ISO9001为代表的自愿性认证市场监管初探
ISO9001 as the representative of the market regulation of voluntary certification
近年来，我国外向型经济不断发展，越来越多的企业开始重视、引入和建立以ISO9001为代表的各种国际通行的先进管理体系。为了规范辖区内的自愿性认证行为，净化自愿性认证市场，无锡检验检疫局不断加强认证市场的执法监督力度，并采取有效措施提高认证行政执法的有效性。
In recent years, China's foreign economy continues to develop, more and more enterprises begin to pay attention to, introducing and establishing the ISO9001as representatives of the various international advanced management system. In order to standardize the area of voluntary behavior voluntary certification certification, purify the market, Wuxi inspection and Quarantine Bureau to strengthen the supervision of law enforcement certification market, and take effective measures to improve the effectiveness of administrative law enforcement certification.
    一、人员资质的“真空期”
A "vacuum period, personnel qualification"
    检查人员在审阅辖区内某进出口企业的认证材料时发现，北京某认证机构（下称A机构）在对该企业进行质量管理体系（QMS）再认证审核时，某审核员在“自愿性认证活动执法监管系统”中登记的注册号，在中国认证认可协会（CCAA）资料库中显示审核时为“过期失效”状态。经联系，A机构解释为审核时，该审核员的再注册资料已经递交至CCAA，但当时尚未获得批准。在审核结束后不久，CCAA才正式批准了该审核员的再注册申请，并换发了新的注册证，新注册证上的有效期延续了上一张证的失效日期。
Inspectors in the review area of an import and export enterprise certification material found in Beijing, a certification authority (hereinafter referred to as A ) in the enterprise quality management system ( QMS ) and certification audit, an auditor in the" voluntary certification activities of law enforcement supervision system" board of record registration, certification and Accreditation Association ( in Chinese CCAA ) database display audit" expired" state. Upon contact, A mechanism explanation for the audit, the auditor to registration information has been submitted to the CCAA, but when the fashion not approved. At the end of the audit shortly after, CCAA was formally approved by the auditor to application for registration, and issue a new license, a new registration certificate the validity of a continuation of the previous card expiry date.
    笔者认为，审核活动发生时，该审核员资质确属失效状态，虽然已提交了再注册申请，但无论是认证机构，还是审核员本人，对能否获批并不知晓。因此，A机构有违反《中华人民共和国认证认可条例》（下称《认证认可条例》）第39条，即“从事评审、审核等认证活动的人员，应当经认可机构注册后，方可从事相应的认证活动”的嫌疑。但考虑到发现此案时，该审核员的再注册申请在CCAA的网站上查询状态已为批准状态，且新换发的注册证有效期延续了上一张的有效期，故无锡检验检疫局对该认证机构进行了批评教育，并发放了《管理体系认证有效性行政监督检查问题通知书》，要求认证机构加强对人员注册的管理：一是按照时间要求尽量提前递交注册资料；二是在未明确注册申请得到批准前，不得安排相应人员参加审核。
The author thinks, the audit activity occurs, the auditor qualification is failure state, although have submitted applications for registration again, but whether it is the certification body, or auditor himself, to be approved without the knowledge of. Therefore, A mechanism" in violation of the people's Republic of China Certification and accreditation Ordinance" (hereinafter referred to as the" attestation approves ordinance" ) thirty-ninth, namely" engaged in audit, audit certification activities such as personnel, should be registered by the accreditation bodies, may carry out the certification activities accordingly.". But considering that the case, the auditor to register on the CCAA website states have approved state, and the new reissue of the registration certificate validity period lasted a period of validity, the Wuxi inspection and Quarantine Bureau of the certification body was criticized for education, and issued a" management system effectively administrative supervision and inspection issues notice", the requirements for certification agencies to strengthen the registration management: one is in accordance with the time requirements as far as possible in advance submit registration information; two is not expressly approved prior to application for registration, must not arrange corresponding personnel to participate in audit.
    虽然CCAA规定再注册应在注册证书到期前3个月内向CCAA提出再注册申请，但事实上可能会存在一段审核员资质“真空期”，即审核员资质已到期，虽然已向CCAA递交了再注册申请，但CCAA尚未作出是否批准的决定。严格来讲，在这段真空期内，审核员不应从事审核活动。
Although the CCAA provisions to registration should be registered in the certificate expire within 3 months before the CCAA proposes to registration, but may in fact there will be a period of auditor qualification" vacuum period", namely the auditor qualification has expired, while the CCAA has to submit application for registration again, but CCAA has yet to make a decision of approval or disapproval. Strictly speaking, in this paragraph of vacuum period, the auditor should not be involved in the audit activities.
