ISO/IEC 17025 in Analytical Laboratories

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Management Summary Introduction Management Requirements Technical Requirements Recommendations for Implementation Steps Towards Accreditation Documentation Internal and External Audits How to deal with Multiple Regulations and Quality Standards	References Links Questions and Answers Expert Advice on Selected Topics About Labcompliance Tutorials

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1. Management Summary

ISO/IEC 17025 is a quality standard for testing and calibration laboratories. The current release was published in 2005. There are two main sections in ISO/IEC 17025 - Management Requirements and Technical Requirements. Management requirements are related to the operation and effectiveness of the quality management system within the laboratory and has similar requirements to ISO 9001. Technical requirements address the competence of staff, testing methodology, equipment and quality and reporting of test and calibration results. The standard is the basis for accreditation from an accreditation body.
Implementing ISO/IEC 17025 has benefits for laboratories but there are also additional work and costs required.

Main benefits are:

• Having ISO/IEC 17025 accreditation status will get direct access to more contracts for testing and/or calibration. Some public and private organizations only give contracts to accredited laboratories.
• Having ISO/IEC 17025 accreditation status will improve the reputation and image of the laboratory. This will also help to get more contracts from organizations that don’t mandate accreditation but give preference to accredited laboratories in competitive situations.
• When correctly implemented, the quality system can help to continually improve the quality of data and effectiveness of the laboratory.
• ISO/IEC 17025 is the basis for most other quality systems related to laboratories, for example, Good Manufacturing Practices and Good Laboratory Practices.

Analytical testing laboratories seeking ISO 17025 will be impacted in a couple of areas. The main difference between formal accreditation and 'just' good analytical practices is the amount of documentation to be developed. There is no doubt that any good analytical laboratory uses qualified analysts, and for performing tests, 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 17025 accreditation requires formal documentation for about everything. It's similar to operating in a regulated environment; ‘what is not documented is a rumor’, assessors consider it as 'not being done'.
The overall impact on analytical laboratories can be best illustrated on the entire sample/data workflow in a laboratory.

Figure 1 shows a typical workflow of samples and test data along with the ISO 17025 requirements on individual steps and the laboratory.

Figure 1: ISO/IEC 17025 Requirements for Analytical Laboratories

 

• 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.
• Quality of test results should be monitored.
• The test report should not only include test results, but also an estimation of the overall measurement uncertainty. It should also include either detailed information on the sample and test condition, or a link to a reference document.
• Records should be well maintained to ensure data integrity and availability.

There are also some requirements that impact more 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. Material such as calibration standards should be qualified and traceable to SI units or to certified reference material.
• Nonconforming test results should be documented and controlled.
• People should be qualified for the assigned task, for example, through education, experience or training.
• Environmental conditions such as temperature, humidity and electromagnetic interference should be monitored and controlled.
• All routine tasks should follow written procedures.
• There are additional requirements that not only impact the sample analysis but also the entire organization of the laboratory.
• Specific documents should be developed and maintained, for example, policies and a quality plan.
• Known current problems should not only be corrected but a preventive action plan should be developed to avoid reoccurrence of the same or similar problems.
• All complaints from clients should be formally followed up.
• There should be a formal program to manage suppliers, service providers and subcontractors.
• The organizational structure should be such that there are no conflicting interests that could impact quality.
• Compliance with ISO/IEC 17025 and internal procedures should be assessed during regular internal audits.

Key steps towards accreditation are:

1. Management defines a project owner.
2. The project owner studies details of the standard and supporting literature and other relevant information.
3. The project owner defines the preliminary scope of accreditation and prepares a list with requirements together with the laboratory.
4. The project owner performs a gap analysis with the help of the laboratory professionals to see the difference between the requirements and what is currently implemented in the laboratory.
5. Based on the outcome of the gap analysis the project owner together with laboratory, financing and documentation professionals and external consultants estimates the costs for accreditation.
6. Estimated costs are presented to management together with incremental opportunities.
7. Management decides to go for the project.
8. The project owner leads implementation steps.

2. Introduction

Companies have to continuously deliver high-quality products and/or services if they want to be successful in the marketplace in the long term. Quality improvement has become a key national and international business strategy. Most companies are using quality systems as a method of assuring the consistent conformity of products or services to a defined set of standards or customer expectations.

Quality Systems

Several Quality System Standards were developed in various countries in the 1960's and 1970's. The MIL-Q-9858A in the United States in 1963 and the BS 5750 in the United Kingdom in 1979 are probably the most important ones. The ISO 9000 series of quality standards were established in 1987 for implementing and maintaining a quality system which is internationally accepted and can be used as a criterion for third party quality assessment.

ISO/IEC 17025 - Laboratory Quality System

Laboratories play an important role in the quality systems of the companies. The ISO/IEC 17025 (1) can be used as a standard to develop and establish a quality system in the laboratory and for assessment by their clients or third parties. The standard is also being used as a criterion for laboratory accreditation.

The first edition (1999) of the International Standard "General Requirements for the Competence of Testing and Calibration Laboratories" was produced as a result of extensive experience in the implementation of ISO/IEC Guide 25 and EN 45001, both of which it replaced. It 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 of the first edition referred to ISO 9001:1994 and ISO 9002:1994. These standards have been superseded by ISO 9001:2000, which made an alignment of ISO/IEC 17025 necessary. In the second edition of ISO 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 this International Standard will therefore also operate in accordance with ISO 9001. Accreditation bodies that recognize the competence of testing and calibration laboratories use this International Standard as the basis for their accreditation.

