ISO/IEC 17025 is the first internationally recognised standard relating to calibration and testing activities and provides guidance for the development and implementation of a laboratory quality management system. The standard was developed as a collaboration between ISO and the International Electrotechnical Commission and covers various requirements, including sampling, which are relevant to the provision of calibration and testing services.

The current revision of the standard was issued in 2017 to address market trends and improvements in laboratory technology and reinforced the need for the assessment of risk across all aspects of the business in addition to clarification and expansion of the requirements of the previous revision of the standard. It provides a set of criteria which a laboratory may use as a framework for establishing an effective quality management system focusing on providing customers with assurance regarding the quality of data provided. This standard overlaps to some extent with more generic standards such as ISO 9001: 2015 but contains additional technical requirements relating to the operation of a modern laboratory such as validation of equipment and methods, uncertainty determination, quality controls and reporting of results.

ISO/IEC 17025 covers all the activities and innovative ways that modern laboratories should operate along with all activities associated with laboratory management including contract review, staff competence, equipment and metrological traceability, laboratory infrastructure, document control, testing proficiency, sampling and specimen preparation, reporting and validation of results, as well as quality related activities such as auditing, corrective actions, management review and improvement. It provides a benchmark for laboratories seeking accreditation and a laboratory operating in accordance with the requirements of ISO/IEC 17025 is recognised as being technically competent and able to offer valid and reliable results and in general would either be accredited by the national accreditation body or would be seeking accreditation.

ISO/IEC 17025 laboratory accreditation provides a laboratory recognition amongst other competent testing and calibration laboratories and enables consumers to identify and choose dependable testing, calibration, and measuring services. It also provides confidence that the results reported by a laboratory are accurate and have been obtained by technically competent personnel, using correct calibration or test methods that in turn satisfy the relevant international standards or customer specified requirements.

Whenever producing testing or calibration reports, accredited laboratories may use the accreditation body’s symbol on their reports. Test reports and certificates of accredited laboratories are accepted globally and as such reduces the need for additional testing and the associated costs and accreditation can therefore also be seen to support growth in international trade.

Accreditation is also considered by many laboratories to be a valuable marketing tool and in many organisations operating within industry sectors such as automotive, aerospace, oil & gas consider accreditation to be a mandatory requirement for those laboratories providing a service to them because accreditation provides assurance that the offered services are 3rd party approved and transparent. Achieving and maintaining accreditation means a laboratory can compete confidently and establish themselves above unaccredited competitors.

The key benefits of accreditation include:

• Provision of a documented and systematic approach to the control of laboratory processes
• Defined policies, procedures and supporting documentation
• Reported results are accepted globally as accurate and compliant with specified requirements and standards
• It confirms the competence of laboratory personnel
• It enables the assessment of performance of methods by comparison of results with peer organisations using recognised quality control methods
• Provides greater quality awareness within the laboratory
• Provides improved control of laboratory functions
• Ensures the validity and efficiency of the calibration and/or testing methods, results, and documentation.
• Ensures that the quality of data and is continually improved.
• It protects the integrity of the data, generated by the laboratory, in case of legal implications.
• Provides the opportunity for international as well as national recognition
• Can improve the laboratory image
• Increases business potential and customer satisfaction
• It can be an effective marketing tool when submitting tenders for testing and/or calibration contracts

Within the United Kingdom, ISO/IEC 17025 accreditation is provided by the United Kingdom Accreditation Service (UKAS) who perform the accreditation assessments themselves.

The standard assessment cycle comprises of three key assessment types, namely:

• Initial assessment
• Surveillance
• Reassessment

The initial assessment, as implied by the title, is carried out prior to accreditation being granted and involves a full assessment of the management system and a substantial amount of technical assessment of methods and the associated controls and outputs which includes the witnessed assessment of the individual methods put forward for accreditation performed by technical specialists. This assessment is not only detailed in its approach, but also enables the UKAS assessment team to evaluate the suitability of the management system whilst also confirming that all the relevant requirements of ISO/IEC 17025 are satisfied. The assessment team will also evaluate the risk in relation to the quality of the results being generated and reported whilst also considering the adequacy of the resources available to the laboratory in relation to the long-term maintenance of the management system and continued compliance with the specific UKAS accreditation criteria. During this assessment it is recognised that the management system will have only recently been developed and implemented and therefore many aspects may be lacking appropriate data to confirm its effectiveness and therefore the assessment team are looking to confirm that the policies, procedures, and processes are in place and considered to be suitable.

