ISO Issues New Conformity Assessment Standards

This article describes the following new Conformity Assessment standards:

ISO 17000:2004, Conformity assessment – Vocabulary and general principles
ISO Guide 60:2004, Conformity assessment – Code of good practice
ISO Guide 67:2004, Conformity assessment – Fundamentals of products certification
ISO Guide 28:2004, Conformity assessment – Guidance on third-party certification system for products
ISO 17011:2004, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies

ISO 17000:2004 and ISO Guide 60:2004 – Standards to Harmonize Conformity Assessment and Facilitate World Trade

One of the main challenges facing the international trading system is the diverse conformity assessment practices and approaches that persist in different countries and contexts. ISO is contributing to a solution in the form of two essential reference documents for conformity assessment designed to reduce technical barriers to trade and to prevent the emergence of new ones.

These two documents are intended to be used in conjunction with, or when preparing, ISO International Standards or Guides relating to conformity assessment, and also to support the implementation of the World Trade Organization’s Technical Barriers to Trade Agreement.

Conformity assessment has become an important component of world trade. At its simplest, “conformity assessment” means checking that products, materials, services, systems, or people measure up to specified requirements (regulations, standards, specifications, etc.). Unless trading partners adhere to identical (or equivalent) conformity assessment procedures and requirements, or recognize each other’s conformity assessment results, then the costly problem of discriminatory, non-transparent, and unnecessary obstacles to trade will persist.

The first “solution document” is a new standard, ISO 17000:2004, Conformity assessment – Vocabulary and general principles, that collects and compiles into one glossary-type document all terms and definitions applicable to conformity assessment in English, French, and Russian. It facilitates a coherent approach to the description of conformity assessment activities and the use of harmonized conformity assessment terminology, as well as, contributing to a common understanding of conformity assessment terms.

The second document, ISO Guide 60:2004, Conformity assessment – Code of good practice, recommends good practices for all elements of conformity assessment, including conformity assessment normative documents, bodies, systems, schemes, and results. It is for use by individuals and bodies who wish to provide, promote, or use ethical and reliable conformity assessment services that are characterized by WTO principles like openness, transparency, impartiality, coherence, and consensus.

ISO Guide 67:2004 and ISO Guide 28 :2004 – Guides to the Principles and “How-To” of Product Certification

From checking the safety, health, or environmental protection of products to improving their acceptance by the market, these two new guides aim to improve understanding of the diverse functions and types of “product certification” designed to deliver confidence within supply chains, and to consumers in the global market.

At each stage along their life cycle, products – designed, produced, distributed, used, and ultimately disposed of – may give rise to societal concerns such as health, safety, or environmental impacts, durability, compatibility, and suitability. One method of providing reassurance to users to allay their concerns is through product certification. For example, retailers of consumer goods rely on certification as evidence that aspects such as the safety of food and drugs have been verified by a third party, thus giving confidence that products they place on their shelves for sale to the public are not likely to bring harm to their customers.

ISO Guide 67:2004, Conformity assessment – Fundamentals of products certification, is intended to foster understanding of the wide range of possibilities that fall within the context of product certification, and thereby assist those wishing to develop product certification for a particular purpose, and those with responsibility for evaluating such systems. It describes some of the activities of product certification, identifies basic elements and types of product certification, and shows some of the ways of combining these elements to design a product certification scheme. <>

ISO Guide 28:2004, Conformity assessment – Guidance on third-party certification system for products, provides guidelines for those verifications undertaken independently of the supplier and the end user, carried out by a third party and known as “third-party conformity assessment”, including sampling, testing, evaluation, surveillance, and responsibility for the certification decision. It also addresses conditions for use of a mark of conformity – which may result from this type of verification – and the conditions for granting a certification of conformity. This second edition, which replaces ISO Guide 28:1982, has been updated to be in alignment with ISO 9001:2000, and with new documents such as ISO 17000:2004, Conformity assessment – Vocabulary and general principles, and ISO 17030:2003, Conformity assessment – General requirements for third-party marks of conformity, as well as, to reflect modern certification practices.

ISO 17011:2004 (One-Stop Accreditation to Boost Cross Border Trade)

This new standard aims to harmonize requirements worldwide for organizations that assess the competence of “conformity assessment” bodies. It will provide a global benchmark for “accreditation bodies” to ensure that they operate in a consistent, comparable, and reliable manner worldwide, thereby providing confidence to purchasers and regulators and facilitating cross-border trade.

Conformity assessment bodies (CABs) check that products, materials, services, systems, or people measure up to the specifications laid out in a relevant standard. A lack of confidence in their competence to perform these tasks may result in redundant, costly, and time-consuming assessments by different accreditation bodies in different countries. Such costs could be drastically reduced if a CAB could be assessed once and the results accepted globally. This process is known as a “one-stop accreditation”.

ISO 17011:2004, Conformity assessment – General requirements for accreditation bodies accrediting conformity assessment bodies, sets out a uniform set of requirements for bodies that verify the activities of conformity assessment bodies – from testing, inspection, and management system certification to personnel certification, product certification, and calibration. It will also prove useful in the peer evaluation process for mutual recognition arrangements between accreditation bodies which will allow the contracting parties to recognize the results of each other’s inspections, testing, certification, or accreditation for goods and services traded internationally.

The standard’s potential for facilitating cross-border trade was witnessed by its recent adoption by the International Laboratory Accreditation Cooperation (ILAC) and the International Accreditation Forum (IAF) as the base set of requirements for their national and regional members. ISO 17011:2004 replaces three sets of overlapping requirements for the same attributes: ISO Guide 58:1993 (laboratories), ISO Guide 61:1996 (certification bodies) and ISO/TR 17010:1998 (inspection bodies). 

In collaboration with ISO, a transition period has been agreed by IAF and ILAC members for accreditation bodies to meet the requirements of the new ISO 17011:2004 by 1 January 2006.