ISO/IEC 17025 is divided into five chapters, two annexes and one bibliography section:

• Chapter 1: Scope
• The standard covers the technical activities of a laboratory and the management and organizational aspects to perform the technical activities in a competent way.
• Chapter 2: Normative References
• Chapter 3: Terms and Definitions
• Chapter 4: Management Requirements
  Most of the requirements are similar to those specified in the ISO Standard 9001:2000
• Chapter 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
• Bibliography

Most important are chapters 4 and 5 on management and technical requirements. Besides official requirements these chapters also include notes with further explanations and recommendations.

Scope and Contents of this Tutorial

Implementing a quality system such as ISO/IEC 17025 has an impact on a laboratories organization and operation. This tutorial will discuss some of the specific requirements along with their implications for testing laboratories.
This tutorial is especially useful for chemical analytical laboratories that seek accreditation according to an internationally recognized standard. Examples are food testing, environmental testing, chemical testing, clinical testing, pharmaceutical testing and other testing laboratories.
The tutorial will guide laboratory personnel and managers and QA managers and staff through the entire process of ISO/IEC 17025 accreditation.
It also helps laboratories that have to work under different quality systems to efficiently set up procedures for compliance with all requirements.
It covers:

• Management requirements.
• Technical requirements.
• • Recommendations for Implementation.
• Steps toward ISO/IEC 17025 Accreditation.
  Documentation
• Internal and External Audits
• Implementing multiple quality systems

The tutorial and its reference material should give a good understanding of why 17025 is important, what the requirements are and what are the key points for implementation. It also helps to improve the overall quality of analytical results and at the same time, to improve the recognition of the laboratory and its employees.

The tutorial is not a substitute for the standard itself. It does not list all requirements but rather it focuses on the most important ones and the ones that need specific attention according to the opinion of the author. The tutorial also does not include tools such as example quality manual, operating procedures and all the templates that would help to quickly implement ISO/IEC 17025. For this we recommend looking for special packages that are available from service providers, for example, the ISO 17025 Accreditation Package from Labcompliance (2).

 

3. Management Requirements

Management requirements are related to the operation and effectiveness of the quality management system within the laboratory and has similar requirements to ISO 9001. This part is divided into fifteen chapters.

Organization

This chapter ensures that the roles and responsibilities of the laboratory, the management and key personnel are defined.

Key points are:

• An organizational structure and responsibilities and tasks of management and staff should be defined.
• The organizational structure should be such that departments having conflicting interests do not adversely influence the laboratory´s quality of work. Examples are commercial marketing or financing.
• A quality assurance manager should be appointed.
• All personnel should be free from any commercial and financial pressure that may adversely impact the quality of calibration and test results.

Management System

• This chapter should ensure that a management system is implemented, maintained and continually improved.
• Key points are:
• 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.

Document Control

Individual paragraphs in this chapter should ensure that all documents related to the management system are uniquely identified and created, approved, issued and changed following documented procedures.

Key points are:

• 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 development of initial documents.
• Review of Requests, Tenders and Contracts
• This chapter should ensure that requirements of requests, tenders and contracts are well defined, reviewed, understood and documented.
• Key points are:
• The review by the laboratory supervisors should ensure that the laboratory has technical capability and the 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 should ensure that tests and calibrations subcontracted to 3rd parties are performed according to the same quality standards as if they were done in the subcontracting laboratory.

Key points are:

• The competence of the subcontracted party should be ensured, for example, through a documented quality system, e.g., ISO 17025.
• The subcontracting laboratory is responsible to the customer for the subcontractor’s work.

Purchasing Services and Supplies

This chapter should ensure that services and supplies delivered by 3rd parties do not adversely impact the quality and effectiveness of laboratory operations.

Key points are:

• Suppliers should be selected and formally evaluated to ensure that services and supplies have 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 should ensure that the laboratory continually meets customer requirements.

Key points are:

• The laboratory should cooperate with customers to clarify their requests and to listen to their inputs.
• The laboratory should have a formal program to get ongoing feedback from customers.
• The laboratory should allow customers to audit the laboratory.

Complaints

This chapter should ensure that any customer complaints are documented, evaluated and adequately followed up.

Key points are:

• 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 and calibrations and other laboratory operations should conform with previously defined specifications such as laboratory specifications or specifications as defined by clients. This chapter should ensure that nonconforming test and calibration results are adequately followed up and that corrections are initiated.

Key points are:

• There should be a policy and process that come into effect when results do not conform with procedures.
• Corrective actions should be taken immediately to avoid reoccurrence.
• 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.

Improvement

This chapter should ensure that the effectiveness of the management system is continually improved.

Key points are:

• 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.

Corrective Action

This chapter should 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 are:

• Corrective actions can be triggered through nonconforming tests or other work, customer complaints, internal or external audits, management reviews and through observations from staff.
• Corrective actions should be selected and implemented to eliminate the specific problem and prevent reoccurrence 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 Action

Preventive actions should be initiated when potential sources of nonconformities have been identified. Nonconformities could be technical or related to the management system. The objective is to prevent reoccurrence of the same or similar nonconformities.

Key points are:

• There should be a procedure to identify potential sources of nonconformities and to define preventive actions to prevent reoccurrence of these nonconformities.
• Preventive actions should not be limited to one specific nonconformity, for example, due to the use of a specific non-calibrated instrument for testing. The preventive action plan should ensure that non-calibrated instruments will not be used for testing.
• The effectiveness of the preventive action should be monitored and evaluated.

