Standardisation and certification

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Emilia Dobrescu, INCDPM



Standardisation and certification in the field of safety and health at work (OSH) have undergone a continuous development in recent years, closely related to the development of the specific legislation and the state of art.

This article contains a description of the processes of standardisation and of the role of standards in ensuring a clear definite level of quality or safety of the products. There are presented: definition and classification of standards, standardisation organisations, activities included in evaluation of conformity and certification (of products, processes, services or training) and the significance of CE marking of conformity.



The term “standard” has been used and is still used in some countries related to the conditions for safety at work [1] or to the skills of employers and good behavior of people, but also related to characteristics (dimensions, forms, physical or chemical properties, etc) of products. The significance of the term “standard” used to be: a generally accepted document that provides rules, guidelines or characteristics for activities or their results, whatever the provider of the document is (tradition, a manufacturer, a governmental authority or a standardisation association)[2].

The first standards appeared during the Industrial Revolution with the need to make interchangeable part and dealt with sizes for screws, nuts bolts and other threaded fasteners, then pipe sizes or shoe size. In the late 19th century safety standards appeared, prepared by governmental authorities in United States of America, England. At the beginning of the 20th century standardisation organisations have been formed.

In the late years, in order to avoid missunderstanding, the international standards organisations made efforts to establish a clear terminology making the difference between the rules depending the provider, as [2]:

- normative document = ‘document (any medium with information recorded on or in it ) providing rules, guidelines or characteristics for activities or their results; it covers standards, technical specifications, codes of practice and regulations’;

- technical specification = ‘document prescribing technical requirements to be fulfilled by a product, process or service and, whenever appropriate, the procedure(s) by means of which they may be determined; it may be a standard, a part of a standard or independent of a standard’;

- code of practice = ‘document that recommends practices or procedures for the design, manufacture, installation, maintenance or utilization of equipment, structures or products; it may be a standard, a part of a standard or independent of a standard’;

- regulation = ‘document providing binding legislative rules, adopted by an authority’;

- standard = ‘document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context’.

Standards have public availability and should be based on the consolidated results of science, technology and experience, and aimed at the promotion of optimum community benefits.

Standardisation consists in activity of ‘establishing, with regard to actual or potential problems, provisions for common and repeated use, aimed at the achievement of the optimum degree of order in a given context’ [2]. In particular, the activity consists of the processes of formulating, issuing and implementing standards. Usually the standardisation is a process based on consensus of the interested parties forming the standardisation organisation.

The subject of standardisation can be any topic to be standardized, meaning any material, component, equipment, system, interface, protocol, procedure, function, method or activity; the phrase ‘a product, a process or a service’ is usually used. Standardisation can cover different fields: engineering, transport, agriculture; quantities and units.

Objectives and application

Standardisation may have one or more specific aims, to make a product, process or service fit for its purpose, comprising but not restricted to:

  • variety control or variety reduction, meaning the selection of the optimum number of sizes or types of products, processes or services to meet prevailing needs;
  • usability;
  • compatibility, suitability of products, processes or services for use together under specific conditions, without causing unacceptable interactions;
  • Interchangeability or the ability of one product, process or service to be used in place of another to fulfill the same requirements; it may be “functional interchangeability”, or “dimensional interchangeability”;
  • health;
  • safety = freedom from unacceptable risk of harm;
  • protection of the environment;
  • product protection against climatic or other adverse conditions during its use, transport or storage;
  • mutual understanding, achievement of an easier communication, facilitation of processes and tasks;
  • economic performance;
  • trade.

In standardisation, the safety of products, processes and services takes generally in consideration the goal to achieve the optimum balance of a number of factors, including non-technical factors such as human behavior in order to eliminate or reduce avoidable risks of harm to persons and goods to an acceptable degree.

A standard is used by companies or authorities as references in order to:

- prove, towards the customers, a certain level of quality /the performances of a product;

- ensure compatibility, allowing the new product to be used by the consumers in connection with others owned product;

- ensure interchangeability;

- improve efficiency to handle people, their interactions, cases, modernization, bureaucratization, homogenization, and centralization of society (in social sciences, when establishing criteria for diagnosing mental disease);

- enable organisations to focus their attention on delivering excellence in customer service, whilst providing recognition of success through a third party organisation;

- demonstrate the compliance with the regulations.

