make sure that amendments meet the requirements. Refer to the original report if there’s a need to issue a new report.
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.
This process must be readily available to any interested party. If the issued complaint is significant to the laboratory’s activities, the laboratory must confirm it is responsible for the complaint. The laboratory must also be responsible for all decisions when handling a complaint.
Clause 7.10 states that a laboratory must have a procedure when results or activities do not conform to its procedures or the agreed requirements made by the customer. The laboratory must keep records of nonconforming work. It must take corrective action if the laboratory believes nonconformities may reoccur.
For nonconformances, the procedure must include:
- Personnel responsible and authorized for handling nonconforming work;
- The creation of actions based upon the risk level;
- An evaluation of the nonconforming work’s importance, including an impact analysis;
- The decision to be taken for the nonconformity;
- Assurance that the customer is informed;
- Personnel responsible for authorizing the continuation of work;
7.11 Control of Data and Information Management
Control of data and information is a vital aspect of executing activities. A laboratory must verify it has access to information essential in conducting its activities. It must ensure that the information management system used for collection, processing, recording, reporting, storing and/or retrieving data is validated for functionality. This includes the proper function of interfaces within the laboratory information management system. In the case of modifications to commercial software or changes to software configuration, they must be authorized and validated before usage.
When a laboratory information management system is handled and preserved off-site or through external providers, the laboratory must ensure that the system operator or provider complies with all applicable requirements. Furthermore, the laboratory must ensure the availability of instructions, manuals, and reference data significant to the management system. Use appropriate and systematic means to check calculations and data transfers.
For further assistance regarding the process requirements of ISO 17025, QSE Academy has prepared documents, templates, forms, and files for your convenience. Your laboratory can also get tips and advice from our expert ISO consultants.