Control of Records

This chapter should ensure that all records in a laboratory are uniquely identified, that they are readily available when needed and that they are protected against non-authorized access for viewing or changing.

Key points are:

• 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, e.g., test reports of analytical measurements, original observations should be retained together with processing parameters that would 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. In this case the original record should be crossed out and still be 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. It is recommended to use a system that prevents overwriting original records and stores changes in an electronic audit trail that can be viewed and printed.

Internal Audits

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 are:

• 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.

Management Reviews

Requirements in this chapter should ensure the continued suitability and effectiveness of the quality system, policies and testing and calibration procedures.

Key points are:

• here should be a schedule and procedure for periodic management reviews.
• Recommended review frequency is once a year.
• he management review should include a discussion on the outcome from 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. Such activities should be monitored for effectiveness.

4. Technical Requirements

Technical requirements address the competence of staff, sampling and testing methodology, equipment and quality and reporting of test and calibration results. This chapter is divided into ten sections.

General

The technical requirements part starts with a general chapter. It makes readers aware of the fact 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 the factors can contribute to the measurement uncertainty should be used when developing test and calibration methods.

Personnel

Personnel probably have the highest impact on the quality of test and calibration results. This chapter should ensure that all laboratory personnel who can impact test and calibration results are adequately qualified for their job.

Key points are:

• Only competent personnel should perform testing and calibrations. This includes part-time as well as full-time employees and 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 are not 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 which are mostly common sense. For example, one clause recommends having effective separation between neighboring areas when the activities therein are incompatible. An example would be to separate laboratories which 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, for example, means 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 and standard methods and measurement uncertainty and control of data.

Key points are:

• 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, their latest edition should be used.
• Deviations from standard methods or from otherwise agreed methods should be reported to and agreed by the customer.
• 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 be introduced following 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 sample and required information.
• Sometimes, standard and in-house developed 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 tests to prove that the requirements can be fulfilled by using the method and a statement on the validity.

Key points for measurement uncertainty are:

• 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 are:

• Calculations used for data evaluation should be checked. Checking calculations is best done during software and computer system validation. As an example, spreadsheet formula as defined by a specific user should be verified with an independent device, for example, 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 be validated.
• Any modification or configuration of a commercial computer system should be validated. Examples for such configurations are 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 availability of electronic records. For example, computers and electronic media should be maintained under environmental and operating conditions to ensure integrity of data.

Equipment

Well-functioning, performing and maintained equipment are prerequisites to ensure ongoing accurate 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 to perform 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, for example, version numbers of firmware and software. It also includes calibration and test protocols.
• The calibration status should be indicated on the instrument together with the last and the next calibration.

Measurement Traceability

Traceability of equipment to the same standard is a prerequisite for comparability of test and calibration results. Ideally all measurements should be traceable to SI units. 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 are:

• Calibration of equipment should be traceable to the International System of Units (SI).
• 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.

Sampling

This chapter has been added 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 are:

• 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 location should be recorded.

Handling Test and Calibration Items

This chapter should ensure that the sample integrity is maintained during transport, storage and retention and that it is 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 should ensure the quality of results on an ongoing basis, for example, through regular analysis of quality control samples.

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, replicate tests or calibrations using the same or different methods and retesting or recalibration of retained items.

Reporting of Results

This paragraph 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.
• Statement on estimated uncertainty of measurement (for test reports (‘where applicable’).
• When opinions and interpretations are included, the laboratory shall document the basis upon which the opinions and interpretations have been made.
• Opinions and interpretations shall be clearly marked as such in a test report or calibration certificate.

5. Recommendations for Implementation

Now that you have an overview on required management and technical controls we will give recommendations on how to efficiently comply with some key requirements. The scope of this tutorial does not allow going into all the details and we cannot cover all requirements. We will focus on topics which most likely are new to laboratories without a quality system. These include: specific organizational structure, formal equipment calibration and testing, measurement traceability and uncertainty. We try to balance missing detailed information by providing references to official guidelines, textbooks and other literature. For example, EURACHEM/CITAC, EUROLAB and ILAC have developed guidance documents for measurement uncertainty and traceability in measurement (3-9). ISO has published a "Guide to the Expression of Uncertainty in Measurement" (10). A EURACHEM-UK working group has developed a guidance for qualification of analytical instruments which was published in "Accreditation and Quality Assurance" (11). EUROLAB has published a technical report called "Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005" (12). Huber has authored a text book “Validation and qualification in Analytical Laboratories” and Thompson et al. gave recommendations for an "International Harmonized Protocol for Proficiency Testing of Chemical Analytical Laboratories" (14). Help is also readily available from accreditation bodies. For example, A2LA has a "Policy on Measurement Traceability" (15) and Labcompliance provides a complete "ISO/IEC Accreditation Package" with an example master plan, SOPs, forms and checklists (2).

Organizational Structure

ISO/IEC requires that organizational arrangements should be such that departments with conflicting interests do not adversely influence compliance with the standard. For example, finance and QA should operate independently from laboratory activities. Figure 2 shows an example of an organization chart. Finance and QA do not report to laboratory management but rather to the director of the company.

Figure 2: Example for Organizational Structure (from Reference 2)

 

Equipment

Each laboratory should have a plan on how to ensure adequate equipment functioning and performance before and during sample measurement. Main activities are calibration, checks to verify specified performance and maintenance.

