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.

1. Strategic Certification:
How to get to market quicker
in the electronics industry.

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. ● / 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. 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. ● / 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. ● / 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. ● / 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. 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. ● / 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. ● / 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. ● / 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. ● / 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. 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