ISO质量体系_iso9003质量体系认证

(48) 2024-06-02 08:01:01

ISO13485:

8.5.2纠正措施

组织应采取措施,以消除不合格的原因,防止不合格的再发生。纠正措施应与所遇到不合格的影响程度相适应。

应编制形成文件的程序,以规定以下方面的要求:

—评审不合格(包括顾客抱怨);

—确定不合格的原因;

—评价确保不合格不再发生的措施的需求;

—确定和实施所需的措施,适当时,包括更新文件(见4.2);

—记录任何调查和所采取措施的结果(见4.2.4);

—评审所采取的纠正措施和其有效性。

8.5.3预防措施

组织应确定措施,以消除潜在不合格的原因,防止不合格发生。预防措施应与潜在问题的影响程度相适应。

应编制形成文件的程序,以规定以下方面的要求:

b) 确定潜在不合格及其原因;

c) 评价防止不合格发生的措施的需求;

d) 确定和实施所需的措施;

e) 记录任何调查和所采取措施的结果(见4.2.4),和

f) 评审所采取的预防措施和其有效性。

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QSR820:

Subpart J—Corrective and Preventive

Action

§ 820.100 Corrective and

preventive action

(a) Each manufacturer

shall establish and maintain procedures

for implementing corrective and preventive action. The

procedures shall include requirements for:

(1) Analyzing

processes, work operations, concessions, quality audit reports,

quality records, service records, complaints, returned product, and

other sources of quality data to identify existing and potential

causes of nonconforming product, or other quality problems.

Appropriate statistical methodology shall be employed

where necessary to detect recurring quality problems;

(2) Investigating the cause of nonconformities relating to product,

processes, and the quality system;

(3) Identifying

the action(s) needed to correct and prevent recurrence of

nonconforming product and other quality problems;

(4) Verifying

or validating the corrective and preventive action to ensure that

such action is effective and does not adversely affect the finished

device;

(5) Implementing and recording changes in methods and procedures

needed to correct and prevent identified quality problems;

(6) Ensuring

that information related to quality problems or nonconforming

product is disseminated to those directly responsible for assuring

the quality of such product or the prevention of such problems;

and

(7) Submitting

relevant information on identified quality problems, as well as

corrective and preventive actions, for management review.

(b) All activities required under

this section, and their results, shall be

documented.

J章-纠正和预防措施

§ 820.100 纠正和预防措施

A、 每一个制造商应该建立和维护实施纠正和预防措施的程序。程序应该包含要求:

[1]

分析工艺、工作活动、让步接收、质量审计报告、质量记录、服务记录、抱怨、返回产品和其它各种数据源,识别不合格产品现存的和潜在的原因。如果有必要,应用适当的统计方法探测出重复发生的质量问题。

[2] 调查和产品、工艺和质量系统有关的不合格原因。

[3] 识别纠正和预防不合格产品和其它质量问题重复发生所需要的行动。

[4] 验证和确认纠正和预防措施是有效的,并且对最终产品没有副作用。

[5] 执行和记录纠正和预防识别出的质量问题所需的方法和程序的变化。

[6] 保证和质量问题或不合格产品有关的信息发布给对保证这些产品质量或预防这些问题直接负责的人。并且:

[7] 识别出的质量问题相关的信息,还有纠正预防措施,提交给管理评审。

B、 这部分所要求的所有活动,和活动结果,应该记录在案。

THE END

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