Why YOU need a Certification Strategy

How compliance efforts go wrong

Clients call when they have problems. They sent some product to a certification body, some tests were done and the product failed. Now what? Usually the delivery date for the certified product is approaching quickly, and no time is available to react. Delivery is delayed and the customer is upset. The business may even be lost.

This process goes wrong for a number of reasons:

  1. The end goal for the certification and the intermediate requirements were not considered
  2. The certification body chose the standard, and the manufacturer had no idea what the standard required
  3. The samples were not carefully prepared for the certification body
  4. Information was missing or partially missing

Certification Motivation

What motivates a manufacturer to certify a product? The decision to certify comes about for a variety of reasons, including:

  1. Legal requirement for the market
  2. Customer request
  3. Liability limitation
  4. Marketing advantage over competitor’s offerings

I’ve talked about the differences between CE Marking and traditional Certification processes in a number of articles, including this one recently, so I won’t repeat myself here. In Canada, Federal [1, 125(m)(iii)] and Provincial law [2, 113] requires anyone selling an electrical product to ensure that it bears an electrical safety mark, and this is supported in the Canadian Electrical Code [3, 2-024]. This requirement is often overlooked in the industrial / commercial market where post-installation equipment inspection, called “Field Evaluation”, is common.

In the US, each State has a slightly different approach, so you will need to check out the requirements in the states where your product is sold so that you can ensure compliance with the local requirements. From a workplace perspective, the US OSHA requires that all electrical products used in the workplace bear a mark from a Nationally Recognized Testing Laboratory (NRTL) [5].

Certifying your product provides some degree of liability limitation, in that it shows that you met the minimum legal requirements for your marketplace. To really limit your liability effectively, you will need to do more than just meet the minimum requirements, and you will need documentation of everything done to meet or exceed those requirements.

If you offer certified products in a market where this is uncommon, you have a marketing advantage as long as your customers understand the advantages certified product brings. If certification is rare in your markets, you may need to undertake some educational marketing to help customers “get it”.

Another key point needs to be considered: Product volume. Certification costs money and takes time. If you are selling less than 200 units per year of a given product in your line, certification for that product is unlikely to be feasible. For product volumes from one to 200 units per year, Field Evaluation provides a much more time and cost effective way to get your product marked.

The diagram shows the general process flow for this activity. If you are choosing to use Field Evaluation instead of Certification, substitute “Field Evaluation” wherever you see “Certification” in the diagram.

Flow chart showing certification process flow.
Certification Process Flow

Selecting standards

Selecting the “right” standard for your product can be a challenge, especially in the industrial market where products are often highly specialized, “one-off” products. In many of these cases, no standard that specifically covers the product may exist. For relatively simple products, or for products that are very common, like TV’s, computers, and audio-video equipment, there are “Product Family” standards that specifically cover these types products.

Not every standard is a certification standard. Most of the certification standards are focused on electrical and fire safety. The concerns are the prevention of electrical shock, arc flash, and fire. Certification standards will typically include specific tests that must be passed to show compliance with the requirements. Design standards, on the other hand, will provide general performance requirements and sometimes prescriptive feature requirements, but no test requirements. This is typical in the industrial machinery sector where standards like CSA Z432 [6] and the ANSI B11 family [7] of standards apply. In these cases, you may be able to have the product certified for electrical safety, but not for machinery safety. This does not eliminate corporate liability for the machinery hazards, requiring manufacturers to be knowledgeable and diligent in applying design standards.

Developing a Certification Strategy

To develop a sound strategy, I recommend a “bottom-up” approach. To apply this idea, start with the bill of materials for the product. Look first at the purchased products: How many of these items are either already certified by their manufacturer? All of the certified items can be eliminated from further consideration for the moment. Next, consider the purchased but un-certified products. Contact all of your suppliers to determine which of these products can be purchased certified, and adjust the bill of materials to reflect the part numbers for the certified versions.

