标准编号:	CNCA-00C-006-2014
中文名称:	强制性产品认证实施规则工厂检查通用要求
英文名称:	Implementation Rules for Compulsory Product Certification - General Requirements for Factory Inspection
行业分类:	CN
发布日期:	2014-01-02
实施日期:	2014-9-1
标准状态:	现行
翻译语言:	英文
文件格式:	PDF
中文字符数:	10000 字
翻译价格(元):	1000.00 元
交付时间:	付款后 1 个工作日

0. Introduction

According to the requirements of "Regulations on Compulsory Product Certification", manufacturers shall control the consistency of their certified products, and their quality assurance capacity shall persistently meet the certification requirements. The Rules is formulated with a view to standardizing and guiding manufacturers producing products within the Catalogue of Products Subject to China Compulsory Certification (hereinafter referred to as CCC certification) to establish the quality assurance capacity required to ensure products being persistently in conformity with CCC certification.

During the specific implementation of certification, the factory shall establish the quality assurance capacity required by the Rules according to the requirements of the Rules and corresponding product certification implementation rules/regulations and in terms of product features and their characteristics in manufacturing and processing for the purpose of ensuring the consistency of certified products they produced and the type test samples.

Notes: The factories in the Rules involve certification clients, producers and manufacturers.

1 Application Scope

The Rules specifies the basic requirements of factory quality assurance capacity and is one of the criterion for implementing factory inspection by certification authorities.

2 Terms and Definitions

2.1 Certification Technology Director

a person who belongs to the producer and/or manufacturer, masters the requirements of certification standards, confirms and approves the change(s) of the certified product according to the responsibility scope specified in product certification implementation rules/regulations, and undertakes the corresponding responsibilities

2.2 Consistency of Certified Products (Product Consistency)

the certified products produced shall be consistent with the type test samples. The specific requirements for product consistency are specified in the product certification implementation rules/regulations

2.3 Routine Inspection

to eliminate nonconforming products caused by accidental factors in production, 100% inspection will usually be carried out on to-be-certified products during the final production stage. Routine inspection is allowed to be carried out with the proven equivalent and fast methods

Note: As for special products, sampling inspection may be adopted as routine inspection according to the requirements of product certification implementation rules/regulations.

2.4 Verification Inspection

the sampling inspection carried out to verify whether certified products meet the certification standards persistently

2.5 Periodical Verification Inspection for Key Components

the periodical sampling inspection carried out to verify whether the quality characteristics of key components persistently meet the certification standards and/or technical requirements

Note: “Key component” is a general term of parts and components, accessories, raw materials, etc., which play a key role for products meeting the requirements of certification standards.

2.6 Function Inspection

a inspection check carried out to determine whether the intended functions of the inspection and test instruments/equipment meet the specified requirements

3 Factory Quality Assurance Capacity Requirements

The factory is the responsibility subject for product quality, its quality assurance capacity shall persistently meet the certification requirements, the products it produced shall meet the standard requirements, and it shall ensure that the certified products are consistent with the type test samples. The factory shall receive and cooperate in all factory on-site inspections, market inspections and sampling tastings conducted by the certification authority according to the Rules and relevant product certification implementation rules/regulations.

3.1 Responsibilities and Resources

3.1.1 Responsibilities

The factory shall specify responsibilities, authorities and interrelationship for personnel at all levels concerned to certification requirements and shall also appoint a quality director from its management level; regardless of responsibilities of the appointed person in other aspects, he/she shall be provided with the following responsibilities and authorities:

(a) Ensuring that the requirements of this document are established, implemented and maintained effectively in the factory;

(b) Ensuring the product consistency and the conformity of products with the standards;

(c) Using the CCC certificate and mark correctly and ensuring that the certificates for CCC marked products are continuously valid.

The quality director shall be competent for the work and may also act as the certification technology director.

3.1.2 Resource

The factory shall be equipped with necessary production facilities and inspection and test instruments/equipment so as to stably produce products which meet the requirements of certification standards; shall allocate corresponding human resource and ensure that the staff engaged in such work having influence on product certification quality possess necessary ability; and shall establish and maintain requisite environment and facilities suitable for the production, inspection and test, storage, etc., of products.

