Clause 7: Process Requirements
Clause 7- Process Requirements is broken down into 11 subclauses:
- 7.1 Review of Requests, Tenders and Contracts
- 7.2 Selection, Verification and Validation of Methods
- 7.3 Sampling
- 7.4 Handling of Test and Calibration Items
- 7.5 Technical Records
- 7.6 Evaluation of Measurement Uncertainty
- 7.7 Ensuring the Validity of Results
- 7.8 Reporting of Results
- 7.9 Complaints
- 7.10 Nonconforming Work
- 7.11 Control of Data and Information Management
7.1 Review of Requests, Tenders and Contracts
ISO 17025, requirement 7.1 states that your laboratory must have a procedure for the review of requests, tenders, and contracts. This procedure must ensure that:
- The requirements are defined, documented and comprehended
- The lab has the capability and resources to meet the requirements
- If external providers are used, the lab must meet requirements of 6.6
- The suitable methods or procedures are selected and are capable of meeting the customer’s requirements
The laboratory needs to have good communication with the customer. Also, the lab must ensure that the customer’s needs are met, but also inform the customer if their methods are inappropriate or out of date, or if their request can not be completed because it would compromise the integrity of the lab.
7.2 Selection, Verification and Validation of Methods
7.2.1 Selection and verification of methods
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. Methods, procedures and supporting documentation need to be kept up to date and made available to all personnel.
In addition, ISO 17025:2017 mandates that the lab stays up-to-date with methods as appropriate and when the customers do not specify a method, the lab chooses the best and latest valid version. The lab must communicate what method they are using with the customer.
When choosing a method, the lab needs to verify that this method has been published either internationally, regionally, or nationally, or by another reputable technical organization. Scientific journals and texts are also valid publications. The lab must verify that it can perform the methods that they choose.
Another requirement of ISO 17025 Section 7.2 is that labs need to retain records of verification. Additionally, when method development is required, the development needs to be planned and assigned to competent personnel. Periodic reviews need to take place for method developments.
7.2.2 Validation of Methods
ISO/IEC 17025 requires laboratories to validate methods that they use. This includes non-standard methods, laboratory-developed methods and standard methods. The validation of the methods needs to be as extensive as necessary to meet the needs of the given application. If changes are made to a validated method, the influence of the changes needs to be understood.
The laboratory retains the following records of validation:
- The validation of the procedure used
- Specification of the requirements
- Determination of the performance characteristics of the method
- Results obtained
- A statement on the validity of the method
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. 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. Sampling needs to use appropriate statistical methods.
Sampling methods must describe:
- The selection of samples or sites
- The sampling plan
- The preparation and treatment of samples
When the laboratory is sampling, they must retain appropriate records of samples. These records must include, when appropriate:
- References to the sampling method
- Date and time of sampling
- Data to identify and describe the sample
- Personnel performing the sample
- 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
7.4 Handling of Test and Calibration Items
The laboratory must have a procedure for transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items. 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. 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 addition the laboratory must:
- Establish handling instructions
- Have a system for the unambiguous identification of test or calibration items
- Retain identification while the lab is responsible for the item
- Ensure that items do not get confused
- Accommodate a sub-division of an item or groups of items and the transfer of items
- Record any deviations
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. If required by the customer, the lab must include a disclaimer in the report indicating which results may be affected by the deviation. And, if applicable, the lab should record what environment items need to be stored in.
7.5 Technical Records
ISO 17025:2017 clause 7.5 states the requirements for technical records. 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. When you are keeping records, you need to include the date and identify personnel responsible for lab activities. Records should include the original observations, data and calculations, and be recorded at the time they are made. If changes are made, these amendments need to be tracked to previous versions or to the original observations. Retain all the files, including the original and amendments, including the date of alteration, altered aspects and personnel responsible for any alterations.
