General Requirements for Laboratory Competence

In this document, the following verbs are used:

— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.

Impartiality and confidentiality

The laboratory shall maintain impartiality, and identify and eliminate risks to its
impartiality. In addition, the laboratory should maintain a policy of confidentiality. The
information derived from laboratory results shall remain between the client and lab personnel
unless legal reasons dictate otherwise; in this case the client should be informed.

Personnel
The laboratory personnel shall have an organised structure headed by management. The
laboratory is a legal entity responsible for its activities and results. All personnel shall be
competent, impartial and adherent to the laboratory’s management system. Criteria for
competence in education, qualification, training and skills shall be documented and personnel
should be monitored for adherence to criteria. Specific personnel shall be authorized to
develop, modify, verify and validate experimental methods, analyse results and report to
management and clients.

Facility
The Laboratory shall be fit for purpose and not subject to adverse conditions that might
influence experimental results. The conditions required for interference-free analyses shall
be documented and monitored. Measures to control contamination and interference from
both outside the laboratory and between different areas of the laboratory shall be
implemented, monitored, reviewed and documented.-

Equipment
The laboratory shall be equipped with the instruments, reagents, consumables and apparatus
required to competently carry out the analyses it proposes. Procedures for the use,
maintenance, transport and storage of equipment shall be carried out in such a way that it is
not damaged or contaminated, and verification of suitability for use carried out. Equipment
capable of producing measured results shall be verified as falling between acceptable
calibration tolerances, and a schedule of calibration be maintained and recorded. Equipment
giving questionable results shall be taken out of service and labelled as such until repaired
and validated. A log of all equipment shall be maintained; this shall give full details of the
instruments identity, providence, location, calibration and repair status. The laboratory shall
maintain integrity of its measurement results by means of an unbroken chain of calibrations
in SI units, using certified reference materials or consensus standards accepted as providing
results that are fit for purpose.

External Providers
Externally sourced products and services shall be evaluated and monitored to ensure
suitability for purpose; requirements for such products and services shall be communicated to
the provider. External personnel shall be competent and qualified for outsourced work.

Additional docs; Pre-qualification of outside product/ service provders

Process Requirements
The laboratory shall have a procedure of reviewing requests, tenders and contracts to ensure
that requirements are understood and documented and that the laboratory has the capability
and resources to carry out the work. Appropriate analyses meeting the clients requirements
shall be agreed upon; if the method requested is inappropriate or outdated, the client shall be
informed. If the client requests a statement of conformity to a specific standard, this standard
and the criteria for meeting it shall be clearly communicated to the client, who must agree to
accept the result. The request or tender and the contract to supply the service shall be in
agreement; any differences should be resolved before the laboratory’s work commences and
the client informed if the work deviates from the agreed contract. Such deviation shall call
for the review and emendation of the contract. The laboratory shall allow clients to monitor
the laboratory’s performance and handling of items needed for verification purposes.
Records of contracts, deviations, subsequent reviews and discussions with the client shall be
retained.

Additional Doc: User requirement specification/ order form/menu of available tests, those
that we are not prepared to do.

Quote, Timeframe for results, Small contract.

Methods and Procedures: Validation
The laboratory shall use appropriate procedures for all analyses; such methods shall be
documented, kept up to date and accessible to applicable personnel. The laboratory shall
select the most appropriate published and current analysis if none is requested by the client,
having verified that it can properly perform the analysis. If a method needs to be developed,
this shall be planned, reviewed, authorized and documented by competent personnel. Any
deviation from standard methods shall be documented, technically justified, authorized and
accepted by the client prior to commencing analysis. Non-standard or modified methods
must be validated prior to their use: Method validation can be accomplished by one or more
of the following:

Calibration or evaluation of bias and precision using purchased reference standards,

Systematic assessment of factors influencing results,

Testing robustness of method by varying experimental parameters and comparing results

Comparing results with other pre-validated methods,

Interlaboratory comparison

Evaluation of the measurement uncertainty of results based on knowledge of method theory

and empirical experience of the performance of the method.

