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ANSI推出自愿性认证机构认证机构获得FDA-食品安全现代化法(FSMA)认证

发布时间: 2017-12-28 14:56:49   审校:睿智   浏览次数:

 

美国国家标准学会(ANSI)是美国自愿标准化体系的协调组织,已经启动了一个认证机构自愿试点认可计划,要求获得美国食品和药物管理局(FDA)的食品安全现代化法案(FSMA)认证 - 国外供应商认证计划ANSI将于20171016日(周一)至2017121日(周五)这一期间接受对于该新计划的申请。

FDA FSMA关于人类及动物用进口食品的外国供应商验证计划(FSVP)的最终规定要求进口商开展某些以风险为基础的活动,以核实进口到美国的食品是否否按照适用的安全标准。该规定自2017年5月30日起生效,是对行业,消费者群体,联邦、州、地方、部落与国际食品药品安全监管机构,学术界与其他利益相关者开展广泛调查后取得的结果。

作为回应,ANSI为认证机构(CBs)推出了自愿性试点认可计划,要求获得FDAFSMA最终规则的认可。ANSI的这一自愿性计划的目的是以独立第三方为基础,对CBs进行评估,以确定他们是否符合FDA法规、国际标准 ISO/IEC 17065合格评定——产品、过程和服务认证方案要求和相关认证计划的要求。符合这些要求的CBs将获得认可,成为ANSI认可的认证机构(ANSI ACBs),从而可以在自愿的基础上,按照FDA-- FSMA-外国供应商验证计划,对外国食物供应商进行食品安全审查,并签发资格证书。

通过向CBs提供执行国外供应商审核机会,ANSI加强了审查的严密性,并提高了进口食物的安全性。

我们鼓励有兴趣参与此次ANSI自愿性试点认可计划的认证机构索取ANSI的申请文件包。必须在截止日期2017121前将填写完毕的申请文件包提交给ANSI。

如需获取关于该新试点认证计划的申请文件包,请联系负责产品/过程/服务认证计划的ANSI高级项目主管雷纳尔多·费格雷多(Reinaldo Figueiredo)(rfigueir@ansi.org; 202.331.3611)。

关于ANSI

美国国家标准协会(ANSI)是一个非营利性民间组织,其使命在于通过宣扬、促进和保障自愿性标准化与合格评定体系的完整性,以提升美国的国际竞争力与美国人民的生活水平。该协会由企业、专业学会与行业协会、标准制定机构、政府机构以及消费者与劳动者组织组成,代表着世界范围内125000多家公司和组织以及350万专业人士的不同利益。

该协会是美国在国际标准化组织(ISO)的正式代表,并通过美国国家委员会成为美国在国际电工委员会(IEC)的正式代表。

 

ANSI Launches Voluntary Pilot Accreditation Program for Certification Bodies Seeking Accreditation for FDA-Food Safety Modernization Act

(FSMA)-Foreign Supplier Verification Programs

The American National Standards Institute (ANSI), coordinator of the U.S. voluntary standardization system, has initiated a Voluntary Pilot Accreditation Program for Certification Bodies seeking accreditation to the U.S. Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) - Foreign Supplier Verification Programs. ANSI is accepting applications for this new program from Monday, October 16, 2017, through Friday, December 1, 2017.

The FDA FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable safety standards. The rule, with first compliance dates that began on May 30, 2017, is the result of outreach to industry, consumer groups, the agency’s federal, state, local, tribal, and international regulatory counterparts, academia, and other stakeholders.

In response, ANSI has launched a Voluntary Pilot Accreditation Program for Certification Bodies (CBs) seeking accreditation to the FDA FSMA Final Rule. The objective of ANSI’s voluntary program is to evaluate CBs on an independent third-party basis to determine their compliance with the requirements of FDA regulations; the international standard ISO/IEC 17065Conformity assessment – Requirements for bodies certifying products, processes, and services; and pertinent certification scheme requirements. The CBs that comply with such requirements will be recognized as ANSI Accredited Certification Bodies (ANSI ACBs) to conduct food safety audits and issuing of certifications on foreign food suppliers in accordance with FDA–FSMA - Foreign Supplier Verification Programs on a voluntary basis.

By providing CBs with the opportunity to execute foreign supplier audits under this pilot accreditation program, ANSI serves to enhance the rigor of the audits and improve the safety of imported foods.

Certification Bodies interested in participating in the ANSI Voluntary Pilot Accreditation Program are encouraged to request the ANSI application package. The completed application package must be submitted to ANSI by the deadline of December 1, 2017

To obtain an application package for this new pilot accreditation program, please contact Reinaldo Figueiredo (rfigueir@ansi.org; 202.331.3611), ANSI senior program director, product/process/services accreditation programs.

About ANSI

The American National Standards Institute (ANSI) is a private non-profit organization whose mission is to enhance U.S. global competitiveness and the American quality of life by promoting, facilitating, and safeguarding the integrity of the voluntary standardization and conformity assessment system. Its membership is comprised of businesses, professional societies and trade associations, standards developers, government agencies, and consumer and labor organizations. The Institute represents the diverse interests of more than 125,000 companies and organizations and 3.5 million professionals worldwide.

The Institute is the official U.S. representative to the International Organization for Standardization (ISO) and, via the U.S. National Committee, the International Electrotechnical Commission (IEC).

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