7.6 Evaluation of Measurement Uncertainty
As an ISO/IEC 17025:2017 accredited laboratory, it is important to understand where measurement uncertainty is coming from. The laboratory needs to identify the contributions to the uncertainties. When you are evaluating for uncertainty, you need to consider all contributions that are significant, even arising from sampling. If you perform calibrations, the lab needs to evaluate its own equipment for uncertainty. When performing testing you are required to evaluate measurement uncertainty. If the test method excludes rigorous evaluation of measurement uncertainty, labs should make estimates of uncertainty based upon understanding theoretical principles or from practical experience.
7.7 Ensuring the Validity of Results
The laboratory shall have a procedure for monitoring the validity of results. As an ISO/IEC 17025:2017 accredited lab, ensuring the validity of results should be a top priority. One of the goals of validity is to be able to identify trends using statistical techniques. To meet the requirements, the laboratory must develop a procedure for monitoring the validity of their results. The main goal is to understand if the system or process may be inefficient so you can take preventive action. Proficiency testing is now more important than ever and is addressed in 7.7.2. If you are looking to be accredited to ISO 17025, you also need to become certified to ISO/IEC 17043:2010.
7.8 Reporting of Results
ISO/IEC 17025:2017 clause 7.8 is divided into several subclauses:
- 7.8.1 General
- 7.8.2 Common Requirements for Reports
- 7.8.3 Specific Requirements for Test Reports
- 7.8.4 Specific Requirements for Calibration Certificates
- 7.8.5 Reporting Sampling- Specific Requirements
- 7.8.6 Reporting Statements of Conformity
- 7.8.7 Reporting Opinions and Interpretations
- 7.8.8 Amendments to Reports
7.8.1 General. Reporting results is very important and needs to be done by carefully following the requirements of the standard if your lab’s goal is to become ISO/IEC 17025 accredited. The results need to be reviewed and authorized prior to release. When reporting the results, 7.8.1 states that they need to be provided in a clear, concise and accurate way and include any information that the lab agreed with the customer and that is necessary for interpretation of the results and all information required by the methods used.
7.8.2 Common Requirements for Reports. This subclause identifies what needs to be provided in the results. When an organization is creating a report, they need to pay careful attention to identify who was responsible for testing and calibration, and 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 additional requirements to 7.8.2. These are more specific requirements where necessary for the interpretation of the test results, calibration certificates and reporting sampling.
7.8.6 Reporting Statements of Conformity
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. The laboratory needs to give a statement of conformity that states which specifications, standards or parts are met or not, and what decision rule was applied.
7.8.7 Reporting Opinions and Interpretations
If opinions and interpretations are expressed, the lab needs to ensure that only personnel authorized to do so release the respective statement. If this happens, the lab needs to document the basis upon which these statements are made. The lab also needs to clarify if any opinions or interpretations expressed are based upon the results obtained from tests or calibrations. If opinions or interpretations are communicated to the customer, records need to be retained, even if communication is made verbally.
7.8.8. Amendments to Reports
If an issued report needs to be changed, amended or re-issued, the changes need to be clearly identified. The amendments need to be issued in a form of a further document, or data transfer and include the statement “Amendment to Report, serial number (or other identification method)”. Labs need to ensure that amendments meet the requirements. If a complete new report needs to be issued, you must refer to the original that it replaces.
If your lab wants to be ISO 17025:2017 accredited, managing customer complaints is important and you must have a documented process to receive, evaluate and make decisions on how to handle ISO 17025 complaints. The process needs to be readily available to any interested party. If the issued complaint is relevant to activities performed by the laboratory, the laboratory needs to confirm it is responsible for the complaint, and the lab needs to be responsible for all decisions made around handling this complaint.
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. 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.
For nonconformances, the procedure needs to include:
- 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
- Assurance that the customer is notified
- Who is responsible for authorizing the resumption of work
7.11 Control of Data and Information Management
Control of data and information is a critical component for laboratories in order for them to perform activities. Labs need to verify that they have the necessary access to data and information needed to perform all of its activities. The lab needs to 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. If there are changes made to software configuration or modifications to commercial software, they need to be authorized and validated before used.
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. The laboratory must ensure that the instructions, manuals, and reference data relevant to the management system are made available to personnel. Furthermore, calculations and data transfers need to be checked in an appropriate and systematic manner.
Please note that certain text from the ISO 17025 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.