The extent of testing depends on the complexity and use of the equipment. Each laboratory should have processes on how calibration and testing is performed for different types of equipment. Preferably the whole range of equipment should be divided into a few categories, for example, A, B and C and calibration and/or verification tests should be associated with each category. Instruments in the simplest category A such as stirrers and mixers usually don’t need to be tested but only visually inspected. Category B instruments such as balances and pH meters should be calibrated according to manufacturer SOPs and more complex instruments such as gas chromatographs should be fully tested according to their intended use.

In the following paragraphs we give recommendations on how to specify, test and maintain analytical equipment for ISO/IEC 17025 compliance.

Documenting Specifications

ISO/IEC 17025 requires that equipment and software should comply with specifications that are relevant to the tests. Therefore, the first step in the process is to define and document the equipment specifications.

• For simple equipment such as balances and pH meters the use of manufacturer specifications is recommended.
• For more complex equipment hardware such as gas chromatographs or mass spectrometers the manufacturer’s specifications can also be used. This is only recommended as long as all vendor-specified functions are required by the intended applications over the full specified range. Alternatively the user can define his/her own specification according to the intended use of the instrument.
• Commercial software and computer systems typically provide more functionality than required by a specific user. Therefore, for computer systems, the user should define his/her own specifications according to the system use. A functional specifications list will help define user specifications.

Selecting a Vendor

 Selecting equipment suppliers should follow a documented procedure and well-defined criteria. Such criteria are:

• Vendor’s equipment meets the user’s requirement specifications
• Leading position of the vendor in the marketplace.
• Design, development and manufacturing of equipment and software in a quality system environment, e.g., ISO 9001.
• Installation, familiarization and training services
• Metrology based calibration and functional testing services through qualified engineers
• Phone and onsite support in local language.

Installation and Documentation

Installation can be performed by the vendor or by the user. Steps include:

• Verification that the location meets the environmental specifications as defined by the vendor.
• Installation of equipment hardware according to vendor specifications.
• Installation of software and start-up according to vendor specifications
• Documentation of hardware and software, e.g., vendor, product number, model number, serial number and location.

Initial Testing for Calibration and/or Performance Verification

Equipment used for measurement should be tested before initial use to ensure its suitable performance. This is performed through calibration, for example, the mass of a balance, or through verification with specified performance characteristics, for example, sampling precision of a gas chromatograph.

Steps for testing include:

• Develop test procedures and test protocols.
• Define acceptance criteria based on documented specifications
• Select and order traceable test tools, for example, reference weights for calibration of a balance.
• Make sure that test engineers have the right qualifications to perform the tests.
• Perform the tests and document test results.
• Verify that acceptance criteria are met.
• Label the equipment with the status, e.g., last and next calibration.
• Maintain records of calibration and checks.

These tests can be performed by the vendor or by the user. Advantages of testing by the vendor can be demonstrated using the Agilent Functional Verification Service (FVS) for gas and high-performance liquid chromatography as example . This service was specifically developed to meet ISO/IEC 17025 requirements.

• Agilent has decades of knowledge and experience with factory and field testing of equipment. As a result the selection and sequence of the test is optimized for highest speed and lowest instrument downtime, without comprising accuracy and calibration specifications.
• Agilent engineers bring along calibrated test tools that meet traceability requirements.
• Agilent engineers also bring certificates to document qualification.
• Agilent’s tests are combined with recommended preventive maintenance for all the critical functional components of the equipment.
• Agilent provides global lab-to-lab consistency via standardized and well recognized maintenance and verification testing protocols.
• Agilent’s calibration and test certificates are globally well recognized by internal auditors and official assessors.

Testing During Ongoing Use

Equipment characteristics and performance can change over time. Therefore, the equipment quality program should have ongoing measures to prove that the equipment is suitable for its intended use, which means equipment should be routinely tested.

The type and frequency of such tests depends on the equipment. For example, a balance is checked daily with laboratory reference weights and a chromatograph can be checked using well-defined quality control samples.

In addition to the more frequent tests that only challenge a subset of all specifications, it is recommended to repeat all the initial tests as described above, for example, for chromatographs, once a year. A balance is also typically calibrated once a year by the vendor with calibrated and traceable standard weights.

Maintenance and Repair

The laboratory should have a maintenance plan to carry out preventive maintenance activities and a procedure for unplanned repair to ensure ongoing performance and reliability.

• Defective equipment should not be used for tests and calibration. Smaller devices should be taken out of the laboratory and bigger instruments should be clearly labeled as being defective. Specified functioning and performance should be verified after repair.
• Records of maintenance and repairs should be maintained.

Software and Computer Systems

ISO/IEC 17025 requires computer systems and software used for acquisition, processing, recording, reporting, storage and retrieval of test and calibration data to be validated when the software is developed, configured or customized by the user. Commercial Off-the-Shelf (COTS) software, for example, word processors or databases may be considered to be validated.

EUROLAB has developed a technical report with recommendations for "Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005" (12). The report not only advises on validation steps for different software and system risk categories but also has recommendations on how to ensure security, availability, integrity and confidentiality of electronic records.

The report divides software into five categories:

1. Operating systems.
2. Firmware as built into automated equipment.
3. Standard software packages, e.g., word processors and non-configurable computerized analytical systems.
4. Configured software packages, e.g., Excel formulae and configurable computerized analytical systems.
5. Custom built software.

Figure 3 shows simplified validation activities for all five categories.

