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Implementing ISO/IEC 17025 has benefits for laboratories, but the work and costs involved should also be considered before proceeding.
Main Benefits of Correctly Implemented ISO/IEC 17025:
Implementing ISO/IEC 17025 as part of laboratory quality initiatives provides benefits for both, laboratory and business, such as:
- Having access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories. Accreditation will also help in getting more contracts from organizations that don’t mandate accreditation, but do give preference to accredited laboratories in competitive situations.
- Improved national and global reputation and image of the laboratory.
- Continually improving data quality and effectiveness of the laboratory.
- Having a basis for most other quality systems related to laboratories, such as Good Manufacturing Practices and Good Laboratory Practices.
Analytical testing laboratories seeking ISO/IEC 17025 will be affected in multiple areas. The main difference between good analytical practices and formal accreditation is the amount of documentation to be developed. There is no doubt that any good analytical laboratory uses qualified analysts, checks the performance of equipment used for testing, and validates analytical methods. However, many times the outcome of the tests is not fully documented. ISO/IEC 17025 accreditation requires formal documented environment – ‘what is not documented is a rumor,’ and is viewed by assessors as ‘not being done.’
The overall impact of accreditation on an analytical laboratory can be best illustrated by looking at the whole sample/data workflow. Figure 1 shows a typical laboratory workflow of samples and test data, together with ISO/IEC 17025 requirements.
Requirements along the analytical workflow
- Sampling should be performed according to a sampling plan, and all sample details should be documented.
- Samples should be uniquely identified and the sample integrity should be protected during transport and storage.
- The quality of test results should be monitored.
- Test reports should include test results as well as an estimation of the overall measurement uncertainty. The report should also include either detailed information about the sample and test conditions, or a link to a reference document.
- Records should be properly maintained to ensure data integrity and availability.
Some requirements impact greater than one workflow step:
- All analytical methods and procedures should be validated. This includes methods and procedures for sampling, testing and data evaluation.
- Equipment used for sampling and testing should be calibrated, tested and well-maintained. Materials such as calibration standards should be qualified and traceable to System International (SI) units, or to some other certified reference material.
- Nonconforming test results should be documented and controlled.
- People should be qualified for their assigned tasks through education, experience or training.
- Environmental conditions such as temperature, humidity and electromagnetic interference should be monitored and controlled.
- All routine tasks should be performed according to written procedures.
Some additional requirements impact not only sample analysis, but also the organization of the entire laboratory:
- Specific documents should be developed and maintained, including individual policies and a quality plan.
- Known existing problems should be corrected, and an action plan should be developed to avoid recurrence of the same or similar problems.
- All complaints from clients should be formally followed up.
- A formal program should be used to manage suppliers, service providers, and subcontractors.
- The organizational structure should be such that there are no conflicting interests that could affect quality.
- Compliance with ISO/IEC 17025 and internal procedures should be assessed during regular internal audits.
Key Steps towards Accreditation:
There are eight key steps towards laboratory accreditation:
- Management defines a project owner.
- The project owner studies details of the standard, supporting literature, and other relevant information
- The project owner defines the preliminary scope of accreditation, and works with laboratory professionals to prepare a list with requirements.
- The project owner and laboratory professionals perform a gap analysis to determine the difference between the requirements and what is currently implemented in the laboratory.
- Based on the outcome of the gap analysis, the project owner, laboratory professionals, financing and documentation professionals, and external consultants estimate the costs for accreditation.
- Estimated costs are presented to management, along with incremental opportunities.
- Management decides to proceed with accreditation.
- The project owner leads implementation steps.
ISO/IEC 17025 – Laboratory Quality System
Laboratories play an important role in company quality systems. The ISO/IEC 17025 (1) can be used as a standard to develop and establish a quality system for a laboratory, and also for assessment by laboratory clients or third parties. The standard can also be used as a criterion for laboratory accreditation. Working according to global standards is especially important for laboratories to ensure validity and global comparability of test & calibration results. One of the goals of using global standards is to reduce the number of tests required in national and international trading.
The first edition of the “International Standard General Requirements for the Competence of Testing and Calibration Laboratories” was produced as a result of extensive experience in implementing ISO/IEC Guide 25 and EN 45001; it replaced these earlier standards in 1999. This new standard contains all the requirements that testing and calibration laboratories have to meet if they wish to demonstrate that they operate a management system, are technically competent, and are able to generate technically valid results.