As for external resources which shall be used by leasing, the factory shall ensure their continuous availability and correct application, and shall also keep the records of relevant external resources, such as the contract agreement and service record.

3.2 Documentation and Records

3.2.1 The factory shall establish and maintain documented procedures to ensure effective control of the files required by this document, necessary external files and records. The product design standards or specifications shall not be inferior to the requirements of the certification standards for the product. As for the main contents which may affect the product consistency, the factory shall have necessary drawings, templates, list of key components, process documents, operation instructions and other design documents, and ensure continuous effectiveness of the documents.

3.2.2 The factory shall ensure the sufficiency and suitability of the documents and use the valid versions of the documents.

3.2.3 The factory shall ensure the records to be clear, complete and traceable, so as to serve as the evidence for product meeting the specified requirements. The retention period of quality-related records shall meet the requirements of the laws and regulations to ensure the previous post-inspection record can be obtained in this inspection, and shall be at least 24 months.

3.2.4 The factory shall identify and keep the important documents and quality information related to product certification, such as the type test report, factory inspection results, status information (valid, suspended, withdrawn, cancelled, etc.) of CCC certificate, approval of certification change, supervised sampling inspection reports, product quality complaints and handling results, etc.

3.3 Control of Procurement and Key Components

3.3.1 Control of procurement

The factory shall identify and define the technical requirements of procured key components in the procurement document, and these technical requirements shall also ensure that the final products meet the certification requirements.

The factory shall establish and keep the list of the qualified producers/manufacturers of key components, and make procurement from them; the factory shall keep the procurement and application records, etc., of key components, such as the procurement list, ex-warehousing/warehousing list, accounts, etc.

3.3.2 Quality control of key components

3.3.2.1 The factory shall establish and maintain documented procedures, verify and/or inspect whether the technical requirements of key components are fulfilled during procurement (entering the factory) and keep related records.

3.3.2.2 As for the quality characteristics of the procured key components, the factory shall select suitable control modes to ensure their continuous conformity with the technical requirements of key components and to ensure that the final products meet the certification requirements, and shall also keep related records. Suitable control modes may include:

(a) As for CCC certificate or the voluntary product certification results which may be recognized by the compulsory certification of final products, the factory shall ensure the validity of the certificates.

(b) As for the key components without relevant certificates, their periodical verification inspection shall meet the requirements of product certification implementation rules/regulations.

(c) As for the control scheme formulated by factory, its control effect shall not be inferior to the requirements in Article 3.3.2.2 (a) or (b).

3.3.2.3 When procuring key components from dealers and traders, the factory shall take adequate measures to ensure the consistency of procured key components as well as their continuous conformity with the technical requirements.

As for the key parts, components, subassemblies, assemblies and semifinished products entrusted to subcontractors for producing, the factory shall control them as procured key components, so as to ensure the subcontracted products continuously meeting the specified requirements.

Self-produced key components shall be controlled according to Article 3.4.

3.4 Production Process Control

3.4.1 The factory shall identify the process which may affect the quality of certified products (referred to as critical process) and the identified critical process shall meet the relevant requirements. The operators of critical process shall possess appropriate capacity; the critical process shall be so controlled as to ensure the conformity of the certified product with the standards as well as the product consistency; where the quality of certified products cannot be guaranteed if no document is provided for the critical process, then corresponding operation instructions shall be prepared to control the production process.

3.4.2 If there is any requirement for the environment conditions during production, the factory shall ensure the working environment meeting the specified requirements.

3.4.3 If necessary, the factory shall monitor and measure the appropriate process parameters.

3.4.4 The factory shall establish and maintain a maintenance system for production equipment to ensure that the capacity of the equipment continuously meets the production requirements.

3.4.5 If necessary, the factory shall inspect, monitor and measure the products and their characteristics at the proper stage of the production according to the specified requirements, so as to ensure the conformity of products with the standards as well as the product consistency.

3.5 Routine Inspection and/or Verification Inspection

The factory shall establish and maintain documented procedures to control the routine inspection and/or verification inspection on final products; the inspection procedures, which shall include the inspection frequency, items, contents, procedures, judgment, etc., shall meet the relevant requirements. The factory shall carry out inspections and keep relevant records.

As for the inspection entrusted to an external organization, the factory shall ensure its capacity meets the inspection requirements and shall keep the evaluation results of relevant capacity, such as the laboratory accreditation certificate.

