Using Conformity Assessment in regulatory practice

ISO and IEC provides guidance on how to reference standards in regulations in their website on Using and referencing ISO and IEC standards to support public policy.

The following are examples of referencing the International Standards contained in the CASCO toolbox in regulation, and using conformity assessment schemes in various regulated sectors.

For more examples, please visit the Public Sector Assurance website. It provides case studies from around the world in key policy areas that show how different conformity assessment tools help government officials and regulators deliver results.

Livestock Disease Control Regulations

Australia (2006)

 

Regulation 37 Standards for testing

For the purposes of section 16(3)(a) of the Act the prescribed standards for the testing, analysis and diagnostic examination of any sample or specimen for the purpose of determining whether it is infected with a disease are -

  • the standards relevant to that disease in the Australian and New Zealand Standard Diagnostic Procedures as approved by the Primary Industries Standing Committee as amended and in force from time to time; and
  • in any other case, the standards relevant to that disease in the Australian Standard Diagnostic Techniques for Animal Diseases as published by the Standing Committee on Agriculture and Resource Management in 1993 as amended and in force from time to time.

For the purposes of section 16(4) of the Act the prescribed standard of accreditation for the facilities and operational practices of veterinary diagnostic laboratories is accreditation in accordance with ISO/IEC 17025:2005General requirements for the competence of testing and calibration laboratories published 6 December 2005 as amended and in force from time to time.

Accreditation of Building Consent Authorities

New Zealand

 

Building Consent Authorities

From 31 March 2009, only registered Building Consent Authorities (BCAs) may perform building consenting and inspection functions in terms of the Building Act 2004. The Act provides for Territorial Authorities and private organizations to apply for registration. Also, local government authorities will need to be registered to carry out building control work on dams.

Accreditation Criteria

The Department of Building and Housing has published standards and criteria for accrediting Building Consent Authorities under the Building (Accreditation of Building Consent Authorities) Regulations 2006. IANZ undertakes the assessments of Building Consent Authorities against these standards and criteria for registration by the Department of Building and Housing.There are 19 regulations, of which applicants are expected to meet 11 of the standards and criteria by 31 March 2009. The most important are that a Building Consent Authority must have:

  • appropriate policies, systems and procedures in writing record how it ensures that it implements effective policies, procedures and systems;
  • it must record the key decisions it makes, the reasons for them, and the outcomes and actions of those decisions.
Assessment Criteria

To assist applicants, the Department of Building and Housing has published the Building Consent Authority Accreditation Preparation and Self-assessment Guide (published February 2007). The purpose of the guide is to:

  • assist organisations that apply to become building consent authorities to prepare their policies, processes and procedures for accreditation assessment and ongoing compliance;
  • assist organisations to assess how well existing policies, processes and procedures comply with the accreditation requirements;
  • assist organisations to assess how well implemented their existing and new systems; and
  • provide good-practice guidance that may be used (or adapted for use) by building consent authorities to demonstrate compliance with the accreditation standards.

This should be read in conjunction with the Department’s Building Consent Authority Development Guides (published in 2006).

Hazardous Substances (Compressed Gases) Regulations

New Zealand (2004)

 

Part 6 - Labelling and marking, Marking of cylinders and fire extinguishers.

Clause 39 Markings for cylinders and fire extinguishers
  1. A refillable cylinder and a fire extinguisher (whether refillable or not) must be marked with the following information:
    • the register number of the cylinder design to which the cylinder or fire extinguisher was manufactured:
    • the manufacturer's serial or batch number for the cylinder or fire extinguisher.
  2. A refillable cylinder must be marked with the following information…
  3. A fire extinguisher must be marked with a fire extinguisher registration number issued by a product certification body.
Clause 23B Fire extinguisher registration number
  1. A low-pressure fire extinguisher must have a fire extinguisher registration number issued under subclause (2).
  2. A product certification body may issue a fire extinguisher registration number for a low-pressure fire extinguisher if it is satisfied that the fire extinguisher—
    • has been manufactured in accordance with this Part; and
    • meets the quality assurance requirements specified in the fire extinguisher's design.
Clause 3 Interpretations:

‘product certification body’ means a body accredited to ISO/IEC Guide 65 by a national or New Zealand joint accreditation agency operating to ISO/IEC 17011:2004.