Management requirements in the first edition refer to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an update of ISO/IEC 17025 necessary. In the second edition of ISO/IEC 17025, released in 2005, clauses were amended or added only when considered necessary in the light of ISO 9001:2000.
Testing and calibration laboratories that comply with ISO/IEC 17025 will, therefore, also operate in accordance with ISO 9001.
Accreditation bodies that recognize the competence of testing and calibration laboratories use ISO/IEC 17025 as the basis for their accreditation.
ISO/IEC 17025 is divided into five clauses, two annexes, and one bibliography section:
- Clause 1: Scope
The standard covers the technical activities of a laboratory as well as the management and organizational aspects to perform the technical activities in a competent way.
- Clause 2: Normative References
- Clause 3: Terms and Definitions
- Clause 4: Management Requirements
Most of the requirements are similar to those specified in the ISO Standard 9001:2000.
- Clause 5: Technical Requirements
Most of the requirements come from the ISO Guide 25.
- Annex A: Cross References to ISO 9001:2000
- Annex B: Guidelines for Establishing Applications for Specific Fields
- The most important clauses are clause 4 and 5, describing management and technical requirements. In addition to official requirements, these clauses also include notes with further explanations and recommendations
Management requirements pertain to the operation and effectiveness of the quality management system within the laboratory. The requirements are similar to ISO 9001. This clause is divided into fifteen chapters, described below.
This chapter ensures that the roles and responsibilities of the laboratory, the management, and the key personnel are defined.
- An organizational structure, as well as responsibilities and tasks of both, management and staff, should be defined.
- The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratory’s work quality. Examples include commercial marketing or financing departments.
- A quality assurance manager should be appointed.
- All personnel should be free from any commercial or financial pressure that could adversely affect the quality of calibration and test results.
This chapter describes how to ensure that a management system is implemented, maintained, and continually improved.
Key points :
- There should be policies, standard procedures, and work instructions to ensure the quality of test results.
- There should be a quality manual with policy statements that are issued and communicated by top-level management.
- The effectiveness of the management system should be continually improved.
Individual paragraphs in this chapter describe how to ensure that all documents related to the management system are uniquely identified and created, approved, issued and changed, following the documented procedures.
Key points :
- All official documents should be authorized and controlled.
- Documents should be regularly reviewed and updated if necessary. The review
frequency depends on the document itself. Typical review cycles are between one and three years.
- Changes to documents should follow the same review process as for the
development of initial documents.
Review of Requests, Tenders, and Contracts
This chapter describes how to ensure that requirements of requests, tenders and
contracts are well defined, reviewed, understood and documented.
Key points :
- The laboratory supervisor’s review should ensure that the laboratory has the technical capability and resources to meet the requirements.
- Changes in a contract should follow the same process as the initial contract.
Subcontracting of Tests and Calibrations.
This chapter describes how to ensure that tests and calibrations subcontracted to third parties are performed according to the same quality standards as if they were done in the subcontracting laboratory.
Key points :
- The competence of the subcontracted party should be ensured, through a documented quality system, such as ISO/IEC 17025.
- The subcontracting laboratory is responsible to the customer for the subcontractor’s work, except in the case where the customer or the regulatory body specifies which subcontractor should be used.
Purchasing Services and Supplies
This chapter describes how to ensure that services and supplies delivered by third parties do not adversely impact the quality and effectiveness of laboratory operations.
Key points :
- Suppliers should be selected and formally evaluated to ensure that services and supplies are of adequate quality.
- Records of the selection and evaluation process should be maintained.
- The quality of incoming material should be verified against predefined specifications.
Service to the Customer
This chapter describes how to ensure that the laboratory continually meets customer requirements.
Key points :
- The laboratory should communicate with customers to clarify requests and get customer input.
- The laboratory should have a formal program to collect feedback from customers on an ongoing basis.
- The laboratory should allow customers to audit the laboratory.
This chapter describes how to ensure that any customer complaints are documented, evaluated, and adequately followed up.
Key points :
- There should be a policy and procedure for the resolution of complaints received from customers.
- Records of complaints and all steps taken when resolving the complaint should be maintained. This includes documentation of investigations and corrective actions.
