ISO/IEC 17025 in Analytical Laboratories
Introduction
Companies have to ensure delivering continuously consistent high
quality products and/or services if they want to be successful in
the marketplace long term. Quality improvement has become a key
national and international business strategy. Quality derives from
good design, selection of high quality parts, a well controlled
manufacturing process and finally continuous quality control. 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. When a company purchases parts
from another company, a supplier's quality system should be assessed
to establish confidence in the supplier's quality system
capabilities. Companies using analytical equipment to control the
quality of products have to make sure that the equipment produces
analytical data reliably and with high quality.
Part of a quality system can be an qualification of the purchaser
organization at the vendor's site to verify adherence to the
company’s own standards or standards established by an industrial
association. The purpose of such audits is to determine whether or
not the supplier conforms to pre specified contractual procedures
imposed by the purchaser. Larger corporations developed Supplier
Quality Assurance (SQA) programs to improve the quality of the
purchased goods and to reduce costs associated with incoming
materials inspection. It has been common for suppliers to be
assessed several times by many purchasers. This was time consuming
and expensive. Replacing repeat purchaser assessments with an
independent third party assessment reduces the number of visits and
is more economical for both the supplier and the purchaser.
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 have been 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.
Testing laboratories play an important role in the quality
systems of the companies. The ISO/IEC 17025 can be used by
laboratories as a standard to develop and establish a Quality System
in the laboratory and for the assessment by their clients or by
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 the result of extensive experience in
the implementation of ISO/IEC Guide 25 and EN 45001, both of which
it replaced. It contained all of 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.
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 this second edition (2005),
clauses have been 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 should use this
International Standard as the basis for their accreditation.
The standard ISO/IEC 17025 mainly includes two parts: management
and technical requirements. The standard has been updated in updated
mainly in the area of management controls.
Implementing a quality system based on ISO 9000 series and/or
ISO/IEC 17025 have an impact on a laboratories organization and
operation. This tutorial will discuss some of their specific
criteria along with their implications for testing laboratories.
2. Scope of this Tutorial
This tutorial is useful for chemical analytical laboratories that
seek accreditation according to an internationally recognized
standards. Examples are food testing, environmental testing,
chemical testing, clinical testing, and other testing laboratoroes.
The tutorial will guide laboratory personnel and managers
personnel, and QA managers, through the entire process of ISO
17025 certification.
It also helps laboratories that have to work under different
quality systems to efficiently set up procedures for compliance with
all requirements.
It covers
- Overview of ISO 17025
- Management requirements
- Technical requirements
- Impact on analytical laboratories.
- Implementing ISO 170 25
- Required documentation
The tutorial and its reference material
should give a good understanding why 17025 is important 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.
3. ISO 17025 Content Overview
ISO/IEC 17025 is divided into two principal parts:
- Management requirements (Sect 4)
Most of the requirements are new and are similar to those
specified in ISO Standards 9001 and 9002.
- Technical requirements (Sect 5)
Most of the requirements come from ISO guide 25. There are also
new ones, the most important one of them is to "Report
measurement uncertainty".
Management Requirements
This part aligns management aspects of ISO/IEC DIS 17025 with ISO
9001. It is expected that laboratories implementing ISO/IEC 17025
would only need a single quality system.
Management requirements include 15 paragraphs on
- Organization and management (4.1)
- Quality system (4.2)
- Document control (4.3)
- Review of request, tenders and contracts (4.4)
- Subcontracting of tests and calibrations (4.5)
- Purchasing services and supplies (4.6)
- Service to the customer (4.7)
- Complaints (4.8)
- Control of non-conformity testing and/or calibration work
(4.9)
- Improvement (4.10)
- Corrective action (4.11)
- Preventive action (4.12)
- Control of records (4.13)
- Internal audits (4.14)
- Management reviews (4.15)
Technical requirements
This chapter includes 10 paragraphs such as
- General information (5.1)
- Personnel (5.2)
- Accommodation and environmental conditions (5.3)
- Test and calibration methods including sampling (5.4)
- Equipment (5.5)
- Measurement traceability (5.6)
- Sampling (5.7)
- Handling of test and calibration items (5.8)
- Assuring the quality of test and calibration results (5.9)
- Reporting the results (5.10)
4. Management Requirements
This part includes elements of ISO 9001 and is divided in
Organization
Roles and responsibilities of the laboratory, the management and
key personnel
Quality system
Laboratory shall implement a quality system appropriate to the
scope of its activities
Document control
This chapter has paragraphs on creation, approval, issue and
change of documents.
