7.2.1 Selection and Verification of Methods
The laboratory shall use appropriate methods and procedures for all laboratory activities, ensuring measurement uncertainty evaluation and statistical data analysis when applicable.
7.2.1.1 Use of Appropriate Methods
The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for the evaluation of measurement uncertainty and statistical techniques for data analysis.
“Method” as used in this document can be considered synonymous with the term “measurement procedure” as defined in ISO/IEC Guide 99.
7.2.1.2 Availability of Methods and Documentation
All methods, procedures, and supporting documentation, such as instructions, standards, manuals, and reference data relevant to laboratory activities, shall be kept up to date and made readily available to personnel (see 8.3).
7.2.1.3 Use of Latest Valid Methods
The laboratory shall ensure that it uses the latest valid version of a method unless it is not appropriate or possible to do so. When necessary, additional details shall be supplemented to ensure consistent application.
International, regional, or national standards or other recognized specifications that contain sufficient and concise information on how to perform laboratory activities do not need to be supplemented or rewritten as internal procedures if these standards are written in a way that they can be used by operating personnel in a laboratory. Additional documentation may be necessary for optional steps in the method or additional details.
7.2.1.4 Selection of Methods When Not Specified
When the customer does not specify the method to be used, the laboratory shall select an appropriate method and inform the customer of the method chosen.
Recommended sources of methods include:
- International, regional, or national standards
- Reputable technical organizations
- Relevant scientific texts or journals
- Manufacturer-specified methods for equipment
Laboratory-developed or modified methods can also be used.
7.2.1.5 Verification of Methods
The laboratory shall verify that it can properly perform methods before introducing them by ensuring that the required performance is achieved.
Records of verification shall be retained. If the method is revised by the issuing body, verification shall be repeated to the necessary extent.
7.2.1.6 Method Development
When method development is required, it shall be a planned activity assigned to competent personnel equipped with adequate resources.
As method development progresses, periodic reviews shall be carried out to confirm that customer needs are still being met. Any modifications to the development plan shall be approved and authorized.
7.2.1.7 Deviations from Methods
Deviations from methods for all laboratory activities shall occur only if the deviation has been:
- Documented
- Technically justified
- Authorized
- Accepted by the customer
Customer acceptance of deviations can be agreed upon in advance in the contract.