If changes are made to a method thus validated and this alters the original validation, a new
validation shall be carried out. The performance of such validated methods shall be relevant
to client’s needs and can include “measurement range, accuracy, measurement uncertainty,
limit of detection, limit of quantification, selectivity of the method, linearity, reproducibility,
robustness against external influences or interference from the sample matrix and bias.” The
laboratory shall record the validation procedure used, what requirements were specified, how
the performance characteristics of the method were determined, the experimental results and
a statement of the validity of the method describing why it is deemed fit for purpose.

Sampling
Sampling shall be carried out according to a plan using a method that takes into account
factors to be controlled in order to ensure a representative sample. The sampling plan and
procedure shall be based on statistical methods and be available to personnel at the place
sampling is carried out. The sampling procedure shall describe the selection of sites and
samples, the suitable sampling plan and the preparation and treatment of samples to render
them fit to be analysed. Records shall be created and retained detailing the sampling method
used,, date and time, descriptive data to identify the sample, ID of personnel collecting the
sample, equipment used, environmental and transport conditions, a diagram or map to
identify the sampling location and any deviations from the standard sampling plan. The
laboratory shall have a procedure for the collection, transport, receipt, handling, storage,
retention disposal or return of the test sample, ensuring that its integrity is protected. An
unambiguous system for identifying the sample shall be created and adhered to in a manner
similar to the ‘Chain-of-custody’ employed in law. When the sample is received, deviations
from the sampling plans specified conditions shall be recorded and if a sample seems
unsuitable for analysis, the client shall be consulted and the reply recorded. In this case a
disclaimer should be issued in the report describing which results could be affected. If
samples require special storage conditions, these shall be recorded as well.

Records
The laboratory shall ensure that technical records of each analysis include the time, date
and identity of the personnel involved in the analysis and are detailed enough that the
analysis can be duplicated in conditions as close as possible to the original. Any
amendments to the original record can be traced back in a ‘chain of custody’, with any
amendments initialed and dated by the personnel responsible.

Elements of the analysis that contribute to ‘measurement uncertainty’ shall be evaluated

and recorded; if the test method precluded rigorous evaluation of such uncertainty, an
estimation shall be made based on an understanding of theoretical principles or practical
experience of the method of analysis.

The laboratory shall have a procedure for ensuring the validity of results, recording them in
such a way as to facilitate the application of statistical tests. Monitoring of results shall
include, but is not limited to:

Use of reference materials,

Validation of results using alternative instrumentation,

Functional checks of measuring equipment,

Comparison to working standards

Replicate tests using the same or different methods,

Retesting retained samples

Correlating results for alternative characteristics of a sample,

Reviewing reported results,

Intralaboratory comparisons

Blind sample testing.

Laboratory performance shall be monitored by participating in interlaboratory comparisons

and by proficiency testing and these results shall be analysed and used to improve laboratory
proficiency.

Reports
Results from the laboratory’s analysis shall be reviewed and authorized prior to release to
the client. The Results Report shall be clear, accurate and objective, including all the
information sought by the client and required for interpretation of the results. Such reports
shall be retained as technical records.

The laboratory shall be responsible for all of the information in the report; reports should
include the information in Appendix A. Data provided by the client shall be clearly described
as such, and if the client has performed the sampling the report should state that the results
apply to the sample as received. Reports shall also include sampling data.

Statements of conformity shall document the decision rule employed and the exact
specifications and/or standards which have or have not been met.

Opinions and interpretations shall originate only from personnel authorized to express them
and be identified as such. Face to face communication with the client shall be recorded and
retained. The reason for amendments to reports shall be stated, and the amendment take the
form of another report identifying the document to which it refers.

Complaints and Nonconformities

A complaints procedure shall be documented and freely available to the public with
instructions as to receiving, investigating, evaluating and dealing with complaints. Outcomes
of a complaint shall be reviewed by personnel not involved in the laboratory activities in
question. Acknowledgement of reception of the complaint and its resolution shall be
provided to the client.

The laboratory shall have a procedure for activities or work that do not conform to its own
procedures or agreed client requirements. Responsibilities for management of
nonconforming work shall be defined and remedial actions such as repeating work are based
on risk levels previously agreed by the laboratory. Nonconforming work and its implications
for past and future results shall be evaluated before an action plan is decided upon and
responsibility for the resumption of work is defined. If it is deemed that the nonconforming
work could recur, a corrective action plan shall be implemented.

