Quality Systems
General
Quality Management Systems (QMS) have existed for over 50 years. They have evolved as a direct result of customer pressure to ensure that organisations can demonstrate the capability to produce quality products and services through independent third party certification.
The production of a set of international standards by the International Organisation of Standardisation (ISO) reflects the expanding importance of QMS. As a result, many organisations apply discrete QMS in specific business areas to meet changing customer and regulatory requirements.
Many laboratories have adopted discrete QMS and have actively sought to keep pace with the need for expansion of such systems whilst seeking to deliver continual improvement of the quality of their science.
Accreditation Standards
The formal recognition that a testing laboratory has been deemed competent to carry out specific tests or specific types of tests is defined as accreditation (European Norm EN45001). To achieve this, competence must be assessed by an independent third party.
The objective of laboratory accreditation is to improve the consistency of analytical data, to improve comparability of data generated in different laboratories and to reduce the number of analyses. For example, the results of analyses performed in different laboratories in different countries should be the same within previously specified limits.
Test laboratories that wish to apply for accreditation must fulfil minimum requirements according to national or international standards.
The accreditation criteria developed for assessing a laboratory's competence are largely based on the laboratory's Quality Assurance (QA) programme and cover:
- Management and organisation.
- Qualified and continuously trained personnel.
- Availability and maintenance of equipment.
- Validation of test methods and procedures.
- Availability of working procedures.
- Sample handling.
- Proper use of (certified) reference material (CRM).
- Participation in proficiency testing.
- Content of test reports.
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ISO/IEC 17025:2005 Calibration and Testing Laboratories
ISO/IEC 17025 - General Requirements for the Competence of Calibration and Testing Laboratories was published in December 1999 and was the result of a joint partnership between the International Organisation for Standardisation (ISO) and the International Electrotechnical Commission (IEC). The standard replaced ISO Guide 25 and EN 45001. The first edition (1999) of ISO/IEC 17025 has now been superceded by ISO/IEC 17025:2005. This second edition incorporates amendments to align the Standard to ISO 9001.
ISO 17025 was developed specifically to provide guidance to laboratories on both Quality Management and the technical requirements for proper operation. The standard can be considered to be the technical compliment to ISO 9001 and addresses issues such as: the technical competence of personnel, ethical behaviour of staff, use of well defined test and calibration procedures, participation in proficiency testing, and contents of test reports and certificates.
ISO 17025 seeks to harmonise laboratory accreditation and acceptance of test data worldwide. All participating countries are required to accept test results performed by accredited members of those other countries.
Within the United Kingdom the assessment of laboratories against ISO 17025 is carried out by the United Kingdom Assessment Service (UKAS). For a list of national accreditation bodies see www.fasor.com/iso25/
Good Laboratory Practice (GLP) Regulations 1999
The principles of GLP were developed by the Organisation for Economic Cooperation and Development (OECD) and subsequently ratified by the European Commission (EC) and transposed into EC directives. The GLP Regulations implement these directives within the United Kingdom.
The GLP Regulations apply to any test facility which conducts, or intends to conduct, a regulatory study. A regulatory study is a study for which the regulatory authority to whom the data will be submitted, requires that study to be conducted in compliance with the principles of GLP (The Good Laboratory Practice Regulations 1999 and Guide to UK GLP Regulations).
GLP is concerned with the organisational processes and the conditions under which certain laboratory studies are planned, performed, monitored, recorded, archived and reported. Principally, it facilitates the proper conduct of studies, promotes their full and accurate reporting, and provides a means whereby the validity and integrity of studies can be verified. The application of GLP to regulatory studies assures the quality of the data generated and allows its use by Government regulatory authorities in hazard and risk assessment in particular of new studies.
Within the United Kingdom, the responsibility for monitoring test facilities for compliance with the principles of GLP rests with the United Kingdom Monitoring Authority (GLPMA). For details of bodies responsible for monitoring test facilities see www.oecd.org
The work of the GLPMA is carried out by a unit within the Inspection and Enforcement Division of the Medicines Control Agency (MCA), which is an executive Agency of the Department of Health (DH).