Review of requests, tenders and contracts
The laboratory shall establish and maintain procedures for the
review of requests, tenders and contracts
Subcontracting of tests
When a laboratory subcontracts work whether this work shall be
placed with a competent subcontractor. A competent subcontractor is
one that, for example, complies with this International Standard for
the work in question
Purchasing services and supplies
Requirement for a policy and procedure(s) for the selection and
purchasing of services and supplies it uses that affect the quality
of the tests and/or calibrations. Purchased supplies, reagents etc
should be checked before use.
Laboratory shall evaluate suppliers of critical consumables,
supplies and services
Service to the client
What it basically says is that clients should be allowed to audit
the laboratory
Complaints
The laboratory shall have a policy and procedure for the
resolution of complaints received from clients or other parties.
Control of nonconforming testing and/or calibration work
There should be procedures in case of non-conformance to
specifications. Actions should be defined in case of such
non-compliance, e.g., could be holding the work, or notification of
the client, or recall the work. If this appears to be a general
problem, a corrective action plan should be developed
Corrective action
Corrective action plans be in place in case of non-conforming
work. Start with an investigation to determine the cause of the
problem. Actions should be taken to prevent recurrence of the
problem. Actions should be based on risk analysis.
Preventive action
Identify the need for improvements and potential sources of
non-conformance. This is a pro-active process to identify
opportunities of improvement rather than reaction of identified
problems or complaints. Preventive action might involve analysis of
data, including trend analysis, risk analysis and participation in
proficiency testing
Control of records
Procedures for identification, collection, indexing, access,
filing, storage, maintenance, disposal of quality and disposal of
quality and technical records. Records should be protected against
damage. Records can be on paper and on electronic media. There
should be procedures to protect and back-up records and to prevent
unauthorized access. The paragraph also lists details of contents of
technical records. It also has the clear requirement that records
must not be erased or deleted in case of corrections, this holds for
paper records as well as for electronic records. Changes must be
signed.
Internal audits
The laboratory shall periodically, and in accordance with a
predetermined schedule and procedure, conduct internal audits of its
activities to verify that its operations continue to comply with the
requirements of the quality system and this International Standard.
Recommended audit cycles: one year.
Management reviews
Management shall periodically conduct a review of the
laboratory's quality system and testing and/or calibration
activities to ensure their continuing suitability and effectiveness,
and to introduce necessary changes or improvements
It is interesting to note that some of the paragraphs have
similar requirements as the CGMP regulations. Examples are
requirements for document control, control of records, and
preventive actions and corrective action plans.
5. Technical Requirements
Technical requirements - general
This chapter deals with factors that can influence the quality of
tests results. It is divided in 10 sections:
Personnel
The chapter on personnel includes five paragraphs
- Competence through appropriate education, training,
experience and/or demonstrated skills. This may include relevant
knowledge of the technology and legislation/standards and to
understand significance of deviations.
- Formulation of goals for education, training and skills.
Policy to identify training needs.
- People should be contracted by the lab or the lab should
make sure that people are supervised and competent
- Development and maintenance of job descriptions with
responsibilities
- Laboratory shall authorize people for specific tasks
Key element of personnel is appropriate training and
documentation of all training activities. The training needs for all
personnel whose work affects quality must be identified. For
example, the operator of a GC/MS needs to get trained before (s)he
operates the instrument and internal auditors will have to be
trained prior to conducting internal audits.
