NSF 223-2013 Conformity Assessment Requirements for Certification Bodies that Certify Products Pursuant to NSF ANSI 60 Drinking Water Treatment Chemicals - Health Effects.pdf

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1、NSF International Standard / American National StandardNSF/ANSI 223 - 2013 Conformity Assessment Requirements forCertification Bodies that Certify Products Pursuant to NSF/ANSI 60: Drinking WaterTreatment Chemicals - Health EffectsNSF International, an independent, not-for-profit, non-governmental o

2、rganization, is dedicated to being the leading global provider of public health and safety-based risk management solutions while serving the interests of all stakeholders. This Standard is subject to revision. Contact NSF to confirm this revision is current. Users of this Standard may request clarif

3、ications and interpretations, or propose revisions by contacting: Chair, Joint Committee on Drinking Water Additives c/o NSF International 789 North Dixboro Road, P.O. Box 130140 Ann Arbor, Michigan 48113-0140 USA Phone: (734) 769-8010 Telex: 753215 NSF INTL FAX: (734) 769-0109 E-mail: infonsf.org W

4、eb: http:/www.nsf.org i NSF International Standard/ American National Standard for Drinking Water Additives Conformity Assessment Requirements for Certification Bodies that Certify Products Pursuant to NSF/ANSI 60: Drinking Water Treatment Chemicals Health Effects Standard Developer NSF Internationa

5、l Designated as an ANSI Standard September 15, 2013 American National Standards Institute NSF/ANSI 223 2013 ii Prepared by The NSF Joint Committee on Drinking Water Additives Recommended for Adoption by The NSF Council of Public Health Consultants Adopted by NSF International May 2012 Revised Januar

6、y 2014 Published by NSF International PO Box 130140, Ann Arbor, Michigan 48113-0140, USA For ordering copies or for making inquiries with regard to this Standard, please reference the designation “NSF/ANSI 223 2013.” Copyright 2013 NSF International Previous editions 2012 Unless otherwise specified,

7、 no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from NSF International. Printed in the United States of America. iii Disclaimers1NSF, in performing its functions in a

8、ccordance with its objectives, does not assume or undertake to dis-charge any responsibility of the manufacturer or any other party. The opinions and findings of NSF repre-sent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Standard by anyone.

9、NSF shall not incur any obligation or liability for damages, including consequential damages, arising out of or in connection with the use, interpretation of, or reliance upon this Standard. NSF Standards provide basic criteria to promote sanitation and protection of the public health. Provisions fo

10、r mechanical and electrical safety have not been included in this Standard because governmental agencies or other national standards-setting organizations provide safety requirements. Participation in NSF Standards development activities by regulatory agency representatives (federal, lo-cal, state)

11、shall not constitute their agencys endorsement of NSF or any of its Standards. Preference is given to the use of performance criteria measurable by examination or testing in NSF Standards development when such performance criteria may reasonably be used in lieu of design, mate-rials, or construction

12、 criteria. The illustrations, if provided, are intended to assist in understanding their adjacent standard requirements. However, the illustrations may not include all requirements for a specific product or unit, nor do they show the only method of fabricating such arrangements. Such partial drawing

13、s shall not be used to justify im-proper or incomplete design and construction. Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The an-nexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifying or-ganization. 1T

14、he information contained in this Disclaimer is not part of this American National Standard (ANS) and has not been processed in accordance with ANSIs requirements for an ANS. Therefore, this Disclaimer may contain material that has not been subjected to public review or a consensus process. In additi

15、on, it does not contain requirements necessary for conformance to the Standard. iv This page is intentionally left blank.v Contents 1 General . 1 1.1 Purpose 1 1.2 Scope . 1 1.3 Normative references . 1 2 Definitions . 2 3 General requirements . 3 4 Product testing (during initial certification and

16、on-going surveillance) . 3 5 Facility audits 3 5.1 Facility audit requirements . 3 5.2 Facility audits during surveillance 4 Annex A . A1 vi This page is intentionally left blank.vii Foreword2 NSF/ANSI 223 establishes minimum requirements for certification organizations to be used when certifying pr