Now, the harder part. All of the remaining items on the bill of materials need to be looked at for certification. Anything that cannot or need not be certified, e.g., nuts and bolts, other mechanical parts that are not pressure bearing, can be excluded from consideration. You now have a short list of uncertified components that require certification.

For each item on the short list, research the standards available. The Scope of the standards will help guide you regarding their applicability. Once you have a matched list of components and standards, you can extend that research to include the top level product.

Now you have the beginning of a compliance strategy. The next piece of the puzzle involves the internal evaluation of each component against the standards chosen. This give you the ability to revise your thinking, either of the standard you chose or of the design and construction of the component. Making good choices at this stage to either correct issues found in the design or construction of the component, or in the selection of the standard, can save you huge amounts of time and effort once the certification body gets involved.

Once the components have successfully passed the internal “pre-compliance” evaluation, you can get the certification body involved, and start the formal compliance process for each component. As this part of the process progresses, the certification body may have additional questions or requests for information. To reduce these in-process questions, make sure that each component is clearly identified, that you have unique part numbers for each part, and that you have provided information on the materials used in the construction of the component, as well as detailed engineering drawings.

As the component certification work progresses, you can start on the top level product certification work. The top level product needs to go through the same sort of internal pre-compliance process as the components so that you can be as certain as possible that the product will meet the requirements when it gets to the certification lab.

Preparation of the data package and the sample(s) of the top-level product that will be submitted must be done carefully. Construction of the samples must match the manufacturing drawings and instructions as closely as possible. Once everything is ready, the samples can be submitted for evaluation.

Working with your Certifier

Dealing with a Certification Body can be very challenging. Much of the experience will be based on the project engineer that is responsible for your product’s evaluation. It’s important to set up a good relationship with this person at the beginning, because once problems start to crop up in the lab you will need to be able to talk to this person. Making sure that you have the “right” standards selected for your product is really important, and the project engineer must agree with you. They can refuse to certify a product if they feel that the standard chosen is incorrect, and since they have the final word, there is no arguing with them. An open discussion at the beginning of the project to discuss the standards selected is a good place to start. If your ideas and theirs deviate in a big way, you may have to compromise on their selection, or worse, stop the project and review the problems encountered.

Once the product is certified, the Certification Body will conduct regular audits on the manufacturing facility(ies) to make sure that the production testing is being done, production records are kept, and that the QA programs are ensuring that only good product leaves the plant.

An important part of the QA process is the Customer Complaints Program. Manufacturers must have a program in place to record customer complaints, and to respond to those complaints. A decision tree that helps customer service representatives differentiate between safety-related and non-safety related complaints should be developed. Safety related complaints should result in engineering review of the problems and determinations about the cause of the problems. If these are related to manufacturing or design issues, and especially if these are related to compliance with the requirements of the certification standard, a recall of the product may be needed. If this is the case, get the Certifier involved as soon as possible. Failure to act, and failure to inform the certifier can result in the certification being revoked.

References

[1]     Canada Labour Code, [online]. Available: http://canlii.ca/t/522fd. Accessed: 2014-01-27.

[2]     Ontario Electricity Act – Marking requirements Avaialble:Ontario Electricity Act. Accessed: 2014-01-27.

[3]     Canadian Electrical Code, CSA C22.1. 2012.

[4]     National Electrical Code, NFPA 70. 2014.

[5]     Occupational Safety and Health Standards, 1910 Subpart S, Electrical, Installatin and Use. 29 CFR 1910.303(b)(2), [online]. Available: https://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=9880. Accessed: 2014-01-27.

[6]     Safeguarding of Machinery. CSA Z432. 2004.

[7]     Safety of Machines. B11.org, [online]. Available: http://b11standards.org/standards/. Accessed: 2014-01-27.

