All labs operating according to ISO/IEC 17025 are required to have a procedure (or procedures) for identification, collection, indexing, access, filing, storage, maintenance and disposal of quality and technical records. Clause 4.13 covers the control of records, while the control of data related to testing or calibration is covered by clause 5.4.7.
Table 1 contains a list of clauses that specifically call out the requirement for record-keeping. This does not mean that these are the only records that must be kept, simply that these records are the minimum necessary for a laboratory quality system. The clauses listed below can be individually examined for each of their record-keeping requirements.
|1||Reviews, including any significant changes, of requests, tenders and contracts||4.4.2|
|2||Evidence of compliance with ISO/IEC 17025 for subcontractors||4.5.4|
|3||Actions taken to check compliance with specified requirements of purchased services and supplies||4.6.2|
|4||Evaluations of suppliers of critical consumables, supplies and services||4.6.4|
|7||Internal audits and corrective actions||4.14.3|
|8||Follow-up(s) to corrective actions to determine effectiveness||4.14.4|
|9||Management Reviews and corrective/preventive actions||4.15.2|
|10||Relevant authorization(s), competence, educational and professional qualifications, training, skills and experience of all technical personnel, including contracted personnel||5.2.5|
|12||Each item of equipment and its software||5.5.5|
|13||Data from monitoring the validity of tests and calibrations undertaken||5.9.1|
Another consideration relating to records could be the collection of evidence in order to document that some requirement has been fulfilled. For example, clause 4.2.3 states "Top management shall provide evidence of commitment to the development and implementation of the management system and to continually improving its effectiveness". Without maintaining some type of record, it would be difficult to claim in an audit that this requirement has been met. For some laboratories, the management review (clause 4.15) may contain sufficient details to show compliance with 4.2.3, while other laboratories may use meeting notes, tracking of staff goals, gantt charts, or other means to show the commitment to the development of the quality system. Another example could be the validation of test (or calibration) methods, whether standard or non-standard. A record of the criteria considered, including a description and justification, for a particular method may be important in some cases and should therefore be documented.
Evidence of traceability for test or calibration results is certainly a major area of concern for laboratories and the records to prove traceability certainly need to be in order. A calibration certificate for an item of equipment from an accredited laboratory with the proper scope should be enough in most cases, but what about sensitive equipment requiring frequent checks (see 5.5.10), are the results from the checks also traceable? Are the results from the checks recorded in a way so that trends can be statistically analyzed (see 5.9.1) to ensure the validity of the results? Certainly, records would be required. Procedures may also need to incorporate instructions on how to perform the checks, how to analyze the data, and what are the acceptable criteria for acceptance.
Record-keeping in a laboratory is no simple task, and can overwhelm any laboratory if not considered carefully. It is important to maintain any and all records in order to show that test or calibration results are valid, traceable to a national standard, and for any of the reasons required in Table 1. Developing the procedure(s) required by clause 4.13 should be done with due consideration for not burdening the laboratory while ensuring that the records sufficiently meet the needs of ISO/IEC 17025, customer needs, and any regulatory requirements.