【正文】 r establishing and reviewing quality objectives. The quality objectives need to be consistent with the quality policy and the mitment to continual improvement, and their achievement needs to be measurable. The achievement of quality objectives can have a positive impact on product quality, operational effectiveness and financial performance and thus on the satisfaction and confidence of interested parties.NOTE Statements in parentheses do not apply to ISO 9001.Figure 1 – Model of a processbased quality management system Role of top management within the quality management systemThrough leadership and actions, top management can create an environment where people are fully involved and in which a quality management system can operate effectively. The quality management principles (see ) can be used by top management as the basis of its role, which is as follows:a) to establish and maintain the quality policy and quality objectives of the organization。b) to promote the quality policy and quality objectives throughout the organization to increase awareness, motivation and involvement。c) to ensure focus on customer requirements throughout the organization。d) to ensure that appropriate processes are implemented to enable requirements of customers and other interested parties to be fulfilled and quality objectives to be achieved。e) to ensure that an effective and efficient quality management system is established, implemented and maintained to achieve these quality objectives。f) to ensure the availability of necessary resources。g) to review the quality management system periodically。h) to decide on actions regarding the quality policy and quality objectives.i) to decide on actions for improvement of the quality management system. Documentation Value of documentationDocumentation enables munication of intent and consistency of action. Its use contributes for a) achievement of conformity to customer requirements and quality improvement,b) provision of appropriate training.c) repeatability and traceability,d) provision o objective evidence, ande) evaluation of the effectiveness ad continuing suitability of the quality management system.Generation of documentation should not be an end in itself but should be a valueadding activity. Types of document used in quality management systemsThe following types of document are used in quality management systems:a) documents that provide consistent information, both internally and externally, about the organization’s quality management system。 such documents are referred to as quality manuals。b) documents that describe how the quality management system is applied to a specific product, project or contract。 such documents are referred to as quality plans。c) documents stating requirements。 such documents are referred to as specifications。d) documents stating remendations or suggestions。 such documents are referred to as guidelines。e) documents that provide information about how to perform activities and processes consistently。 such documents can include documented procedures, work instructions and drawings。f) documents that provide objective evidence of activities performed or results achieved。 such documents are referred to as records.Each organization determines the extent of documentation required ad the media to be used. This depends on factors such as the type and size of the organization, the plexity and interaction of processes, the plexity of products, customer requirements, the applicable regulatory requirements, the demonstrated ability of personnel, and the extent to which it is necessary to demonstrate fulfillment of quality management system requirements. Evaluating quality management systems Evaluating processes within the quality management systemWhen evaluating quality management systems, there are four basic questions that should be asked in relation to every process being evaluated.a) Is the process identified and appropriately defined?b) Are responsibilities assigned?c) Are the procedures implemented and maintained?d) Is the process effective in achieving the required results?The collective answers to the above questions can determine the result of the evaluation. Evaluation of a quality management system can vary in scope and enpass a range of activities, such as auditing and reviewing the quality management system, and selfassessments. Auditing the quality management systemAudits are used to determine the extent to which the quality management system requirements are fulfilled. Audit findings are used to assess the effectiveness of the quality management system and to identify opportunities for improvement.Firstparty audits are conducted by, or on behalf of, the organization itself for internal purposes and can form the basis for an organization’s selfdeclaration of conformity.Secondparty audits are conducted by customers of the organization or by other persons on behalf of the customer.Thirdparty audits are conducted by external independent organizations. Such organizations, usually accredited, provide certification or registration of conformity with requirements such as those of ISO 9001.ISO 19011 provides guidance on auditing. Reviewing the quality management systemOne role of top management is to carry out regular systematic evaluations of the suitability, effectiveness and efficiency of the quality management system with respect to the quality policy and quality objectives. This review can include consideration of the end to adapt the quality policy and objectives in response to changing needs and expectations of interested parties. The review includes determination of the need for actions.Amongst other sources of information, audit reports are used for review of the quality management system. SelfassessmentAn organization’s selfassessment is a prehensive and systematic review of the organization’s activities and results