Measurement Traceability

ISO/IEC 17025 requires reference material used for calibration of measurement equipment to be traceable to SI Units, where possible. Typically laboratories use their own internal reference material for calibration. Traceability of such material to SI units can be achieved through an unbroken chain of comparisons between laboratory reference material and SI units. An example is shown in Figure 4.

 

Figure 4: Traceability Chain of Laboratory Reference Material

Working standards are regularly compared by an accredited laboratory with secondary standards which are calibrated by a national metrology institute or an accredited reference laboratory. For this kind of comparison the measurement uncertainty should be known and documented in calibration certificates so that the measurement uncertainty of the working standard can be estimated and reported.

This concept works well for physical measurement such as meter (m) for length, kilogram (kg) for mass and Kelvin (K) for temperature. For this reason reference balance masses, thermometers and thermocouples should be traceable to SI Units through an unbroken chain of comparisons performed by accredited laboratories and national metrology institutes.

For most reference material used for chemical measurements traceability to SI units is very difficult and not practical. The traceability chain in Figure 4 ends at the lower level, e.g., at suppliers of standard reference material, for example, NIST, at suppliers of certified reference material or at a company’s accredited metrology laboratory. When traceability to SI is not possible, ISO/IEC 17025 recommends the use of certified reference material that is provided by a competent supplier and is well characterized. Alternatively well-defined methods also called primary or definitive methods as agreed by all parties can be used to establish traceability. This topic has been discussed in different working groups. For example, detailed recommendations have been published by ILAC (7) and EURACHEM/CITAC (8). X.R. Pan (17) suggested a classification scheme of reference material used for chemical measurements. The classification as described below is well accepted in chemical laboratories.

 

Primary Reference Material

• Also called primary standards.
• Developed by a national metrology laboratory.
• Certified by primary/consensus method.
• Traced back to SI units and/or verified by international comparison

Certified Reference Material

• Also called secondary standards.
• Derived from primary reference material with statement of uncertainty.
• Usually prepared by a specialized reference laboratory.
• Certified by reference methods or comparison methods.
• Recognized by national or otherwise specialized authoritative organization.
• Working Reference Material
• Also called internal reference material.
• Derived from certified reference material.
• Accuracy verified by well characterized and validated methods.

 

Measurement Uncertainty

There is an uncertainty associated with every test and calibration. For testing, this occurs from errors arising at the various stages of sampling, sample preparation, measurement and data evaluation. In other words, whenever any quantitative measurement is performed, the value obtained is only an approximation of the true value. Users of the measurement data should have an idea of how much the reported result may deviate from the true value.

ISO/IEC 17025 recommends the results of quantitative measurement to be reported as both a single value and together with the possible deviation from the true value. This is logical for any report with quantitative results. It is, for example, of no use if a report on a food sample states 0.1 percent of compound X, and the user of the data is still unsure whether this could be 0.05 or 0.4 percent. An uncertainty statement provides the user with information on the approximate measurement tolerances and the expected limits within which the true value of the measurement, such as analyte concentration, is supposed to lie. Without such documentation, although the analyst can estimate the level of uncertainty many times, the client or user of the data cannot.

Information on uncertainty is of particular importance if a specification limit is to be verified and reported. For example, if according to a purchasing agreement, a product can only be released if compound X is below 0.5 percent, the test report may not contain a statement about compliance if the measurement results extended by the measurement uncertainty is above 0.5 percent. When parameter(s) are claimed to be within a specified tolerance the measurement value(s) extended by the estimated uncertainty of measurement shall fall within the specification limit.

ISO has published a "Guide to the Expression of Uncertainty in Measurement" (10). It establishes general rules for evaluating and expressing uncertainty in measurement across a broad spectrum of measurements. EURACHEM has produced an excellent document containing much more detail on how the concepts of the ISO guide can be applied in chemical measurement (4). The whole process of measurement uncertainty is schematically shown in Figure 5. The basic ideas are explained in this tutorial, but for more detailed information, readers are encouraged to study the EURACHEM document (4).
The concept of evaluating uncertainty is fairly straightforward. It requires a detailed knowledge of the nature of the measurand and of the measurement method, rather than an in-depth understanding of statistics.

 

Figure 5: Estimating Measurement Uncertainty

 

1. Develop the specifications by writing a clear statement of exactly what is to be measured and the relationship between this and the parameters on which it depends. For example, if the measurement temperature has an influence on the result, the measurement temperature should also be defined.
2. Develop a workflow diagram for the entire sampling, sample preparation, calibration, measurement, data evaluation and data transcription process (see Figure 1 for analytical sample testing).
3. Identify and list sources of uncertainty for each part of the process or for each parameter. Possible sources for errors may be derived from non-representative sampling, operator bias, a wrongly calibrated instrument, lack of ideal measurement conditions, chemicals with impurities and errors in data evaluation.
4. Estimate and document the size of each uncertainty, for example, as standard deviations or as RSDs. These data should be gathered from a series of measurements. Where experimental evaluation is impossible or impractical, the individual contributions should be estimated from whatever sources are available. Sources for this kind of estimation can be found in the supplier’s information or in the results of interlaboratory studies or proficiency testing. The procedures and thoughts behind the way the contributions have been measured or estimated should be documented.
5. Combine separate contributions in order to give an overall value. For example, where individual sources of uncertainty are independent, the overall uncertainty can be calculated as a multiple of the sum of squared contributing uncertainty components, all expressed as standard deviations. Computer software or spreadsheet programs can help to automate this calculation.