Standardisation improves the suitability of products, processes and services for their intended purposes, prevents the barriers to trade and facilitates the technological cooperation. In European Union, it is considered that standardisation can make an important contribution to the development of sustainable industrial policy, unlock the potential of innovative markets and strengthen the position of European economy by capitalizing more efficiently on its knowledge basis [3] .

Standards elaboration

Standardisation levels

The geographical, political or economic extent of involvement in standardisation process leads to the levels of standardisation given in Table 1. Each level is coordinated by a standardisation organisation, gathering interested parties from the relevant region: individual manufacturers and users/ consumers or professional organisations, trade-unions, reprezentative of research institutes or testing laboratories , public authorities, certification bodies etc. The lists in the table are not exhaustive, only some examples of standardisation organisation and documents being given.

Table 1: Levels of standards

Level of coverage Particular aspects Coordinated by (examples of organisations, non-exhaustive) Examples of standards
International standardisation - opened to relevant bodies from all countries ISO (International Organization for Standardization) ISO xxxx:abcd

ISO EN xxx:abcd

ISO/PAS xxx: abcd

IEC (International Electrotechnical Commission) IEC' 'xxxx:abcd

ISO/IEC xxx: abcd'

ASTM International

(an international standard organisation, formerly known as the American Society for Testing and Materials (ASTM))

ASTM A(E, F) xx-ab

B xx-ab

IUPAC (International Union of Pure and Applied Chemistry) IUP xxx
Regional - opened to relevant bodies from countries from only one geographical, political or economic area of the world;

- In every continent there are at least 2 regional organisations.'

CEN (European Committee for Standardisation), EN xxx:abcd
CENELEC (European Committee for Electrotechnical Standardisation), CEI xxx:abcd
ARSO -ORAN' (African Regional Organization for Standardisation),' ARS xx
COPANT (Pan American Standards Commission), NORMA COPANT xxxx-abcd



National standardisation - takes place at the level of one specific country

'- one organisation/ country'

AFNOR (Association Française de Normalisation) NF xxx:abcd

NF EN xxx:abcd

BSI (British Standards Institution - BSI Group- Great Britain) BS xxx:abcd

BS EN xxx:abcd

Provincial standadization - take place on a branch or sectoral basis (e.g. ministries), at local levels, at association and company levels in industry and inindividual factories, workshops and offices - branch standards and company standards OHSAS xxxx: abcd

X ST (or TS) xxxx:abcd

(where X = name of company or association; ST = code for the document/ technical specification)

Source: Overview by the author

ISO (International Organization for Standardization) is the world's largest developer and publisher of International Standards. ISO is a non-governmental organisation, including 163 countries national standardisation organisations (one member per country), with a Central Secretariat in Geneva, Switzerland. Other international organisations, governmental and non-governmental, in liaison with ISO also take part in the process of elaboration of new standards. ISO has developed over 19,000 International Standards. Over 1,000 new ISO standards are published every year.

CEN is the major provider of European Standards and technical specifications and the only European organisation recognized, according to European Directive 98/34/EC, for the planning, drafting and adoption of European Standards in all areas of economic activity, with the exeption of electrotechnology ( CENELEC) and telecommunication (ETSI) [4]. CEN is a non-profit organisation, created in 1975. CEN National Members are the National Standards Bodies (NSB) of the 27 European Union countries, Croatia and Turkey plus three countries of the European Free Trade Association (Iceland, Norway and Switzerland). There is one member per country. The CEN Members have voting rights in the General Assembly and Administrative Board of CEN and provide delegations to the Technical Board, which defines the work programme.

In order to avoid barriers to trade caused by deferring national standards in the different member states of the EU, the European Directive 98/34/EC stipulates a mutual obligation of the CEN National Members to implement European Standards as national standards and to withdraw any conflicting national standards, as well as a procedure to inform both the other member states and the Commission in advance when a new national standards is planned to be adopted.

CEN has signed the ‘Vienna Agreement with the International ISO through which common European and international standards can be developed in parallel. More than 30% of the European Standards adopted by CEN are identical to international standards. In addition a number of ENs developed by CEN are closely linked to ISO standards.

