The specific requirements for customer complaints in ISO/IEC
17025:2017 can be found in section 7.9.2 to 7.9.7 of the
standard . These requirements include:
The specific requirements for non-conformities in ISO/IEC
17025:2017 can be found in section 7.10.1 to 7.10.3 and
section 8.7 of the standard . These requirements include:
- The laboratory should have a description of the handling
process for complaints available to any interested party upon
request .
- Upon receipt of a complaint, the laboratory should confirm
whether the complaint relates to laboratory activities that it is
responsible for and, if so, should deal with it .
- The laboratory should have a process for receiving, validating,
investigating the complaint, and deciding what actions are to be
taken in response to it [T3a].
- The laboratory should track and record complaints, including
actions undertaken to resolve them [T3b].
- The laboratory should ensure that any appropriate action is
taken [T3c].
- The laboratory receiving the complaint should be responsible
for gathering and verifying all necessary information to validate
the complaint [T3d].
- Whenever possible, the laboratory should acknowledge
receipt of the complaint and provide the complainant with
progress reports and the outcome [T3e].
- The outcomes to be communicated to the complainant should
be made by, or reviewed and approved by, individuals not
involved in the original laboratory activities in question [T3f].
- Whenever possible, the laboratory should give formal notice
of the end of the complaint handling to the complainant [T3g].
- The laboratory should have a procedure that is
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 .
- When a nonconformity occurs, the laboratory should
react to the nonconformity and, as applicable, take action
to control and correct it, address the consequences, and
evaluate the need for action to eliminate the cause(s) of
the nonconformity .
- Corrective actions should be appropriate to the effects of
the nonconformities encountered .
- The laboratory should retain records as evidence of the
nature of the nonconformities, cause(s), and any
subsequent actions taken, as well as the results of any
corrective action .
- The laboratory should evaluate the significance of the
nonconforming work, including an impact analysis on
previous results, and make a decision on the acceptability
of the nonconforming work .
- Where necessary, the customer should be notified and
work should be recalled .
- The laboratory should retain records of nonconforming
work and actions taken .
- Where the evaluation indicates that the nonconforming
work could recur, or that there is doubt about the
conformity of the laboratory's operations with its own
management system, the laboratory should implement
corrective action .
These requirements aim to ensure that complaints from
customers are properly received, investigated, and resolved by
the laboratory, and that the complainant is kept informed
throughout the process.
In ISO/IEC 17025:2017, non-conformities and complaints are two distinct concepts with different
implications. Here are the key differences between non-conformities and complaints:
1. Definition:
- Non-conformity: A non-conformity refers to any aspect of the laboratory's activities or results that do
not conform to its own procedures or the agreed requirements of the customer .
- Complaint: A complaint, on the other hand, is a specific type of feedback received from a customer
regarding the laboratory's services, processes, or results .
2. Scope:
- Non-conformity: Non-conformities can encompass a wide range of issues within the laboratory's
activities, including deviations from procedures, equipment failures, or environmental conditions
outside specified limits .
- Complaint: Complaints specifically relate to customer dissatisfaction or concerns about the laboratory's
services, processes, or results .
3. Handling Process:
- Non-conformity: ISO/IEC 17025:2017 outlines a procedure for handling non-conformities, which
includes actions such as controlling and correcting the non-conformity, evaluating the need for
corrective action, and retaining records of non-conforming work and actions taken .
- Complaint: The standard also provides requirements for handling customer complaints, which involve
processes such as receiving, validating, investigating, and deciding on appropriate actions in response to
the complaint .
4. Responsibility:
- Non-conformity: The responsibility for managing non-conformities lies with the laboratory, including
evaluating the significance of the non-conforming work, making decisions on acceptability, and
implementing corrective actions if necessary .
- Complaint: The laboratory receiving the complaint is responsible for gathering and verifying necessary
information, acknowledging receipt of the complaint, providing progress reports and outcomes to the
complainant, and ensuring that outcomes are communicated by individuals not involved in the original
laboratory activities .
In summary, non-conformities refer to deviations from procedures or customer requirements within the
laboratory's activities, while complaints specifically relate to customer dissatisfaction or concerns. Nonconformities are managed internally by the laboratory, while complaints involve a specific feedback
process with the customer.
Essential info to register a COMPLAINT.
ISO/IEC 17025:2017 does not explicitly specify the essential information required to file a customer
complaint. However, based on the standard's requirements for handling complaints , the following
information is typically considered essential when filing a customer complaint:
1. Contact Information: The complainant should provide their name, organization (if applicable),
address, phone number, and email address. This information is necessary for the laboratory to
communicate with the complainant and provide updates on the complaint.
2. Description of the Complaint: The complainant should provide a clear and detailed description of the
complaint, including the specific issue, concern, or dissatisfaction they have with the laboratory's
services, processes, or results. It is important to include relevant facts, dates, and any supporting
documentation or evidence.
3. Relevant Samples or Test Results: If the complaint relates to specific samples or test results, the
complainant should provide relevant information, such as sample identification numbers, test methods
used, and any associated data or reports. This information helps the laboratory to identify and
investigate the specific issue raised in the complaint.
4. Date and Time of Occurrence: The complainant should indicate the date and time when the issue or
incident occurred. This information helps the laboratory to correlate the complaint with specific
laboratory activities or events.
5. Any Previous Communication: If there has been any previous communication or attempts to resolve
the issue, the complainant should provide details of those interactions. This helps the laboratory to
understand the history of the complaint and any previous actions taken.
6. Desired Outcome: The complainant should clearly state their desired outcome or resolution for the
complaint. This information helps the laboratory to understand the complainant's expectations and
work towards a satisfactory resolution.
Essential info to register a NON-CONFORMITY.
The following information is typically considered essential when filing a non-conformity:
1. Description of the Non-Conformity: Provide a clear and detailed description of the non-conformity,
including the specific aspect of the laboratory's activities or results that do not conform to its own
procedures or the agreed requirements of the customer. Include relevant facts, data, and any
supporting documentation or evidence.
2. Identification of the Non-Conforming Work: If applicable, provide information to identify the specific
work or process that resulted in the non-conformity. This may include sample identification numbers,
test methods used, equipment used, or any other relevant details.
3. Date and Time of Occurrence: Indicate the date and time when the non-conformity was identified or
occurred. This helps in correlating the non-conformity with specific laboratory activities or events.
4. Impact Analysis: Evaluate the significance of the non-conforming work and its potential impact on
previous results or future operations. This analysis helps in determining the appropriate actions to
address the non-conformity.
5. Root Cause Analysis: Conduct a review and analysis to determine the causes of the non-conformity.
This involves identifying the underlying factors or reasons that led to the non-conformity.
6. Similar Non-Conformities: Determine if similar non-conformities exist or could potentially occur. This
helps in identifying any systemic issues or trends that need to be addressed to prevent recurrence.
7. Corrective Actions Taken: Document any actions taken to control, correct, or address the nonconformity. This includes describing the specific steps or measures implemented to eliminate the
cause(s) of the non-conformity and prevent its recurrence.
8. Records of Non-Conformity: Retain records as evidence of the nature of the non-conformity, its
cause(s), and any subsequent actions taken. This documentation helps in demonstrating the laboratory's
compliance with the standard and its commitment to addressing non-conformities.