The whole procedure should be documented in such a way that sufficient information is available to allow the result to be reevaluated if new information or data become available. A complete documentation should include:

• A description of the methods used to calculate the measurement result and its uncertainty from the experimental measurements.
• The values and sources of all corrections.
• A list of all components of uncertainty with full documentation on how each of these was evaluated.

Reference 4 includes many practical examples with data from different analyses, as well as formulas for evaluating, calculating and reporting standard and expanded uncertainty. Sample analysis reports should include an uncertainty number, which is typically expressed as:

Result = x ± u (units)
or
Result = x (units)
Uncertainty = u (units)

6. Steps Towards ISO/IEC 17025 Accreditation

ISO/IEC 17025 accreditation should be well thought out and well prepared. It can be quite expensive but can also have big benefits. The balance between costs and benefits should be worked out and documented.

Going for ISO/IEC 17025 will impact the entire laboratory and supporting services such as human resources, documentation and finance departments. Therefore, while the decision to initiate and fund the project will be made by management, all affected departments should be involved in the process.

The entire process is divided into two phases: Investigation phase and implementation phase. In the investigation phase information is collected to decide if going for accreditation makes business sense. Once the decision is made the laboratory develops and implements documentation in preparation for the accreditation assessment.
Figure 6 illustrates the steps for both phases.

Figure 5. Steps towards ISO/IEC 17025 accreditation

Investigation

1. Management initiates, funds and otherwise supports the investigation.
2. Management nominates a project owner. Ideally the person should be well experienced in laboratory operations, have a good business understanding, good communication skills and a good understanding of quality systems.
3. The project manager with support from management recruits a project team. Members should come from the laboratory management, QA, finance, human resources, training and documentation groups.
4. The project team defines the scope of the intended accreditation. This could include all calibrations and/or tests performed in a lab or just part of them.
5. The project team studies the accreditation requirements in detail. The main source is the standard ISO/IEC 17025, that is supported by official guidelines, other literature and by external expert advice.
6. The project team develops a requirements list. The list should also include all documents as required by the standard, for example, policies, a quality plan and procedures for most of the requirements.
7. The project team prepares a gap analysis through a comparison between ISO requirements as listed above and what is already available and implemented. A gap exists where existing policies, processes or procedures do not fully meet the stated requirements. This should include all processes and procedures for management controls and technical controls such as for sampling, method validation, equipment calibration, qualification and maintenance, people qualification and others.
8. Using the outcome of the gap analysis the project team develops a task list. The list is completed with additional tasks such as selecting and dealing with an accreditation body.
9. The project team together with the help of an external consultant makes an estimation of the overall ISO/IEC implementation costs. This should not only include costs for initial set-up but also for maintaining the quality system. The costs are compared with direct and tangible estimated additional return that comes from getting accreditation status. Tangible returns are, for example, savings through more efficient operation.
10. The team makes a rough estimation of the return of investment for both short and long term and makes a recommendation to management.
11. Management decides to accept or reject the proposal and go for the accreditation or not.

Implementation

1. If the decision is made to pursue accreditation the project owner forms implementation teams for different areas. It is most important that all affected departments at all management levels are represented in the teams.
2. The project owner with the help of QA searches for an accreditation body and selects the one that best fits the laboratory´s needs. There are several possibilities to find accreditation bodies. Probably the best way is to ask accredited laboratories about their experiences.
3. The teams develop documentation, e.g., procedures under the supervision of the project owner.
4. The project owner arranges for staff training.
5. Quality assurance performs an internal audit and initiates corrective actions, if necessary.
6. The selected accreditation company performs a pre-assessment.
7. The project owner initiates corrective actions.
8. The accreditation company performs an accreditation audit.

7. Documentation

ISO/IEC requires different types of documentation as illustrated in the documentation pyramid in Figure 7.

Figure 7: Documentation Pyramid

 

A policy documents the laboratory´s intent to implement ISO/IEC 17025. The Quality Manual is the top tier of the document hierarchy. It describes the approaches to achieve quality data. It also includes policy statements describing the intent and goal of the laboratory to conform with ISO/IEC requirements. For example, a policy statement could be: All personnel involved in calibration and testing should be competent for the assigned task.

A process or generic procedure describes how various quality requirements can be achieved. For example, it describes how the requirement ‘Personnel should be competent for the assigned task’ can be implemented

Standard Operating Procedures or Working Procedures are step-by-step instructions on how to exactly perform a specific task, for example, how to calibrate a specific instrument.
Records are generated on a day-by-day basis. Examples are analytical results from product tests or calibration records of a balance.

All documents should be well controlled, for example, each change should be authorized and logged and the updated document should get a new revision number or code.

Policies and Quality Manual

Policies including the quality policy statement should be documented in the quality manual. The quality policy statement should be written by senior management. It should outline the laboratory’s commitment to quality. The quality manual describes the quality system and documents the laboratory's goal and overall concept on how to conform with ISO/IEC17025. It should also describe how the remainder of the quality system documentation is organized. It should be developed by working groups representing different departments.

Processes

Processes or standard procedures describe how various ISO/IEC 17025 requirements can be achieved. For example, it describes how the requirement ‘All personnel involved in calibration and testing should be competent for the assigned task’ can be implemented. Another example is the laboratory´s approach to calibrate and check different types of equipment. For a better understanding, process flow charts should be included in a process description.