Understanding European Declarations of Conformity or Incorporation

Updated 2014-10-29

In order to understand the various types of EU Declarations, it’s important to first understand a bit about the system that uses them. Two systems of product safety evaluation are in wide use globally: Certification, and Marking. Understanding the differences between these two systems is important for anyone who gets involved with regulatory compliance activities. It’s also important to know that these Declarations have no relationship to the compliance declarations often used in commercial supply chains. Supply chain declarations are simply used to make sure that vendors attest to the fact that they supplied what the customer ordered. This type of document has no relationship to the EU Declarations discussed here.

Certification vs. Marking

The oldest existing system for product safety is the Certification system. This system was first introduced by William H. Merrill [1], [2] in the early days of Underwriters Laboratories [3]. In this system, an objective third party organization reviews the design and construction of a product against the requirements of an established standard. Testing is normally a part of the evaluation process, requiring a person or organization to submit a number of samples of the product. Some of the samples will normally be destroyed in the testing process. Tests can include any aspect of the design related to safety, which could include the evaluation of toxicity of finishes, flammability of plastics and other materials used in the product, water and dust tightness, voltage withstand, etc. The components used in the product will also be assessed. Those that have been assessed before and are “listed” may be exempt from further evaluation, unless they are used in a way that is different from their intended application (i.e., at a higher voltage, a higher or lower temperature, etc.). Once the evaluation is complete and the product has successfully completed all the required tests, the certifying laboratory will issue the manufacturer a license to apply the laboratory’s mark to the product, and a certificate attesting to the product’s conformity with the requirements is issued, thus the term “certification.” From this point forward, the construction of the product is frozen. Any changes to the components used or the construction of the product must be reviewed and approved by the certifier.

The certifying laboratory will also start a series of regular factory audits, usually on a quarterly basis, to make sure that the product continues to conform to the performance of the original test samples. This is done at the manufacturer’s expense. The factory visits will continue until production of the product is discontinued, or the certification is ended for another reason. Application of a certifying laboratory’s mark to a product without having passed through the certification process and obtained the license from the owner of the mark is fraud. In fact, even putting a mark on your product that might be confused with an existing certification mark can be fraud.

Currently, there are sixteen accredited product safety certification bodies in Canada, and fifteen Nationally Recognized Testing Laboratories (NRTL) in the USA. Many of the organizations that are accredited in the US are also accredited in Canada.

Proportional drawing showing design of EU CE Mark graphic
CE Mark

The “marking” process is a relatively new system, introduced by the European Union (EU) in the 1993 [4] as part of the introduction of the EU CE Marking system. The EU vision included the elimination of technical barriers to trade by creating a unified market within the EU Member States. The “Single Common Market” [5] was created in 1987, and this necessitated the harmonization of product safety requirements across all of the Member States. The CE Mark was introduced [6] as a sign that the product met the relevant product safety requirements. As part of this, the EU did not want to add unnecessary cost for manufacturers, so rather than implementing a certification system like that used in North America, it was decided to use a “self-declaratory” process [7] for everything except the most hazardous products. Manufacturers would be required to determine what product safety laws, called Directives, applied to their products, and furthermore what technical standards applied to their products. Standards were harmonized under the various directives, and these documents, with numbers starting with “EN”, were given special status. Use of harmonized EN standards in the design and manufacture of a product confers a “presumption of conformity” with the directive(s) under which the standard is harmonized. Not all EN standards are harmonized. A list of harmonized standards is published about once a year for each Directive in the C version of the EU official journal. Only those standards, referenced by date, allow for presumption of conformity with the essential requirements of the directive [13]. You can find the lists of Harmonized Standards here.

Once the manufacturer is satisfied that all the required measures have been taken, and has compiled a Technical File for the product, the CE Mark can be placed on the product, an EU Declaration issued and the product shipped.

Declarations

Under the CE Marking system, the manufacturer’s declaration is a contract between the manufacturer of a product and the EU Member State(s) in which the product is sold. Depending on the Directives that apply to the product there are a few possible variations on what is required:

Directive Declaration of Conformity Declaration of Incorporation
Machinery X X*
Low Voltage X
EMC X
PED X**

*Under the Machinery Directive, Partially Completed Machinery does not receive a CE Mark, although it is required to have a Declaration of Incorporation.