The range of test facilities monitored by the GLPMA include those involved in the health and environmental safety testing of human and veterinary pharmaceuticals, agrochemicals, cosmetics, food and feed additives and industrial chemicals.
Comparison Between ISO/IEC 17025 and GLP
| ISO/IEC
Standard 17025 |
GLP |
|
ISO Members |
OECD Members
|
|
The
same standard for all ISO members
|
Different regulations in different countries |
|
Designed for repetitive studies |
Designed for single studies
|
|
Needs to get additional guidelines for specific
applications (for example, safety, health)
|
Very specific in some areas
|
|
General statements for responsibilities of
personnel
|
Very specific responsibilities of personnel
|
|
No internal audit through QA for each study |
Audit of each study through internal QA
|
|
Description of Quality System in Quality Manual |
Description of Quality System in SOPs
|
|
Studies need not to be signed by QA |
Each study must be signed by QA
|
|
No study plans required (standardized methods
should be used)
|
Study plans required for each study
|
|
Written operating procedures without specific
format |
SOPs with detailed requirements for format and
content
|
|
Analysis methods must be verified through
inter-laboratory tests
|
Validation through inter-laboratory tests not
required
|
|
No specific requirements for storage of records and
reports |
Specific requirements for storage, retention and
archiving
|
|
Inspection through legal authorities not required
|
Inspection through legal authorities required
|
|
Documented complaints procedures |
In case of problems, only course of law
|
|
Storage of test samples and data until client
accepts results |
Storage of test samples
according to local regulatory requirements
|
An example of a QA Framework
The Joint Code of Practice
The Joint Code of Practice came fully into force in the United Kingdom on 1 June 2004. The Code, jointly sponsored by the Department for Environment, Food and Rural Affairs (Defra), the Food Standards Agency (FSA), the Biotechnology and Biological Sciences Research Council (BBSRC) and the Natural Environmental Research Council (NERC), was introduced with the aim of improving:
- The quality of research processes in the research for which they provide funding.
- Public confidence in the results of publicly funded research to reduce the risk of policies and actions based on incorrect findings.
The Code has also been endorsed by the Department of Agriculture and Rural Development for Northern Ireland (DARDNI), the Scottish Executive Environment and Rural Affairs Department (SEERAD) and the Welsh Assembly Group and Rural Affairs Department (WAGARAD).
The Code applies to all research funded by Defra, FSA, DARDNI, SEERAD and WAGARAD and also to research funded by BBSRC and NERC in their own institutes. It is intended to apply to all types of research, but the overriding principle is fitness for purpose. The individual provisions should therefore be interpreted with that in mind (The Joint Code of Practice, Revised April 2003).
Whilst broadly similar to the principles of ISO 17025, the Joint Code of Practice applies to individual projects and covers the following areas:
- Responsibilities.
- Competence.
- Project Planning.
- Quality Control.
- Health and Safety.
- Handling of Samples and Materials.
- Facilities and Equipment.
- Documentation of Procedures and Methods.
- Research Work/Records.
Individual Project Managers are responsible for:
- Ensuring that the provisions of the Code are adhered to.
- Acknowledging compliance with the Code as part of the Tendering process.
ISO 9001:2000
ISO9001 promotes the adoption of a process approach when developing, implementing and improving the effectiveness of a Quality Management System, to enhance customer satisfaction by meeting customer requirements.
The standard is generic and is intended to be applicable to all organisations, regardless of type, size and product provided and specifies requirements for a Quality Management System where an organisation:
- Needs to demonstrate its ability to consistently provide product that meets the customer and applicable regulatory requirements and;
- Aim to enhance customer satisfaction through the application of the system, including processes for continual improvement of the system and the assurance conformity to customer and applicable regulatory requirements.