Standards

Public Utilities (Water Supply) Regulations

Singapore

 

Clause 5 Requirements for water fittings
  1. Every water fitting shall be:
    1. of an appropriate quality and standard;
    2. suitable for the circumstances in which it is used;
    3. fit for the conveyance of potable water;
    4. except in the case of exposed terminal fittings such as taps, resistant to dezincification if such fitting is made of brass; and
    5. capable of withstanding a hydrostatic field test pressure of not less than 12 bars or an internal water pressure of not less than 11/2 times the maximum pressure to which the fitting is designed to be subjected in operation, whichever is the greater.
  2. For the purposes of paragraph (1)(a), a water fitting is of an appropriate quality and standard only if it conforms to:
    1. such standard as the Board may stipulate from time to time for compliance, being:
    2. an appropriate Singapore Standard;
    3. an appropriate British Standard; or
    4. some other standard which provides an equivalent or higher level of protection and performance; and
    5. such other requirements as the Board may stipulate from time to time for compliance.
  3. For the purposes of paragraph (2)(a), a water fitting shall be treated as conforming with a standard stipulated by the Board if it is certified or tested as complying with such standard by:
    1. a product certification body or a testing laboratory accredited by the Singapore Accreditation Council or any of its Mutual Recognition Arrangement partners; or
    2. such other product certification body or testing laboratory as the Board may allow.
  4. Any person who wishes to supply or install any water fitting for which no standard or requirement has been stipulated by the Board under paragraph (2) shall submit a request to the Board for the Board to stipulate the appropriate standard and requirement for that fitting for compliance.

medical devices

Canada

 

A copy of the quality management system certificate certifying that: the quality management system under which the device is manufactured satisfies: National Standard of Canada CAN/CSA-ISO 13485:03, Medical devices — Quality management systems — Requirements for regulatory purposes.

Testing laboratory accreditation

Mexico

 

A copy of the accreditation certificate that states: “The accreditation under which the laboratory was accredited satisfies: NMX-EC-17025-IMNC-2006/ISO 17025:2005 — General requirements for the competence of testing and calibration laboratories" — shall be presented.

The reference to the standard can also be included in a regulatory document.

Code of Federal Regulations for Energy

United States

 

The ANSI Standard MH5.1 (1971) “Basic requirements for cargo containers” and the (ISO) 1496 (1978) “General cargo containers”, have been approved for incorporation by reference by the Director of the Federal Register: A copy of each of these standards is available for inspection at the NRC Library, 11545 Rockville Pike, Rockville, Maryland.

Access to funding for medical testing

Australia

 

Pathology testing in Australia is carried out at both public and private laboratories. Partial reimbursement of the costs of medical testing is permitted under the universal public health insurance scheme in Australia (known as Medicare).

For reimbursement claims to be accepted, the pathology laboratory used must be an accredited pathology laboratory under the Health Insurance Act 1973 (Cth) (HI Act). One of the conditions of gaining this status is the maintenance of an accreditation by the National Association of Testing authorities&nbs (NATA), the relevant national accreditation body in Australia.

NATA have a formal Memorandum of Understanding with the federal Department of Health and Ageing (DoHA) which endorses its accreditation role.
Medical testing (pathology) laboratories apply to NATA to be accredited in accordance with relevant guidelines issued by the National Pathology Accreditation Advisory Council (NPAAC) which reflect the requirements of ISO 15189, Medical laboratories - Requirements for quality and competence. As a competent accreditation body NATA itself fulfils the requirements of  AS ISO/IEC 17011:2005Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies.

Through this conformity assessment scheme the federal government of Australia controls the quality of medical testing laboratories indirectly through controlling the access to funding. Access is only granted after the laboratories meet accreditation requirements and demonstrate their adherence to relevant standards. The federal Department of Health and Ageing (DoHA) do not directly accredit laboratories but instead rely upon the national technical accreditation system through NATA to achieve this outcome. This saves DoHA the direct expense of undertaking the accreditation service, and removes the Department from a conflict of interest that might be perceived if they were to accredit public health laboratories.

Standards

Equipment Used in environments with an explosive atmosphere

 

UNECE: Common Regulatory Framework for Equipment Used in Environments with an Explosive Atmosphere 2011

Part 4 - Common Regulatory Objectives, Recognition of conformity assessment bodies

Clause 33

The accreditation of conformity assessment bodies and test laboratories has to follow the applicable ISO/IEC International Standards (see appendix D.1). The accreditation body has to be member of International Laboratory Accreditation Cooperation/International Accreditation Forum (ILAC/IAF). One member of the assessor team needs competence in the field of explosion protection (see e.g. the list of approved IECEx Assessors).

