Ce Brochure


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siddhartha consultancy services
HR Consulting
Competency Mapping
Assessment Center
Performance Evaluation and Linking
with Reward Systems

Designing HR Processes
HR Outsourcing
Training Need Analysis
Training Evaluation

Psychometric Testing
Personality Profiling
Individual, Team and Organizational Tests
Organizational Survey

Recruitment for National and Overseas
Skills and Competency based selection
Competency Assessment for short listed candidates to fulfill the exact needs of jobs

Training Programmes at SCS
Managerial Skills
Communication Skills
Presentation Skills
Team Building
Emotional intelligence
Time and Task Management
Creativity and Problem Solving
Analytical Thinking and Decision Making
Soft skill training for management trainees
Stress Management
HR for Line Managers
Interviewing Skills
Mentoring and Coaching
Competency Mapping
Psychometric Testing

ISO 9001 /- Quality Management System
ISO 14001 - /Environment Management System
OHSAS 18001 - /Occupational Health & Safety
ISO 22000 / HACCP / BRC - /Food Safety Management
ISO 27001 - /Information security Management System
Software Management , Risk Assessment/ Design Management, Audit Services

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Ce Brochure

  1. 1. SIDDHARTHA CONSULTANCY SERVICES CE MARKING Add: D-35, Pandav Nagar, Opp. Mother Dairy New Delhi-92 www.scsuniversal.com Services Offered by SCS: Liaison with notified bodies and competent authorities in EC. Auditing against MDD and essential requirements. Assisting with clinical investigations to meet multi-national requirements and conformance with EN 540 and US FDA GCP requirements. Arrange representative in the EC. Assist in Vigilance reporting. Assist in registration of distributed products with competent authorities in each EC country. Customer Complaint handling in EC. Process Validations (IQ/OQ/PQ/PPQ) Software Validations. Packaging & Shelf Life Validations. Failure Modes & Effects Analysis . Quality Systems Audits. CE Technical File Generation. Statistical Methodologies & Training. Measurement Systems Validation. Sterilization Validations. Biocompatibility Testing. GMP Compliant Manufacturing Systems. Environmental Clean room Controls.
  2. 2. • ISO 22000, BRC, HACCP - Food Safety Management We are a consulting firm based in New Delhi India • ISO/TS 16949 Global Automotive Management System having high profile team of • ISO 27001 - Information security Management System Certified Lead Auditors for • SDLC, CMMi – Software Development Life Cycle (ISO 9001, ISO 14001, OHSAS 18001, ISO 22000, • Design Management / CE Marking and ISO 27001, CE Marking At SCS we believe in offering high-quality integrated services to fulfil our customers’ requirements and expectations. Our unmatched resources and Having wide & variety of understanding of global economics translate into professional experience consistent quality of customer services. and exposure to latest best Our aim is to turn knowledge in to reality for the benefit of practices followed globally. our customers, our people and our societies. Our objective is to adding SCS has team of qualified Consultants which include Engineers with Management Backgrounds with vast value to those enterprises Industrial Expertise. looking to drive-up Our Values: Hard and dedicated team work coupled with business. At SCS we integrity & Commitments towards People and Societies. provide business solutions We believe in change. to meet the vast majority We are thankful to give us an opportunity to introduce you of company needs around the roadmap for effective mapping of your existing system business improvement, to CE Marking for wide acceptability to Europe market. You hassle-free operations, can see above services offered for CE marking overview along with scope and activity plan for Documentation, excellence, and growth Training and implementation. We will appreciate your response in order to explain you in detail about our proposal, but if you have any question in the mean time, you can reach us. Sincerely yours, The quality services we deal are as follows. Gajendra Khare • ISO 9001 - Quality Management System Director- Siddhartha Consultancy Services • ISO 14001 - Environment Management System Mobile- 09971090494, gkhare@scsuniversal.com • OHSAS 18001 - Occupational Health & Safety gajendra.khare@gmail.com