Data and Information

The laboratory shall have access to the data and information it requires to perform
laboratory activities. The laboratory information management system (LIMS) shall be
validated for functionality and thereafter any changes should be validated and documented.
Data in the LIMS shall be safe from unauthorised access, protected against tampering and
data loss and be maintained so that data integrity is safe. All instructions, manuals, reference
data and procedure documents shall be readily available to personnel.

Management System
The laboratory shall establish, document, implement and maintain a management system
capable of supporting the goal of this document. This system shall control management
system documents, records, actions to address risks and opportunities, improvement,
corrective actions, internal audits and management reviews. Management personnel shall
establish, document and maintain policies and objectives in accordance with the purposes of
this document, addressing the competence, impartiality and consistency of laboratory
operations and planning for their continual improvement. The laboratory shall control and
maintain the documentation required to fulfil this document, and these document should be
periodically reviewed and updated, with changes and revision number prominent. Outdated
documents shall be clearly identified. Controls to identify, store, protect backup, archive and
dispose of documents shall be implemented. The laboratory shall assess the risks and
opportunities associated with laboratory activities in order to achieve intended results and
enhance opportunities to achieve objectives and improvements, and plan to implement them
after evaluation. Actions taken shall be proportional to the potential impact on the validity of
results.
Risks and Improvements
The laboratory shall identify and act on opportunities for improvement, seeking feedback
from clients and laboratory personnel. If a nonconforming result occurs, the laboratory shall
take action to control and correct it and address the consequences by reviewing and analysing
the nonconformity, determining its cause and searching for similar causes of nonconformity
elsewhere. Any action needed shall be implemented and its effectiveness reviewed.
Corrective actions shall correlate with the nonconformities, and shall be recorded, as well as
their results.

Internal Audits
The laboratory shall conduct internal audits at planned intervals to ensure the lab meets the
requirements of it management system and of this document; planning, establishing,
maintaining and reporting the findings of the audit system. The audit criteria and scope shall
be defined and results reported to management so that appropriate corrective action may be
implemented and results recorded.

Management System
The laboratory management system shall be reviewed at planned intervals to ensure its
suitability, adequacy and effectiveness. Information shall include changes in internal and
external issues affecting the laboratory, fulfilment of objectives, suitability of procedures,
results of actions from previous management reviews, audit outcomes, corrective actions and
their results, assessments by external bodies, changes in volume of work or range of
laboratory activities, client and personnel feedback, complaints, effectiveness of
improvements, adequacy of resources, results of risk identification and training. A record of
the management review shall contain all decisions and actions related to the effectiveness of
the management system, improvement of laboratory activities in relation to the fulfilment of
this document, the provision of additional resources and any need for change.
Appendix A

Reports shall contain:

A title (e.g. Test Report, Calibration Certificate or Report of Sampling);

The name and address of the laboratory;
The location of performance of the laboratory activities, including when performed at a customer
facility or at sites away from the laboratory’s permanent facilities, or in associated temporary or
mobile facilities;
Unique identification that all its components are recognized as a portion of a complete report and a
clear identification of the end;
The name and contact information of the customer;
Identification of the method used;
A description, unambiguous identification, and, when necessary, the condition of the item;
The date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to
the validity and application of the results;
The date of performance of the laboratory activity;
The date of issue of the report;
Reference to the sampling plan and sampling method used by the laboratory or other bodies where
these are relevant to the validity or application of the results;
A statement to the effect that the results relate only to the items tested, calibrated or sampled;
The results with, where appropriate, the units of measurement;
Additions to, deviations, or exclusions from the method;
Identification of the person(s) authorizing the report;
Clear identification when results are from external providers (NSAI, 2004).

Additional information which may be included; environmental conditions, measurement uncertainty,

opinions and interpretations.

Calibration certificates should also include:

Measurement uncertainty in the same units as the item being measured

Environmental conditions during the calibration

A statement specifying the metrological traceability of the measurements

Results before and after adjustment and/or repair

Statement of conformity to required specifications

If appropriate, opinions and interpretations.

Reference
NSAI. (2004). General requirements for the competence of testing and calibration
laboratories. ISO/IEC 17025:2017, 44(0), 3–5.