Control of Nonconforming Testing and/or Calibration Work
Tests, calibrations, and other laboratory operations should conform to previously
defined specifications such as laboratory specifications or client-defined specifications.
This chapter describes how to ensure that nonconforming test and calibration results are adequately followed up, and that corrections are initiated.
Key points :
- There should be a policy and a process that comes into effect when results do not conform to procedures.
- Corrective actions should be taken immediately to avoid recurrence.
- The significance of nonconforming work should be evaluated, for example, the possible impact on other testing or calibration work.
- If necessary, customers should be notified.
This chapter describes how to ensure that the effectiveness of the management
system is continually improved.
Key points :
- Suggestions for improvements should be taken from audit reports, analysis of data, customer complaints and suggestions, corrective and preventive actions, and management reviews.
- Suggestions should be collected over time, and reviewed by management for suitable actions.
This chapter describes how to ensure that the root cause of nonconforming work
or deviations from laboratory and management procedures are identified, and that
adequate corrective actions are selected, implemented, documented and monitored.
Key points :
- Corrective actions can be triggered through nonconforming tests or other work, customer complaints, internal or external audits, management reviews, and observations by staff.
- Corrective actions should be selected and implemented, to eliminate the specific problem, and prevent recurrence of the same problem.
- As the first step in the process, the root cause of the nonconformity should be identified.
- The effectiveness of the corrective action should be monitored and evaluated.
Preventive actions should be initiated when potential sources of nonconformities
have been identified. Nonconformities may be technical or related to the management system. The objective is to reduce the likelihood of the occurrence of such potential nonconformities.
Key points :
- There should be a procedure to identify potential sources of nonconformities and define preventive actions to prevent occurrence of these nonconformities.
- The effectiveness of the preventive action should be monitored and evaluated.
Control of Records
This chapter describes how to ensure that all records in a laboratory are uniquely
identified, readily available when needed, and protected against unauthorized access for viewing or changing.
Key points :
- There should be procedures for identification, collection, indexing, storage, retrieval, and disposal of records
- Records should be stored such that their security, confidentiality, quality and integrity are ensured throughout the required retention time
- For technical records such as test reports of analytical measurements, original observations should be retained, along with processing parameters that will allow tracking final results back to the original observations.
- Record format can be hard copies or electronic media. There should be procedures to protect and back-up electronic records, and to prevent unauthorized access.
- Records can be corrected if there are mistakes. The original record should be crossed out, but still visible.
- When electronic record systems are used, the same principle applies. The laboratory should ensure that original records are not overwritten by the system, and that corrections are recorded together with the original records. Using a system that prevents overwriting original records, and stores changes in an electronic audit trail that can be viewed and printed is highly recommended.
Internal audits should verify that the laboratory complies with ISO/IEC 17025 and with internal technical and quality procedures. Internal audits are also an excellent preparation for external assessments, and can help to continually improve the quality system.
Key points :
- The laboratory should have a procedure and a schedule for internal audits. Internal audits can either cover the whole laboratory and all elements of the quality system at one specific period of time or can be divided into several subsections.
- The schedule should be such that each element of the quality system and each section of the laboratory are audited yearly.
- The audit program should be managed by the quality manager.
- Audit findings related to the quality of test and calibration results should be reported to customers.
- Audit follow-up activities should include corrective and preventive action plans (CAPA). The effectiveness of the plans should be monitored.
Requirements in this chapter describe how to ensure the continued suitability and
effectiveness of the quality system, policies, and testing and calibration procedures.
Key points :
- There should be a schedule and procedure for periodic management reviews. Recommended review frequency is once a year.
- The management review should include a discussion about the outcome of recent internal audits and external assessments, corrective and preventive actions, results of proficiency testing, customer complaints and feedback, and any recommendations for improvements.
- Management should decide on follow-up activities. These activities should be monitored for effectiveness.
Technical requirements address the competence of staff, sampling and testing methodology, equipment, and the quality and reporting of test and calibration results.
This clause is divided into ten chapters.
The technical requirements clause starts with a general chapter. This chapter’s purpose is to make readers aware that the correctness and reliability of test and calibration results are determined by a variety of factors.
Key points are:
- The different factors impacting the quality of results should be documented. They include, for example, sampling, equipment, test methods, and environmental conditions.