In general, each country or economy has a single recognized National Standards Body, which is the sole member in ISO, as well as in CEN. A National Standards Body may be either public or private sector organisations, or combinations of the two. The national standardisation includes a process of adoption of international or regional standards, as well as a process of development of new, specific standards.

Processes of standardisation

The following types of processes for elaboration of normative documents are met:

- emergence as de facto standard: tradition, market domination, etc;

- published by a Standards organisation:

- in a closed consensus process;

- in a full consensus process, usually opened to all interested and qualified parties and with formal procedures for due-process considerations;

- published by a government or regulatory body;

- published by a corporation, union, trade association, etc.

Most of the standards organisations and in particular international and regional sandardization organisation participate in the development of specific standards through technical committees established by the respective organisation to deal with particular fields of technical activity. The technical committees of regional and international standardisation organisations use to collaborate in fields of mutual interest.

The process of development of european standards usually includes the steps described below, which are similar to those applied by other standardisation organisation:

- Proposal, that could be introduced by any interested party; most proposal are submitted by the National Standards Bodies.

- Acceptance of proposal by decision of CEN Technical Board and/or of the appropriate CEN Technical Committee and allocation of the project to one of the working groups for the drafting of a standard.

- Drafting - the EN is developed by experts appointed in a working group, on the basis of consensus.

- CEN Enquiry – the releasing of the draft for public comment, when everyone who has an interest may comment on the draft and these views are collated by the 31 National Standards Bodies and analyzed by the CEN Technical Committee.

- Adoption by weighted vote.

- Publication of the EN (in English, French and German).

- Review of the EN. European standards, as well as ISO or National standards are regulary updated, usually at every five years; they are also submitted to a process of amendment or revision, following the request of the members or of the European Commission, when necessary to keep pace with the state of the art or to improve the safety level.

The adoption of international or regional standards leads to national standards. These national standard can be substantially the same as the international ones in technical content or may have editorial differences (as to appearance (use of symbols and measurement units, substitution of a point for a comma as the decimal marker) or differences resulting from conflicts in governmental regulations or industry-specific requirements (e.g.: caused by fundamental climatic, geographical, technological or infrastructural factors, or the stringency of safety requirements that a given standard authority considers appropriate).

European standards are identically transposed by the national standards organisations members of CEN, the only accepted differences being the national cover-pages and national explenatory notes

Types of standards and other normative documents

Each standard is identified by a code composed by groups of letters specific to the standards organisation (see table 1) and a unique numeric index, followed by the year of approval.

The normative documents can be classified taking into account:

  1. the level of standardisation (see above);
  2. the process of standardisation;
  3. the content, the subject of standardisation;
  4. the way of implementation.

Depending on the process of standardisation, the documents established by the international standards organisations (ISO, CEI) as well as by CEN are delivered as:

- Standard – document issued when the process of standardisation respects all the established rules;

- Publicly Available Specification (eg. ISO/PAS) - a document representing the consensus of a worhing group,which have been approved by the simple majority of the members of the Technical Committee; usually, it is a consultative document, giving more solutions;

- Technical Specification (e.g. ISO/TS ) - a pre-standard, submitted to a simplified vote procedure in a Technical Commitee which contains technical requirements for innovative technology or various alternatives which need to coexist in anticipation of future harmonization;

- Technical Report (e.g. ISO/TR 10017) - a document that has not the content of a standard, prepared when it is considered urgent to give additional information or advise on a subject and submitted to a simplified vote procedure in a Technical Commitee;

- Guide - a document providing rules, orientation, advice or recommendations relating to European standardisation (e.g.: information or guidance on matters of conformity assessment in relation to the standardisation activities).

Following the subject of standardisation, the standards and in particular the OSH related standards can be classified, for example, in:

- Basic standard = standard that has a wide-ranging coverage or contains general provisions for one particular field; it may be used as a standard for direct application or as a basis for other standards (e.g. EN ISO 7731 related to auditory danger signals for public and work areas, EN 420 containing general requirements for protective gloves);.

