ANSI NSF 223-2015 Conformity Assessment Requirements for Certification Bodies that Certify Products Pursuant to NSF ANSI 60 Drinking Water Treatment Chemicals - Health Effects.pdf

1、NSF International Standard / American National StandardNSF/ANSI 223 - 2015 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/ANSI 223 2015 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 Develope

5、r NSF International Designated as an ANSI Standard June 7, 2015 American National Standards Institute 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 January 2014

6、 Revised June 2015 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 2015.” Copyright 2017 NSF International Previous editions 2013, 2012 Unless ot

7、herwise specified, 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 Disclaimers1 NSF, in performing

8、 its functions in accordance with its objectives, does not assume or undertake to discharge any responsibility of the manufacturer or any other party. The opinions and findings of NSF represent its professional judgment. NSF shall not be responsible to anyone for the use of or reliance upon this Sta

9、ndard by anyone. 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 heal

10、th. Provisions for 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

11、, local, state) 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, materials,

12、or construction 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

13、partial drawings shall not be used to justify improper or incomplete design and construction. Unless otherwise referenced, the annexes are not considered an integral part of NSF Standards. The annexes are provided as general guidelines to the manufacturer, regulatory agency, user, or certifying orga

14、nization. 1 The 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 proce

15、ss. In addition, it does not contain requirements necessary for conformance to the Standard. 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 certific

16、ation and on-going surveillance) . 3 5 Facility audits 3 5.1 Facility audit requirements . 3 5.2 Facility audits during surveillance 4 Annex A Examples of Conformity Assessment Activities . 7 This page is intentionally left blank.vii Foreword2 NSF/ANSI 223 establishes minimum requirements for certif

17、ication organizations to be used when certifying products 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-H

18、ealth Effects. This was prompted by concerns that while 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 facili

19、ty inspection requirements, was incorporated into NSF/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 review

20、s, as they constitute only a small portion of the issues 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 include

21、d representatives from industry, certification organizations, 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, mo

22、st production of direct additives occurred in or was 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 Internat

23、ionals Corruption Perceptions Index (CPI) is perhaps 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, ende

24、mic diseases, labor laws, business etiquette and corruption. 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 t

25、hree of these sources in order for a score to be calculated. 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 mo

26、ves to a wider variety of source countries and raw 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 lo

27、cations in countries with a CPI score of . 4 Transparency International, Alt-Moablt 961, 10559 Berlin, Germany, . NSF 2017 NSF/ANSI 223 2015 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 thi

28、s Standard. 2.2 authorized registered formulation: A 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 treat

29、ed water or another non-reactive substance. NOTE The 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 certific

30、ation body used for the purpose of ensuring certification 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 sto

31、ck: A store or supply of a chemical, accumulated or 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

32、 single source product, dissolved with treated water 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

33、certified product. 2.10 original product: A NSF/ANSI 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 (on

34、e of the products in the group) as being representative 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:

35、A company that places a new product label over the 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 tha

36、t opens the packaging of a product, places it into 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 suppli

37、er or manufacturer to transfer their bulk NSF/ANSI 60 certified products or materials from storage or initial transport vessels directly into other shipping vessels or packagings without further adjustments except for NSF 2017 NSF/ANSI 223 2015 3 dilution with treated water. 2.17 treated water: De-i

38、onized water, distilled water, recirculated water within 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

39、 water, condensate water originating from a potable 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

40、 written record of the determination of compliance with NSF/ANSI 60 in conjunction with this Standard. 3 General requirements ISO/IEC 17065 and ISO/IEC 17020 have no detailed requirements for certification systems, schemes or programs only for certification bodies. This Standard is setting requireme

41、nts for certification programs in which products shall be certified to NSF/ANSI 60. Formal certification documents (ISO/IEC 17065, section 7.8, and ISO/IEC 17020) shall indicate that the certification system utilized fulfills this Standard, by noting: “Products certified via a product certification

42、program in accordance with NSF/ANSI 223.” 4 Product testing (during initial certification and on-going surveillance) As part of initial certification and on-going surveillance (ISO/IEC 17065, section 7.9, and ISO/IEC 17020), except as noted below, a product shall be sampled and tested at least once

43、per calendar year for the chemistry-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 applicabl

44、e); 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. NSF 2017 NSF/ANSI 223 2015 4 5.2 Facility audits during surveillance 5.2.1 Except a

45、s allowed pursuant to 5.2.2 or required 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 trans

46、fer facility. 5.2.2 If a facility 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 a

47、t least 36 months after all deficiencies 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

48、 allowable concentration limits 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. the facility has significantly or repeatedly deviated from its

49、authorized registered formulation (including changes to approved constituent chemicals, or blending with products from unauthorized suppliers); 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; the facility has demonstrated a sustained lack of willingness or ability