3.6 Inspection and Test Instruments/Equipment

3.6.1 Basic requirements

The factory shall be equipped with sufficient inspection and test instruments/equipment to ensure that the capacity of instruments/equipment used in such links as procurement, manufacture, and final inspection/test can meet the inspection and test requirements during the batch production of certified products.

Inspectors/testers shall be able to correctly use instruments/equipment, master the inspection and test requirements, and apply them effectively.

3.6.2 Calibration and verification

The inspection and test instruments/equipment used to determine that the produced certified products meet the relevant requirements shall be calibrated or verified per specified period, and this period may be set according to their use frequency, previous calibration condition, etc. As for instruments/equipment need internal calibration, the factory shall specify their calibration methods, acceptance criteria and calibration period, etc. Calibration or verification shall be traced back to national or international benchmark. The calibration or verification state of instruments and equipment shall be easy to be identified by the user and manager. The factory shall keep the calibration or verification records of instruments and equipment.

As for the calibration or verification entrusted to an external organization, the factory shall ensure the capacity of this organization meeting the requirements of calibration or verification and shall keep the relevant capacity evaluation results.

Note: As for critical monitoring and measuring devices in the production process control, the factory shall manage them according to the requirements of product certification implementation rules/regulations.

3.6.3 Functional check

If necessary, the factory shall carry out function check on the routine inspection equipment according to the specified requirements. If the result of function check fails to meet the requirements, the products detected shall be traceable; if necessary, these products shall be re-detected. The factory shall specify the measures that shall be taken by the operators upon finding the function failure of instruments and equipment.

The factory shall keep the records for function check results and those for measures taken when the instruments and equipment are in failure.

3.7 Control of Nonconforming Products

3.7.1 As for nonconforming products found in such links as procurement, manufacture and inspection, the factory shall take measures, like marking, isolating and disposing, to avoid unintended use or delivery of nonconforming products. The reworked or repaired products shall be reinspected.

3.7.2 As for any external information concerning the nonconformity of certified products, like supervision and random inspection at national and provincial levels, product recall and customer complaints, the factory shall analyze the reason for the nonconformity and take appropriate corrective measures. The factory shall keep the records of nonconformity, cause analysis, disposal and corrective measures, etc., of the certified products.

0.Introduction
1.Scope
2.Terms and Definitions
3.Criteria of Factory Inspection Activities
4.Factory Inspection Requirements
5.Determining Basic Requirements for Factory Inspection
6.Determining the Mode, Contents and Inspection Team of Factory Inspection
7.Risk Control for Manufacturer Relocation
8.Disposal after Finding the Nonconformity of Certified Products
9.Factory Inspection for Certificate Recovery
10.Special Requirements for Adding CCC Mark
11.Judgment for Factory Inspection Conclusion

2014年第1号


国家认监委关于发布工厂质量保证能力要求
等强制性产品认证实施规则的公告

为进一步促进强制性产品认证实施科学、规范、有效，根据《中华人民共和国认证认可条例》和《强制性产品认证管理规定》以及《国家认监委关于明确强制性产品认证实施规则类文件调整方案及要求的通知》（国认证〔2013〕39号），我委制定了两个强制性产品认证通用实施规则：《强制性产品认证实施规则工厂质量保证能力要求》，用于规范指导强制性产品认证目录内产品生产企业建立确保产品持续符合CCC认证要求的质量保证能力；《强制性产品认证实施规则工厂检查通用要求》，用于规范指导强制性产品认证指定认证机构工厂检查工作实施的一致性，现予以发布。
上述两个通用实施规则与后续发布的具体产品认证实施规则配套使用，于2014年9月1日起实施。
特此公告。

附件：1.《强制性产品认证实施规则工厂质量保证能力要
求》（编号：CNCA-00C-005）
2.《强制性产品认证实施规则工厂检查通用要求》
（编号：CNCA-00C-006）