The initial assessment is the first part of the assessment cycle, and it is fairly typical for a laboratory to receive a number of nonconformities (termed findings in the UKAS reports) but these are generally found to be related to documents requiring further clarification or procedures and processes that are lacking detail or do not fully reflect the laboratory practices or requirements of the relevant governing standards or specifications.

Once the nonconformities have been addressed and closed out the assessment report and supporting documents are passed to the UKAS decision maker for review and confirmation that accreditation should be granted prior to the formal grant letter, accreditation certificate and schedule of accreditation being issued to the laboratory.

Following the grant of accreditation, the assessment cycle is established as three surveillance visits followed by a reassessment, with the first surveillance being scheduled approximately six months after accreditation is formally granted. The next and subsequent assessments would then be performed annually.

The first surveillance visit is generally used to confirm the suitability of those procedures and processes that may not have been examined in detail at the time of the initial assessment, due to a lack of data, for example, internal audits and QC activities. Each of the three surveillance assessments will cover approximately a third of the methods identified on the schedule of accreditation and will typically be of a shorter duration than the initial assessment. The reassessment will be of a similar duration to the initial assessment and will include a review of all aspects of the management system and all methods identified on the schedule of accreditation.

In addition to the routine assessments described above, new methods may be added to the schedule of accreditation by request; this is covered by an Extension to Scope assessment which is focused specifically on the new method(s) and is typically carried out as a site visit. On those occasions when an extension is based upon a generically similar method the assessment may be performed as a desktop assessment based upon the submission of the relevant supporting documentation.

Every UKAS assessment is a systematic, independent, and documented process which provides an objective assessment to evaluate the extent to which the ISO/IEC 17025 requirements, and other applicable audit criteria, have been met.

Following the successful achievement of becoming an accredited laboratory, many laboratories consider the hard work complete, and the ongoing maintenance of accreditation will be simple and straightforward. However, as many laboratories come to realize, the difficulties associated with ensuring that the quality management system is maintained and updated as required by the obligations arising from being accredited are greater than expected. The Plan-Do-Check-Act (P-D-C-A) cycle is an important tool for ensuring that your quality management system is continuously improving and adding real value to your organisation. To ensure the continuous improvement of your quality management system, it is extremely important to ensure that a robust auditing approach is applied based upon the laboratory internal audit schedule that covers all aspects of the quality management system as well as the technical activities including the review of the application of the procedures and processes associated with the accredited methods. In addition, operational risk and opportunities should be continuously monitored and reviewed to ensure that meaningful objectives and improvements are identified and established during the management review.

Another key factor associated with the maintenance of accreditation is to ensure that the quality management system is in a state of readiness and in the event that an unannounced assessment visit arose, all information would be readily available, quality management system related activities, such as internal audits, supplier evaluations, QC evaluations, procedure reviews are up to date and staff competence has been confirmed for all personnel involved with the performance of the accredited methods. It is therefore important that full recognition is given to the need for adequate resources to enable these activities to be managed on a continual basis to ensure that the quality management system activities are kept up to date to reduce the effort required to adequately prepare for scheduled assessments.

In addition to the above, a laboratory should ensure that its laboratory methods are based upon established engineering or scientific principles such as industry recognised methods or international standards. Laboratories must also continually ensure that objectivity and impartiality is maintained, and all results issued are accurate, valid, and verified. The laboratory quality management system, and operational procedures and processes shall be reviewed and continually evaluated through internal audits, monitoring of data, QC activities and management review. The rationale being that nonconformities and opportunities for improvement can be identified and appropriate actions can be taken to continually improve the laboratory’s quality management system and its performance.

For information, the following information provides an overview of the topics and examples of the activities that are reviewed and evaluated during the assessment visits.

(i) Quality Manual

The quality manual is the core of the quality management system. It should be kept up to date and where changes have been made, these will need to have been communicated to all relevant staff.

A copy should be available for the assessment team; it is always helpful to provide a “uncontrolled” hard copy for ease of reading.

