Scheduled courses are a cost effective solution for companies looking to increase their general knowledge of the CE marking process and the requirements of the most common directives. They are best suited to companies who want to train 1 - 5 members of staff.
The format of scheduled courses is a full day with several sessions including plenty of time for your questions, as well as a take-away information pack and CD/DVD of the core presentation material.
Click on a title for more information on each course
• Machinery Directive - essential health and safety requirements for Medical Devices
September 7th Manchester
Many medical devices are 'machines' according to the definition in the Machinery
Directive. The recent amendment to the Medical Devices Directive recognises this, and requires manufacturers to incorporate the essential requirements of the Machinery Directive within their risk assessment for medical devices which are also machines.
This session explains the relationship between the two directives and sets out the obligations of manufacturers. It also discusses the process of risk assessment for machinery to help manufacturers of medical devices comply with the new requirements.
• Introduction to CE marking Electrical Equipment
September 15th London
This course is intended to give participants a basic grounding in the structure and requirements for CE marking electrical equipment and appliances. It focuses on who is responsible and what they have to do, how to find and apply standards as well as the documentation you need to produce and keep.
We will focus on the Low Voltage and EMC directives, and includes topics such as standards, assessment, the role of notified bodies, as well as technical documentation and control of on-going production. We will also take a brief look at the Radio and Terminal Equipment Directive and the environmental directives (WEEE, RoHS and EuP).
• Introduction to CE marking Medical Devices
October 13th Manchester
This course is intended to give participants a basic grounding in the structure and requirements for CE marking medical devices. It focuses on who is responsible and what they have to do, how to find and apply standards as well as the documentation you need to produce and keep.
We will focus on the classification of devices, standards, assessment, the role of notified bodies, technical documentation and the vigilance procedure. We will also take a brief look at the other directives which overlap with medical devices, including R&TTE, EMC, LVD and the environmental product directives.
• Introduction to CE marking Pressure Equipment
November 10th Nottingham
Topics include the categorisation of equipment, relationship with other directives, self certification and the role of notified bodies, as well as technical documentation and control of ongoing production. We will also take a look at the Simple Pressure Vessels directive.
The course will suit equipment designers and importers, purchasers, management and anyone who needs to know how to CE mark pressure equipment or how to identify whether suppliers' equipment has been correctly CE marked.
• Machinery, PUWER and site safety
December 9th Nottingham
This course will help participants understand the relationship between CE marking and PUWER. You will be given an understanding of how to carry out your own assessments and how to identify whether your suppliers and contractors are properly fulfilling their legal and contractual obligations.
We will focus on the main industrial equipment directives including Machinery, Low Voltage, EMC, ATEX and Pressure Equipment. We will also consider how modifications and repairs must ensure continued compliance with the essential safety requirements and basic obligations of PUWER.
Tailored courses are built to meet the specific needs of a particular client and are the preferred option if you need to train more than five of your staff or if you have some very specific product related issues which you'd like to examine in more depth.
Tailored training usually takes place at the client's site and we will ask you for examples of your specific product issues so we can ensure these are covered during the session.
Courses are based on a modular structure and clients can select the modules which cover their particular interests. We will also adjust the content of these modules on the basis of dialogue with the client in advance of the course.
The following four overall course structures meet most client needs but please contact us if you think you need something different:
Option 1: Full day: Powerpoint presentation and assessment training based on a sample product
Morning: Powerpoint presentation
• General CE marking and selected specific directives (see below for content)
• Questions and answers from presentation and client specific issues
Afternoon: Product assessment
• Assessment of a sample of client's product used as the basis of training client staff in the use of checklists and standards
Follow-up report (extra-cost option)
• Detailed formal report of non compliances identified in sample product, including draft Declaration of Conformity and advice on technical file content
Option 2: Full day: Powerpoint presentation , Q&A and factory tour
Morning: Powerpoint presentation
• General CE marking and selected specific directives (see below for content)
• Questions and answers from presentation and client specific issues
Afternoon: Factory tour and examination of client's specific equipment/procedures
• On-site visit to manufacturing and design facilities to discuss current practice and procedures and how this needs to be updated to reflect the requirements for CE marking, including discussion of likely resource requirements.
Follow-up report (extra-cost option)
• Detailed formal report to outline the requirements of the applicable directives and identify changes in practice (and resource implications) required to ensure client is properly fulfilling their obligations.
Option 3: Full day: Powerpoint presentation and discussions at Conformance offices
Morning: Powerpoint presentation
• General CE marking and selected specific directives (see below for content)
•Questions and answers from presentation and client specific issues
Afternoon: Review/discussion of client documentation and procedures
• Review client's Declaration of Conformity, technical file and control of production procedures to ensure up-to-date references to standards and compliance with guidance, Recommendations for Use.
Follow-up report (extra-cost option)
• Detailed formal report to outline the requirements of the applicable directives and identify changes in practice (and resource implications) required to ensure client is properly fulfilling their obligations.
Option 4: Full day: Powerpoint presentation and exercises at client's site
Morning: Powerpoint presentation
• General CE marking and selected specific directives (see below for content)
•Questions and answers from presentation and client specific issues
Afternoon: Exercise(s) based on client projects/products
• We will split the trainees up into groups of 3 - 5 people and set them exercises to test the knowledge gained in the morning session and give them an opportunity to apply what they have learned to your company's CE marking problems. Our trainer will be on hand to facilitate the workshop and answer questions. A roundup session at the end of the day will allow trainees to share what they have learned and ask further questions.
Follow-up report (extra-cost option)
• Detailed formal report to outline the requirements of the applicable directives and identify changes in practice (and resource implications) required to ensure client is properly fulfilling their obligations.
The following modules are available (please click on a title to see more details):
General Introduction to CE marking
• European single market
• Legislative structure
• Enforcement and penalties
• New Approach Directives
• Responsibilities of various parties
- Manufacturer
- Importer/retailer
- Users
• Common requirements
- EHSRs
- Documentation
- Declaration
• Standards
- Creation
- Structure
- Selection
- Application
• Notified bodies
• Technical File
- Content
- Storage
- Delivery
• Declaration of Conformity
- Signatories
- Liability
• Production control
• Foreseeable misuse
• Workplace safety vs. single market directives
- Article 100a
- PUWER
• Military exclusion
• Resources
• Questions and answers
Electromagnetic compatability (EMC)
• History/background
• Scope of application (equipment, systems, apparatus and components)
• Exclusions
• CE-mark, e-mark and E-mark
• Standards and EMC assessment
• EMC phenomena and environment
• Testing/Notified Body involvement
• Likely risk factors
• EMC assessment
• Functional EMC safety
• Fixed installations
• Technical documentation
R+TTE
• History/background
• Scope of application (definition of TTE, broadcast receivers, aero/maritime applications)
• Exclusions
• Relationship with other directives
• Standards
• Notified Body involvement
• Operator licensing and non-harmonised frequency allocation
Low Voltage Directive
• Scope of application and exclusions
• Relationship with other directives
• Safety standards
• Testing and conformity assessment
Machinery Directive
• Scope of application and exclusions
• Relationship with other directives
• Standards
• EHSRs
• Principles of safety integration
• Control system reliability
• Declaration of Incorporation
• Global conformity assessment for combined machinery and installations
• Differences between the old and new Directives
Medical Directive
• Scope of application, definitions of medical devices
• Exclusions
• Device classification
• Relationship with other directives
• Standards
• Self-certification, measuring and sterility
• Notified Body involvement
• Authorised Representative, registration with MHRA
• Product efficacy and clinical trials
• Vigilance procedure
• Product marking
• Declaration of Conformity
• Technical documentation
• Differences between the old and new Directives
ATEX Equipment Directive
• Scope of application, definition of explosive atmosphere
• Exclusions
• Relationship with other directives including ATEX Worker Directive
• Equipment classification (gas, dust, mining)
• Hazardous area classification
• Standards
• Notified Body involvement
• Product marking
• Declaration of Conformity
Pressure Equipment Directive
• Scope of application, definition of equipment and accessories
• Exclusions
• Simple Pressure Vessels Directive
• Relationship with other directives
• Equipment classification
• Standards
• Attestation modules
• Notified Body involvement
• Written procedures, NDT, welding, final inspection/test
• Product marking
Construction Products Directive
• Scope of application
• Countries where the CPD applies
• Relationship with Building Regulations
• Standards
• Type testing and Notified Bodies
• Marking and declaration of performance
• Declaration of Conformity
Noise Emissions of Outdoor Equipment Directive
• Scope of application, list 1 and list 2 machines
• Noise marking and noise limits
• Noise measurement procedures
• Notified Body involvement
• Declaration of Conformity
• Conformity of Production and regular re-assessment
Toy Safety Directive
• Scope of application and exclusions
• Definition of a toy
• Relationship with other directives (esp. ‘grey area’ products)
• Safety standards
• Conformity assessment and Notified Body testing
• Technical File
General Product Safety Directive
• Scope of application and exclusions
• Relationship with other directives
• Enforcement and penalties
• ‘Safety’ and applicable standards
• Obligations for suppliers, producers, distributors
• Exchange of information
Environmental Directives ( WEEE & RoHS, EUP)
• Scope of application and exclusions
• Relationship between directives
• Banned substances
• Documentation
• Testing for banned substances
• Obligations for suppliers, producers, distributors
• Producer registration
• Requirements in other member states
• Framework requirement and 'lots'
• Proposed developments and current activity
If you would like to discuss your company's training needs and the development of a tailored training course, please contact us.