Top 10 Deficiencies ISO/IEC 17025:2017

ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories underwent
its latest revision in 2017. Relative to the 2005 version, ISO/IEC 17025:2017 contains some notable changes
that laboratories must account for in order to meet the requirements of the new standard. As the most
recognized accreditation body for testing and calibration laboratories, A2LA has a firsthand perspective
on what aspects of ISO/IEC 17025:2017 laboratories tend to struggle with the most. Our database allows
us to extract details of the cited deficiencies and the following list provides insight into the top ten sections
cited. These findings come from both initial and renewal assessments. As you prepare for assessment to
ISO/IEC 17025:2017, you may find this list a helpful way to focus your attention on frequently overlooked or
misunderstood sections of the standard.

10 This clause has multiple parts, all of which cover the selection, verification, and validation of
methods. Laboratories not only have to select methods appropriate to their customer’s needs
7.2.1: Method but must also have the appropriate documentation and records to show verification and
validation validation of those methods.

9
An internal audit needs to confirm compliance to ISO/IEC 17025, the laboratory’s own
management system, and the laboratory activities. The language in this section is somewhat
broad, as it allows the laboratory to determine the frequency and depth of the audits of these
8.8: Internal
areas depending on the laboratory’s needs and risk tolerance. Once the internal audit plan is
auditing
decided records of implementation are required.

8 This section is where the requirements for reporting the results of laboratory activities are found.
There are many variables here depending on the customer contract, the type of laboratory
7.8: Reporting activities performed, and the methods run, so organizations must take an attentive and
requirements individualized approach to applying the requirements of this section.

This section specifies that the laboratory must have a procedure for monitoring the validity

7 of results and includes required elements the procedure should include. The laboratory must
collect and analyze the data from monitoring activities to evaluate and potentially improve
7.7: Quality their activities. It also states that laboratories should monitor performance by comparison with
checks- results from other laboratories, which is referred to as proficiency testing. This section frequently
internal and uses phrases such as “where appropriate” and “where available.” For some laboratories,
external specific elements of these requirements will not be applicable, but the laboratory should be
prepared to account for why that is the case.

6 The focus of this section is the traceability and reproducibility of results. All laboratory activities
must have technical records that are detailed enough to reproduce the exact process that
7.5: Technical initially produced them. This means that a large number of factors will need to be consistently
records recorded, and both original records and their amendments must be consistently retained.
 5
It is impossible to fully control what goes on outside your lab, but the quality of externally
provided products and services is still within your control. This section requires that laboratories
determine the suitability of externally provided products and services in a way that supports
6.6:
compliance. It requires that the lab create, document, and maintain procedures, evaluation
Purchasing
criteria, and communication methods for such products and services.

4 This clause requires that laboratories must have procedures for and retain records of
various activities related to the competence, training, and monitoring of personnel. There
6.2.5: is a list of specific topics that need to be addressed, either in one procedure or individual
Training procedures. These procedures must be adhered to for all relevant personnel, and records of
procedures implementation must be maintained in all cases as objective evidence that the procedures
and records are being followed.

3 Previously, the standard focused on training and authorization of personnel, but the 2017
6.2.2: update has added a requirement for documented competencies. These documented
Documented competencies need to include a number of elements, including education, training, and
competencies experience, and each position category that has an influence on laboratory results must have
and supporting a documented level of competency.
records

2
Section 8.9 covers management reviews, but clause 8.9.2 is where deficiencies most
commonly arise. This clause contains a list of the information that must be recorded as part of
a management review. This list includes 15 items, all of which the laboratory must take care to
8.9.2:
cover and record. This section may fall off the list in the next year or so as renewal laboratories
Management
get their management review process in order and conduct these reviews with records
review inputs
showing each input.

Based on our data, this section of the standard is the one that has most frequently proven
challenging to laboratories, regardless of industry. In this version of the standard the term

1 equipment is used to refer to all types of laboratory resources, including measuring equipment,
reference standards, reference materials, reagents, consumables, etc. This section requires
6.4: procedures for all equipment, including but not limited to accessibility, maintenance, storage,
Equipment calibration and record-keeping. Section 6.4.13 specifically is a common source of deficiencies: it
lists the specific equipment records that laboratories must maintain for all the equipment in their
facility which can influence the activities listed on their scope of accreditation.

For more information about accreditation to ISO/IEC 17025:2017 through A2LA,

visit A2LA.org or contact our accreditation experts here.

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