- The extent to which impacting factors can contribute to the measurement uncertainty should be taken into account when developing test and calibration methods.
Personnel probably have the highest impact on the quality of test and calibration
results. This chapter describes how to ensure that all laboratory personnel who can impact test and calibration results are adequately qualified.
Key points are:
- Only competent personnel should perform testing and calibrations. This includes part-time as well as full-time employees, as well as all management levels.
- Competence can come from education, experience or training.
- Management should define and maintain tasks, job descriptions, and required skills for each job.
- Based on required skills and available qualifications, a training program should be developed and implemented for each employee.
- The effectiveness of the training should be evaluated. If the training is related to a specific test method, the trainee can demonstrate adequate qualification through successfully running a quality control or proficiency test sample. A statement from the trainee such as ‘I have read through the test procedure’ is not enough.
- Management should authorize personnel to perform specific tasks, for example, to operate specific types of instruments, to issue test reports, to interpret specific test results, and to train or supervise other personnel.
- The date of this authorization should be recorded. The associated tasks should not be performed before the authorization date.
Accommodation and Environmental Conditions
This chapter has been included to ensure that the calibration and test area environment will not adversely affect the measurement accuracy. It includes five sections with information that is mostly common sense. One clause recommends having effective separation between neighboring areas when the activities therein are incompatible. An example would be to separate laboratories that analyze extremely low traces of a solvent from those which consume large quantities of the same solvent for liquid-liquid extraction.
Key points are:
- Environmental conditions should not adversely affect the required quality of tests. This means, for example, that equipment should operate within the manufacturer’s specifications for humidity and temperature.
- The laboratory should monitor, control, and record environmental conditions. Special attention should be paid to biologic sterility, dust, electromagnetic disturbances, radiation, humidity, electrical supply, temperature, sound, and vibration. Tests should be stopped when the environmental conditions are outside specified ranges.
- Areas with incompatible activities should be separated.
- Access to test and calibration areas should be limited to authorized people. This can be achieved through pass cards.
Test and Calibration Methods and Method Validation
Accurate test and calibration results can only be obtained with appropriate methods that are validated for the intended use. This chapter deals with the selection and validation of laboratory-developed, standard methods and measurement uncertainty, and control of data.
Key points for accurate test and calibration results:
- Methods and procedures should be used within their scope. This means the scope should be clearly defined.
- The laboratory should have up-to-date instructions on the use of methods and equipment.
- If standard methods are available for a specific sample test, the most recent edition should be used.
- Deviations from standard methods or from otherwise agreed-upon methods should be reported to the customer and their agreement obtained.
- When using standard methods, the laboratory should verify its competence to successfully run the standard method. This can be achieved through repeating one or two critical validation experiments, and/or through running method specific quality control and/or proficiency test samples.
- Standard methods should also be validated if they are partly or fully out of the scope of the test requirement.
- Methods as published in literature or developed by the laboratory can be used, but should be fully validated. Clients should be informed and agree to the selected method.
- Introduction of laboratory-developed methods should proceed according to a plan.
- The following parameters should be considered for validating in-house developed methods: limit of detection, limit of quantitation, accuracy, selectivity, linearity, repeatability and/or reproducibility, robustness, and linearity.
- Exact validation experiments should be relevant to samples and required information.
- Sometimes, standard and in-house validated methods need to be adjusted or changed to ensure continuing performance. For example, the pH of a HPLC mobile phase may have to be changed to achieve the required separation of chromatographic peaks. In this case, the influence of such changes should be documented, and if appropriate, a new validation should be carried out.
- Validation includes specification of the requirements and scope, determination of the characteristics of the methods, appropriate testing to prove that the requirements can be fulfilled by using the method, and a statement on validity.
Key points for measurement uncertainty:
- The laboratory should have a procedure to estimate the uncertainty of measurement for calibrations and testing.
- For uncertainty estimation the laboratory should identify all the components of uncertainty.
- Sources contributing to the uncertainty can include the reference materials used, the methods and equipment used for sampling and testing, environmental conditions and personnel.
Key points for control of data:
- Calculations used for data evaluation should be checked. This is best done during software and computer system validation. As an example, spreadsheet formulas defined by a specific user should be verified with an independent device such as a handheld calculator. Data transfer accuracy should be checked. Accuracy of data transfer between computers can be automatically checked with MD5 hash sums.