国家认监委
2014年1月2日











附件1
编号：CNCA-00C-005



强制性产品认证实施规则


工厂质量保证能力要求







2014-01-02发布 2014-09-01实施
中国国家认证认可监督管理委员会发布
目 录

0.引言························································5
1.适用范围····················································5
2.术语和定义··················································5
2.1认证技术负责人············································5
2.2认证产品一致性（产品一致性）·······························5
2.3例行检验··················································6
2.4确认检验···················································6
2.5关键件定期确认检验········································6
2.6功能检查···················································6
3.工厂质量保证能力要求········································6
3.1职责和资源·················································7
3.2文件和记录·················································8
3.3采购和关键件控制···········································8
3.4生产过程控制···············································9
3.5例行检验和/或确认检验·····································10
3.6检验试验仪器设备··········································10
3.7不合格品的控制···········································12
3.8内部质量审核·············································12
3.9认证产品的变更及一致性控制·······························12
3.10产品防护与交付··········································13
3.11CCC证书和标志···········································13
0.引言
按照《强制性产品认证管理规定》的要求，生产企业应控制获证产品一致性，其质量保证能力应持续符合认证要求。为规范指导强制性产品认证（以下简称CCC认证）目录内产品生产企业建立确保产品持续符合CCC认证要求的质量保证能力，制定本实施规则。
在认证工作具体实施中，工厂应以保证生产的认证产品与型式试验样品的一致性为目标，根据本实施规则及相应产品认证实施规则/细则的要求，针对产品特性和生产加工特点，建立符合本实施规则要求的质量保证能力。
注：本实施规则中的工厂涉及认证委托人、生产者、生产企业。
1.适用范围
本实施规则规定了工厂质量保证能力的基本要求，同时也是认证机构实施工厂检查的依据之一。
2.术语和定义
2.1认证技术负责人
属于生产者和/或生产企业内部人员，掌握认证依据标准要求，依据产品认证实施规则/细则规定的职责范围，对认证产品变更进行确认批准并承担相应责任的人。
2.2认证产品一致性（产品一致性）
生产的认证产品与型式试验样品保持一致，产品一致性的具体要求由产品认证实施规则/细则规定。
2.3例行检验
