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NEWS
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ISSUE 9 September 2015
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MIKE’S TECHNICAL TIPS
European Union – EMC Directive 2008/108/EC Call to Action
The European
Directive 2008/108/
EC has been
recast and will be
renumbered 2014/30/
EU coming into force
on the 20 April 2016.
The recast directive
calls for two main
essential compliance
points:
1. Relevant equipment shall be so designed and
manufactured, having regard to the state of
the art, as to ensure that:
9
9
The electromagnetic disturbance does not
exceed the level above which radio and
telecommunications equipment or other
equipment cannot operate as intended
9
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It has a level of immunity to the
electromagnetic disturbance to be expected
in its intended use which allows it to operate
without unacceptable degradation of its
intended use
2. Specific requirements for fixed installations
9
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Installation and intended use of components
9
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A fixed installation shall be installed applying
good engineering practices and respecting
the information on the intended use of its
components with a view to meeting the
essential requirements.
Important Information
There has been provision made for all products
in compliance with 2004/108/EC that have or
will be placed on the market prior to 20 April
2016 to still be considered compliant. Any
major changes made by the manufacturer/
distributor/incorporate to the existing
equipment/installation would mean that the
responsible person/persons/organization will
have to reissue their declaration of conformity
against the recast Directive.
There have been NOmajor changes to the
“Essential Requirements”of the Directive from
2004/108/EC, the format and scope of the
Directive has altered. In essence, some products
that did not previously come under the EMC
Directive now do and some previously covered
product types are excluded and covered by
alternative legislation.
The recast Directive has been redrafted tomatch
the layout and language of other later Directives
and the document has been updated and
contents brought into linewith a Brussels decision
No: 768/2008/EU on a common framework for the
Marketing of Products in the EU.
For manufacturers there is one most important
change. The recast Directive requires that marking
on the product includes a single address, NOT
just the name or registered trade mark and not
forgetting to identify the newDirective number
2014/30/EU on the rating plate and within the
appropriate O&M& Instructionmanuals.
Other changes included in the recast Directive
cover the Technical File content, Declarations
of Conformity layout and must be continuously
updated as required when modifications have
been made to the equipment/product and the
penalties of Non conformity against the EU
Directive and other Directives which are deemed
to be relevant to the product in circulation within
the EU community.
Conclusions
Compliance with the EMC Directive is not a new
process so should be familiar ground regards
the compliance route/s available to those
responsible for placing the equipment on the
market. The recast Directive doesn’t bring a
whole new raft of new obligations, but it does
have different scope of products identified
within it and uses clearer language to explain
your obligations. It is more explicit about how an
organization communicates with its customers,
supply chain and the authorities.
Compliance with the EMC Directive is
compulsory with in Europe for those devices
covered by the Directive and it is policed,
non – conformity carries a serious penalty.
You must also note your obligations to meet
“other” appropriate Directives before placing
the CE Mark on your equipment meaning
due diligence is very important when
reporting and recording the test results in your
Management System regime.
PSSA
Technical and Standards News
Mike Webb, PSSA Technical
Product Assessor.
Verified Product
FRONTIER - PITTS LIMITED
Product registration No: 00004
Terra V Gate (ATTL)
All the major ISO management systems standards
are undergoing quite significant changes. ISO
9001 (Quality) and ISO 14001 (Environment) are
due to be published this month. Although there
will be a transition period, now is the time to
understand the changes and put plans in place to
get your company up to the new standards.
The new standards share a common structure,
which should make implementation of multiple
standards easier and with less duplication – and
less documentation! Key sections are:
• Context of the organisation – requiring an
understanding of stakeholders and their
requirements
• Leadership – ensuring that the management
systems requirements are integrated into the
organization’s processes
• Planning – the achievement of objectives and
actions to address risks and opportunities
• Support – including resources management
and communications
• Operation – planning and control of the
Time to Transition
supply of products and services
• Performance evaluation – including
monitoring, measuring, audit and review
• Improvement – both incremental and radical
• Some of the key changes in the new
standards are:
• Requirements for senior management to be
involved and accountable for the respective
management systems, aligning themwith
business strategy
• Adopting risk-based thinking. References to
‘preventive action’have gone. Organizations
must now evidence that they have
determined, considered and acted upon risks
and opportunities that may (positively or
negatively) impact on their systems’ability to
deliver their intended results.
• While ISO 9001: 2008 promoted the adoption
of a process approach, ISO 9001: 2015 in
particular now sets out specific requirements.
• New clauses have been introduced regarding
business context, both internal and external.
Organizationsmust now identify issues, risks and
requirements from their business environments,
define their impact on the intended results of
their systems and act accordingly.
More forward looking organisations will take
the opportunity to review their existing systems
and determine how the new standards can
produce tangible business improvements. The
increased focus on risk management should lead
organisations to think more about protective
measures, including security.
PSSA Members currently participating in
the Verification Scheme will recognise that
the Scheme already contains many of the
requirements in the new standards and no
additional requirements to the Scheme are
anticipated as a result of the publication or the
new standards.
Business Keys Limited, PSSA Verification
Scheme Managers, are running several training
courses (in partnership with the Chambers of
Commerce) to help businesses adopt the new
standards in a way that increases business value.
They also offer bespoke consultancy to individual
companies. Details can be obtained from
stephen.munden@businesskeys.co.uk