  3. 3. Add: B-7&8, Ganesh Nagar,Pandav Nagar Complex New You too can learn to do CE self-certification. With the CE Delhi-92 . www.scsuniversal.com Marking Navigation System is easy. CE Marking b. Is it possible for you to do in-house testing/inspections, CE Mark is the gateway for the companies who want to or do you need to subcontract this? export to Europe. The European community has implemented a system to protect the health of consumers Many of the required test and conformity assessments can and user of manufactured products. CE Mark assures the be performed by your company. Simply because it is a user of a product that it conforms to the requirements of visual inspection or because it does not require special relevant directive of European union and harmonized equipment and test equipment is available (or can be European standard. The License is granted by agencies obtained). notified by European Union. c. Do you want to combine CE marking with other WHAT DO YOU NEED TO KNOW TO GET AN ACCURATE (private) certifications/markings (e.g. GS, TUV, NEMKO, OVERVIEW OF THE COSTS OF CE MARKING? DEMKO, SEMKO etc. etc.)? You need to clarify the following points before opt for CE There are testing and certification bodies that are Marking: accredited for various international markings and certification schemes. With one basic test in combination - Which CE directive or CE directives apply/applies to with some targeted additional test, your product can be the product? approved for many markets, and thus you can spread the - Which standards apply to the product? And do costs of certification over a bigger number of products. these standards have the status of European harmonized standards or not? d. Can you buy CE approved parts or components that - Which certification procedure or procedures will make your own CE marking effort easier? apply/applies? I can give you a practical example: one of my clients manufacturers a small optical inspection tool (a small car With this information you can compare quotes from with a video camera) with a RF remote control module. The service providers such as test laboratories, certification RF module was purchased from a vendor, and it already bodies and consultants and ensure that will provide the was CE approved. And as a result, my client did not have to same service test his product against the RF standards. BUT THERE IS MORE. e. Have you thought about the internal company resources you require for the CE marking? Do these have To determine the costs of CE certification you also should to be included in your budget? take into account the following aspects: What I mean here is the costs of the persons who will have a. Are you required to involve a 3rd party certification to dedicate time to the initial CE marking, and afterward to body, or are you allowed to do self-certification? keeping updated with the regulations and standards. The biggest myth about CE marking is: "To get CE marking, products must be tested and certified f. Have you taken into consideration that the existing by a third party certification body". design may not pass the conformity assessments, and that This myth has cost a lot of companies a lot of money. In it needs to be modified? How much time and money does almost 90% of the cases, the CE marking regulations allow it cost us to make design changes? How much does it cost products to be self-certified for CE marking. In other words, us to do the re-testing? you can do the CE marking yourself and you are not required to have the product certified by a third party As you can see there are many things to consider. All certification body. Obviously, CE marking self-certification aspects mentioned above have an effect on the costs. In can save your company a lot of time and money. most cases you can do a lot yourself, possibly with some
  4. 4. guidance and instructions, and thus saving a lot of money. as its 'intended purpose'. Only when COUNTRIES Risk analyses, the compilation of the Technical File, these factors are clear, the correct conformity assessment against essential requirements of CE directives (yes, a product can be Netherlands the directives and standards, the Declaration of covered by more than one CE Conformity. These all can be done by you or your directive at the same time), Norway colleagues, if you invest a little time in learning how to do European harmonized standards and Portugal it. certification procedure can be determined. Poland The biggest costs in CE certification are inherent to the In many cases the CE directives offer time that test laboratories, certification bodies and two or more certification procedures Slovakia consultants need to spend on your products. I think that by that may be used. The costs looking at