Following the update of ISO 17025 in 2017, the world of standards became intrigued about its relation to the Quality Management System (QMS) and ISO 9001:2015. Here?s the thing?ISO 17025 has some aspects that relate to the requirements of ISO 9001. It can also lead to accreditation certification depending on an organization?s QMS. To help you further understand these standards, QSE Academy has created this succinct explanation about their likeliness and dissimilarities.

什么是ISO 17025:2017？

ISO 17025:2017, ?General Requirements for the Competence of Testing and Calibration Laboratories,? is this standard?s third edition.

It serves as a requirement for the competence, impartiality, and consistent operation of testing and calibration laboratories. This is regardless of an organization?s size or the number of employees.

它包括有关的一般要求。

• Clause 4 – impartiality and confidentiality
• Clause 5 – structural requirements
• Clause 6 – resources such as personnel, equipment, technical, facilities, and environmental conditions

同时，第7条包含了重要的流程要求。

1. 审查请求、投标和合同? Ensure you can conduct precisely what the customer wants.
2. 方法的适用性? Choosing, verifying, and validating methods.
3. 抽样调查? Necessary planning and documentation for sampling before testing.
4. 处理项目? 处理测试和校准项目的程序。
5. 测量的不确定性? Evaluating and reporting the calibration?s measurement uncertainty.
6. 结果的有效性? 确保结果的有效性。
7. 结果报告? 向客户报告结果，包括一般和具体要求，以及更新报告。
8. 数据和信息管理? 处理数据和实验室信息系统，以保证其有效性和使用。
9. 投诉和不符合要求的工作? 管理投诉和对不合格品的纠正措施。
10. 记录 ? 开发和保存技术记录。

这些要求使实验室能够表现出按照国际标准开展活动的能力。

ISO 17025: 2017与 ISO 9001: 2015

Here?s the main difference?ISO 9001 applies to all kinds of businesses in all industries or sectors. On the other hand, ISO 17025 is only valuable for testing and calibration laboratories.

When it comes to similarities, you can look into Clause 8 of ISO 17025 about management system requirements. It implies the necessity of a management system to guarantee a laboratory?s consistent operation. It also provides the opportunity to address such requirements within a current standard?s management system. For organizations not implementing ISO 9001, ISO 17025 needs a set of minimum QMS requirements. Thus, ISO 9001 implementation and certification aren?t required in complying with ISO 17025.然而，一些组织会发现ISO 9001对实施ISO 17025很有用。

除此以外，这里还有一些它们之间类似的管理要求。

• 内部审计
• 管理审查
• 应对风险和机遇的行动
• 纠正措施
• 改进
• 管理系统文件
• 管理体系文件的控制
• 记录的控制

请注意，当你的组织只具备ISO 17025的最低要求，而不是ISO 9001的要求时，你仍然要解决其他因素。

First, ISO 17025 doesn?t specify identifying internal and external issues or interested parties. Hence, you still need to determine the context of the organization and develop a QMS scope.

其次，ISO 9001包括质量目标的制定，与ISO 17025不同。

Next, ISO 17025 doesn?t include leadership commitments or quality policy.

Moreover, ISO 17025 has monitoring and measuring requirements, but these don?t inescapably address all of the requirements from ISO 9001.

最后，ISO 17025有资源和支持方面的要求，但它并没有涵盖所有的ISO 9001要求。

你的组织如何能够最大限度地利用ISO 9001和ISO 17025？

正如前面所解释的，在实施ISO 17025之前遵循ISO 9001的所有要求是有好处的。例如，ISO 9001附带的条款使得管理组织的背景、质量目标、领导力和记录信息变得容易。因此，你的实验室可以使用流程方法和基于风险的思维来提高运营效率。

ISO 17025和ISO 9001都是国际标准，规定了对质量管理系统的要求。然而，这两个标准之间有一些关键的区别。

ISO 17025是专门针对实验室的，而ISO 9001可以被任何组织使用。

ISO 17025包括对能力、设施和设备等方面的具体要求，而ISO 9001则没有这些要求。

ISO 17025是许多认证机构的认证要求，而ISO 9001则不是。

因此，虽然ISO 17025和ISO 9001之间有一些相似之处，但也有一些关键的区别。各组织在实施质量管理系统之前，应仔细考虑哪种标准适合他们。

What?s Next?

           Keep in mind that your laboratory doesn?t necessarily need ISO 9001, but it?s an asset when pursuing ISO 17025 accreditation certification.

Should you need more information, we?ve allotted articles about ISO 9001 and ISO 17025 on our website.

QSE学院还提供工具包，帮助你的实验室实施这些标准。