ISO IEC17020标准和实施讲解.ppt

ISO/IEC17020标准和实施 陈伟升 二00八年六月 背景简介 国际上，检查机构认可始于1988年，依据ISO导则39 1995年ISO导则39被EN45004替代，并于1998年转变成ISO17020 为什么检查 Public health and safety 公共卫生和安全 Guard against fraud 防欺诈保护 To give regulators and consumers confidence 向管理部门和消费者提供信心 What Do Regulators Want 管理部门需要什么 Confidence in the process 对过程的信心 Confidence in the outcome 对输出产品的信心 Minimum risk of failure of product or service 产品或服务失败的最低风险 No risk to public health or safety 对公共卫生和安全无风险 Minimise liablity to regulator 将管理部门的义务最小化 为什么ISO 17020 Personnel – changes, qualifications are maintained and verified 人员—变动，资格保持和验证 Traceable records for each step in the inspection process 检查过程每一步的记录可溯源 Identity of the inspector is known for each inspected item 对每一个检查项目，检查员的身份都是已知的 Consistency of inspection decisions 检查决定的一致性 Some History 历史概况 二十世纪八十年代，大多数检查机构从事以下领域的检查： Boilers lifts and cranes 锅炉、电梯和吊车 Mines and quarries 矿厂和采石场 Motor vehicles 机动车辆 Buildings 建筑物 Food safety 食品安全 Chinese Accreditation Bodies 中国的认可机构中国合格评定国家认可委员会 Accreditation can provide:认可可以提供： Assurance of competent inspection bodies 确保有能力的检查机构 Assurance of competent inspectors 确保有能力的检查员 Reliable inspection reports 可靠的检查报告 Based on documented best practice standards in operation at the time 基于当前运作中文件化的最佳实施标准 National consistency 国家一致性 Technical validity of inspection process 检查过程的技术有效性 Accreditation of Inspection Bodies检查机构的认可 Not simply compliance with a standard 不是简单地符合某一标准 Ensures that the level of inspection is appropriate for the product/service being inspected 确保检查的程度对于被检查的产品 / 服务来说是适当的 Ensures an understanding of the inspection system, both technically and the management system 确保从技术和管理体系两方面理解检查体系 How? 怎样做？ By assessment of 通过下列评审 Technical competence 技术能力 Professional judgement 专业判断 Quality system 质量体系 ISO 17020 Compliance ISO 17020符合性 Personnel competence 人员能力 Equipment suitability 设备适宜性 Best practice inspection activi