- Terminology standard = standard that is concerned with terms, usually accompanied by their definitions, and sometimes by explanatory notes, illustrations, examples, etc (e.g.: EN 1005-1 and EN 1005-2 containing terms and definition on human physical performance related to safety of machinery, CEN ISO/TR 11610:2004 containing vocabulary on protective clothing or EN 60743: 2001/ IEC 60743: 2001 on terminology for tools, equipment and devices designed for live working).

- Testing standard = standard that is concerned with test methods (mechanical, electrical, chemical ergonomic or practical testing, specific to groups of products, to materials or on human subjects), sometimes supplemented with other provisions related to testing, such as sampling, use of statistical methods (ISO 2859-1, ISO 2859-2, ISO/TR 10017), sequence of tests.

- Product standard = standard that specifies requirements to be fulfilled by a product or a group of products, to establish its fitness for purpose; it may include in addition, directly or by reference, aspects such as terminology, sampling, testing, packaging and labeling and, sometimes, processing requirements; a product standard can be either complete or not, respectively it specifies all or only a part of the necessary requirements (e.g.: EN 81- standard on parts on safety rules for the construction and installation of different types of lifts, EN ISO 11612 regarding protective clothing against flames and heat)..

- Process standard = standard that specifies requirements to be fulfilled by a process, to establish its fitness for purpose (e.g.: EN ISO 9001 for quality management systems, OHSAS 18001 on occupational health and safety management systems).

- Service standard = standard that specifies requirements to be fulfilled by a service, to establish its fitness for purpose (e.g.: service standards prepared in fields such as laundering, hotel-keeping, transport, car-servicing, telecommunications, insurance, banking, trading).

- Safety standards = a standard concerned with freedom from unacceptable risk of harm; it can be a standard dealing with evaluation of risks (e.g. EN ISO 12100 on risk assessment and risk reduction of machinery, EN ISO 11079 regarding determination and interpretation of cold stress when using required clothing insulation and local cooling effects, PAS 1010 – draft document on psychosocial risk management) or a product standard containing safety requirements, such as those mentioned above;

-Environmental standard = a policy guideline that regulates the effect of human activity upon the environment; it may specify a desired state (e.g. lake pH should be between 6.5 and 7.5) or limit alterations (e.g. no more than 50% of natural forest may be damaged).

- Interface standard = standard that specifies requirements concerned with the compatibility of products or systems at their points of interconnection.

- Standard on data to be provided = standard that contains a list of characteristics for which values or other data are to be stated for specifying the product, process or service (e.g.: data to be stated by suppliers in the information file).

Application of standards and other normative documents in OSH

Practically every country has established by legislation health and safety conditions for workplace or for groups the products [5] .

In European Union, the OSH legislation is formed of:

- European Directives establishing minimum health and safety conditions at workplace, related to a particular activity or to a specific risk, which requires to the employer (who has the entire responsibility) to evaluate the risks and to take all the necessary measures to eliminate or reduce at a level that can not impair the health and safety of the employees; these are the so called ‘social directives’;

- European Directives establishing basic (essential) health and safety requirements to be respected by the products introduced on the market and conditions for their free movement (such as submission to certain procedure for evaluation of the conformity and certification, CE marking, conditions to be fulfilled by the notified bodies applying the procedures); the manufacturer of the product has the entire responsibility to ensure the fulfillment of all the relevant provision; these are the so called European Directive of New Approach and Global Approach and covers products as: machinery, personal protective equipment, medical devices, lifts, recipients under pressure, marine equipment, low tension equipment.

The OSH management systems has to conform with the provisions of both brances of legislation, which are binding.

The provision of the above European Directives are general and difficult to be applied it was evident the need of developing technical documents, standards in order to facilitate the respect of the legal provision. The European standardisation organisations had and yet have an intense activity to generate standards covering workplace or work equipment risk assessment, particular risk management, such as psychosocial risk management [6] . or chemical risk management, basic health and safety requirements, conditions for the management systems of the organisations involved in OHS activities, as well as relevant test and assessment methods. Some of these standards have been developed following a mandate form the European Commission and are known as “harmonized standards”. Being the result of a large consensus and including specifications at “the state of art”, the standards are widely used and have a significant role in ensuring the application of the OSH legislation, although remaining voluntary.