**Under the Pressure Equipment Directive, products falling into the Sound Engineering Practice (SEP) classification are not CE Marked under the PED.

There are unique circumstances under the individual directives that are too detailed to go into here, but it is important to understand that there are variations between Directives.

As with almost any topic in the regulatory field, there are standards that apply to the structure and content of Declarations. In this case EN ISO/IEC 17050-1 [8] and EN ISO/IEC 17050-2 [9]. These standards lay out the general requirements for the structure and content of the manufacturer’s declarations. In addition, each Directive has an Annex that describes the specific types of declarations that are permitted (Declaration of Conformity or Declaration of Incorporation), and the content of the Declaration. If you are interested in the rationale for the use of these standards, you must track back to Decision 768/2008 [10] and Regulation 765/2008/EC [11]. The Decision and the associated regulation set out the requirements for accreditation and market surveillance in the EU Common Market, and resides in at a level above the Sector Directives like the Machinery, Low Voltage or EMC Directives. Under this regulation is a list of harmonised standards, and that list includes the EN ISO/IEC 17050 standards. Note that the linked document was current as of 2014-10-29 and may have been updated since then.

“EC Declaration…” or “EU Declaration…”?

The European Union has gone through several different identities since it was originally formed in the 1950’s. The original six countries came together in 1953 as the European Steel and Coal Community. In 1958, the Treaty of Rome created the European Economic Community (EEC), and then in 1993 the Maastrict Treaty created the European Union (EU) [10].  Upon the entry into force of the Maastricht Treaty in 1993, the EEC was renamed the European Community (EC) to reflect that it covered a wider range of policy. This was also when the three European Communities, including the EC, were collectively made to constitute the first of the three pillars of the European Union (EU), which the treaty also founded. The EC existed in this form until it was abolished by the 2009 Treaty of Lisbon, which merged the EU’s former pillars and provided that the EU would “replace and succeed the European Community” [12]. So in all cases, declarations should bear the title “EU Declaration of…”, regardless of what you find in the current editions of the Directives. This is a fine technical point, and should not result in your declaration being rejected by customs inspectors. If you want to get things right, make sure your documents say “EU”.

NOTE (updated 9-Dec-13) – Some authorities in the EU disagree with this, based on the reality that the National Transpositions of the Directives (the National implementations of the EU Directives) still say “EC”, and until / if they are updated the most correct answer to this question is to follow the text of the National Transpositions of the Directives. In my opinion, this flies in the face of the intent to eliminate technical barriers to trade by harmonizing the legal and technical requirements, however, it is a relatively trivial technical point, and not one that should result in the rejection of a Declaration by the Authorities. If it did, I would recommend strongly challenging the rejection through the appropriate channels. [13], [15].

Use of Logos and the CE Mark on Declarations

There is nothing that I could find that prohibits or requires the use of corporate logos on Declarations. My usual guidance to clients is to publish their Declarations on company letterhead, since the declaration is a de-facto contract, and should therefore be published on official stationery. This is not a requirement, just good practice in my opinion.

I’ve seen many Declarations that also bear the CE Mark. EN ISO/IEC 17050-1 suggests that marks placed on the product should be referenced by and traceable to the Declaration, and that the mark may be shown in an attachment if desired [8, A.1, 6)]. Showing the mark on the face of the declaration is neither required nor explicitly prohibited, but in my opinion, other than attaching a drawing of the mark to the Declaration, I would not use it in this way. The mark is intended to be placed on the product and should be reserved for that purpose.