为剔除生产过程中偶然性因素造成的不合格品，通常在生产的最终阶段，对认证产品进行的100%检验。例行检验允许用经验证后确定的等效、快速的方法进行。
注：对于特殊产品，例行检验可以按照产品认证实施规则/细则的要求，实施抽样检验。
2.4确认检验
为验证认证产品是否持续符合认证依据标准所进行的抽样检验。
2.5关键件定期确认检验
为验证关键件的质量特性是否持续符合认证依据标准和/或技术要求所进行的定期抽样检验。
注：关键件是对产品满足认证依据标准要求起关键作用的元器件、零部件、原材料等的统称。
2.6功能检查
为判断检验试验仪器设备的预期功能是否满足规定要求所进行的检查。
3.工厂质量保证能力要求
工厂是产品质量的责任主体，其质量保证能力应持续符合认证要求，生产的产品应符合标准要求，并保证认证产品与型式试验样品一致。工厂应接受并配合认证机构依据本实施规则及相关产品认证实施规则/细则所实施的各类工厂现场检查、市场检查、抽样检测。
3.1职责和资源
3.1.1职责
工厂应规定与认证要求有关的各类人员职责、权限及相互关系，并在本组织管理层中指定质量负责人，无论该成员在其它方面的职责如何，应使其具有以下方面的职责和权限：
(a)确保本文件的要求在工厂得到有效地建立、实施和保持；
(b)确保产品一致性以及产品与标准的符合性；
(c)正确使用CCC证书和标志，确保加施CCC标志产品的证书状态持续有效。
质量负责人应具有充分的能力胜任本职工作，质量负责人可同时担任认证技术负责人。
3.1.2资源
工厂应配备必须的生产设备、检验试验仪器设备以满足稳定生产符合认证依据标准要求产品的需要；应配备相应的人力资源，确保从事对产品认证质量有影响的工作人员具备必要的能力；应建立并保持适宜的产品生产、检验试验、储存等必备的环境和设施。
对于需以租赁方式使用的外部资源，工厂应确保外部资源的持续可获得性和正确使用；工厂应保存与外部资源相关的记录，如合同协议、使用记录等。
3.2文件和记录
3.2.1工厂应建立并保持文件化的程序，确保对本文件要求的文件、必要的外来文件和记录进行有效控制。产品设计标准或规范应不低于该产品的认证依据标准要求。对可能影响产品一致性的主要内容，工厂应有必要的图纸、样板、关键件清单、工艺文件、作业指导书等设计文件，并确保文件的持续有效性。
3.2.2工厂应确保文件的充分性、适宜性及使用文件的有效版本。
3.2.3工厂应确保记录的清晰、完整、可追溯，以作为产品符合规定要求的证据。与质量相关的记录保存期应满足法律法规的要求，确保在本次检查中能够获得前次检查后的记录，且至少不低于24个月。
3.2.4工厂应识别并保存与产品认证相关的重要文件和质量信息，如型式试验报告、工厂检查结果、CCC证书状态信息（有效、暂停、撤销、注销等）、认证变更批准信息、监督抽样检测报告、产品质量投诉及处理结果等。
3.3采购与关键件控制
3.3.1采购控制
对于采购的关键件，工厂应识别并在采购文件中明确其技术要求，该技术要求还应确保最终产品满足认证要求。
工厂应建立、保持关键件合格生产者/生产企业名录并从中采购关键件，工厂应保存关键件采购、使用等记录，如进货单、出入库单、台帐等。
3.3.2关键件的质量控制
3.2.2.1工厂应建立并保持文件化的程序，在进货（入厂）时完成对采购关键件的技术要求进行验证和/或检验并保存相关记录。
3.3.2.2对于采购关键件的质量特性，工厂应选择适当的控制方式以确保持续满足关键件的技术要求，以及最终产品满足认证要求，并保存相关记录。适当的控制方式可包括：
(a)获得CCC证书或可为最终产品强制性认证承认的自愿性产品认证结果，工厂应确保其证书状态的有效。
(b)没有获得相关证书的关键件，其定期确认检验应符合产品认证实施规则/细则的要求。
(c)工厂自身制定控制方案，其控制效果不低于3.3.2.2(a)或(b)的要求。
3.3.2.3当从经销商、贸易商采购关键件时，工厂应采取适当措施以确保采购关键件的一致性并持续满足其技术要求。
对于委托分包方生产的关键部件、组件、分总成、总成、半成品等，工厂应按采购关键件进行控制，以确保所分包的产品持续满足规定要求。
对于自产的关键件，按3.4进行控制。
3.4生产过程控制
3.4.1工厂应对影响认证产品质量的工序（简称关键工序）进行识别，所识别的关键工序应符合规定要求。关键工序操作人员应具备相应的能力；关键工序的控制应确保认证产品与标准的符合性、产品一致性；如果关键工序没有文件规定就不能保证认证产品质量时，则应制定相应的作业指导书，使生产过程受控。