(Standard) Operating Procedures and Work Instructions

Routine activities follow documented procedures. These are typically defined as standard operating procedures and/or work instructions. While quality manuals and processes describe the tasks and approaches, procedures and work instructions give step-by-step instructions on how to do the tasks. Examples for SOPs are procedures for checking and calibration of equipment. All laboratory SOPs should use the same format, which makes it easy for writing and reading. A good practice is to have a SOP on how to author, review, approve, distribute and update SOPs. Preferably SOPs should be written by senior members of anticipated user groups. This helps ensure that SOPs have the right level of information and are used and followed.

Records

Records to demonstrate conformity with ISO/IEC 17025 and as required by customers should be retained for a specific amount of time. Examples are original laboratory observations, test results, supporting documents such as chromatograms and also training certificates and equipment calibration protocols.

Checklists, forms, templates and examples help implement quality work effectively and consistently. Examples are checklists and worksheets for vendor assessment, handling nonconforming test results and for internal audits. They help document specific tasks consistently and effectively.

Document Control

Development and maintenance of documentation should be controlled through document control and management procedures that are part of the management system. Documents include internal and external documents. Examples for internal documents are SOPs, quality manuals and training plans. Examples for external documents are regulations, standards, test methods and instrument operating manuals.

The procedure for document control should ensure that:

• Official documents are created or acquired, reviewed and approved prior to use.
• Documents are uniquely identified with document and revision number, date of revision and issuing authority.
• A quality list with all controlled documents is maintained by QA. The list includes document and revision number, title, date of issue, date of last review and locations.
•  Internal documents include page number and total number of pages on each page.
• Users of the documents are adequately trained before the documents are released for use.
• Current authorized versions are readily available at the user’s workspace.
• Documents are reviewed according to a schedule and revised to ensure suitability and ongoing conformance with regulations and internal procedures.
• Invalid and obsolete documents are promptly removed from all points of issue or use, or marked as uncontrolled to ensure that only current authorized versions of appropriate documents are available for active use at relevant locations.
• Obsolete documents retained for either legal or knowledge preservation are marked as ‘Archived’, dated and signed. The retention period for the documents conforms with internal procedures.
• Changes to a document are reviewed, approved and communicated to users.
• The changes are recorded in a document change log. The log information indicates the reason and the nature of the change.
• When documents are created, signed and maintained in electronic form, the computer system and records comply with national or international regulations and guidelines for electronic or digital signatures.

8. Internal and External Audits

Internal audits are managed by the quality manager. They verify conformance with the ISO/IEC 17025 requirements and with company policies, processes and procedures. They are also quite useful in preparation for external audits. External auditors can come from clients or from accreditation bodies. They verify that the laboratory is operating in compliance with ISO/IEC 17025.

There should be procedures that clearly outline who is doing what before, during and after internal and external audits. Overall owners should be defined and all employees who may be affected by the audit should be trained. This chapter summarizes recommendations for audits. To make best use of internal audits they should be designed, executed and followed up very much in the same way as external audits are expected to be. The recommendations for preparation, conduct, documentation and follow-up are written for the audited departments, not for the auditors.

Internal Audit Schedule

Internal auditing should follow a predetermined schedule covering all activities over a reasonable period of time. It is inconvenient to audit all activities in a single audit so it should be spread over several quarterly or monthly audits. The schedule for such audits is conveniently drawn as a matrix covering, for example, a year in which dates are set for each part of the quality system. Audit schedules can be organized as horizontal or vertical. A vertical audit checks compliance of, for example, a single test through all steps and records from sampling to archiving of records. A horizontal audit examines every aspect of a single requirement, for example, equipment. shows an example for a horizontal audit.

Figure 8: Example for Horizontal Audit Schedule

Preparation

• Assign an overall owner and host for the audit.
• Assign a technical contact to get access and review the completeness of records and other documentation for items to be audited. The assigned technical contact should be present all the time.
• Set up a work area for the inspectors.
• Review the schedule.
• Prepare and train staff.An audit may be a tough experience for all people involved. They therefore need to be informed on what will happen and what questions may be asked.

Conduct

• Maintain a continuous log of the audit.
• Provide copies (do not give originals away).
• Keep duplicates of all information supplied to auditors.
• Take immediate corrective action, when appropriate.
• Hold a daily debriefing meeting to assess the progress.
• Keep all documents in the work area.
• Accompany the auditor all the time.
• Be courteous and cooperative.
• Answer only questions that are asked.
• If you are unable to answer, tell the auditor openly.
• Protect proprietary information.

Close

• Clarify any open questions or cause for dissatisfaction in the exit meeting.

Follow-up

• Develop a corrective action plan (owners, tasks, deliverables and schedule).
• Develop a preventive action plan (owners, tasks, deliverables and schedule).
• Monitor the plan.

9. Dealing with Multiple Regulations and Quality Standards

Laboratories are frequently faced with a situation where they have to comply with both regulations and quality standards at the same time.

Examples are:

• A clinical laboratory performs contract analyses from pre-clinical and clinical studies for pharmaceutical companies. The laboratory also performs special tests for hospitals. The laboratory has to operate in compliance with US FDA and EU GLP and GCP regulations for clinical and pre-clinical study tests. Some customers also require laboratory accreditation according to ISO/IEC 17025, others also according to ISO 15189, a standard for medical laboratories.
• A chemical company is certified for ISO 9001. The scope of the certification also covers the analytical service laboratory. In addition, the laboratory performs contract analyses for other companies and has received laboratory accreditation in compliance with ISO/IEC 17025. The laboratory has to work in compliance with ISO 9001 and with ISO Guide 17025.
• An independent test laboratory performs GLP studies as a subcontractor for a pharmaceutical company. Occasionally, the laboratory also performs analyses for pharmaceutical manufacturing control departments. The laboratory has also received laboratory accreditation for specific food analyses according to ISO/IEC 17025. The laboratory has to comply with ISO/IEC 17025 and with GLP and cGMP regulations.