Accommodation and environmental conditions
This paragraph has been included to monitor and control that the
environment of calibration and test areas will not adversely affect
the accuracy of measurement. It includes 5 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, on the one hand, extremely low traces of a solvent and on
the other, those which consume large quantities of the same solvent
for liquid/liquid extraction. Key points are:
- Environmental conditions should not invalidate the results
or adversely affect the required quality of tests
- Laboratory shall monitor, control and record environmental
conditions. Pay attention to biologic sterility, dust,
electromagnetic disturbances, radiation, humidity, electrical
supply, temperature, sound, vibration. Stop tests when the
environmental conditions jeopardize the results.
- Separate areas in which there are incompatible activity
- Limit access to test area to authorized people
Test and calibration methods and method validation
This paragraph deals with selection and validation of laboratory
developed and standard methods and with measurement uncertainty and
control of data. The laboratory shall use appropriate methods and
procedures for all tests and/or calibrations within its scope. These
include sampling, handling, transport, storage and preparation of
items to be tested and/or calibrated, and, where appropriate, an
estimation of the measurement uncertainty as well as statistical
techniques for analysis of test and/or calibration data.
Key points for methods are
- Use methods and procedures within it's scope. That means,
the scope must be clearly defined
- Laboratory shall have up-to-date instructions on the use of
methods and equipment
- Select standard methods, if available. Use the latest
available edition.
- Methods developed by the laboratory can be used, but must be
fully calibrated. Clients should be informed on the method
chosen. Clients should agree to the method.
- Introduction of laboratory developed methods should be
introduced following a plan.
- Standard methods should also be validated if they are partly
or fully out of the scope of the test requirement
- Validation may include procedures for sampling, handling and
transportation
- When some changes are made in the validated non-standard
methods, the influence of such changes should be documented and,
if appropriate, a new validation should be carried out
- The range and accuracy of the values obtainable from
validated methods (e.g. the uncertainty of the results,
detection limit, selectivity of the method, linearity, limit of
repeatability and/or reproducibility, robustness against
external influences and/or cross-sensitivity against
interference from the matrix of the sample/test object) shall be
relevant to the client's needs
- Validation includes specification of the requirements,
determination of the characteristics of the methods, a check
that the requirements can be fulfilled by using the method, and
a statement on the validity
- Methods should be clearly documented, a list of
documentation items is given in this paragraph
Key points for measurement uncertainty are
- Laboratory shall have a procedure to estimate the
uncertainty of measurement for ALL calibrations and types of
calibrations
- The laboratory shall at least attempt to identify all the
components of uncertainty and make a reasonable estimation, and
shall ensure that the form of reporting of the result does not
give a wrong impression of the uncertainty.
- Note: Sources contributing to the uncertainty include, but
are not necessarily limited to, the reference standards and
reference materials used, methods and equipment used,
environmental conditions, properties and condition of the item
being tested or calibrated, and the operator
Key points for control of data are
- Calculations and data transfers shall be subject to
appropriate checks in a systematic manner. This means, they
should be validated.
- When computers or automated equipment are used for the
acquisition, processing, recording, reporting, storage or
retrieval of test or calibration data, the computer software
developed by the user is documented in sufficient detail and is
suitably validated as being adequate for use.
- Authors comment: Computer software includes all types of
software, including Macros for spreadsheet programs and data
systems.
- Procedures should be established and implemented for
protecting the data; such procedures shall include, but not be
limited to, integrity and confidentiality of data entry or
collection, data storage, data transmission and data processing
Equipment
This paragraph deals with 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.
Key requirements for equipment are
- Equipment shall comply with specifications relevant to the
tests. Very important: It does not say, according to the
manufacturers specifications, but relevant to the tests.
- Before being placed in service, equipment shall be
calibrated or checked to establish that it meets the
laboratory's specification requirements. In literature this
process is called operational qualification.