3.4.2产品生产过程如对环境条件有要求,工厂应保证工作环境满足规定要求。
3.4.3必要时，工厂应对适宜的过程参数进行监视、测量。
3.4.4工厂应建立并保持对生产设备的维护保养制度，以确保设备的能力持续满足生产要求。
3.4.5必要时，工厂应按规定要求在生产的适当阶段对产品及其特性进行检查、监视、测量，以确保产品与标准的符合性及产品一致性。
3.5例行检验和/或确认检验
工厂应建立并保持文件化的程序，对最终产品的例行检验和/或确认检验进行控制；检验程序应符合规定要求，程序的内容应包括检验频次、项目、内容、方法、判定等。工厂应实施并保存相关检验记录。
对于委托外部机构进行的检验，工厂应确保外部机构的能力满足检验要求，并保存相关能力的评价结果，如实验室认可证明等。
3.6检验试验仪器设备
3.6.1基本要求
工厂应配备足够的检验试验仪器设备，确保在采购、生产制造、最终检验试验等环节中使用的仪器设备能力满足认证产品批量生产时的检验试验要求。
检验试验人员应能正确使用仪器设备，掌握检验试验要求并有效实施。
3.6.2校准、检定
用于确定所生产的认证产品符合规定要求的检验试验仪器设备应按规定的周期进行校准或检定，校准或检定周期可按仪器设备的使用频率、前次校准情况等设定；对内部校准的，工厂应规定校准方法、验收准则和校准周期等；校准或检定应溯源至国家或国际基准。仪器设备的校准或检定状态应能被使用及管理人员方便识别。工厂应保存仪器设备的校准或检定记录。
对于委托外部机构进行的校准或检定活动，工厂应确保外部机构的能力满足校准或检定要求，并保存相关能力评价结果。
注：对于生产过程控制中的关键监视测量装置，工厂应根据产品认证实施规则/细则的要求进行管理。
3.6.3功能检查
必要时，工厂应按规定要求对例行检验设备实施功能检查。当发现功能检查结果不能满足要求时，应能追溯至已检测过的产品；必要时，应对这些产品重新检测。工厂应规定操作人员在发现仪器设备功能失效时需采取的措施。
工厂应保存功能检查结果及仪器设备功能失效时所采取措施的记录。
3.7不合格品的控制
3.7.1对于采购、生产制造、检验等环节中发现的不合格品，工厂应采取标识、隔离、处置等措施，避免不合格品的非预期使用或交付。返工或返修后的产品应重新检验。
3.7.2对于国家级和省级监督抽查、产品召回、顾客投诉及抱怨等来自外部的认证产品不合格信息，工厂应分析不合格产生的原因，并采取适当的纠正措施。工厂应保存认证产品的不合格信息、原因分析、处置及纠正措施等记录。
3.7.3工厂获知其认证产品存在重大质量问题时（如国家级和省级监督抽查不合格等），应及时通知认证机构。
3.8内部质量审核
工厂应建立文件化的内部质量审核程序，确保工厂质量保证能力的持续符合性、产品一致性以及产品与标准的符合性。对审核中发现的问题，工厂应采取适当的纠正措施、预防措施。工厂应保存内部质量审核结果。
3.9认证产品的变更及一致性控制
工厂应建立并保持文件化的程序，对可能影响产品一致性及产品与标准的符合性的变更（如工艺、生产条件、关键件和产品结构等）进行控制，程序应符合规定要求。变更应得到认证机构或认证技术负责人批准后方可实施，工厂应保存相关记录。
工厂应从产品设计（设计变更）、工艺和资源、采购、生产制造、检验、产品防护与交付等适用的质量环节，对产品一致性进行控制，以确保产品持续符合认证依据标准要求。
3.10产品防护与交付
工厂在采购、生产制造、检验等环节所进行的产品防护，如标识、搬运、包装、贮存、保护等应符合规定要求。必要时，工厂应按规定要求对产品的交付过程进行控制。
3.11CCC证书和标志
工厂对CCC证书和标志的管理及使用应符合《强制性产品认证管理规定》、《强制性产品认证标志管理办法》等规定。对于统一印制的标准规格CCC标志或采用印刷、模压等方式加施的CCC标志，工厂应保存使用记录。对于下列产品，不得加施CCC标志或放行：
(a)未获认证的强制性产品认证目录内产品；
(b)获证后的变更需经认证机构确认，但未经确认的产品；
(c)超过认证有效期的产品；
(d)已暂停、撤销、注销的证书所列产品；
(e)不合格产品。





