322
8 Analytical Chemistry and Quality
Box 8.5 lists the specific standards that constitute the EN-45 000 family. As can
be seen, they encompass every quality facet discussed in this chapter.
Box 8.5
EN-4S000
The European Centre for Standardization (CEN) has issued a series of standards based on ISO
Guide 25 and, in broad terms,also on ISO 9000. The following are some of the more important
standards in this family:
• E -45001: General Criteria for the Operation ofTesting Laboratories.
• EN-45 002: General Criteria for the Assessment ofTesting Laboratories.
• EN-45003: General Criteria for Laboratory Accreditation Bodies.
• EN-45004: General Criteria for the Performance of Various Types of Inspecting Bodies.
• EN-45 012: General Criteria for Certification Bodies Operating Quality Systems Certification.
• EN-45013: General Criteria for Certification Bodies Operating Certification of Personnel.
The most relevant document in this quality system is the so-called Quality
Manual, which contains a detailed description of all the characteristics of the
laboratory; special emphasis is placed on Quality Assurance, which should be the
reference, framework and guide for quality system activities, namely: documenting every aspect of analytical quality (organization, work, tools, materials,
methods, results) and facilitating the implementation of external and internal
quality assessment activities.
Compiling the Manual, which is usually based on specific standards, is a labourintensive, expensive task; however, the Manual is indispensable with a view to the
responsible, consistent institution of a quality system in the laboratory. ISO Guide
49 sets the guidelines to develop a quality manual for a testing laboratory.
The Quality Manual should be suited to the laboratory and its parent body
- copying existing manuals is a frequent, but also dangerous and inadvisable
temptation. However, the Manual is not for filing; rather, it should be a tool in
permanent use to aid in the rigorous, consistent, efficient implementation of
quality systems. It is thus an essential element of external evaluation (accreditation) of laboratories. The quality manual should be renewed whenever significant changes occur (e.g. when a CMP that was conducted in the classical manner at the time the Manual was compiled is automated). Box 8.6 describes the
typical contents of the Quality Manual.
Box 8.6
Structure of a Quality Manual
The Qua lity Manual is the reference and action document to be used in implementing quality
systems in the laboratory within the framework of EN-45000.lts contents can vary slightly
depending on the particular public or private body that endorses or supplies it. ln any case, it
contains the following items, all developed to an appropriate extent:
(1) The Quality Policy of the laboratory's parent body and the implementation of the
hierarchical approach of Fig. 8.4.
8 Analytical Chemistry and Quality
Box 8.5 lists the specific standards that constitute the EN-45 000 family. As can
be seen, they encompass every quality facet discussed in this chapter.
Box 8.5
EN-4S000
The European Centre for Standardization (CEN) has issued a series of standards based on ISO
Guide 25 and, in broad terms,also on ISO 9000. The following are some of the more important
standards in this family:
• E -45001: General Criteria for the Operation ofTesting Laboratories.
• EN-45 002: General Criteria for the Assessment ofTesting Laboratories.
• EN-45003: General Criteria for Laboratory Accreditation Bodies.
• EN-45004: General Criteria for the Performance of Various Types of Inspecting Bodies.
• EN-45 012: General Criteria for Certification Bodies Operating Quality Systems Certification.
• EN-45013: General Criteria for Certification Bodies Operating Certification of Personnel.
The most relevant document in this quality system is the so-called Quality
Manual, which contains a detailed description of all the characteristics of the
laboratory; special emphasis is placed on Quality Assurance, which should be the
reference, framework and guide for quality system activities, namely: documenting every aspect of analytical quality (organization, work, tools, materials,
methods, results) and facilitating the implementation of external and internal
quality assessment activities.
Compiling the Manual, which is usually based on specific standards, is a labourintensive, expensive task; however, the Manual is indispensable with a view to the
responsible, consistent institution of a quality system in the laboratory. ISO Guide
49 sets the guidelines to develop a quality manual for a testing laboratory.
The Quality Manual should be suited to the laboratory and its parent body
- copying existing manuals is a frequent, but also dangerous and inadvisable
temptation. However, the Manual is not for filing; rather, it should be a tool in
permanent use to aid in the rigorous, consistent, efficient implementation of
quality systems. It is thus an essential element of external evaluation (accreditation) of laboratories. The quality manual should be renewed whenever significant changes occur (e.g. when a CMP that was conducted in the classical manner at the time the Manual was compiled is automated). Box 8.6 describes the
typical contents of the Quality Manual.
Box 8.6
Structure of a Quality Manual
The Qua lity Manual is the reference and action document to be used in implementing quality
systems in the laboratory within the framework of EN-45000.lts contents can vary slightly
depending on the particular public or private body that endorses or supplies it. ln any case, it
contains the following items, all developed to an appropriate extent:
(1) The Quality Policy of the laboratory's parent body and the implementation of the
hierarchical approach of Fig. 8.4.