- Each item of equipment and its software used for testing and
calibration and significant to the result shall, when
practicable, be uniquely identified
- Records shall be maintained of each item of equipment and
its software significant to the tests and/or calibrations
performed. This includes, for example, version numbers of
firmware and software. It also includes test results for
qualification.
- The laboratory shall have procedures for planned maintenance
- Defective equipment shall be taken out of service, it shall
be isolated and clearly marked to prevents it's use until it has
been repaired
- After repair it should be demonstrated that it performs
correctly
- The status of calibration should be indicated on the
instrument
Measurement traceability
This paragraph deals with traceability of test equipment and
reference standards. Specific requirements are specified for
calibration, testing and reference standards and reference
materials.
Key points for traceability of calibrations are
- For calibration laboratories, the program for calibration of
equipment shall be designed and operated so as to ensure that
calibrations and measurements made by the laboratory are
traceable to the International System of Units (SI)
- Traceability to SI may be a achieved through an unbroken
link of calibration comparisons
- The unbroken chain of calibrations or comparisons may be
achieved in several steps carried out by different laboratories
that can demonstrate traceability
- Traceability to Sl units of measurement may be achieved by
reference to an appropriate primary (national) standard
- Traceability to national measurement standards does not
necessarily require the use of the national metrology institute
of the country in which the laboratory is located
There are certain calibrations that currently cannot be strictly
made in Sl units. In these cases calibration shall provide
confidence in measurements by establishing traceability to
appropriate measurement standards such as:
- the use of certified reference materials provided by a
competent supplier to give a reliable physical or chemical
characterization of a material;
- the use of specified methods and/or consensus standards that
are clearly described and agreed by all parties concerned.
- Participation in a suitable program of interlaboratory
comparisons is required where possible.
Key points for traceability of tests are
- Were traceability of measurements to Sl units is not
possible and/or not relevant, the same requirements for
traceability to, for example, certified reference materials,
agreed methods and/or consensus standards, are required as for
calibration laboratories (see above)
Key points for traceability reference material are
- Reference materials shall, where possible, be traceable to
Sl units of measurement, or to certified reference materials
- Internal reference materials shall be checked as far as is
technically and economically practicable.
Sampling
Key points for sampling are
- The laboratory shall have a sampling plan and procedures for
sampling when it carries out sampling of substances, materials
or products for subsequent testing or calibration
Sampling plans shall, whenever reasonable, be based on
appropriate statistical methods.
- Sampling procedures should describe the selection, sampling
plan, withdrawal and preparation of a sample or samples from a
substance, material or product to yield the required information
- The laboratory shall have procedures for recording relevant
data and operations relating to sampling
Handling test and calibration items
Key points for handling test and calibration items are
- The laboratory shall have procedures for the transportation,
receipt, handling, protection, storage, retention and/or
disposal of test and/or calibration items
- The laboratory shall have a system for identifying test
and/or calibration items
- The laboratory shall have procedures and appropriate
facilities for avoiding deterioration, loss or damage to the
test or calibration item during storage, handling and
preparation
Assuring the quality of test and calibration results
This paragraph should ensure quality of results on a day-by-day
basis. In literature this process is also called performance
qualification (DQ)
Key points are
- The laboratory shall have quality control procedures for
monitoring the validity of tests
- This monitoring shall be planned and reviewed and may
include
- regular use of certified reference materials and/or internal
quality control using secondary reference materials;
-participation in interlaboratory comparison or
proficiency-testing programs;
-replicate tests or calibrations using the same or different
methods
- retesting or recalibration of retained items
Reporting of results
This paragraph describes how test/calibration results should be
reported. It has some general requirements on test reports like
clarity and accuracy but also very detailed requirements on the
contents. The paragraph is divided into sections for calibration
certificates and test reports and it has a section on opinions and
interpretations
Test reports and calibration certificates should include
- a title
- the name and address of the laboratory
- the location where the tests and/or calibrations were
carried out, if different from the 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 used
- a description of, the condition of, and unambiguous
identification of the item(s) tested or calibrated
- the date of receipt of the test or calibration item(s)
- reference to the sampling plan and procedures used by the
laboratory
- - the test or calibration results with, where appropriate,
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")
Other Key points are
- 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
- In the case of transmission of test or calibration results
by telephone, telex, facsimile or other electronic or
electromagnetic means, the requirements of this International
Standard shall be met (e.g., accuracy of transition should be
verified)
6. Impact on Analytical Laboratories
Analytical testing laboratories seeking ISO 17025 will be
impacted in a couple of areas
Developing and implementing management controls as defined in
chapter 4 of this tutorial.
