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过程方法在ISO9001:2008质量管理体系认证审核中的应用案例说明 发布时间: 2011-12-21 20:17 点击:

过程方法在ISO9001:2008质量管理体系认证审核中的应用案例说明
Process method in the ISO9001: 2008 quality management system certification audit application case
过程方法是2000版ISO9000标准的八项原则之一,过程模式的应用是2000版的主要特征,但标准对过程方法在认证审核中的应用方法没有做出详细的解释。本文提出了过程方法在认证审核中的应用模式,供大家讨论。
Process method is the 2000 edition of the ISO9000 standard for one of the eight principles, process model is the application of the 2000 edition of the main character, but the standard of process method in the certification application made no detailed explanation. This paper presents a method of certification audit process in the application mode, offer everybody discussion.
一、申请认证的组织应提交的资料与信息
One, apply for certification organization shall submit the information and materials
1、组织提交的信息与资料应包括:
In 1, the organization presented information and data shall include:
——组织基本信息:法律地位文件、联络信息、组织员工人数等;
-- organization basic information: legal status file, contact information, employee number;
——申请认证的产品范围与责任;
-- application product range and responsibility;
——申请认证的现场及其活动;
Application field and its activities --;
——质量体系文件;
-- the quality system documents;
——能说明组织过程绩效的指标及其发展趋势。
-- to explain organizational process performance index and its development trend.
2、组织基本信息:
In 2, the organization of basic information:
认证机构的申请表均已包括这方面的内容,这里不再赘述。
The certification body form have to include this content, here no longer.
3、申请认证的产品范围与责任
3, to apply for certification of product range and responsibility
a)    产品:应详细说明产品的名称与型号,必要时提供产品清单。产品的归类直接影响过程方法的应用,也影响到审核组专业能力的配备。生产或服务流程不同、功能不同的产品应被视为不同的产品类别。
A ) products: detailed description of the product name and the model, necessary to provide a list of products. Product classification directly affects the use of the process approach, also affect the audit team equipped with professional ability. Production or service flow, different features of different products should be regarded as different product categories.
b)    设计责任:对设计责任的描述可以包括:无产品设计责任(组织按照顾客提供的设计文件进行产品的生产,组织不定义产品的特性)、全部产品设计责任(由组织定义产品的全部特性)、部分产品设计责任(组织负责部分设计工作,如按照顾客的设计文件生产试制样件供顾客进行设计验证与确认、或设计由顾客提供但组织有权进行产品更改等)、与顾客联合设计产品(顾客与组织的设计人员组织设计小组进行联合设计,共同承担设计责任)。组织应说明设计责任的详细情况。
B ) design responsibility: to design responsibility description can include: product design responsibility ( organized according to customer design documents for production, the organization does not define the characteristics of the product ), all products design responsibility ( defined by the organization and all product characteristics), part of the product design responsibility ( the organization responsible for the part of the design work, such as according to customer design document production prototype for customer design verification and validation, or the design provided by the customer but the organization has the right product changes ), and customer design products ( customer and organization design organization design group joint design, shared design responsible ). The organization shall explain the details of design responsibility.
c)    顾客:组织应说明其产品的顾客信息。对相同的产品,组织可能只对部分顾客负有设计责任,也有些产品面对不同的顾客,产品的生产控制流程也不同。当然,有些产品是面向广大的潜在顾客的。
C ) customer: organization shall specify the product customer information. For the same product, organization may only on the part of the customer design responsible, some products face different customers, production control flow is different. Of course, some products are for the vast number of potential customers.
4、申请认证的现场及其活动
4, to apply for certification of the scene and its activity
a)    现场:组织的注册现场与生产服务现场,应逐一列出;
A ) site: organization registration site and production service field, should list;
b)    现场的活动:应描述每一现场的活动。如某个现场是公司总部,负责财务、销售、设计等;两个制造现场,一个负责油漆、电镀、热处理,一个负责机加工、装配;五个服务现场,负责不同区域的售后服务
B ) site activities: should describe each of the field activities. If a site is the company headquarters, responsible for finance, sales, design; two manufacturing site, one for paint, electroplating, heat treatment, machining, assembling a responsible; five field service, responsible for the different regions of the after sale service.