The worldwide standards adopted since the late 1980s are the International Organization for Standardisation (ISO) ISO 9000 series, the most recent version of which is ISO 9000: 2005. These are designed to ensure that customers are guaranteed the same quality when purchasing from a company in any country that has adopted these standards, provided that a company has the following:
• A quality policy
• Standardised processes of quality assurance
• A system of corrective actions
• Management review of the quality systems
Awarding ISO 9000 status to a company means that it has an effective quality management system. It does not mean that its products and services are of the quality demanded by the customer, and in particular does not address the technical requirements of a specified product.
Of the ISO series it is ISO 9001 that applies to the management of a laboratory. This requires that procedures be in place for all activities carried out within the workplace, that these procedures are recorded and that staff carries out the activities described in these procedures. Monitoring is required to ensure compliance and to modify and improve the procedures in the light of experience. The ISO 9001 Flowchart of the areas to be covered and supporting activities are shown in Figure B14. Laboratory management is directly responsible for the following:
• Work Plans. Procedure by which the work plan and targets is constructed with the customer (sponsor) e.g. business unit, marketing or manufacturing functions.
• Costs. Procedure by which expenditure is agreed, monitored and reported back to the customer/sponsor.
• Reporting. Procedure for recording work done for and reporting back to the customer.
• Outcome. Procedure by which the result of a project is agreed with the customer work plan, e.g. new product, process or termination.
• Training. Procedure by which training is identified and provided to staff in order to carry out the work for the customer to the highest standards.
The Quality System must be documented in a clear and efficient manner in the form required by ISO 9000, which must have the following three components:
Policy Statement about what should and should not be done. Rules and principles governing the actions related to the policy. Underlines the objectives or guidelines for managing quality. Part II. Procedures Manual
The manual provides precise details on how a particular procedure will be carried out to achieve the required quality. A procedure is a set of steps designed to meet a specified outcome. Part III. Annexes
All forms, reports, lists etc referred to during the quality assurance process.
Information systems must be in place to maintain the documentation and to ensure that it is up to date. In addition there is a need to maintain and store quality records and training records. This can be carried out within the Office function of the laboratory under the guidance of a Quality Manager.
Only a qualified company of independent experts can give recognition of the Quality System to ISO standards (Quality Audit). The system is subject to ongoing surveillance and assessment of its compliance with the standards. Regular inspection by trained internal auditors is also carried out to assess the company's continued ability to provide products and services of a suitable quality for the customer by asking the following questions:
• Are the procedures realistic?
• Are they appropriate?
• Are they followed correctly?
• Are the required results produced?
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