The most important activity here is to develop a quality manual
that outlines the implementation quality procedures as outlined in
ISO 17025.
Most important other activities are
- Document tasks and responsibilities of management and staff
- Develop procedures on how to handle complaints from clients
- Develop procedures for corrective and preventive action
plans
Documenting Training Activities
While most laboratories pay attention to qualification of
employees ISO 17025 requires such qualification to be documented.
Such documentation should include
- Responsibilities, tasks and job requirements
- Information on education
- Information on qualifications and experience obtained
through previous and and current job
- Gap analysis between job requirements and current
qualifications
- Action plan on how to close gaps
- Training certificates
- Evidence of successful trainings
Internal and external audits
Accredited labs will have to spend quite some time for internal
and external audits.
- Internal audits are required to verify conformance with
internal procedures. They are also quite useful in preparation
for external audits. To make best use of internal audits they
should be designed, executed and followed up very much in same
way as external audits are expected. Because most likely not all
laboratory activities can be audited at one time, thee should be
an internal audit schedule to ensure that all activities are
over a given time frame, for example, over one or two years.
- External audits can come from clients or from accreditation
bodies. There should be a procedure that clearly outlines who is
doing what before, during and after the audit. Overall owners
should be defined and all employees possibly affected by the
audit should be trained.
Developing and implementing procedures to conform with technical
requirements as defined in Chapter 5 of this tutorial
Most likely laboratories are following good analytical but either
analysts don't have documented procedures or results are not
documented. For example all good analysts will only use validated
analytical procedures and they will always will make 5 or 6 test
runs to check an instruments precision before actual samples
However, without operating under a documented quality system they
may not follow SOPs and may not document the results. The
following ISO 17025 should follow written procedures should follow
written procedures and results should be documented
- Equipment such as balances, pH meters, spectrophotometers
should be formally qualified, for example following the 4Q
model: design qualification, installation qualification,
operational qualification and performance qualification. All
qualification activities should follow a qualification plan and
results should be summarized in a qualification report.
- Software and computer systems should be formally validated
for example following the V-model model: requirement
specifications, design specifications, development and testing
code, installation qualification, operational qualification and
performance qualification. All validation activities should
follow a validation plan and results should be summarized in a
validation report
- Analytical methods should be validated. Parameters to be
validated to be validated should include: limit of detection
(LOD), limit of quantitation (LOQ), linearity, range, precision,
reproducibility, selectivity and accuracy. All validation
activities should follow an SOP or validation plan and results
should be summarized in a validation report. Special procedures
should be available for validation or verification of standard
methods and for the transfer of analytical methods.
- Sampling, sample transfer and sample analysis should follow
documented procedures. Most important for sampling is to ensure
representative sampling. The focus of sample transfer should be
to avoid cross contamination of samples and to prevent
degradation because of unfavorable environmental conditions.
- Before samples are analyzed there should should be clear
specifications and acceptance criteria. If acceptance criteria
are not met, the root cause for non-conformance should be
identified, and suitable correction action plans should be
initiated.
- Analysis test results should be reported together with the
measurement uncertainly. This may be strange new to many
laboratories but it makes perfect sense. In my opinion in some
instances an analysis result without knowing and reporting the
uncertainty is useless.