Clause 34

Certificates have to be in line with ISO System No. 5 requirements of the applicable ISO/IEC Guide (see appendix D.2).

Clause 35

Certificates have to be in line with ISO System No. 5 requirements of the applicable ISO/IEC Guide (see appendix D.2).

US Coast Guards Regulations regarding electrical equipment installed in hazardous areas on foreign-flagged Mobile Offshore Drilling Units (MODUs)

The Coast Guard is providing guidance regarding electrical equipment installed in hazardous areas on foreign-flagged Mobile Offshore Drilling Units (MODUs) that have never operated, but intend to operate, on the U.S. Outer Continental Shelf (OCS). Chapter 6 of the 2009 version of the International Maritime Organization (IMO) Code for the Construction and Equipment of Mobile Offshore Drilling Units (2009 IMO MODU Code) sets forth standards for testing and certifying electrical equipment installations on MODUs. The 2009 IMO MODU Code recommends that electrical installations in hazardous areas be tested and certified in accordance with the International Electrotechnical Commission (IEC) 60079 series of standard(s).
They provide for acceptance on the market of IECEx-certified equipment see: http://www.gpo.gov/fdsys/pkg/FR-2012-12-03/html/2012-29138.htm

Toy Safety Certification Scheme

Brazil

 

In Brazil the authority for technical regulations is represented at federal level by several agencies, depending of the area of competence. The regulations can be developed ex officio or upon request of a third party. These regulations are generally based on International Standards, among which ISO standards. Even if the regulation is identical to the international regulation, potential impact of regulations needs to be notified to the World Trade Organization (WTO). The National Institute of Metrology, Quality and Technology (INMETRO) is responsible for this. INMETRO is also responsible for conformity assessment bodies’ accreditation. More information can be found in the Guide to Brazil´s Toy Compliance Requirements.

The choice of conformity assessment activity is based on specific characteristics of the product and can range from certification, inspection to declaration of conformity by the supplier. It is usually voluntary-based, but if the object of conformity affects consumers’ health, safety or environment, conformity assessment should be performed by an accredited third party. A good example of this process is the certification of toys’ safety. All toys placed on the Brazilian market must be certified by an accredited certification body. The voluntary and mandatory certification scheme is described in Figure 4 below. It is adapted from the Guide to Brazil´s Toy Compliance Requirements.

Figure 4. Conformity assessment bodies and voluntary and mandatory certification

The toy safety certification process can use different certification systems that comprise specific technical regulations:

  • MERCOSUR Standard on Toy Safety NM 300:2002, Parts 1-6;
  • NM 300 - 1:2002, Safety of Toys, Part 1: General, mechanical and physical properties, which are based on ISO 8124-1:2000;
  • NM 300 - 2:2002, Safety of toys, Part 2: Flammability, with normative references to ISO 2431:1993;
  • NM 300-4:2002, Safety of toys Part 4: Experimental sets for chemistry and related activities, with normative references to ISO 8317:1989- Child-resistant packaging;
  • Additional requirements or methodologies such as the one to approve the Procedure for Certification of Toys and toxicological testing.

More information can be found on the ABNT website.

Figure 5. The toy safety certification systems and related ISO standards

The toy safety certification also requests accredited certification bodies and laboratories, where the common elements of the systems request the compliance based at least on:

  • ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, including sampling. It covers testing and calibration performed using standard methods, non-standard methods, and laboratory-developed methods.
  • As an IAF/ILAC MLA signatory, INMETRO also shall request confident testing, where a mandatory rule for laboratories is the proficiency testing participation based on ISO 17043:2010, Conformity assessment - General requirements for proficiency testing. The standard specifies general requirements for the competence of providers of proficiency testing schemes and for the development and operation of proficiency testing schemes.
  • Guide ISO/IEC 65:1996, General requirements for bodies operating product certification systems. This Guide has been replaced by: ISO/IEC 17065:2012 Conformity assessment - Requirements for bodies certifying products, processes and services. This new version has been fully revised with more and better terms and definitions, resources, and guidance. Christian Priller, Convenor of the ISO/CASCO working group that developed ISO/IEC 17065 standard says:

“…..Product certification is perhaps the most visible type of certification because it is usually accompanied by a mark that is recognized and appreciated by regulators, consumers and other stakeholders. It is therefore crucial that we ensure the reliability of these claims. I am confident that the new ISO/IEC 17065 will increase trust and comparability of product certification around world.” (ISO News, 3 October 2012).