附件2
编号：CNCA-00C-006



强制性产品认证实施规则


工厂检查通用要求







2014-01-02发布 2014-09-01实施
中国国家认证认可监督管理委员会发布
目 录

0.引言······················································16
1.范围·······················································16
2.术语和定义·················································16
2.1工厂检查·················································16
2.2指定试验··················································17
3.工厂检查活动的准则·········································17
4.工厂检查要求···············································17
4.1工厂专业类别·············································17
4.2工厂检查实施的基本要求.···································18
5.确定工厂检查的基本要求·····································18
6.确定工厂检查的方式、内容和检查组····························18
7.生产企业搬迁的风险控制·····································19
8.获知认证产品不合格信息后的处置·····························19
9.证书恢复的工厂检查·········································19
10.CCC标志加施的特殊要求····································19
10.1需在生产过程中加施CCC标志的要求························20
10.2委托相关方印刷、模压CCC标志的要求························20
11.工厂检查结论判定·········································20
11.1工厂检查结论和不符合项分类······························20
11.2工厂检查结论判定条件····································21
11.3工厂检查的结论告知······································23
0.引言
按照《强制性产品认证管理规定》的要求，在工厂检查活动中，指定认证机构应对产品生产企业的质量保证能力、生产产品与型式试验样品的一致性等情况进行检查。为规范强制性产品认证工厂检查活动,指导指定认证机构工厂检查工作实施的一致性,保证工厂检查活动的针对性和有效性，制定本实施规则。
指定认证机构应根据本实施规则及相应产品认证实施规则的要求，针对产品自身特性和生产加工特点、生产企业分类管理、检查员使用管理等因素，在风险评估的基础上，建立与机构自身特点相适应的工厂检查实施方案。
1.范围
本实施规则适用于指定认证机构工厂检查活动的组织管理、实施、工厂检查结论判定等活动。
2.术语和定义
《强制性产品认证实施规则工厂质量保证能力要求》（简称工厂质量保证能力要求）中确立的以及下列术语和定义适用于本实施规则。
2.1工厂检查
对工厂质量保证能力、产品一致性和产品与标准的符合性所进行的评价活动。工厂检查范围包括产品范围和场所界限。
注：产品范围指认证产品。场所界限指与产品认证质量相关的场所、部门、活动和过程；当认证产品的制造涉及多个场所时，工厂检查的场所界限应至少包括例行检验、加施产品铭牌和CCC标志环节所在场所，必要时还应到其余场所（如关键工序）进一步检查，即延伸检查。
2.2指定试验
为评价认证产品的一致性、产品与标准的符合性，检查组在生产企业现场抽取认证产品并根据认证依据标准选定项目，由生产企业人员所进行的试验。
3.工厂检查活动的准则
(a)客观、公正、公开、保密；
(b)以产品一致性、产品与标准的符合性为关注焦点；
(c)获取认证产品及工厂的真实状况；
(d)选取具有代表性的检查样本；
(e)得出基于风险评估的工厂检查结论判定。
4.工厂检查要求
认证机构应依据工厂质量保证能力要求并结合产品及行业特点，明确并公布工厂检查要求。工厂检查要求应至少包含工厂质量保证能力要求中的适用内容，并在以下方面保持一致：
4.1工厂专业类别
工厂专业类别按相同的产品大类、相同的认证依据标准系列、相同或相似的影响认证产品质量的关键生产工艺、可考虑的特殊情况等进行划分。
同一工厂涵盖不同工厂专业类别时，工厂检查应分别实施。原则上，产品一致性检查、指定试验、抽样检验和确认检验应覆盖不同的工厂专业类别。
4.2工厂检查实施的基本要求
对于同一认证规则下不同认证机构实施认证的产品，关键件清单、关键件定期确认检验、例行检验、确认检验的要求应保持一致。
5.确定工厂检查的场所界限