(ii) Documented Methods & Procedures

All procedures shall be reviewed whenever an event flags a change. Event driven reviews are conducted whenever there is a change to a standard, specification, operating practice, or equipment for example.

As for the quality manual procedures should be kept up to date and accessible to all relevant staff either as a hard copy or via the company intranet.

Several procedures are specified as mandatory within ISO/IEC 17025 and the assessment team will want to ensure that these satisfy the requirements of the standard and are fully implemented within the laboratory. Again, it is useful to provide “uncontrolled” copies to the assessment team as applicable for ease of reading.

(iii) Normative Documents

In addition to the various standards and specifications relevant to the schedule of accreditation, normative documents include those policy and guidance documents issued by the accreditation body or ILAC. These should be identified within the document control register (or similar system) and kept up to date; changes to any of these documents should be identified and where necessary incorporated into the relevant laboratory documents and implemented.

It is quite common for laboratories to receive nonconformities for not identifying that the mandatory documents have been revised or for using out of date or obsolete documents and therefore regular status reviews should be made for all normative documents.

(iv) Schedule of Accreditation

The schedule of accreditation should also be kept up to date and it is advisable to review this on a regular basis against the status of the relevant standards and specifications identified within its contents.

If there are changes to any of the listed standards and specifications a formal review will need to be documented and any changes required to be made to laboratory documentation implemented. The assessment manager will need to be advised of the identified changes prior to the planned assessments and the documented reviews and actions taken will be evaluated during the assessment to implement the amendments to the schedule of accreditation.

This approach is typically carried out during the planned surveillance visits but depending upon the timing of the revisions to the standards a schedule of accreditation may be updated at any time using the extension to scope process.

(v) Master Document List/Register

The master document list or register should identify all documents that apply to the quality management system and is often requested by the assessment manager prior to or during the early part of the assessment. It is important that this document is kept up to date and identifies the status of all documents, including the normative documents as well as the quality management system documents. Where copies of documents are issued to staff or interested parties these shall be suitably controlled and identified on the document list or register.

(vi) Approved Subcontractors List

Where an accredited activity is subcontracted, for a valid reason, then the work shall be sent to an approved subcontractor; the list or document identifying all approved subcontractors must be kept up to date and where necessary any evaluations of the subcontractor shall be performed in accordance with a defined process and schedule. It is important that the status of all subcontractors is reviewed regularly particularly as circumstance may dictate a change in their capabilities; this would be reflected in their schedule of accreditation and therefore copies of the most current version should be readily available.

(vii) Approved Suppliers List

As for approved subcontractors, all suppliers of critical services and products shall be approved and identified in a suitable document or register; the list or document identifying all approved suppliers must be kept up to date and where necessary any evaluations of the supplier shall be performed in accordance with a defined process and schedule. It is important that the status of all suppliers is reviewed regularly to ensure that they still have the capabilities to perform the required service or provide the required products. Unlike subcontractors, a supplier may not have a formal certification or approval, and this will define the methods by which they are evaluated and approved; it is important that the approval process is defined and ensures that the correct service or product is supplied.

(viii) Complaint Log or Register

All complaints shall be logged using an appropriate method. Whatever method is this should enable the information to be readily available to the assessment team if requested. It is important that the information is up to date and where complaints have been investigated the documentation relating to the investigation and details of any actions taken are also available as the assessment team are likely to want to review and evaluate the process applied, the decisions taken, and the subsequent corrective actions implemented to address the complaint. It is important that all complaints are registered, investigated, addressed, and documented in a timely manner as failure to do so may result in a nonconformity being raised by the assessment team. In certain circumstances and depending upon the nature of the complaint this may present a risk to the accreditation if it has not been dealt with in an appropriate and timely manner.

(ix) Customer Feedback

It is a requirement to obtain feedback from customers, typically in relation to the laboratory performance and the service provided; various methods are used to establish feedback, including surveys; where this approach is used then the information received from the customers shall be reviewed, analysed, and reported. The assessment team may request to see the information and the analysis performed and it is important that if any justifiable concerns or deficiencies are identified in the feedback suitable actions are taken and the outcome of those actions is documented. If surveys are not used, then suitable records shall be maintained to demonstrate that customer feedback is being sought. Remember, feedback may be positive as well as negative and may include unsolicited plaudits received by email or verbally and a suitable method for capturing this information should be in place.