your product, you can already estimate that the associated with one or the other Slovenia time investment for conformity assessment, risk analysis or procedure can vary, and thus this is Sweden the compilation alone is at least a full day of work, and one of the aspects to keep in mind. likely more. Multiply this with a reasonable hourly fee, Spain The Medical Device Directive For product testing alone you often need several days to (MDD): United run the required test procedure. I have seen wear and tear The European medical device Kingdom tests for construction products that take 1 month! directive makes it mandatory Greece Sure, you may find laboratories and consultants in the as of 06/28/1998 to fulfill CE market who claim they can do it for a very low fee. My certification requirements in Hungary experience and the experience of my clients with these order to export medical companies is that the provided services are very cheap as devices, of Class I, IIa, IIb, and Iceland well. Please consider this: the CE marking is about III to any country within the Ireland providing evidence that the product complies with the European community. For U.S. applicable requirements. In the case you have to involve a firms, the recommended Italy test laboratory or certification body, it is better to use a strategy is to pursue the CE well-established, reputable company than a cheap certification while the product Luxembourg unknown company. Because when your product's CE is in the approval process by Latvia compliance is challenged, its acceptance by authorities and the FDA. The CE certification your customers depends on the reliability of the (test) can be often achieved prior to Lithuania certificate and report. the FDA's approval, thus enabling the device to be sold Malta My advice: if you want to save money and time on CE in Europe and generating Austria certification, do as much as you can by yourself yourself. substantial revenues. The Don't depend entirely on third parties and consultants. requirements for CE Belgium Perform the conformity assessment. Prepare the Technical certification are very strict but File. Carefully prepare your product for compliance testing, if the product is in advanced Cyprus if you cannot conduct it yourself. But trust me: you can clinical investigation or IDE Czech achieve a lot yourself, if you spend a little time to get (Investigational Device Republic familiar with the rules. Exemption) stages by the FDA, the CE certification can happen Denmark Whether the company can do some or all of the much quicker than the FDA's. conformity assessments themselves, as well as the level Finland of support needed to prepare the required compliance Medical Device classification in France documents, Technical File, user manual and product a nut shell (see 93/42/EEC): labeling. The classification is similar to the Estonia FDA's, except for the sub- Which certification procedure or procedures applies/apply, classification of (a) and (b) for Germany is based on the technical specifications of a product, as well class II products. Class I is for
  5. 5. low risk device, while Class III is for the higher risk Hold a Technical file* Obtain ISO 9001/ISO 13485 devices. The Classification is addressed in detail in certification. 93/42/EEC Annex IX. Here are examples of Audit by notified body according to Annex II. Apply CE classifications: mark. Class I: Class III: Wheel Chairs, Patient electrodes, Scalpels. Dental Hold a Technical file* Obtain ISO 9001/ISO 13485 Drills, Wound Management systems, Hearing Aid certification. Tester. Audit by notified body according to Annex II. Product Dossier Exam by notified body according to Class IIa: Annex II. Apply CE mark. All patient monitoring equipment, Syringes. Needles, Ultrasound devices, External ECGs, Diagnosis devices. Technical File Content : Class IIb: General product description, Design drawings, Lasers Devices for application, Internal ECGs, RF methods of manufacture and diagrams of Generators, Non-energized implants, Treatment components and sub-assemblies, Description and devices. explanation of above-mentioned drawings and diagrams, Result of risk analysis and list of standards Class III : referred to in Article 5 of 93/42/EEC, applied in full or Energized implants, All Intracardiac applications, Heart in part, and descriptions of the solutions adopted if valves, Cauterters, Non-energized implants, All not applied in full. Description of the methods used if devices in contact with the central nervous system. the device require sterility. The results of the design