- Computer software used for instrument control, data acquisition, processing,
reporting, data transfer, archiving, and retrieval developed by or for a specific user should be validated. The suitability of the complete computer system for the intended use should also be validated.
- Any modification or configuration of a commercial computer system should be validated. Examples include defining report layouts, setting up IP addresses of network devices, and selecting parameters from a drop-down menu.
- Electronic data should be protected to ensure integrity and confidentiality of
electronic records. For example, computers and electronic media should be
maintained under environmental and operating conditions to ensure integrity of data.
Equipment that is performing well and properly maintained is a prerequisite for the ongoing accuracy of test and calibration results. This chapter deals with the capacity and quality of equipment. The whole idea is to make sure that the instrument is suitable for performing selected tests/calibrations and is well characterized, calibrated, and maintained.
Key points are:
- Equipment should conform to specifications relevant to the tests. This means that equipment specifications should first be defined so that when conforming to defined specifications the equipment is suitable to perform the tests.
- Equipment and its software should be identified and documented.
- Equipment should be calibrated and/or checked to establish that it meets the laboratory’s specification requirements.
- Records of equipment and its software should be maintained and updated if necessary. This includes version numbers of firmware and software. It also includes calibration and test protocols.
- Calibration status should be indicated on the instrument along with the last and the next calibration dates.
Traceability of equipment to the same standard is a prerequisite for comparability of test and calibration results. Ideally all measurements should be traceable to International System of Units (SI). While this is typically possible for physical measurements such as length (m) and weight (kg), this is more difficult in chemical measurements.
Key points for traceability of calibrations:
- Calibration of equipment should be traceable to the SI units.
- Traceability of laboratory standards to SI may be achieved through an unbroken link of calibration comparisons between the laboratory standard, secondary standard, and primary or national standard.
- If traceability to SI units is not possible, the laboratory should use other appropriate traceability standards. These include the use of certified reference material and the use of consensus standards or methods.
This chapter has been added to describe how to ensure that statistically relevant
representative samples are taken and that all information on the sample and the
sampling procedure is recorded and documented.
Key points for sampling:
- Sampling should follow a documented sampling plan and sampling procedure.
- The sampling plan should be based on statistical methods.
- The sampling procedure should describe the selection and withdrawal of representative samples.
- The sampling location and procedure, the person who took the sample, and any other relevant information about the sampling process should be recorded.
Handling Test and Calibration Items
This chapter describes how to ensure that sample integrity is maintained during transport, storage, and retention and that samples are disposed of safely.
Key points for handling test and calibration items are:
- Test and calibration items should be uniquely identified.
- Sample transportation, receipt, handling, protection, storage, retention, and/or disposal should follow documented procedures.
- The procedures should prevent sample deterioration and cross-contamination during storage and transport.
Assuring the Quality of Test and Calibration Results
This chapter describes how to ensure the quality of results on an ongoing basis through, for example, regular analysis of quality control samples or participation of proficiency-testing programs.
Key points are:
- The validity of test results should be monitored on an ongoing basis.
- The type and frequency of tests should be planned, justified, documented and reviewed.
- Quality control checks can include the regular use of certified reference materials, replicating tests or calibrations using the same or different methods, and retesting or recalibration of retained items.
Reporting of Results
This chapter describes how test/calibration results should be reported. This is important for an easy comparison of tests performed in different laboratories. The chapter has some general requirements on test reports such as clarity and accuracy, but it also has very detailed requirements on the contents.
Test reports and calibration certificates should include:
- The name and address of the laboratory.
- Unique identification of the test report or calibration certificate (such as the serial number).
- The name and address of the client.
- Identification of the method.
- A description and identification of the item(s) tested or calibrated.
- Reference to the sampling plan and procedures used by the laboratory.
- The test or calibration results with the units of measurement.
- The name(s), function(s), and signature(s) or equivalent identification of person(s) authorizing the test report or calibration certificate.
- A statement on estimated uncertainty of measurement (for test reports ‘where applicable’).
- When opinions and interpretations are included, documentation of the basis for the opinions and interpretations.
- Opinions and interpretations clearly marked as such on the test report or calibration certificate.