(x) Nonconformance Reports, Root Cause & Corrective Actions

The assessment team will invariably want to discuss the status of any nonconformities raised during the previous year. A suitable system shall be in place to document nonconformities from all sources, including complaints, internal and external audits or staff feedback and they shall be evaluated in accordance with a documented procedure. The investigation should include an evaluation of the reason for the nonconformities (Root Cause) and any immediate containment actions that are taken as well as the corrective action implemented to prevent a reoccurrence of the nonconformity. It is important that whatever system is used, all nonconformities have been subject to an initial investigation and where corrective actions have been identified these are implemented in a timely manner. It is also expected that the effectiveness of the corrective action is confirmed either by review at the next audit or by a separate audit conducted at a defined interval after implementation of the corrective action.

The assessors will often discuss the approach taken to establish the root cause and the effectiveness of the corrective action and how this was verified.

It is extremely important that this process is managed correctly as in certain circumstances and depending upon the nature of the nonconformity this may present a risk to the accreditation if it has not been dealt with in an appropriate and timely manner. It therefore imperative that when establishing a corrective action, the timescales for implementation are appropriate and realistic; it should not be so long that there is a risk of further nonconformities, and it should not be such that the root cause evaluation has been rushed and an inappropriate corrective action has been implemented. More importantly, it is unwise to delay the process as long-term nonconformities will often result in sanctions being applied by the assessment manager.

(xi) Internal Audits

It is important to continually monitor the suitability of the quality management system and the laboratory operations and to verify that the requirements are being implemented and correctly applied. Therefore, internal audits are a considered to be a key tool for performing these checks and should be structured in such a way that not only are the quality management system procedures and processes evaluated, but each of the laboratory methods is evaluated for effectiveness and to confirm that they satisfy the requirements of those standards and specifications identified on the schedule of accreditation. Internal auditing activities also enable the identification of opportunities for improvement and may also be utilised as a means of monitoring competence of laboratory staff when combined with an audit of laboratory methods.

During the UKAS assessments, the assessment team will review the audit records to ensure that the audits have covered all relevant activities associated with the quality management system and the laboratory operations and will evaluate the information contained within the audit records and reports to confirm that the audit has been performed effectively. In addition to the audit records, the assessment team will evaluate the post audit activities including the reporting of nonconformities, the subsequent root cause analysis and the identification and implementation of corrective actions. It is very important to ensure that a formal audit schedule has been established and that audits are allocated to cover all parts of the quality management system and laboratory operations and that audits are performed in accordance with this schedule; should there be any delays relating to the performance of the audits these shall be clearly identified and suitable justification recorded. Internal audits are considered to be one of the key activities relating to the maintenance of the quality management system and it is extremely important to ensure that audits are carried out as planned and delays managed in an appropriate manner as it is an expectation that all audits will be completed effectively and as planned; failure to do so may present a risk to the accreditation particularly if there are several delays or incomplete audits.

It is also expected that internal auditors are suitably qualified to perform the audits and all auditors should have received appropriate training prior to being assigned to perform an audit.

(xii) Management Reviews

In order to review the performance of the laboratory over a period of time, typically annually, a Management Review meeting shall be conducted. This should be attended by key laboratory staff and if applicable staff with an input into or have an interest in the laboratory operations, for example, corporate or senior management who are not involved with the day-to-day activities of the laboratory but have a responsibility for the resources or strategy of the whole organisation. The assessment team will review the information relating to the management review meeting and this may include the meeting agenda, attendance list, presentations or reports used as input data for discussion during the meeting, outputs from the meeting or minutes of the meeting and details of any actions or objectives identified during the meeting. It would also be expected that the meeting would be used as a mechanism for reviewing information relating to the strategic direction of the laboratory, general operational risks and risks to impartiality, along with data relating to the performance of the quality management system.

As for internal audits management reviews are considered to be one of the key tools for ensuring that the quality management system is effective and for identifying opportunities for improvement and establishing objectives for the next twelve months and therefore failure to conduct or document these meetings present a severe risk to the accreditation, particularly if the period between meetings exceeds expectations.