- Each laboratory should have a formal program for internal
and external quality assurance. The most suitable procedure for
internal quality assurance is the analysis of quality control
sample and plotting the results as quality control charts with
control and action limits. The best tools for external quality
assurance measures is participating in proficiency testing.
- Laboratories should have a program to ensure adequate
quality of chemicals and reference standards. This can be done
through a thorough supplier qualification program or through
inspection of incoming materials.
7. Implementing ISO/IEC 17025
Implementation ISO 17025 in laboratories should be well thought
out. It can be quite expensive but can also have big benefits.
National and international recognition in the market place and
getting on the suppliers list of public organizations and private
companies are just two of them. The balance between costs and
benefits well worked out and documented. Here are some
recommendations for the road towards ISO 17025.
- List all benefits that may arise fro ISO 17025
certification. Benefits should include additional income from
new contract from public and private organizations that only
deal with certified laboratories but also through indirect
business due to recognition of certification.
- Study technical and management requirements of the ISO 17025
- Compare requirements with what is already implemented and
practice in your laboratory
- Make a gap analysis between what is required by ISO 17025
and what is required and define and document additional work as
required by ISO 17025. Such work should not only included
efforts for start-up up but should also include on-going efforts
to maintain accreditation.
- Make a rough estimation of the return of investment short
and long term
- Decide whether to go ISO 17025 certification.
- Search for certification companies and select the one that
fits best your needs. There are several possibilities to find
certification companies. Probably the best one is to ask
certified laboratories about their experience and
recommendations.
- Ask the selected company to make a pre-assessment just to
verify your own assessment about tasks and gaps,
- Reassess your previous decision to go for certification.
- Start to develop and implement procedures as required by ISO
17025.
8. ISO 17025 Audit: Preparation - Conduct -
Follow-up
Internal audits required by all regulations and quality standards
and are an ideal tool to constantly improver the quality and
efficiency and prepare the organization for external audits. This
chapter summarizes recommendations for internal audits. The
recommendations are equally important for external audits.
Preparation
- Obtain all data and documentation for studies to be audited
(don’t let auditors search in file cabinets. Ask and bring the
requested material)
- Assign a technical contact (the study director) to review
the files and answer questions (if the study director is no
longer available, assign another technical person). The assigned
technical contact should be present all the time.
- Review the QA files - prepare an agenda for the
inspection/audit.
- Set up a work area for the inspectors.
- Review the master schedule.
- Present a floor plan of test facility. Prepare staff.
- An audit may be a tough experience for all people involved.
Therefore they need to be informed on what will happen and of
what questions may be asked.
Conduct
- Maintain a continuous log of the inspection.
- 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 inspector all the time.
- Be courteous and co-operative.
- Answer only questions that are asked.
- If you are unable to answer, tell the inspector openly.
- Protect proprietary information.
Close
- Conduct an exit review and ask if there are any questions or
cause for dissatisfaction.
- Finally, create a file of the inspection material and
prepare an audit report.
Follow-up
- Develop a corrective action plan (owners, tasks,
deliverables, schedule)
- Develop a preventive action plan (owners, tasks,
deliverables, schedule)
- Monitor the plan
9. Required Documentation
Before or during ISO17025 a variety of different documents should
be developed. They include a
- high level policy, a quality plan or quality manual to
document a company's strategy, approaches and planning,
- procedures, templates and checklists for consistent and
efficient implementation and
- records developed on a regular basis such as calibration
records, maintenance, training records and test results
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.
Quality Manual
The quality plan should document the laboratory's overall
concept on how to comply with ISO17025. It should be developed at
the highest level and well communicated to all employs
Master Plans
Master plans document the laboratory's approach for certain
tasks. Such information should be available for
- Environmental, Health Safety
- Equipment Qualification
- Computer system validation
- Risk management
Standard Operating Procedures
Routine tasks should follow written procedures. The can be called
standard operation procedures, operating procedures or work
instructions. Below is a list of SOPs that are recommended to
be available.
