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://​can​lii​.ca/​t​/​5​2​2fd. 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/​p​l​s​/​o​s​h​a​w​e​b​/​o​w​a​d​i​s​p​.​s​h​o​w​_​d​o​c​u​m​e​n​t​?​p​_​t​a​b​l​e​=​S​T​A​N​D​A​R​D​S​&​a​m​p​;​p​_​i​d​=​9​880. Accessed: 2014-​01-​27.

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

[7]     Safety of Machines. B11​.org, [online]. Available: http://​b11stand​ards​.org/​s​t​a​n​d​a​r​ds/. 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​.wiki​pe​dia​.org/​w​i​k​i​/​W​i​l​l​i​a​m​_​H​e​n​r​y​_​M​e​r​r​ill. Accessed: 2013-​11-​20.

[2]     “History,” Underwriters Laboratories [online]. Available: http://​ul​.com/​a​b​o​u​t​u​l​/​h​i​s​t​o​ry/. Accessed: 2013-​11-​20.

[3]     “UL (safety organ­iz­a­tion),” Wikipedia [online]. Available: http://​en​.wiki​pe​dia​.org/​w​i​k​i​/​U​n​d​e​r​w​r​i​t​e​r​s​_​L​a​b​o​r​a​t​o​r​ies. 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/​L​e​x​U​r​i​S​e​r​v​/​L​e​x​U​r​i​S​e​r​v​.​d​o​?​u​r​i​=​C​E​L​E​X​:​3​1​9​9​3​L​0​0​6​8​:​e​n​:​H​TML. Accessed: 2013-​11-​20.

[5]     “One mar­ket without bor­ders,” Ed. European Union: europa​.eu [online], 2013. Available: http://​europa​.eu/​p​o​l​/​s​i​n​gl/. Accessed: 2013-​11-​20.

[6]     “CE Marking,” ed: Enterprise and Industry Directorate, European Commission, [online]. Available: http://​ec​.europa​.eu/​g​r​o​w​t​h​/​s​i​n​g​l​e​-​m​a​r​k​e​t​/​c​e​-​m​a​r​k​i​ng/. 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/​l​e​g​a​l​-​c​o​n​t​e​n​t​/​E​N​/​A​L​L​/​?​u​r​i​=​C​E​L​E​X​:​3​2​0​0​8​D​0​768, 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/​l​e​g​a​l​-​c​o​n​t​e​n​t​/​E​N​/​T​X​T​/​?​q​i​d​=​1​4​1​4​5​9​8​7​0​1​7​9​8​&​a​m​p​;​u​r​i​=​C​E​L​E​X​:​3​2​0​0​8​R​0​765. 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/​L​e​x​U​r​i​S​e​r​v​/​L​e​x​U​r​i​S​e​r​v​.​d​o​?​u​r​i​=​O​J​:​L​:​2​0​0​6​:​1​5​7​:​0​0​2​4​:​0​0​8​6​:​E​N​:​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.