(xiii) Training Records

Experienced well trained, knowledgeable laboratory personnel are the biggest asset that a laboratory can have, and it is important to ensure that appropriate systems are in place to establish training needs, identify training provision and the criteria for establishing competence as well as the methods by which competence will be evaluated.

The assessment team will evaluate the suitability of the training process by reviewing the process employed along with a selection of training records for laboratory personnel. Particular attention will be given to the establishment of competence criteria, the assessment of competence and how continued competence is monitored and documented. It is important that this information is kept up to date and is readily available during the assessment. Where necessary, there may be a requirement for certain external qualifications to be held by laboratory personnel (e.g., personnel certification, H&S qualifications etc.) and training records should include reference to these either as direct comments or by alternative methods such as a register of qualifications.

(xiv) Laboratory Environment

It is expected that the environmental conditions within the laboratory are monitored and recorded to ensure that the conditions are within defined parameters. During the assessment of the laboratory methods the assessor will want to verify the conditions at the time the method is being demonstrated and will also want to see objective evidence that laboratory conditions are being monitored and where they have drifted out of specification suitable actions have been taken to investigate the effect it will have had on any work being performed and appropriate corrective actions have been applied.

(xv) Laboratory Methods and Procedures

Laboratory methods or procedures shall be maintained where instructions or clarification of the requirements of standards or specifications are required to ensure that the method is applied in a consistent and repeatable manner. The assessors will review these methods to ensure that they are adequate, up to date, and verified as fit for purpose. It is therefore extremely important that these documents are reviewed whenever a change in equipment, operational methods or the standard/specification is updated to ensure that the accurately reflect the current status. Any changes should be communicated to the relevant laboratory personnel and were necessary training provided and documented.

(xvi) Measurement Uncertainty and Decision Rules

All calibration and test methods performed within a laboratory will have an element of uncertainty assigned to the result generated. There is a requirement to develop measurement uncertainty estimates for all methods, unless there is a genuine reason for it not being applicable. These estimates shall be kept up to date, particularly for those estimates where calibration results influence the outcome and therefore it is important to review these on a regular basis.

During the assessment of the laboratory methods, the assessor may wish to review the measurement uncertainty estimate(s) associated with that method to verify that the appropriate influences have been considered.

Where there is a need to provide a pass/fail verdict on a result or set of results (e.g., where a result is being evaluated against a specification) a decision rule will need to be established; this will require the measurement uncertainty to be known and applied as part of the decision-making process. The decision rule to be applied will need to be documented and agreed with the end user and the assessor will review how the rule was established and communicated to the end user.

(xvii) Metrological Traceability

Accredited measurement results require metrological traceability to be established. Metrological traceability is obtained through the use of equipment calibrated using reference instruments or standards traceable back to national standards by an accredited calibration laboratory or using internal calibration processes that are included within the schedule of accreditation.

The process for managing the calibration of equipment will be examined by the assessment team, with particular attention being given to the selection of calibration laboratories, the appropriateness of the calibration performed for the equipment being used, labelling and identification of equipment, calibration frequency and calibration records or certificates.

During the assessment of laboratory methods, the assessor will request to see copies of calibration records and reports for the equipment used during the assessment; it is important that this information is readily available either as a soft copy held on the intranet or a hard copy stored offline. Occasionally, the assessor may request copies of previous certificates or records to enable a review of any calibration trends or changes in calibration parameters.

All calibration certificates shall be checked and verified prior to putting the equipment back into service and these checks should be documented either by using a formal record or by annotating the calibration certificate. Additionally, the request for calibration or purchase order should clearly identify the calibration requirements such as, calibration standard, calibration range, any specific acceptance criteria and any other information considered important.

A suitable system shall be in use to ensure that all equipment requiring calibration are managed to ensure that they are calibrated in accordance with the defined calibration frequency; this would typically be a data base or similar document.

(xviii) QC activities (Pre-test checks, Inter Laboratory Comparisons & Proficiency Testing)

Another ISO/IEC 17025 requirement is that all laboratories shall participate suitable QC activities such as a proficiency testing scheme; this requirement must cover all activities identified on the schedule of accreditation unless it is inappropriate to do so. It is also important to establish a plan to ensure that all activities are covered within an accreditation cycle (four-year period for UKAS). Wherever possible, it is recommended that a proficiency testing scheme is used as this provides a much larger population of participants and the outcome gives a better comparison with other laboratories. In a number of cases, there may be no suitable proficiency schemes available and alternative methods such as inter laboratory comparisons, testing of reference materials or intra laboratory comparisons may be considered. Whichever approach is taken it is important that the outcome, which is generally provided in report format, is evaluated and actions taken in those cases were a warning or action limit is identified; this should be investigated, and the actions taken along with the reasons for the deficiency documented.