calculations and of the inspections carried out. If the Recommended compliance routes : device is to be connected to other device(s), proof Class I : must be provided that it conforms to the essential Hold a Technical file* requirements when connected. The tests' reports Self-Declaration of Conformity according to Annex VII. and where appropriate, clinical data in accordance Observe provisions of the procedures referred to in with Annex X of 93/42/EEC and the label and Annex IV, V or VI of 93/42/EEC for "sterile" or instructions for use. "Measuring" function devices. Class IIa & IIb : Director, Mr. Gajendra Khare M.Sc. (Maths), DIMS, MPA Former HR and Administration Manager, Apparel Group UAE; Mr. Khare has about 14 years of working experience with many prestigious organization of the country and overseas in the field of Human Resource Development (HRD), Administration, Liasoning, ISO-9000, MIS (Management Information Systems) and others. He has worked on a number of HRD and quality related assignments of various organizations. He has also worked in the area of Management Information Systems and implemented ERP modules in industries. He has been a member of various professional organizations in the fields of HR and quality etc. Mr. Gajendra Khare has developed and implemented various HR solutions to the industries successfully. He has also implemented ISO-9001:2008, ISO 13485:2003 CE and WHO: GMP certification and also handled various administrative assignments and completed successfully. Contact: +919971090494; gkhare@scsuniversal.com; gajendra.khare@gmail.com, web: www.scsuniversal.com
  6. 6. Directive or Products or Title Mandatory from Guideline Type A: Basic Directives ( for all products) 85/374/EEC Liability for Defective Products 30 Jul 1988 1999/34/EC Liability for Defective Products (amending) 10 May 1999 92/59/EEC General Products Safety 1 Jan 1997 2001/95/EC ( new ) General Products Safety Directive 1 Jan 2003 93/68/EEC "CE Marking" Directive 22 Jul 1993 93/465/EEC Conformity Assessment Procedures & CE Marking Rules 22 Jul 1993 Guideline Guide to Implementation of directives based on new approach & global approach Pub. 2000 Type B: Generic Directives (take precedence over Type A) 73/23/EEC Low Voltage Electrical Equipment (LVD) 1 Jan 1997 Framework 2000&2001 Framework of implementation of LVD 73/23/eec (79pages) Pub. 2001 Guideline Guideline on Low Voltage Directive (LVD) 73/23/EEC & Annex I, II Pub. Jul 1997 89/336/EEC Electromagnetic Compatibility (EMC) 1 Jan 1996 Guideline Guideline on Directive of Electromagnetic Compatibility (EMC) 89/336/eec Pub. 2001 Tech-Aspects Technical-Aspects relating Electromagnetic Compatibility EMC 89/336/eec (150pages) Pub. 2001 Framework Framework of implementation of EMC Directive 89/336/EEC Pub. 2000 2002/95/EC RoHS- Restriction of use of Hazardous Substances in Electrical and Electronic Equipment - 2002/96/EC WEEE- Waste from Electrical and Electronic Equipment - Type C: Product-Specific Directives (take precedence over Type A & B) 87/404/EEC Simple Pressure Vessels 1 Jul 1992 88/378/EEC Toys 1 Jan 1990 Guideline Guidance to 88/378/eec Toys (for Scooter & FloatingSeats) Pub. 2001 89/106/EEC Construction Products 27 Jun 1991 Guideline Guidance to Directive 89/106/eec: Construction Products Pub. 2001 89/686/EEC Personal Protective Equipment (PPE) 1 Jul 1995 UsefulFacts Useful Facts relating to Directive 89/686/eec PPE (143pages) Pub. 2001 Framework Framework of implementation of (PPE) Directive 89/686/eec (13pages) Pub. 2001 90/384/EEC Non-automatic Weighing Instruments 1 Jan 2003 90/384/EEC Appliances Burning Gaseous Fuels (AppliGas) 1 Jan 1996 Framework Framework of implementation of (AppliGas) Directive 90/396/eec Pub. 2001 92/42/EEC Efficiency of (Liquid or Gaseous fueled) Hot Water Boilers 1 Jan 1998 93/15/EEC Explosives for Civil Uses 1 Jan 2003 93/42/EEC Medical Devices 14 Jun 1998 Guidelines Guidelines for Classification of Medical Devices Pub. 2001 Guideline Guideline relating to the demarcation between Directives 90/385/eec, 93/42/eec and 65/65/eec. Pub. 1998 90/385/EEC Active Implantable Medical Devices 1 Jan 1995 98/79/EC In Vitro Diagnostic Medical Devices 7 Dec 2003 Guideline Guideline on Medical Devices Vigilance System Pub. 1998 93/65/EEC Air Traffic Management Equipment & Systems 19 Jul 1994
  7. 7. 94/9/EC Equipment used in Potentially Explosive Atmospheres (Atex) 1 Jul 2003 Framework Framework of implementation of (Atex) Directive 94/9/ec, 7pages Pub. 2001 Guideline Guideline on directive 94/9/ec (Atex) Pub. 2000 94/25/EC Recreational Craft 16 Jun 1998