17、oducts to NSF/ANSI 60. Background A change was made to the California Code of Regulations (CCR, adopted on March 9, 2008) that required annual recertification of drinking water treatment chemicals to NSF/ANSI 60: Drinking Water Treatment Chemicals-Health Effects. This was prompted by concerns that w

18、hile some certification organizations provided annual retesting of treatment chemicals other organizations allowed for up to five years to pass in between retests. In 2009 Section 3.8 Conformity Assessment, which contained product testing and facility inspection requirements, was incorporated into N

19、SF/ANSI 60-2009a. However, there were concerns that requirements for the conformity assessment process (facility inspections and periodic retest requirements) in NSF/ANSI 60 would not receive sufficient attention from ANSI during the periodic reviews, as they constitute only a small portion of the i

20、ssues governed by that standard. It was determined that there would be more focus on conformity assessment if the requirements were placed in a separate standard for conformity assessment. A task group was formed to develop the Standard, and included representatives from industry, certification orga

21、nizations, water utilities, and public health agencies. In 2010, the task group was expanded further to include the input of many more manufacturers representatives. It was noted during the discussion that when NSF/ANSI 60 was originally devised, most production of direct additives occurred in or wa

22、s overseen by owners from countries where corruption played an insignificant role in business. Today, a substantial portion of the production of direct additives to water has moved to countries where this is no longer the case. Transparency Internationals Corruption Perceptions Index (CPI) is perhap

23、s the most famous of a number of such indexes constructed to aid international businesses in understanding the conditions they will face in the different countries in which they do business. Such conditions include labor rates, public holidays, endemic diseases, labor laws, business etiquette and co

24、rruption. The index has been constructed annually since 1995 for Transparency International by Prof. Johann Graf Lambsdorff of the University of Passau. The process sources 16 independent surveys of countries, and a country must appear in at least three of these sources in order for a score to be ca

25、lculated. The CPI was revised in 2012 from a scale of 0-10 to 0-100, where the lowest possible level of perceived corruption would equal a score of 100 and the highest possible level of perceived corruption would equal a score of 0. As production moves to a wider variety of source countries and raw

26、material sourcing is further diversified due to cost considerations, there must be a method to differentiate locations where oversight can be relaxed, and where it must be maintained. Therefore NSF/ANSI 223 establishes additional requirements for locations in countries with a CPI score of . 4Transpa

27、rency International, Alt-Moablt 961, 10559 Berlin, Germany, . NSF 2013 NSF/ANSI 223 2013 2 2 Definitions 2.1 audit: An on-site, systematic and documented process that identifies any variances from the established requirements of NSF/ANSI 60 and this Standard. 2.2 authorized registered formulation: A

28、 copy of the formulation of the certified product registered by the certification organization. 2.3 blender: A company that produces a product comprised of a physical mixture of two or more ingredients. The mixture may be further diluted with treated water or another non-reactive substance. NOTE The

29、 definition of blender pertains to physical mixtures of ingredients, and not to chemical products that are produced by a chemical reaction in blended processes. 2.4 certification system: The rules, policies, operations, and procedures of a certification body used for the purpose of ensuring certific

30、ation of products to which the scope of NSF/ANSI 60 applies. 2.5 certified product: A single product or trade designation that appears in the public listings of an NSF/ANSI 60 certification body as an NSF/ANSI 60 certified product. 2.6 chemical stock: A store or supply of a chemical, accumulated or

31、available for manufacturing a product. 2.7 diluter: A company that produces a product composed of a single source product, diluted with treated water to a specific concentration. 2.8 dissolver: A company that produces a liquid product composed of a single source product, dissolved with treated water

32、 to a specific concentration. 2.9 facility: A place (building, room, etc.) that is used to serve a specific manufacturing function. related to the production of a certified product including a blended, diluted, dissolved, re-labeled, or re-packaged certified product. 2.10 original product: A NSF/ANS

33、I 60 certified product prior to being blended, dissolved, diluted, re-packaged, or re-labeled. 2.11 product family: A group of products, under the same chemical category, for which a NSF/ANSI 60 certification body has designated a single product (one of the products in the group) as being representa