在认证批准前，认证机构应与工厂协商确定工厂检查的场所界限，对于生产企业实际地址以外的与产品认证质量相关的场所、部门、活动和过程，应特别关注。
在认证批准后，认证机构应确保工厂检查场所界限的完整性、准确性，为选取具有代表性的检查样本提供必要条件。
6.确定工厂检查的方式、内容和检查组
认证机构应根据工厂检查的具体目的确定其实施方式和内容，如预先通知或不通知的工厂检查、从工厂/市场/使用场所获取样品、抽样或买样，以及工厂检查的条款、各条款的检查重点、产品一致性检查、指定试验、监督抽样等。
认证机构应根据工厂检查的具体目的、方式和内容，确定具备相应能力的检查组成员，并为其提供完整、准确、实时更新的工厂检查所需资料和信息。
对于预先通知的工厂检查，认证机构应在现场检查前与生产企业约定工厂检查时间、确认工厂检查范围和计划安排。
7.生产企业搬迁的风险控制
对于生产企业搬迁，认证机构应采取适当和必要的措施控制可能存在的如下风险：
(a)由于生产条件、人员能力、生产工艺等变化所导致的风险；
(b)工厂在新生产场所生产的产品，未经认证即出厂、销售的风险。
8.获知认证产品不合格信息后的处置
在获知认证产品不合格信息后，认证机构应视情况实施特殊检查或调查；重点分析导致不合格的原因及对认证产品的影响程度，并采取相应的处置措施。
9.证书恢复的工厂检查
对于因质量原因所暂停的证书，在证书恢复的工厂检查时，认证机构应：
(a)关注工厂对证书暂停的原因分析是否全面、充分；
(b)关注工厂采取的措施是否满足产品召回等法律法规要求，纠正和纠正措施是否适当、有效，以避免同类问题的再次发生；
(c)关注在证书暂停期间，是否有相关产品出厂、销售、进口。
10.CCC标志加施的特殊要求
10.1需在生产过程中加施CCC标志的要求
对于需在生产过程中加施CCC标志的，如机动车辆轮胎、电线电缆等，认证机构应重点关注并控制下列可能存在的风险，采取适当和必要的措施以避免其非预期使用或交付：
(a)从加施CCC标志至例行检验之间的，状态未定产品；
(b)已加施CCC标志的不合格品。
10.2委托相关方印刷、模压CCC标志的要求
对于工厂委托相关方印刷、模压CCC标志的，如机动车灯具生产企业委托配光镜生产者将CCC标志模压在配光镜表面等，认证机构应重点关注以下方面的风险，采取适当和必要的措施使风险可控：
(a)相关方加施CCC标志的活动是否受控并符合规定要求；
(b)加施CCC标志的不合格品的非预期使用或交付；
(c)加施CCC标志的合格品是否仅用于向生产企业交付；
(d)相关方所印刷、模压CCC标志的产品是否在强制性产品认证目录内。
11.工厂检查结论判定
11.1工厂检查结论和不符合项分类
工厂检查结论通常分为“工厂检查通过”、“书面验证通过”、“现场验证通过”、“工厂检查不通过”四种。其中，“书面验证通过”指存在不符合项，工厂在规定的期限内采取纠正措施，报认证机构书面验证有效后，工厂检查通过；“现场验证通过”指存在不符合项，工厂在规定的期限内采取纠正措施，认证机构现场验证有效后，工厂检查通过。
工厂检查不符合项分为一般不符合项和严重不符合项两类。其中，一般不符合项指可能对产品认证质量产生轻微影响的不符合项；严重不符合项指认证产品在生产制造或检验过程中产生严重的质量问题，以及产品结构、关键件等与认证批准结果不一致且较为严重的不符合项。
11.2工厂检查结论判定条件
11.2.1工厂检查通过
无不符合项。
11.2.2书面验证通过
属于一般不符合项；或者“现场验证通过”和“工厂检查不通过”以外的情况。
11.2.3现场验证通过
存在不符合项，但没有对产品一致性或产品与标准的符合性产生严重影响，具体例如：
(a)虽有构成系统性不符合的较多一般不符合项，但未对产品一致性或产品与标准的符合性产生严重影响的；
(b)虽有在资源、关键件质量控制、生产过程控制、检验等产品实现的主要质量环节存在不符合项，但未对产品一致性或产品与标准的符合性产生严重影响的；
(c)其他难以通过纠正措施的证明性材料进行书面验证，但未对产品一致性或产品与标准的符合性产生严重影响的。
11.2.4工厂检查不通过
有构成系统不符合的较多一般不符合项或个别严重不符合项，且直接危及产品一致性或产品与标准的符合性时，具体例如：
(a)指定试验结果不合格（原则上）；
(b)关键资源不满足要求，难以保证产品一致性或产品与标准的符合性的；
(c)产品一致性存在问题且较为严重，将导致产品不符合标准要求，如产品结构、关键件变更不符合规定要求的；
(d)认证产品存在缺陷，可能导致质量安全事故的；
(e)认证产品的变更及一致性控制未有效实施，造成产品不一致且质量保证能力系统性失效的；
(f)认证证书暂停期间，工厂未采取整改措施或者整改后仍不合格的；
(g)非法使用CCC标志或证书；
非法使用CCC标志或证书的主要情况有：伪造、变造、出租、出借、冒用、买卖、转让CCC标志或证书，以及盗用CCC标志；在获知证书被撤销或暂停后，继续使用CCC标志或证书；在未获得CCC证书的产品上，故意加施CCC标志；其它故意非法使用CCC标志或证书的情况。
(h)工厂以欺骗、贿赂等不正当手段获得认证证书的;
(i)其它直接危及产品一致性或产品与标准的符合性的严重不符合项。
11.3工厂检查的结论告知
对于工厂检查结论判定为“书面验证通过”或“现场验证通过”的，认证机构应将验证结果及时告知生产企业。
当经过认证机构评定后的工厂检查结论发生变化时，认证机构应及时告知生产企业。