Energy Efficiency products certification

Mexico

 

Energy-Efficiency (EE) standards are procedures and regulations that prescribe the energy performance of manufactured products. A well designed EE standard can help reduce unnecessary electricity and fuel consumption by households and office equipment (e.g. electronic equipment, refrigerators, air conditioners and water heaters). It supports the portfolio of EE policies and climate change mitigation actions and programmes.
Mexico implemented a policy to establish a fund to facilitate the reduction of emissions in energy consumption by replacing incandescent light bulbs with compact fluorescent light bulbs and the project of energy-efficient refrigeration to reduce energy consumptions. This policy was supported by standards. Mexico mandates for EE standards to come from the Federal Law on Metrology and Standardization (LFMN - Ley Federal sobre Metrología y Normalización), which established a list of specific and generic public and private organizations for implementing the Standards’ Programme. The LFMN lists in Article 3 the responsible parties for developing voluntary (NMXs) and mandatory standards (NOMs). The National Commission for Energy Efficiency (CONUEE) is responsible for developing EE standards. It is a decentralized, administrative agency of the Secretary of Energy, with technical and operative autonomy to promote energy efficiency.

Figure 6.  Public organizations in Mexico and EE standards

When a Ministry in Mexico issues technical regulations, these are mandatory, so all products, processes, methods, facilities, services or activities must comply with the Mexican Official Standards that are published in the Official Gazette (DOF). There is a detailed list of current EE standards in Mexico.
To demonstrate compliance with mandatory standards, products such as refrigerators, air conditioners, laundry machines or water heaters shall be certified. The certification and related testing shall be performed by accredited third parties. Private organizations that participate in this EE conformity assessment system in Mexico are:

  • Testing laboratories: independent or operated by manufacturers. When accredited to ISO/ IEC 17025:2005: General requirements for the competence of testing and calibration laboratories, the laboratory does the tests under NOMs requirements and issues the results’ report.
  • Calibration laboratories: accredited to ISO/ IEC 17025:2005 give traceability to the measurement instruments of testing laboratories.
  • Certification bodies: accredited to ISO/ IEC 65:1996: General requirements for bodies operating product certification systems (new ISO/ IEC 17065:2012) and approved by corresponding ministries to certify compliance with EE standards (NOMs). The certification bodies only recognize test reports of accredited laboratories.
  • Accreditation bodies: ensures technical competence of certification bodies, testing laboratories and calibration bodies (Mexican accreditation entity - EMA). A competent accreditation body complies with the requirements of ISO/ IEC 17011:2004 Conformity assessment - General requirements for accreditation bodies assessing and accrediting conformity assessment bodies (CABs).

Example of EE refrigerators:

  • an accredited certification body confirms compliance with requirements of NOM-015-ENER-2012 – Energy efficiency of refrigerators;
  • limits, test methods and labelling by receiving a test report from an EMA accredited laboratory and technical documentation;
  • EE labels are posted to identify the product.

Figure 7 describes the label information:

  1. The efficiency of the product
  2. How much energy (top energy) would be consumed
  3. The mandatory standard for EE refrigerators
  4. Type, mark, model and capacity of the refrigerator
  5. Energy limit (kWh/year)
  6. Energy use (kWh/year)
  7. Energy saving (%) in a range from 0% to 50%.
  8. Notice inviting to the consumer to use EE products and how the label can help to compare the energy saving with other products

There are other systems that exist on the Mexican market, such as the Electric Power Saving Trust Fund (FIDE) label, a voluntary label that identifies energy-efficient products. It certifies that products meet specified standards and identifies them as FIDE certified energy-efficient products. FIDE also requires conformity assessment bodies to be accredited to issue its certificates.
FIDE label covers the products listed below and its targets to increase coverage to 7700 products across 85 companies:

  • Electric three phase induction motors
  • Lamps, ballasts and luminaries
  • Water pumps
  • Commercial refrigerators
  • TV sets and monitors
  • Air conditioners

Regarding EE voluntary standards, Mexico also promotes the use of ISO 50001  Energy management systems, that supports organizations in all sectors to use energy more efficiently and improve environmental performance, through the development of an energy management system (EnMS). The Certification Bodies seeking accreditation on Energy Management Systems program shall comply with ISO/IEC 17021:2011: Conformity assessment – Requirements for bodies providing audit and certification of management systems.

Figure 7. EE labels for refrigerators in compliance with NOM-015-ENER-2012

Standards