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A.4 Quality management system elementsNOTE It is not a requirement of this document to have a full quality management system. However,the minimum elements of a quality management system that are necessary to control the determination ofbioburden as used in the validation and monitoring of health care products to be sterilized are normativelyreferenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards forquality management systems (see ISO 13485) that control all stages of production or reprocessing of health careproducts.A.4.1 DocumentationIn ISO 13485, the requirements in the documentation section relate to the generation and control ofdocumentation (including specifications and procedures) and records.Computers can be used in laboratories for direct and indirect collection, processing and/or storage ofdata. Both the hardware and software used for such applications should be controlled.The computer system in use should be identified, both in terms of hardware and software, and anychanges in either of these aspects should be documented and subject to appropriate approval.If calculations are performed by electronic data processing techniques, the software (e.g. spreadsheetcalculations) should be validated prior to use, and records of this validation should be retained.

ISO/IEC 17025), where applicable, and the data should be evaluated by competent, informedprofessionals.Any laboratory should be committed to providing a quality service and this commitment should bedocumented as a quality policy. The lines of authority and responsibility within the laboratoryorganization should be formally established and documented. An individual should be nominated tobe responsible for the establishment of the laboratory quality system and should have the authority toensure that the system is implemented.The operation of the laboratory should be subject to regular internal audits. The results of the auditshould be documented and reviewed by the laboratory management (see, for example, ISO 15189 orISO/IEC 17025).Requirements for responsibility, authority and human resources are specified in ISO 13485.Requirements for the provision of resources are specified in ISO 13485.Requirements for equipment are specified in ISO 15189 and ISO/IEC 17025.A.4.3 Product realizationIn ISO 13485, the requirements in the product realization section relate to the product lifecycle,from the determination of customer requirements, design and development, purchasing, control ofproduction, and calibration of monitoring and measuring devices.There should be a system for identifying the maintenance requirements for each piece of laboratoryequipment. Equipment that does not require calibration should be clearly identified.Any equipment, or parts thereof, that come into contact with a product, eluent, culture media, etc.,during testing should be sterile. All microbiological media and eluents used to remove microorganismsfrom the product should be prepared in a manner that ensures their sterility.Appropriate quality tests for culture media should include growth promotion tests. Generally, growthpromotion tests are performed on each batch using an inoculum of low numbers [not more than 100colony-forming units (CFUs)] of selected microorganisms. Growth promotion tests are described insome Pharmacopoeias [(e.g. US Pharmacopoeia (USP), European Pharmacopoeia (EP)] that detailsuitable microorganisms. Other recognized quantitative and semi-quantitative methods for mediaquality control are also acceptable.Requirements for purchasing are specified in ISO 13485. In particular, it should be noted that therequirements in ISO 13485 for the verification of purchased products apply to all products and servicesreceived from outside the organization.