According to clause 4.2.5 of ISO/IEC 17025, "the quality manual shall include or make reference to the supporting procedures including technical procedures..." which simply means that the procedures called out by the various clauses within the standard must be referenced, in some manner, within the quality manual itself. This can be accomplished by referencing a Master List, including a list of procedures in the manual, or referencing the procedure within the clause that calls for the procedure. A combination of these could also be used. For example, the Quality procedures could be referenced directly within the clauses requiring them, while the technical (and other) procedures can be included in a separate list. For online, web-based systems, hyperlinks could be provided for the procedures and/or lists. We will reserve any discussion of non-quality procedures for another blog, and concentrate on what procedures are required by ISO/IEC 17025
What procedures are necessary?
As anyone implementing a quality system is well aware of, the use of the word shall translates directly into an order to do something. The same is true for determining what procedures are mandated by the standard. A common phrase, among others, is "shall have policies and procedures", which is an obvious indication that a procedure should be written to address the requirements of the mandating clause. By examining the clauses where the word "procedure" is used, it is possible to create a list, Table 1 below contains a complete list of the procedures referenced by ISO/IEC 17025.
|1||The protection of a customers' confidential information and proprietary rights||4.1.5(c)|
|2||Protecting the electronic storage and transmission of results||4.1.5(c)|
|3||Avoiding involvement in any activities that would diminish confidence in the labs' competence, impartiality, judgement or operational integrity||4.1.5(d)|
|5||A master list or an equivalent document control procedure identifying the current revision status and distribution of documents in the management system||22.214.171.124|
|7||The review of requests, tenders and contracts||4.4.1|
|8||Selecting and purchasing of services and supplies||4.6.1|
|9||The purchase, reception and storage of reagents and laboratory consumable materials||4.6.1|
|14||Control of Records||126.96.36.199|
|15||The protection and back-up of records stored electronically and to prevent unauthorized access to or amendment of these records||188.8.131.52|
|18||Identifying and providing training||5.2.2|
|19||Monitor, control and record the appropriate environmental conditions||5.3.2|
|21||Estimation of uncertainty of measurement||5.4.6|
|22||Control of Data||184.108.40.206(b)|
|23||Safe handling, transport, storage, use and planned maintenance of measuring equipment||5.5.6|
|25||Updating correction factors||5.5.11|
|26||Calibration of Measurement Equipment||5.6.1|
|27||Calibration of Reference Standards||220.127.116.11|
|28||Safe handling, transport, storage and use of reference standards and reference materials||18.104.22.168|
|30||Recording relevant data and operations relating to sampling||5.7.3|
|31||Transportation, receipt, handling, protection, storage, retention and/or disposal of test and/or calibration items||5.8.1|
|32||Avoiding deterioration, loss or damage to the test or calibration item during storage, handling and preparation||5.8.4|
|33||Monitoring the validity of tests and calibrations||5.9.1|
Not all procedures are required for all laboratories. If sampling is not performed, for instance, then none of the sampling procedures would need to exist, and clause 5.7 of the quality manual could simply say non-applicable. On the other hand, for a laboratory that focuses on sampling, there could be a large number of procedures in order to cover the sampling of many different materials. It is also possible to combine some of the references above into a single procedure, or it may be necessary to break up some of the references into multiple procedures, depending on the needs of daily operations. The important note is that it is a good idea to reference, within each procedure, the clause from ISO/IEC 17025 that mandated it. When referencing the procedure from the quality manual, either reference it directly inside the mandating clause, or include the clause in the master list. By doing so, it is much easier for an auditor to clearly see that the requirements of the clause have been met.
One thing to keep in mind when writing any of the procedures listed in Table 1 above, the referencing clause often includes one or more requirements that the procedure needs to include. Some of these requirements, such as those from the control of non-conforming work (4.9.1) require that the responsibilities and authorities are designated. This means that someone in the laboratory has, within their job description, the responsibility and/or authority to stop non-conforming work or hold reports or certificates until the non-conformance is remedied. So, in the process of writing this particular procedure, it is also necessary to update one or more job descriptions. Reference Roles Verses Titles In The Laboratory for more information on various authorities and responsibilities required by ISO/IEC 17025.
Once a laboratory has written all of the necessary procedures, and properly associated them with the mandating clauses, it is also important to follow them. In all practicality, it is usually the responsibility of the top management, per clause 4.2.2(e), to demonstrate commitment to the quality system by pressing the laboratory staff to follow the requirements of the quality system, including the procedures. To do this of course, requires the top management to be intimately familiar with ISO/IEC 17025 and to be persistent and diligent about enforcing procedures. These procedures help operations perform the daily tasks of being a laboratory, and are quite useful for the training of new employees. Well written procedures are fundamental in a quality system implementation.