ISO/IEC 17025:2017 Objective Evidence Requirements: Part 1 Documentation

ISO/IEC 17025 is a much more technical QMS standard that ISO 9001. And while previous versions were better written, the 2017 version still offers significant value. This article discusses the minimum “Objective Evidence” actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective opinion.

Unlike ISO 9001:2015 & AS9100:2016, ISO/IEC 17025:2017 is much more clear in stating its requirements relating to documentation (e.g., procedures). Hence the reason it doesn't need a definition for “documented procedure”.

While ISO/IEC 17025:2017 does not specifically require a Quality Manual, it does state:

8.1.1 General

The laboratory shall establish, document, implement and maintain a management system that is capable of supporting and demonstrating the consistent achievement of the requirements of this document and assuring the quality of the laboratory results. In addition to meeting the requirements of Clauses 4 to 7, the laboratory shall implement a management system in accordance with Option A or Option B.

Also, a critical point to recognize is that ISO/IEC 17025:2017 states:

8.2 Management system documentation (Option A)

8.2.4 All documentation, processes, systems, records, related to the fulfilment of the requirements of this document shall be included in, referenced from, or linked to the management system.

For this reason, most laboratories choose to have a Quality Manual.

# Documents & Procedures Sec.
1 The laboratory shall define and document the range of laboratory activities for which it conforms with this document. The laboratory shall only claim conformity with this document for this range of laboratory activities, which excludes externally provided laboratory activities on an ongoing basis.
[The range of laboratory activities is typically referred to as the “scope”.]
2 The laboratory shall:
c) document its procedures to the extent necessary to ensure the consistent application of its laboratory activities and the validity of the results.
[SUBJECTIVE REQUIREMENT - while “the extent necessary” is completely subjective, this requirement can only be verified through confirming “consistent application” of the laboratories “activities and the validity of the results.”]
3 The laboratory shall document the competence requirements for each function influencing the results of laboratory activities, including requirements for education, qualification, training, technical knowledge, skills and experience.
[This documentation may exist in “Job Descriptions”, Competency Matrices, etc.]
4 The laboratory shall have procedure(s) and retain records for:
a) determining the competence requirements;
b) selection of personnel;
c) training of personnel;
d) supervision of personnel;
e) authorization of personnel;
f) monitoring competence of personnel.
5 The requirements for facilities and environmental conditions necessary for the performance of the laboratory activities shall be documented. 6.3.2
6 The laboratory shall have a procedure for handling, transport, storage, use and planned maintenance of equipment in order to ensure proper functioning and to prevent contamination or deterioration. 6.4.3
7 When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure. 6.4.10
8 The laboratory shall have a procedure and retain records for:
a) defining, reviewing and approving the laboratory’s requirements for externally provided products and services;
b) defining the criteria for evaluation, selection, monitoring of performance and re-evaluation of the external providers;
c) ensuring that externally provided products and services conform to the laboratory’s established requirements, or when applicable, to the relevant requirements of this document, before they are used or directly provided to the customer;
d) taking any actions arising from evaluations, monitoring of performance and re-evaluations of the external providers.
9 The laboratory shall have a procedure for the review of requests, tenders and contracts. The procedure shall ensure that:
a) the requirements are adequately defined, documented and understood;
b) the laboratory has the capability and resources to meet the requirements;
c) where external providers are used, the requirements of 6.6 are applied and the laboratory advises the customer of the specific laboratory activities to be performed by the external provider and gains the customer's approval;
d) the appropriate methods or procedures are selected and are capable of meeting the customers' requirements.
10 The laboratory shall use appropriate methods and procedures for all laboratory activities and, where appropriate, for evaluation of the measurement uncertainty as well as statistical techniques for analysis of data.
11 The laboratory shall retain the following records of validation:
a) the validation procedure used;
12 The laboratory shall have a procedure for the transportation, receipt, handling, protection, storage, retention, and disposal or return of test or calibration items, including all provisions necessary to protect the integrity of the test or calibration item, and to protect the interests of the laboratory and the customer. Precautions shall be taken to avoid deterioration, contamination, loss or damage to the item during handling, transporting, storing/waiting, and preparation for testing or calibration. Handling instructions provided with the item shall be followed. 7.4.1
13 The laboratory shall have a procedure for monitoring the validity of results. The resulting data shall be recorded in such a way that trends are detectable and, where practicable, statistical techniques shall be applied to review the results. This monitoring shall be planned and reviewed and shall include, where appropriate, but not be limited to:
a) use of reference materials or quality control materials;
b) use of alternative instrumentation that has been calibrated to provide traceable results;
c) functional check(s) of measuring and testing equipment;
d) use of check or working standards with control charts, where applicable;
e) intermediate checks on measuring equipment;
f) replicate tests or calibrations using the same or different methods;
g) retesting or recalibration of retained items;
h) correlation of results for different characteristics of an item;
i) review of reported results;
j) intralaboratory comparisons;
k) testing of blind sample(s).
14 The laboratory shall have a documented process to receive, evaluate and make decisions on complaints.
[While the word procedure is not used here, this is typically interpreted as the intent.]
15 The laboratory shall have a procedure that shall be implemented when any aspect of its laboratory activities or results of this work do not conform to its own procedures or the agreed requirements of the customer (e.g. equipment or environmental conditions are out of specified limits, results of monitoring fail to meet specified criteria). The procedure shall ensure that:
a) the responsibilities and authorities for the management of nonconforming work are defined;
b) actions (including halting or repeating of work and withholding of reports, as necessary) are based upon the risk levels established by the laboratory;
c) an evaluation is made of the significance of the nonconforming work, including an impact analysis on previous results;
d) a decision is taken on the acceptability of the nonconforming work;
e) where necessary, the customer is notified and work is recalled;
f) the responsibility for authorizing the resumption of work is defined.
16 Laboratory management shall establish, document, and maintain policies and objectives for the fulfilment of the purposes of this document and shall ensure that the policies and objectives are acknowledged and implemented at all levels of the laboratory organization.
[While not specifically required, this is typically accomplished through a Quality Manual.]
17 The policies and objectives shall address the competence, impartiality and consistent operation of the laboratory.
[Often overlooked are the requirements that must be included in the above documented “policies and objectives”. Particularly “competence” & “impartiality”.]

# 1
For information on how to create/craft the language of the “range of laboratory activities” reference the applicable ANAB Administrative Process Rule: