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Strategic Certification: How to Get to Market Quicker in the Electronics Industry

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This guide from Etratech aims to educate product designers and CTOs on the standards that may impact their visions. It’s best to take a “measure twice, cut once” approach with these, as it can be both time consuming and expensive to attempt compliance after a prototype’s been built.

Standards addressed in this article include:
**“Must-Haves,” like ROHS, CE and WEEE
**“Should-Haves” like ISO 9001 and 14000
**“Nice-to-Haves” like CE and Six Sigma

The content will also address some key industry-specific standards.

Etratech Inc. specializes in the design, development and manufacture of advanced electronic controls and control systems for major multinational companies. We serve original equipment manufacturers (OEMs) and other manufacturing firms with a total solution that extends far beyond traditional electronic manufacturing services (EMS). Our specialty is in microcontroller-based products.

ISO 14001, ISO 9000, TS 16949, ISO 13485.

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Strategic Certification: How to Get to Market Quicker in the Electronics Industry

  1. 1. Strategic Certification: How to get to market quicker in the electronics industry.
  2. 2. How to get to market quicker in the electronics industry. You can have a great idea.You can even bring it to life and prove that it works. But if you can’t get it certified for use, all your efforts will have been for nothing. Although technology is the most trusted industry in Canada according to the Edelman Trust Barometer, with 74 % of Canadians believing that companies in the sector behave with consumers’ interests at heart1, the study found that 42 % of Canada’s ‘informed public’ believes there isn’t enough regulation of business. Regulations and certifications in the electronics sector are here to stay, and we believe they’re going to become more stringent given that overall market distrust is much stronger than trust.2 Does this mean that the more certified you are, the better? No — at least not in the electronics industry. Because there is already a high level of trust, your certification goal should be quality over quantity. But with so many certifications available, where should a manufacturer begin? This white paper will point you in the right direction. It will introduce you to the must-have, should- have and the don’t-have-to-have certifications for electronics companies and their electrically engineered products. It will show you how to get them, and prepare you for how much you should expect to spend on them. When you’re finished reading, you’ll see that a few key quality indicators are all you need to do business anywhere in the world. 1 http://edelman.ca/2014/01/30/2014-edelman-trust-barometer-canadian-findings/ 2 http://www.slideshare.net/EdelmanInsights/2014-edelman-trust-barometer-canada-results ?ref=http://edelman.ca/2014/01/30/2014-edelman-trust-barometer-canadian-findings/ Strategic Certification 2Strategic Certification: How to get to market quicker in the electronics industry.
  3. 3. ● / ROHS In 2003, the Restriction of Hazardous Substances Directive (RoHS — pronounced roe-haas) was created by the European Union. This new and sweeping set of regulations essentially forced many electronics manufactures to create their products differently if they wanted to sell in Europe. At first, it targeted common materials that posed a threat to the health and safety of people and the planet, and greatly limited their amounts. This included lead (Pb) and mercury (Hg) levels in things like switches, as well as cadmium (Cd), hexavalent chromium (Cr VI), polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE). The new acceptable limits were minuscule — in the case of lead, it was less than one thousand parts per million. RoHS proved to be so effective in reducing the presence of hazardous materials in electronics that it began to gain traction, and its principles were slowly adopted around the world. China, Japan, South Korea, Taiwan, India, Norway and the State of California have all enacted their own RoHS laws. Since 2013, RoHS has expanded to include the 68 substances on the EU’s REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) list. The ones most commonly found in the electronics industry are: • Cobalt(II) chloride (cobalt dichloride) – corrosion resistance properties that help prolong the life of metal in products like car parts and gas burners1,2,3 • Trichloropropane – a chemical intermediary that helps produce other chemicals used in EEE production • Strontium chromate – as an anti-corrosive primer for zinc, magnesium, aluminum and alloys used in aircraft manufacture • Chromic acid, oligomers of chromic acid and dichromic acid – for instrument repairDichromic acid – for instrument repair • Chromium trioxide – to increase the thickness of aluminum • Cobalt(II) diacetate – helps paint dry and harden varnishesCobalt(II) sulfate – creates pigment for products • Sodium chromate – corrosion inhibitor in the oil industry, wood preservative • Potassium chromate – an oxidizing agent • Potassium dichromate – wood treatment • Boric acid – used to make the glass in LCD displays, and also in pyrotechnics • Trichloroethylene – a degreaser for products with metal parts (continues) The Must-Haves 3Strategic Certification: How to get to market quicker in the electronics industry.
  4. 4. ROHS (continued) • Aluminosilicate Refractory Ceramic Fibres – high temp insulation wool for industrial furnaces • Zirconia – used in electroceramics • Tris(2-chloroethyl)phosphate – a flame retardant • Anthracene – organic semiconductor • Lead chromate – creates yellow paint • Lead chromate molybdate sulfate red (C.I. Pigment Red 104) – creates red paint • Lead sulfochromate yellow (C.I. Pigment Yellow 34) – creates yellow paint • 4,4’-Diaminodiphenylmethane (MDA) – used to make epoxy resins and adhesives • Benzyl butyl phthalate (BBP) – used to make the plastic found in conveyor belts • Bis(2-ethylhexyl) phthalate (DEHP) – used in the medical biz to make plastic tubes and IV bags • Anthracene – used to the make the black smoke at the Papal conclave • Hexabromocyclododecane (HBCDD), including all major diastereomers – flame retardant It has also expanded by product category and now applies to medical devices and monitoring/ cooling equipment. It’s scheduled to apply to all EEE (electrical and electronic equipment) by 2019. Getting RoHS certified There is no official RoHS product certification process and no official RoHS-compliancy mark. Instead, regulators rely on the manufacturers to self-declare as RoHS compliant. This involves collecting a material breakdown of every piece that makes up your final product and checking it against the RoHS Directive. It will cost you man-hours, but nothing out-of-pocket. Generally, you only have to do this once, and while it requires some effort, it’s far less painful than having your product turned away at a port of import for a RoHS violation. RoHS compliance is simple to follow: either you’re within the legal limit or you’re not. If you fail a RoHS inspection, expect to have many problems resuming to import to the country in which the noncompliance occurred. The Must-Haves (continued) 4Strategic Certification: How to get to market quicker in the electronics industry.
  5. 5. ● / WEEE This certification is mandatory if you want to do business in Europe. Standing for Waste Electrical and Electronic Equipment, the purpose of this certification is to ensure that (a) your product can be disposed of safely and (b) that you’ve partnered with an EEE disposal company that knows how to dispose of your product properly. Before you start lamenting the long reach of the regulators, you should know that the language of the WEEE directive explicitly allows producers to pass the costs of maintaining WEEE certification and partnering with a Designated Collection Facility (DFC) on to the customer, as long you’re transparent and don’t charge more than what is considered reasonable within the industry. Getting WEEE certified Unlike RoHS which requires neither an official certification nor an on-product mark, WEEE requires both. There are a number of companies that can help you secure mandatory membership in a Producer Compliance Scheme (a collection of companies that work together to finance the WEEE collection protocols), register with the necessary environmental agencies and produce mandatory sales and disposal reports for your PCS. Just search online for WEEE certifiers and you’ll find one. Expect to pay a yearly fee to maintain your WEEE certification, plus any fees your WEEE consultancy charges. WEEE fees vary by country, by amount of waste and other factors, so it’s difficult to estimate without speaking to a WEEE consultant. Often, the company bringing the product to market, rather than the electronics designer and manufacturer pays the fees. However, considering the European market size (742 million people and counting), it would behoove you to get your WEEE. The Must-Haves (continued) 5Strategic Certification: How to get to market quicker in the electronics industry.
  6. 6. ● / INTEROPERABILITY CERTIFICATIONS If your EEE is being built to work with one of the wireless technology standards (Wi-Fi, Bluetooth, ZIGBEE, Z-Wave, etc.), a compatibility test is mandatory to make sure it actually works within the standard. If successful, you’ll qualify to have the standard’s logo on your packaging — which is what customers look for when purchasing. There are two ways to build a circuit into you product that meets interoperability certification. The first (and more difficult) method is to design your own circuit. It requires an expert in the field who can build it, and a sizeable investment in the hardware/technology to get it done. It can cost in excess of $ 20,000 and could take months to complete. The benefit is that you’ll have full control of the process. The second — and much easier — method is to pre-purchase complete circuits (known as modules) from a chip manufacturer. This is essentially a plug-and-play solution. The benefit here is that all the interoperability work is done so you can focus on building the very best device. Getting interoperability certified Once you think you have the right setup, getting certified is as simple as demonstrating your device’s interoperability to the appropriate certification organization. Each standard has its own; for Bluetooth it would be Bluetooth Special Interest Group whereby a Bluetooth Quality Expert (BQE) would test and certify your product. You’ll pay a one-time fee to have your product certified, but once it is, you’re good to go. The Must-Haves (continued) 6Strategic Certification: How to get to market quicker in the electronics industry.
  7. 7. ● / CE CERTIFICATION If you plan to do business in Europe, a CE certification is mandatory. This stamp indicates that a product is safe for purchase there. Depending on the kind of EEE you produce, there are certain tests that must be passed in order to receive a CE certification: • EN 55103-1 : 1995 Electromagnetic Compatibility Product Family Standard for Audio, Video, Audio-Visual and Entertainment Lighting Control Apparatus for Professional Use, Part 1: Emissions • EN 61000-3-2 : 1995 + A14 : 2000 Limits for Harmonic Current Emissions (equipment input current <=16A per phase) • EN 61000-3-3 : 1995 Limitation of Voltage Fluctuations and Flicker in Low-Voltage Supply Systems Rated Current <=16A • EN 55103-2 : 1996 Electromagnetic Compatibility Product Family Standard for Audio, Video, Audio-Visual and Entertainment Lighting Control Apparatus for Professional Use, Part 2: Immunity • EN 61000-4-2 : 1995 Electrostatic Discharge Immunity (Environment E2-Criteria B, 4k V Contact, 8k V Air Discharge) • EN 60065 : 1998 Safety Requirements Audio Video and Similar Electronic Apparatus Getting CE certified Like RoHS, CE certification is generally self- directed, meaning that you would make sure your product meets the requirements. Every product has different requirements, which you can easily find online at europa.eu (just search for CE markings). As for cost, it can range from under $ 100 up to over $ 50,000 depending on the product. But if you want to do business in Europe, it’s well worth the investment. The Must-Haves (continued) 7Strategic Certification: How to get to market quicker in the electronics industry.
  8. 8. Up until now, the certifications we’ve discussed have been product-based. ISO certifications (ISO stands for International Organization for Standardization) are different in that they’re system- based, which means the way you do business is being certified. ISOs focus on the Quality Management Systems (QMS) of an operation, from engineering to manufacturing to marketing. Their purpose is to ensure that no corners are being cut, that the people you have in your organization are qualified to perform their jobs and that consumers aren’t being sold a false bill of goods. The Should-Haves 8Strategic Certification: How to get to market quicker in the electronics industry.
  9. 9. ● / ISO 9001 & ISO 14000 The certifications in this section highly recommended if you want to do business to with major brands and retailers. Highly respected organizations will not consider working with you if you don’t have ISO 9001 certification, and many will insist that you have ISO 14000 certification. Let’s look at each individually. ● / ISO 9001 ISO 9001 is a certification of overall quality management; proof that you do what you say you do. Reputable brands and companies insist having this for two reasons. Firstly, like people, organizations are judged by the company they keep; they’re not interested in dealing with subpar vendors, suppliers or partners. In fact, our policy is to be wary of any company that doesn’t require ISO 9001 certification from the companies they associate with. Secondly, dealing with an uncertified partner could put a company in an actionable position should something happen that could have been avoided by their vendor, supplier or partner. ● / ISO 14000 This ISO is environment-based, and focuses primarily on processes that reduce emissions, waste and other environmentally unfriendly practices. ISO 14000 is relatively new, and given the current people/planet/product climate, more and more companies look for it from their vendors, suppliers and partners. It’s also a valuable certification to have from a PR perspective, as many end users want to know that the companies behind the products they use are mindful of the environment and do what they can to protect it. In the next section, we’ll look at some other certifications that hold weight with the public, but this is a big one. Getting ISO 9001 & ISO 14000 certified The process for getting these certifications is the same process described for the previously mentioned ISOs. The Should-Haves (continued) 9Strategic Certification: How to get to market quicker in the electronics industry.
  10. 10. ● / CSA & UL CERTIFICATION Like RoHS and interoperability certifications, CSA and UL are product-focused. A CSA or UL mark on a product indicates that it has been independently tested for safety, performance, energy efficiency and sanitation. Both are highly recommended as a stamp of quality, and like other non-mandatory ISOs, many highly regarded companies won’t consider stocking or using your product unless it’s certified with either a CSA or UL stamp. Let’s look a bit deeper into each of them. ● / CSA CSA stands for the Canadian Standards Association. Because it appears on over a billion products around the world, products without a CSA stamp stand out as less credible than those that have it. ● / UL UL stands for Underwriter’s Laboratory, a non-profit testing organization established in 1894 by the Fire Underwriter’s Association in the United States. It’s not as comprehensive as the CSA, as its primary focus is safety. While it’s recognized worldwide as a credible standard, it’s most often seen in the U.S. Getting CSA or UL certified There are two ways to obtain CSA or UL certification: you can approach the organizations directly or you can employ the services of a third party servicer such as ETL. From a consumer acceptability perspective, CSA and UL are more widely recognized and trusted. However, CSL, UL and ETL are all assessed by independent third parties, so any will do — it’s a matter of deciding which will work best for your product, audience and organization. Note that if you plan on pursuing a CSA / UL certification, we highly recommend going straight to the source. The Should-Haves (continued) 10Strategic Certification: How to get to market quicker in the electronics industry.
  11. 11. ● / ISO 9000 If you obtain either the ISO/TS 16949 : 2009 or ISO 13485 : 2003, an ISO 9000 certification is not necessary because the requirements have been folded into both of these. ● / FDA / HEALTH CANADA CERTIFICATION Medical devices are required to meet the Food and Drug Administration (United States) and Health Canada (Canada) standards. However, the ISO 13485 : 2003 certification includes everything those two organizations look for, so you’ll be covered on that front. ● / SIX SIGMA Like the ISOs, Six Sigma is a process certification that indicates a commitment to continuous improvement. It’s very popular on a management level, and many top companies pursue it; but it’s not mandatory. However, it’s an extremely valuable training program. We have many Six Sigma black belts on our staff and their contributions since being certified have been substantial. The Don’t-Have-to-Haves 11Strategic Certification: How to get to market quicker in the electronics industry.
  12. 12. ● / ISO/ TS 16949 : 2009 & ISO 13485 : 2003 Many of the ISOs are not mandatory, but ISO/TS 16949 : 2009 and ISO 13485 : 2003 are mandatory if you’re producing electronics for the automotive or medical industry, respectively. These two ISOs are mandatory because the nature of the products being made can pose serious health and safety risks to the end user if proper procedures are not followed. Getting ISO/TS 16949:2009 & ISO 13485:2003 certified Contrary to popular belief, the ISO organization itself does not issue certifications. Instead, it has granted licenses to private companies that complete the certification process. Our preferred ISO certifier is a company headquartered in the UK called BSI. They’re affordable and easy to work with. To get certified by a private licensing company, the first step is to send a select group of employees from your organization to be trained by the certifying company’s team on the principles of the ISO in question. You’ll want to send senior employees from each of your departments so they can return and pass on what they learn to their direct reports. Upon their return from training, they’ll compare your company’s operating procedures to the ISO requirements and adjust them accordingly. Once you’re satisfied that your operation meets the requirements, you then produce a detailed document outlining all your procedures and send it off to the certifying company for review. This is known as the first audit. They’ll review your document and return it with either an A-OK or recommendations for improvement. Again, when you’re satisfied that your procedures are in line with the certifying company’s recommendations, you’ll call them back and arrange a second audit, whereby they come to your place of business for an inspection. If you pass, you’ll receive your ISO certification. If you don’t, you won’t. It’s extremely important that you do not book your second audit until you know you can pass it. If you fail, it will extremely difficult to pass it at a later date. ISO certifications have to be renewed every three years, and like the initial certification, if you fail a subsequent certification, it’s almost impossible to get recertified. The Don’t-Have-to-Haves (continued) 12Strategic Certification: How to get to market quicker in the electronics industry.
  13. 13. Contact us today to learn how we can set your product apart from the competition. www.Etratech.com sales@Etratech.com +1 905–681–7544 Canada • USA • Europe • Hong Kong • China etratech company/etratech etratech etratechinc If you take one thing away from this white paper, it’s this: certification isn’t difficult, but it does require a company-wide commitment, especially as it relates to the non-mandatory certifications. You should expect to pay between $ 4,000 and $ 6,000 a year to maintain them, but from a credibility perspective in the marketplace, and from an improved-process perspective within your organization which should lead to more profitability, it’s a wise investment. Etratech has been committed to certification for over 25 years, and for us, the benefits have been outstanding. We’re happy to share our stories with you, and help further point you in the right directions. Final Thoughts

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