Summary

Summing up the discussion, EU Declarations:

  • should be based on EN ISO/IEC 17050-1 and supported by documentation (e.g., a Technical File) as laid out EN ISO/IEC 17050-2 and the relevant Annexes to the applicable directives.
  • should state “EU Declaration of Conformity” or “EU Declaration of Incorporation” as appropriate
  • shall include the relevant statements from the directives (i.e., “a sentence expressly declaring that the machinery fulfils all the relevant provisions of this Directive and where appropriate, a similar sentence declaring the conformity with other Directives and/or relevant provisions with which the machinery complies. These references must be those of the texts published in the Official Journal of the European Union;” and “ a sentence declaring which essential requirements of this Directive are applied and fulfilled and that the relevant technical documentation is compiled in accordance with part B of Annex VII, and, where appropriate, a sentence declaring the conformity of the partly completed machinery with other relevant Directives. These references must be those of the texts published in the Official Journal of the European Union;” [14])
  • shall carry a listing of the relevant directives
  • may include the manufacturer’s logo, but use of letterhead is unclear
  • shall include the manufacturer’s information AND the EU Authorized Representative’s information
  • should be included as a hardcopy with the shipping paperwork
  • should be included in the product documentation
  • may be made available on the company web site (many manufacturers do this)
  • shall include all of the relevant information as laid out in the Annexes to the relevant Directives.

References

[1]     “William Henry Merrill,” Wikipedia [online]. Available: http://en.wikipedia.org/wiki/William_Henry_Merrill. Accessed: 2013-11-20.

[2]     “History,” Underwriters Laboratories [online]. Available: http://ul.com/aboutul/history/. Accessed: 2013-11-20.

[3]     “UL (safety organization),” Wikipedia [online]. Available: http://en.wikipedia.org/wiki/Underwriters_Laboratories. Accessed: 2013-11-20.

[4]     “Council Directive 93/68/EEC of 22 July 1993”, Ed. European Union: Eur-Lex [online], 1993. Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31993L0068:en:HTML. Accessed: 2013-11-20.

[5]     “One market without borders,” Ed. European Union: europa.eu [online], 2013. Available: http://europa.eu/pol/singl/. Accessed: 2013-11-20.

[6]     “CE Marking,” ed: Enterprise and Industry Directorate, European Commission, [online]. Available: http://ec.europa.eu/growth/single-market/ce-marking/. Accessed: 2013-11-20

[7]     Guide to the implementation of directives based on the New Approach and the Global Approach. Luxembourg: Office for Official Publications of the European Communities, 2000.

[8]     “Conformity assessment — Supplier’s declaration of conformity — Part 1: General requirements,” ed. Geneva: ISO Standard 17050-1, 2004.

[9]     “Conformity assessment — Supplier’s declaration of conformity — Part 2: Supporting documentation,” ed. Geneva: ISO Standard 17050-2, 2004.

[10]   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. Ed. European Union: Eur-Lex [online], 2008. Available: http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32008D0768, Accessed: 2018-10-29.

[11]     Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (Text with EEA relevance). Ed. European Union: Eur-Lex [online], 2008. Available: http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1414598701798&uri=CELEX:32008R0765. Accessed: 2018-10-29.

[12]     “The European Union in Slides,” Ed. Luxembourg: European Commission, 2013.

[13]     D. E. Powell, “Re: [PSES] Rejected Manufacturer Declarations,” D. Nix, Ed., personal email, 2013.

[14]     “DIRECTIVE 2006/42/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 17 May 2006 on machinery, and amending Directive 95/16/EC (recast)”, ed. European Union: Eur-Lex, 2006.Available: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2006:157:0024:0086:EN:PDF. Accessed: 2013-11-20.

[15]   G. Gremmen, “Re: [PSES] Rejected Manufacturer Declarations,” D. Nix, Ed., personal email, 2013.

Acknowledgements

This article came about because a client of mine had some questions regarding declarations. I put the question to the members of the IEEE Product Safety Society‘s EMC-PSTC list, a group of over 650 experienced product safety professionals, to verify and validate my opinion before i responded to my client. I want to acknowledge contributions to the discussion by the following members of that list, in alphabetical order: Gert Gremmen, Brian Kunde, Chuck McDowell, Brian O’Connel, Douglas E. Powell, Mark Schmidt, Joshua E. Wiseman, John Woodgate, and Sam Yogasunthuram.