SOPs indicated with (*) are included in the ISO 17025
Accreditation Package from Labcompliance:
www.labcompliance.com/books/iso17025
- Document Control and Management (S-105) *
- Facilities and Environmental Conditions (S-151) *
- Qualification of Equipment (S-240) *
- Retirement of Computer Systems (s-261) *
- Validation of Macro Programs and other Application Software.
(S-263) *
- Quality Assessment of Software and Computer
System Suppliers.(S-274) *
- Retention and Archiving of Electronic Records (S-315) *
- Scanning of Paper Records for GxP Compliant Archiving.
(S-316) *
- Data Back-up and Restore. (S-317) *
- Generation and Maintenance of SOPs for Laboratories (S-504)
*
- Laboratory Management Reviews (S-510) *
- Auditing Laboratory Systems (S-511) *
- Training for Laboratory Personnel (S-513) *
- Purchasing of Services and Supplies (S-514) *
- Laboratory Complaint Handling (S-520) *
- Review of Requests, Tenders and Contracts (S-521)
- Subcontracting of Tests (S-522) *
- Providing Services to Customers (S-524)
- Control of Non-conforming Tests (S-525) *
- Identification and Control of Records (S-526) *
- Sampling for Analytical Testing. (S531) *
- Preparation of Working Standards (S-532) *
- Measurement Traceability (S-533)
- Handling of Analytical Test Samples(S-534)
- Maintenance of Laboratory Equipment (S-541) *
- Selection of Analytical Methods and Procedures (S-611)
- Validation of Analytical Methods (S-612) *
- Validation of Chromatographic Methods (S-613) *
- Transfer of Analytical Methods (S-614) *
- Ongoing Performance Control of Analytical Equipment (s-621)
- Verification of Standard Methods (S-623) *
- Measurement Uncertainty in Analytical Testing (S-624)
- Calibration of Analytical Balances (S-641) *
- Qualification of Refrigerators (S-644) *
- Validation of Laboratory Computer Systems
(S-656) *
- Analytical Data Review and Validation (S-671)
- Reporting of Analytical Test Results. (S-672)
Records
Examples or records that should be developed on a regular basis
include:
- Laboratory notebook
- Qualification and validation protocols
- Calibration records
- Equipment maintenance records
- Test results
- Training records
- Others
10. How to Deal with Multiple Regulations and
Quality Standards
Laboratories are frequently faced with a situation where they
have to comply with regulations from different countries or with
both regulations and quality standards at the same time Examples are
as follows:
- A pharmaceutical company markets a drug in different
countries. Manufacturing and quality laboratories has to comply
with the cGMP of all countries. In this case, the analytical
control laboratory also has to work in compliance with the GMPs
of the countries in which the drug is marketed.
- 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 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 17025. The laboratory has to comply with ISO
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 the figure below.
The quality manual should place the company’s own quality system
first and foremost. This may be based on a well-known quality
standard, such as ISO 9001 or ISO 17025. The quality manual and
operating procedures should include aspects of various regulations
and quality standards applied within the company. For specific
regulations, such as GLPs, it should include sections that apply
only to those particular regulations. For example, it might mention
that if the analysis is to be done for a GLP study, raw data must be
archived for the required archiving period. For a non-GLP type of
analysis, such long archiving is not usually required.
- Recommendations for combined GxP and Quality Standard
Systems
11. References
L. Huber, ISO 17025
Accreditation Package, 2008 edition
L.Huber,
Validation and Qualification in Analytical Laboratories, Text book,
2007 edition
L.Huber,
Validation of Computerized Analytical and Networked Systems, 2003
edition
L.Huber, Computer
System Validation Package, 2006 edition
12. Links to Other Websites
To be updated on an ongoing basis
13. 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, 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.
14. Expert Advice on Selected Topics
This chapter will be updated on an on-going basis