    二、新认证领域的“真空期”
Two, a new authentication domain" vacuum period"
    检验检疫人员在对辖区内某化工企业进行日常监管时发现，该企业有一张某机构（下称B机构）颁发的“FAMI-QS认证”证书。但在国家认证认可监督管理委员会（下称国家认监委）网站上查询，却查询不到该机构关于“FAMI-QS认证”的备案信息，同时也未查询到在国内有机构具备该项认证的审核资质。
Inspection and quarantine personnel in the area of a chemical industry enterprise in daily supervision over the enterprises have found, a mechanism ( hereinafter referred to as B ) awarded the " FAMI-QS certification" certificate. But in national attestation approves supervisory management committee ( hereinafter referred to as the CNCA ) website, but not to inquire about the mechanism of" FAMI-QS certification" of the record information, but also not to inquire the domestic institutions have the certification audit qualification.
    FAMI-QS（欧洲饲料添加剂和预混合饲料质量体系），是基于ISO9001、HACCP以及欧盟各国在饲料安全领域推荐的GMP+, FEMAS, Q+S等认证基础上建立的欧盟统一认证制度，对进入欧盟的饲料添加剂和预混合饲料开展的强制认证，整合了欧盟各成员国间不同的认可要求，是唯一适用于整个欧洲的饲料添加剂和添加剂预混合饲料生产的质量安全控制体系。
FAMI-QS ( European feed additives and feed quality system ), is based on the ISO9001, HACCP and the European Union countries in the field of feed safety recommended GMP+, FEMAS, Q+S certification is established based on the unified EU certification system, to enter the European Union feed additives and pre-mixed feed the compulsory certification, the integration of EU member states the different recognition requirements, is only applicable to the whole European feed additives and additive premix feed production and quality safety control system.
    本案例中，B机构作为第三方机构，对企业相关产品是否符合欧盟的准入标准进行了审核，并颁发了认证证书，完全符合《认证认可条例》中关于认证的定义。但《认证认可条例》第18条第2款明确规定，属于认证新领域，前款规定的部门尚未制定认证规则的，认证机构可以自行制定认证规则，并报国务院认证认可监督管理部门备案。可见，FAMI-QS在国内虽属认证新领域，但是亦应及时向国家认监委进行备案。
In this case, the B organization as the third party organization, the enterprise related products for compliance with EU standards of access were reviewed, and issued a certificate, complete with the" attestation approves ordinance" on the certification of definition. But the" attestation approves ordinance" clearly stipulated in paragraph eighteenth and second, which belongs to the new field of certification, the provisions of the preceding paragraph Department has not yet developed the certification rules, the certification body can make the certification rules, and submit the certification and accreditation administration departments for the record. Visible, FAMI-QS in domestic is certified new field, but also should be timely to the CNCA record.
    笔者认为，对于国内应用范围较小且暂无相关认证规则的，只要符合《认证认可条例》中关于认证定义的要素，相关认证机构就应主动向国家认监委进行备案。国内外新型认证层出不穷，国家主管部门不宜发布一个适用于《认证认可条例》管理的认证目录。因为一旦限定了目录，则目录的更新将永远滞后于认证的发展。这对于新型认证来讲，会形成一定时间的“真空期”，不利于国内认证市场的监管。
The author thinks, for domestic application scope is smaller and the related certification rules, as long as the" attestation approves ordinance" on certification defines the elements, the relevant certification institutions shall take the initiative to the CNCA record. Domestic and foreign new certification emerge in an endless stream, the competent national authorities should not be released an application to" attestation approves ordinance" management certification directory. Because once the limit is directory, directory update will always lag behind the development of attestation of. The new certification, will form a certain time" vacuum period", not good for domestic certification market supervision.
    三、缩短审核时间与减少、遗漏程序
Three, to shorten the time and reduce the omission procedure, audit
    根据辖区内某企业提供的QMS审核资料，检查人员发现某认证机构（下称C机构）实际审核时间比审核计划缩短了4小时。经查询《管理体系审核时间（QMS、EMS、OHSMS）》（CNAS-CC15），该企业的QMS审核人/天数应为4人/天，而该机构编制的《现场审核计划》上人/天数虽然为4人/天，但实际审核仅为3人/天。
According to the area of some enterprises to provide QMS audit data, inspection staff found a certification body ( hereinafter referred to as C ) the actual audit time is shortened by 4 hours than the audit plan. The query" management system audit time ( QMS, EMS, OHSMS )" ( CNAS-CC15), the QMS audit / stay shall be 4/ day, and the organization of the" plan" on site audit / days although4/ day, but the actual audit is only 3person / day.