The respect of harmonized European Standards at the design and manufacture of the products under European Directive of New Approach and Global Approach is the most common application of the normative documents related to OSH. The greatest part of models of personal protective equipment, machinery and safety components, electrical equipment to be used at low voltage or in potentially explosive atmospheres, lifts or recipients under pressure are manufactured in such a way to fulfill the corresponding harmonized standards, with the goal to accomplish the basic health and safety requirements of the relevant European Directives.

Standards are also applied by the certification bodies, directly or indirectly (in parallel tests) when evaluating the safety of a product. During the process of evaluation of conformity by notified bodies, not only items of the model but also the information file of the manufactured are tested and examined in order to ensure that the performances related to safety and health are in accordance with the harmonized standards and there is no risk for the users.

For simple products or for products submitted to evaluation of conformity procedures at a notified body, the conformance to the standards is almost general. For more complex products which are put on the market only under the manufacturer responsibility, particularly in SMSs, there are gasps in declaring and respecting all the standards to be applied. As for the respect of the latest edition of the standards, it happens pretty seldom that the conformity is not achieved at the date when these ones are entering in force, especially when the legislation does not impose a validity limit for the certificates.

The employers use standards as references when establishing the specifications for purchasing work equipment or personal protective equipment to be used at workplace.

Every employer of an organisation can also use the standards for evaluation of conformity with OSH legislation at work place [7], for risk evaluation, risk management or implementation and assesment of the eficiency of a OSH management system.

Especially great organisations, disposing of sufficient personnel with adequate formation in OSH, apply the standards in every stage of activity, developing their own specific methods or good practices.

Small firms, due to the lack of time and of expertise in OSH problems, ask for rapid, easy to understand concepts and easy to apply solution, for detailed demands for specific control measures. It is important for them that OSH to be integrated into curricula of the educational system, in particular in vocational training, these allowing them to manage OSH mainly by direct contact and as a natural part of daily work and professionalism. In small firms, published good practices for risk management are seen as real solutions for OSH identified problems and are more often successfully implemented than standards, the latter being considered to need a higher level of knowledge and competence [7] . Another strategy of small organisation is to identify the state of art and to comply with professional standards, a good OSH being considered to be part of the craftsmanship or professionalism of the enterprise and its workers.

After the first issues of national or international documents or standards containing OHS management system models, many top managers opposed to their implementation, taking into consideration especially the costs for develpment and certification of the systems. There was also an opposition against establishment of an European or Intrenational Standard. After the emergence of the evidences on the benefits of implementing the existing specifications on OHS management system, the managers' opinion has essentially changed. An International Standard on OHS management system is going to be prepared. More of that, the discussions in the recent years were focused towards making obligatory the OHS management system specifications, for example by including their references in legislation.[8] [9].

The national accreditation bodies applies the relevant standards related to the management systems (EN ISO/CEI 17021, EN 45011, EN ISO/CEI 17025 etc) when assess the technical competence and integrity of the personnel or the independence and confidentiality of the activities accomplished by product, system or personnel certification bodies or by testing laboratories. The conformity of the management systems with the conditions included in such standards is presumed to give also the conformity with the conditions included in the European Directives for the notified bodies.

Finally, standards and certification is seldom regarded by the public authorities as an alternative or complement for the health and safety regulation. Although the great majority of the standards related to OSH remains voluntary (with few exceptions, referring especially to test methods), due to the presumption of conformity and the consensus of the interested parties, the respect of a standard related to OSH is in most cases considered a compliance to the legal provision and a way to avoid the controversies. Legislation, as European Directive regarding chemical agents, noise or other physical agents asks for a periodical control of such factors at work place, meaning a risk control, by tests applying specified standard methods, thus practically transforming these voluntary documents into mandatory ones. Similarly, the implementation of elements and/or certification of the OSH management system are strongly recommended in some countries, Great Britain, Denmark, at least in high risk sector, as chemistry industry [10] .