International companies frequently face this kind of problem. Their laboratories not only have to comply with regulations from different countries but also, simultaneously, with quality and accreditation standards. The solution to this problem is to combine all regulations and quality standards in a single quality manual and a single set of operating procedures. The recommended documents and how they relate to each other are shown in Figure 7.

The quality manual should place the company’s own quality system first and foremost. This may be based on a well-known laboratory quality standard, such as ISO/IEC 17025.

The quality manual and operating procedures should include aspects of various regulations and quality standards applied within the company. For specific requirements only required by single regulations the quality manual and procedures should include sections that only apply to those particular regulations. For example, in the ‘responsibility’ section it should mention that for GLP studies the function of a study director is required. The tasks and responsibilities should be described in a SOP.

References

1. ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories, 2005.
2. Labcompliance, ISO/IEC17025 Accreditation Package, 2009.
   http://www.labcompliance.com/books/iso17025
3. EURACHEM/CITAC Guide, Use of Uncertainty Information in Compliance Assessment, 2007.
4. EURACHEM/CITAC Guide CG4, Quantifying Uncertainty in Analytical Measurement, ISBN 0-948926-15-5, 2000.
5. EUROLAB, Measurement Uncertainty Revisited: Alternative Approaches to Uncertainty Evaluation, 2007.
6. ILAC, Introducing the Concept of Uncertainty in Association with the Application of the Standard ISO/IEC 17025, 2002.
7. ILAC Policy on Traceability of Measurement Results, 2002.
8. EURACHEM/CITAC Guide, Traceability in Chemical Measurement: A Guide to Achieving Comparable Results in Chemical Measurement, 2003.
9. EUROLAB, Guide to the Evaluation of Measurement Uncertainty for Quantitative Test Results, 2006.
10. ISO Guide 98-3, Uncertainty of measurement -- Part 3: Guide to the Expression of Uncertainty in Measurement (GUM:1995), Geneve, Switzerland, 2008.
11. P. Bedson and M. Sargent, The Development and Application of Guidance on Equipment Qualification of Analytical Instruments, Accreditation and Quality Assurance, 1 (6), 265-274 (1996).
12. EUROLAB Technical Report 2/2006, Management of Computers and Software in Laboratories with Reference to ISO/IEC 17025:2005.
13. L. Huber, Validation and Qualification in Analytical Laboratories, Interpharm, Informa Healthcare, New York, USA, 1998. Second revision 2007.
14. M. Thompson, S. Ellison and R. Wood, International Harmonized Protocol for Proficiency Testing of Chemical Analytical Laboratories, Pure Appl. Chem., Vol. 78, No. 1, pp. 145–196, 2006, www.iupac.org/publications/pac/2006/pdf/7801x0145.pdf.
15. American Association for Laboratory Accreditation, A2LA Policy on Measurement Traceability, 2005.
16. ISO/IEC Guide 2, Standardization and Related Activities: General Vocabulary, 2005.
17. X. R. Pan, Hierarchy of Reference Materials Certified for Chemical Composition, Metrologia 34 (1997) 35-39.

Links to Other Websites 

To be updated on an ongoing basis

• ISO Organization
  For ordering ISO Standards and Other Documents
• EURACHEM
  Has useful downloads that help to implement ISO 17025
• Labcompliance Tutorial: Computer System Validation
  Useful information how to validate computer systems in laboratories
• Laboratory Compliance Package
  Comes with laboratory compliance master plan, 30+ SOPs and Checklists
• ISO 17025 Accreditation Package

Frequently Asked Questions 

This chapter will be updated based on questions and contributions from visitors

Q: Is ISO 17025 Accreditation required and sufficient to comply with FDA Regulations, such as GLP and GMP?

Most requirements are the same or very similar, but ISO 17025 is neither required nor sufficient. However, many FDA laboratories have ISO 17025 implemented.

Rev 2: 2005

Q: When has ISO/IEC 17025 been introduced ?

Rev 1: 1999

Rev 2: 2005

Q: Is there any website where you can view or download the ISO 17025 Standard?

ISO Standards are copyright protected. I am not aware of a website with free download.

Q: Which organizations can award ISO 17025?

There are many in each country. To find them in your area, use Google Search.

Q: What to do in case there is no proficiency testing scheme for my application?

Do everything you can to proof accuracy of your analytical data. Mechanisms include: extensive use of certified reference material, verification of accuracy with an independent analysis method and cross check of results within other departments in you organization. Document the steps you took. 

Q: Is an ISO/IEC 17025 accredited laboratory also automatically ISO 9001 Certified?

ISO 17025 has a statement that testing and calibration laboratories that comply with the International Standard will also operate in accordance with ISO 9001.

On  the other hand it states that  demonstrated conformity to this International Standard does not imply conformity of the quality management system within which the laboratory operates to all the requirements of ISO 9001. This means, ISO 17025 conforms to related requirements of ISO 9001, but it does not contain all the requirements as specified in ISO 90001. So the answer to question above is 'no'.

Expert Advice on Selected Topics

This chapter will be updated on an on-going basis