1.1 What is Quality?
1.2 Quality Management
1.3 Quality Assurance
1.4 Quality Control
1.5 Good Laboratory Practice (GLP)
1. Quality Management (QM)
2. Quality Assurance (QA)
3. Quality Control (QC)
Note. An even wider concept of quality management is presently coming into vogue: "Total Quality Management" (TQM). This concept includes additional aspects such as leadership style, ethics of the work, social aspects, relation to society, etc. For an introduction to TQM the reader is referred to Parkany (1995).
- what error was made?
- where was it made?
- when was it made?
- who made it?
- why was it made?
1. First-line control: Instrument performance check.2. Second-line control: Check of calibration or standardization.
3. Third-line control: Batch control (control sample, identity check).
4. Fourth-line control: Overall check (external checks: reference samples, interlaboratory exchange programmes).
1. First-line control: Instrument check / calibration.
2. Second-line control: Batch control
3. Third-line control: External check
- means are available (adequate personnel and facilities)
- efficient use of time and means (costs aspect)
- expertise is available (answering questions; aftercare)
- upholding and improving level of output (continuity)
- allow better laboratory management (including quality management)
- improve efficiency (thus reducing costs)
- minimize errors
- allow quality control (including tracking of errors and their cause)
- stimulate and motivate all personnel
- improve safety
- improve communication possibilities, both internally and externally.
- say what you do
- do what you say
- do it better
- be able to show what you have done
- Organization and Personnel
- Equipment and Working materials
- Analytical or testing systems
- Quality control
- Reporting and filing of results.
* ISO: International Standardization Organization; IEC: International Electrical Commission; OECD: Organization for Economic Cooperation and Development; CEN: European Committee for Standardization, EN: European Standard; NEN: Dutch Standard.