European harmonized standards

The "New Approach", defined in a Council Resolution of May 1985, introduced, among other things, a clear separation of responsibilities between the EC legislator and the European standards bodies CEN, CENELEC and ETSI in the legal framework allowing for the free movement of goods. The New Approach is based on a few key principles [10]:

- a clear separation between the European Economic Community (EEC) legislation and European standardisation;

- EEC legislative harmonization (e.g. EEC Directives) is limited to the essential requirements (safety requirements of general interest) needed to ensure the free movement of products throughout the Community;

- the producer has an obligation to prove his products fulfils the essential requirements, following one or more module of certification, but alternate paths are possible;

- the European standardisation bodies have the task of drawing up the corresponding technical specifications meeting the essential requirements of the directives, compliance with which will provide a presumption of conformity with the essential requirements; such specifications are referred to as "harmonized standards";

- standards are not mandatory, they are still voluntary;

- public authorities are responsible for the protection requirements on their territory (e.g. market surveillance);

- safety clauses require the Member States to take all appropriate measures to withdraw unsafe products from the market.

An European standard covers the specific role of harmonised standards if it also fulfils the following conditions:

- it is developed following a standardisation mandate issued by the Commission according to the procedure of Directive 98/34/EC[4];

- it is developed in taking due account of the essential requirements;

- its reference is published in the Official Journal with the indication of the Directive for which the presumption of conformity should apply.

An European harmonized standard comprises only conditions related to the safety use of the product and not to other performances in use of the product, as fiability. The European Commission publishes and periodically up-dates the list of harmonized standards in the framework of the implementation of each European Directive of New Approach and Global Approach.

Whenever a standard is found inadequate to fulfil the role it had been assigned under the EC legislation, a particular procedure is establish in directives to retrieve it from the lists published in Official Journal, meaning to withdraw the presumption of conformity with health and safety requirements.

The transposition of "harmonised standards" into national standards and the withdrawal of diverging national standards is mandatory în the EU countries.


Certification and accreditation

Certification is a third-party attestation (i.e., issue of a statement) that specified requirements related to products, processes, systems or persons have been fulfilled; the specified requirements are usually one or more standards.

Certification involves a conformity assessment, also known as compliance assessment which includes any activity to determine, directly or indirectly, that a process, product, or service meets relevant technical standards and fulfills relevant requirements.

A third party conformity assessment is performed by a person or a body that is independent of the respective supplier and user interests. Usually, the manufacturer or suplier submit the manufactured products to a first-party conformity assesment and the users can achieve a second party conformity assesment[2].

The body performing the evaluating of conformity/certification is also submitted to a process of independent assessment, by an accreditation body which verify its compliance with coresponding requirements established in the relevant harmonized standards (such as EN ISO/CEI 17021, EN 45011, EN ISO/CEI 17025).

Additionally, the World Trade Organization governs conformity assessment through the Agreement on Mutual Recognition in Relation to Conformity Assessment, signed July 4, 2000.

Conformity assessment activities may include:

- Testing

- Surveillance

- Inspection

- Auditing or evaluation

- Certification and/or registration

- Accreditation

In the field of assesment of conformity with safety standards, the main known types of certification are:

- product certification (e.g. certification of PEE, machines, medical devices in accordance with the modules of corresponding European Directives or voluntary certification of high voltage equipment);

- certification of occupational health and safety system;

- professional certification of experts in the field of health and safety (certification of training).

A product certification system includes the totality of rules, procedures and management for carrying out a third party product conformity assessment. The main elements of such systems are established, for examples in European Directives of Global Approach and New Approach.

A product certification scheme is a product certification system related to specific products to which the same specified requirements, specific rules and procedures apply. A product certification scheme includes performance tests and quality assurance tests or qualification requirements stipulated in contracts, specifications.

In the certification of occupational health and safety system, a certification body applies an external, third-party programme audit in order to assess and demonstrate the compliance of the OSH MS of an organisation to the requirements of one or more occupational international or national standards, such as OHSAS 18001 ANSI/AIHA Z10-2005, CSA Z1000-06, UNIE 81900, AS/NZS 4801:2001 or to “recognition’ schemes OSH management system is usually voluntary implemented by an organisation in order to improve its OSH performance and is certified with the scope to increase the confidence of the clients and other parties in its commitment to prevent accidents and ill-health and to upgrade its brand image [7]. In some countries of Asia, the certification of OSH management system is binding. In Australia it is mandatorial the certification of OSH management systems according to safety standards for high risk industries, such us construction, gas fiting [1].