    《认证认可条例》第18条中明确规定，认证机构应当按照认证基本规范、认证规则从事认证活动。《认证机构管理办法》第25条又对上述规定进行了细化，认证机构应当按照认证基本规范、认证规则规定的程序对认证全过程实施有效控制，确保认证和产品测试过程完整、客观、真实，并具有可追溯性，不得增加、减少或者遗漏认证程序和活动，并配备具有相应能力和专业的认证人员对上述过程进行评价。这种情况包括有意或者无意，善意或是恶意。现场存在明显问题认证审核时未发现，减少审核人/天数，认证人员不到现场或是冒名顶替等都属于认证活动缺失。因此，C机构缩短审核时间的行为违反了上述条款，无锡检验检疫局执法人员对C机构实施了相应的行政处罚。
Certification and Accreditation" eighteenth" in specific provision, the certification institution shall, in accordance with the basic requirements for certification, certification rules undertake certification activities. " Certification agency management approach" to the provisions of article twenty-fifth to undertake refining, the certification institution shall, in accordance with the basic requirements for certification, certification regulations and procedures for certification of the whole process of the implementation of effective control, to ensure that the certification and product testing process is complete, objective, true, and traceable, may increase, decrease or omission of any certification program and activity, and equipped with the corresponding ability and professional certification of the process evaluation. This includes intentionally or accidentally, for good or ill. The scene there is an obvious problem certification audit has not found, reduce audit / certification personnel not to stay, live or take another's place by counterfeiting belong to the certification activities lack. Therefore, C reduce audit time behavior in violation of the above provisions, Wuxi inspection and Quarantine Bureau law enforcement officers of C mechanism implemented corresponding administrative penalty.
    《认证机构管理办法》第54条对“审核时间严重不足，低于认证基本规范、认证规则规定的”明确了“国家认监委或者地方认证监管部门应当责令其限期改正，逾期未改正的，可以处3万元以下罚款”；第55条对“增加、减少、遗漏认证基本规范、认证规则规定程序要求，认证人员未到审核现场或者未对认证委托人的纠正措施进行有效验证即出具认证证书的”明确了“地方认证监管部门应当责令其改正，处5万元以上10万元以下罚款，有违法所得的，没收违法所得；情节严重的，国家认监委应当责令其停业整顿6个月直至撤销其批准证书，并予公布”。
" Certification agency management approach" fifty-fourth to" audit time serious insufficient, below the basic certification standards, certification rules" clear " the scarc or local certification regulatory departments shall order them to correct within a prescribed time limit, overdue correction, can be more than 30000 yuan in fines;" fifty-fifth to" increase, decrease the basic requirements for certification, omission, certification rules procedures, certification personnel not to audit the field or not on the certification client corrective measures are effective verification is issued by the certificate of" clear " local certification regulatory departments shall order it to correct,50000 yuan more than100000yuan shall be imposed, the illegal income confiscated, income; if the circumstances are serious, the scarc shall order it to suspend business for 6 months until the revocation of the certificate of approval, and make an announcement".
    笔者认为，具体在处罚实施时，可以分为两种情况：一种是认证机构的计划符合相应规范、规则，而审核组擅自缩短时间（如晚到早走或减少人数）的，适用罚则第54条；另一种是认证机构在制定计划时不符合相应规范、规则的，则可适用罚则第55条。
The author thinks, in particular in penalty implementation, can be divided into two types: one is the certification body plan is in line with the corresponding norms, rules, and the audit team to shorten the time ( such as of late to leave early or to reduce the number of ), penalty applies fifty-fourth; another is a certification body in the formulation of plans did not meet the corresponding norms, rules can be applied, the fifty-fifth penalty.
    近年来，无锡检验检疫局在自愿性认证行政执法过程中采取了两条措施：一是采取前述从书面到现场再到机构的“三查”方式，形成了有覆盖、有重点的调查方式，显著提高了发现问题的比率。二是采用三层措施形成对辖区内违法违规认证活动监管的全覆盖，即对轻微违规的机构采取发放“整改通知书”的方式督促其限期整改，对严重违法违规的机构严格按照《认证认可条例》和《认证机构管理办法》进行调查和行政处罚，对于无法开展调查工作的非法认证行为，采取发放《行政提示书》的方式告知受审核方其认证既无效又非法，有效抑制了非法认证的生存空间。
In recent years, Wuxi inspection and Quarantine Bureau in voluntary certification process of administrative law enforcement to take two measures: one is to take the written to the scene to the mechanism from the "three examinations", formed a cover, a focused survey, significantly improve the discovery rate. Two is made of three layer forming area measures on illegal certification supervision full coverage, i.e. for minor violations organization to adopt the issuance of " rectification notice" to urge the rectification within the prescribed time limit, the serious illegal organizations in strict accordance with the" attestation approves ordinance" and" certification agency management approach" to investigate and administrative punishment, to conduct investigation of illegal act of authentication, adopt extend" administrative hint book" way to inform the auditee the certification is invalid and illegal, effectively restrain the illegal attestation living space.
    自90年代初我国开始质量体系认证以来，自愿性认证市场经历了从无序到规范的发展过程，总体来看，处于一种螺旋式上升的发展态势。优秀的产品必须要有完善的管理体系作为支撑，完善的管理体系则需要有效的认证来保证。因此，认证监管部门、认证机构和受审核方都要充分认识到做好体系认证的重要意义，共同提高认证有效性，更好地将中国制造产品推向国际市场。
Since the early 90's in China since the beginning of quality system certification, CQC certification market has experienced from disorder to regulate the process of development, overall, in a spiral development trend. Excellent product must have a sound management system as a support, a sound management system is the need to ensure effective certification. Therefore, certification authorities, certification bodies and the auditee should fully realize the important significance to the certification system, jointly improve the effectiveness of certification, to better products to the international market of Chinese manufacturing.