34、tive of the group of products for the purposes of NSF/ANSI 60 certification testing for that group of products. 2.12 product manufacturer: The original chemical manufacturer of a product used as a drinking water treatment chemical. 2.13 re-labeler: A company that places a new product label over the

35、original label or replaces the original label on a product without opening the original packaging, provided that the new product label provides the same information on the products chemical nature and characteristics. 2.14 re-packager: A company that opens the packaging of a product, places it into

36、another container or package, seals the container or package, and labels the product. 2.15 storage: A space or a place for storing a water treatment product. 2.16 transfer facility: A location that is used by the NSF/ANSI 60 certified product supplier or manufacturer to transfer their bulk NSF/ANSI

37、60 certified products or materials from storage or initial NSF 2013 NSF/ANSI 223 2013 3 transport vessels directly into other shipping vessels or packagings without further adjustments except for dilution with treated water. 2.17 treated water: De-ionized water, distilled water, recirculated water w

38、ithin a plant originating from a potable water source, water treated on-site to potable water quality with the exception of disinfection, potable well water, well water treated on-site to potable water quality or a higher purity grade, demineralized water, condensate water originating from a potable

39、 water source. 2.18 unannounced facility audit: A site audit of a facility as part of surveillance of a product manufacturer, a blender, a diluter, a dissolver, a re-labeler, a re-packager or a transfer facility without prior notice, that includes a written record of the determination of compliance

40、with NSF/ANSI 60 in conjunction with this Standard. 3 General requirements ISO Guide 65 and ISO Guide 17020 have no detailed requirements for certification systems, schemes or programs only for certification bodies. This Standard is setting requirements for certification programs in which products s

41、hall be certified to NSF/ANSI 60. Formal certification documents (ISO/IEC Guide 65, section 12.3, and ISO/IEC Guide 17020) shall indicate that the certification system utilized fulfills this Standard, by noting: “Products certified via a product certification program in accordance with NSF/ANSI 223.

42、” 4 Product testing (during initial certification and on-going surveillance) As part of initial certification and on-going surveillance (ISO/IEC Guide 65, Section 13, and ISO/IEC Guide 17020), except as noted below, a product shall be sampled and tested at least once per calendar year for the chemis

43、try-specific analytes contained in Tables 4.1, 5.1, 6.1 visual inspection of production, process and equipment; collection of samples pursuant to 4; validation of formulations; validation of approved suppliers; review of analytical procedures and methods (if applicable); NSF 2013 NSF/ANSI 223 2013 4

44、 review of records related to formulation control; and review of chemical stock control records. NOTE Audit items noted above shall be conducted on-site at the facility; desk or remote audits shall not be allowed. 5.2 Facility audits during surveillance 5.2.1 Except as allowed pursuant to 5.2.2 or r

45、equired pursuant to 5.2.3 and 5.2.4, an organization certifying a facilitys product(s) shall audit the facility at least once per calendar year. NOTE Examples of a facility includes a product manufacturer, blender, diluter, dissolver, re-packager, re-labeler, or transfer facility. 5.2.2 If a facilit

46、y has one or more of the deficiencies listed below, upon knowledge of such a deficiency(ies), a certifying organization shall begin auditing the facility at a frequency of at least four times per calendar year and shall not revert to the audit frequency in 5.2.1 for at least 36 months after all defi

47、ciencies have been resolved. Administrative deficiencies (e.g., supplier name changes due to mergers and acquisitions, editorial corrections of procedures and policies) or other minor changes that do not impact a products ability to meet the NSF/ANSI 60 single product allowable concentration limits

48、for contaminants, shall not require the increased frequency of audits specified above, unless the administrative deficiencies have the potential to adversely affect a products ability to meet NSF/ANSI 60. a) The facility has significantly or repeatedly deviated from its authorized registered formula

49、tion (including changes to approved constituent chemicals, or blending with products from unauthorized suppliers); b) The facilitys/companys manufacturing processes, materials storage and handling systems and/or shipment processes are in such state - that assurance of efficacy or purity of the certified product are negatively compromised or in a condition that product compliance with NSF/ANSI 60 is likely to be negatively affected; c) The facility has demonstrated a sustained lack of willingness or ability to meet administrative requir