The certification, where a person is certified as being able to competently complete a job or task, usually by the passing of an examination, becomes more and more spread. Usually the standards of reference are professional standards established by national standardisation bodies, by professional associations and in some countries, approved by public authorities.

There are two general types of professional attestation:

  • valid for a lifetime, once the exam is passed; it is usually known as qualification;
  • valid for a period, with recertification after a certain period of time (usually 3 years) [1].

Professional certifications can also differ within a profession by the level or specific area of expertise they refer to. Professional certification does not refer to the state of legally being able to practice or work in a profession. That is licensure, which is usually administered by a governmental entity for public protection purposes and a professional association administers certification. Licensure and certification are similar in that they both require the demonstration of a certain level of knowledge or ability.

Certification of the OSH products, systems or personnel, by a third-party inspection body, including in the field of safety, can be voluntary (OSH management system, high voltage equipment, rescue lifting devices etc) or can be mandatory, being imposed by a technical regulation, such us European Directives of New Approach and Global Approach. While voluntary OSH certificate have a high performance goal and deal with several aspects of product, including safety and performances in use, binding certification looks for proofs that the object of assessment is over the lowest acceptable level of certain aspects (usually safety as in CE marking).

Evaluation of conformity according to European Directives. CE marking

The European Directives of New Approach and Global Approach establish rules for evaluation of conformity with the basic health and safety requirements for groups of products. The manufacturer has the responsibility to submit each type of product to one or more modules of evaluation of conformity, some of them involving a third party body. Such third party bodies shall be also submitted to an assessment of their system conformity and their personnel with the requirements of the directives and/or of the harmonized standards referring to quality system (such as ISO CEI 17021, EN 45011). This assessment is performed by the national accreditation body and/or the national authority for implementation of the respective directive. Then, each third party body is notified by the State Member to the European Commission, which allocates it an identification number and publishes its name and address, as well as the tasks it may perform. [11]

Only notified bodies for a particular type of product and procedure/module are allowed to apply the module of evaluation of conformity conform to European Directives of Global Approach and New Approach. Information regarding the notified bodies and their tasks for each European Directive are published by the European Commission.

A product covered by an European directive shall at least be submitted to module A - internal production control, which covers internal design and production control and is performed by the manufacturer, not requiring that a notified body to take action.

Each type of product, depending of its complexity and the risks related to its application shall be submitted to a procedure /module in phase of design (before serial production) and during production.

The most common applied module is module B - „EC type - examination” which is performed in design phase and consists of examination by a notified body of the model (including by testings) and of the technical file of the manufacturere.

During the production, other modules are to be applied by notified bodies, such as:

    - module D: conformity to type based on quality assurance of the production process,
     - module E: conformity to type based on product quality assurance.
     - module F: conformity to type based on product verification, covering the production

phase and follows module B.

     - module G: conformity based on unit verification, covering the design and production phases.
    - module H: conformity based on full quality assurance, covering the design and production phases.

There are also some particular modules, derived from the above ones.

The conformity with harmonized European standards applied to the model and process, if it is the case, gives the presumption of conformity with the basic health and safety requirements of the European Directives.

The manufacturer bears ultimate responsibility for the conformity of the product with the basic health and safety requirements and the provisions of the relevant directives, as well as with the harmonized standards claimed to be respected.

The binding modules of conformity deal only with the safety aspects of the product.

If the product has been submitted to all the relevant modules of conformity assessment and each item to be put on the market is conform to the relevant basic health and safety requirements of all directives to be applied, the manufacturer may affix on each item the CE marking, in form and with the dimensions prescribed by the relevant directive(s).

If a product falls within the scope of a directive that provides for the CE marking, the CE marking shall be affixed to all new products, whether manufactured in the Member States or in third countries and also to used and second hand products imported from third countries.

Directives may exclude the affixing of the CE marking on certain products. These products may circulate freely on the European market if they are accompanied by, for example, a declaration or certificate of conformity.