During the assessment the assessors may wish to review information relating to those activities completed since the previous assessment visit.

(xix) Reporting

The assessment team will review a selection of certificates or reports to ensure that the format including the use of the accreditation logo is appropriate and all information required to be reported by the controlling standard or specification is included and is reported to the correct precision. A check will also be performed against the requirements of the contract or order to check whether any additional information is correctly along with details of any decision rules that have been applied (if applicable). Another important check will be made on the reporting of any non-accredited results to ensure that a suitable disclaimer is in place.

For a laboratory that does not issue certificates or reports the review will follow a similar approach but will also include an evaluation of how results are issued, checked, and verified. These checks will also ensure that suitable levels of authority are in place for the checking and authorising the release of the results.

(xx) Miscellaneous

In addition to the topics identified above, the assessment will also include a review of procedures, processes, and records associated with the following activities:

• Confidentiality
• Contact review (e.g., requests, quotes, purchases orders, etc.)
• Identification/Handling of test or calibration items
• Document retention periods and storage (including data back-up)
• Purchasing documents (relevant to services and supplies)

Having these records readily available will allow the assessment team to see how work is processed from receipt of enquiry to release of results and enables them to verify that the laboratory is operating in accordance with the quality management system.

It is clear from the information presented above that there are many benefits to having ISO/IEC 17025 accreditation but in order to maintain that accreditation a considerable amount of work also needs to be done.

Many laboratories have recognised that whilst the initial steps to gain accreditation were difficult and resource hungry, the work required to maintain the system is far greater than they expected and requires laboratory resource to be diverted from routine laboratory activities in order to support the quality functions.

Outsourcing some of the quality management system functions enables laboratory resources to continue to focus on the important daily laboratory operations while contributing to the organisational strategic objectives. It also provides a valuable support in relation to questions raised on how best to manage the accreditation requirements and to continually monitor and develop the quality management system as and when those requirements are updated and revised whilst also providing a level of confidence that the quality management system is being maintained in accordance with the requirements for continued maintenance of accreditation.

Furthermore, it provides a means of demonstrating independence and impartiality in those areas where limited resource can present a challenge particularly where laboratory personnel are evaluating their own areas of work.

Outsourcing also provides access to specialised expertise and skills which may not be readily available within the organisation, whilst also giving access to opportunities to introduce laboratory best practice.

Two levels of service can be offered, namely basic QMS support and QMS support with assistance with the ongoing development of the quality management system along with the integration of new activities.

Basic QMS support would include assistance with the following activities:

• Review of normative documents and updating of QMS documentation as applicable
• Establishing an internal audit schedule covering the quality management system and laboratory methods
• Conduct internal audits as per the audit schedule, including a pre-assessment gap analysis prior to the UKAS assessment
• Assistance with root cause analysis, identification of corrective actions and review of their effectiveness
• Maintenance of CAR database
• Supplier audits and evaluation, as applicable
• Development and updating of measurement uncertainty estimates
• Identification and scheduling of participation in PT Schemes and subsequent review of results
• Assistance with the preparation for and reporting of management review meetings; where requested attend the meeting to discuss quality management system activities
• General advice and support relating to ISO/IEC 17025 and UKAS requirements

QMS Support with ongoing developmentof the quality management system would include assistance with above activities and the following additional activities:

• Assistance with the evaluation of risks to the laboratory operation
• Assistance with the identification of quality objectives and meaningful monitoring and measurement plans
• Assistance with the identification and implementation of laboratory best practice
• Assistance with the identification of improvements to the quality management system to support business development and growth
• Development and implementation of new procedures and processes
• Training in quality management system activities
• Assistance with the introduction of new laboratory methods, verification of equipment performance and validation of new laboratory methods as applicable

Assistance with the integration of corporate systems into the laboratory quality management system where required