With very few exceptions, the CE mark is applied on each manufactured product under the entire responsibility of the manufacturer, the notified body being implied either in the design phase or in the production phase, but only at random intervals. Thus, related to one sample of product, the CE marking can be considered as a self declaration of the producer, not as an independend certification. There are are other systems in place, which independently certify the safety of a product and ensure a higher level of safety than just CE. Such a system is GS mark (Geprüfte Sicherheit, proved safety), in Germany, which can be applied on voluntary basis, according to the German Equipment and Product Safety Act . The GS mark is applied on a technical equipment after testing the type by an authorized, independent body which certifies that the product meets the safety requirements and as long as the testing and certification body monitors the products and ensures that only products corresponding to the type and the law are placed on the market. [12]

The conformity of a product with all the relevant directives and/or with all relevant harmonized standards does not automatically mean that the product is fit for a particular usage at the work place. It still remains the responsibility of the employer to establish which of the products put on the market are adequate for their needs, taking into account the eventual pictograms, codes or level of performances market on the product or inscribed in the information file.


  1. 1.0 1.1 1.2 WORKPLACE RELATIONS MINISTERS’ COUNCIL, ’Comparison of Occupational Health and Safety Arrangements in Australia and New Zealand’, 5th Edition September 2008. Retrieved 08 October 2012 at:
  2. 2.0 2.1 2.2 2.3 ISO/IEC 17000:2005 ‘Conformity assessment -- Vocabulary and general principles’, CEN 2005
  3. European Commission Communication ‘Towards an increased contribution from standardization to innovation in Europe’ March 2008.
  4. 4.0 4.1 ‘Directive 98/34/EC of the European Parliament and of the Council laying down a procedure for the provision in the field of technical standards and regulations is the most important legal act concerning European standardization‘, amended by Directive 98/48/EC of the European Parliament and of the Council of 20 July 1998 and Council Directive 2006/96/EC of 20 November 2006
  5. Ali ‘B. O. ‘Fundamental principles of occupational health and safety’, Geneva, International Labor Office, 2001, Retrieved 18 June 2012 at:
  6. Leka S., A. Jain, M. Widerszal-Bazyl, D. Zolnierczyk-Zreda, G.I.J.M. Zwetsloot,  (2011) ‘Developing a standard for psychosocial risk management: PAS 1010, special issue on OSH Management Systems’. Safety Science, 49, 7 pp. 1047-1058
  7. 7.0 7.1 7.2 Zwetsloot G.I.J.M., A. Hale & S. Zwanikken (2011), ‘Regulatory risk control through mandatory occupational safety and health (OSH) certification and testing regimes (CTRs), special issue on OSH Management Systems’, Safety Science, 49, 7 pp. 995 – 1006
  8. The Compass, American Society of Safety Engineering, “impact of ANSI Z10perspectives from ASSE Membres” Retrieved 31 October 2012 at:
  9. Adele L. Abrams, “Legal Perspectives on ANSI Z10-2005 Significant Implications for SH&E Practitioners & Employers”, in The Compass, American Society of Safety Engineering, Retrieved 31 October 2012 at:
  10. 10.0 10.1 ‘Council Resolution of 7 May 1985 on a new approach to technical harmonization and standards’, Official Journal C 136 , 04/06/1985 P. 0001 – 0009
  11. ‘Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC‘. Available at:
  12. Máté Péter Vincze “Evaluation of the feasibility of a consumer safety mark”, Framework Contract on Evaluations ENTR / 04 / 093, Lot 1, Final report: 1 October 2008, Retrieved 31 October 2012 at:

Links for future reading

1) Wikipedia, ‘Standardization‘,Retrieved 08 October 2012 at:

2) Wikipedia, ‘List of technical standard organisations, Retrieved 08 October 2012 at: ‘ List_of_technical_standard_organisations

3) BSI Group, ‘ About standards‘, Retrieved 08 October 2012 at:

4) ISO, ‘About us‘, Retrieved 08 October 2012 at:

5) CEN, ‘About us‘, Retrieved 08 October 2012 at:

6) ISO, ‘Products‘, Retrieved 08 October 2012 at:

7) EU-OSHA, ‘Nando (New Approach Notified and Designated Organisations) Information System‘, Retrieved 08 October 2012 at:


Emilia DOBRESCU, palmerk
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