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Certifications can be a useful tool to add credibility, enhance corporate image by demonstrating their products or services meet the expectations of customers or regulatory compliances.

CE Marking Registration

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CE Mark is a Certification mark for Health, Safety and Environment protection standards to sell medical products in EEA (European Economic Area), CE mark is recognized worldwide.

CE Mark is a declaration by manufacturer that, the products they are sell in EEA are meeting the requirements of EC Directives. In order to market products in the European countries, the products must have a CE mark which declares that a product meets all the relevant European Medical Device Directives.

The benefits of CE certification is that it is a legal requirement to trade your products in the European market. The CE Mark, which is affixed to a product or its packaging, is considered proof that a product have met the requirements of the harmonized European standard. CE marking on a product indicates to all authorities that the product is in compliance with the essential health and safety requirements of all directives that apply to the product.

We have the technical expertise and domain experience to provide CE marking services. Our professionals help you in the process of making a defined and comprehensive technical file with all product details required for CE marking.

The technical file is a comprehensive collection of information and data that details everything about your medical device / product. If you manufacture a Class I devices, a less complex CE Mark Technical File may be required. In case of Class IIa, IIb and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class IIa, IIb, and III (Design Dossier). CE Marking technical file or dossier incorporates definite data about the design.

Benefits of CE Marking Certification:
     Entry to the European market.
     Consistent product quality.
     Increase in market value (Local & International).
 Improves trust of Users.

Steps to follow CE Mark on the product :
    ✔ Determine the applicable CE directives/regulations. And identify the applicable European harmonized standards.
    ✔ Identify which essential requirements of the CE marking directive/regulations apply to the product.
    ✔ Identify which requirements of the European harmonized standards apply to the product.
    ✔ Conduct and document the conformity assessment against the essential requirements and the requirements from the standards And Risk analysis to critical products.
    ✔ Provide the users with the information required to use the product safely.
    ✔ Ensure consistency of production, thus proving the assessed sample and the production are identical.
    ✔ Prepare a document that are necessary to show compliance with all relevant requirements – Technical File.
    ✔ Draw up and sign a Declaration of Conformity.
    ✔ Affix the CE mark to your product.

An in-appropriate & insufficient data compiled in the Technical File may result in unexpected delays or even prevent market entry.

We provide technical support & guidance for developing technical file to ensure meeting of the compliances with CE Directives.

RoHS Certification

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RoHS stands for Restriction of Hazardous Substances. RoHS is a European Union Directive 2002/95/EC. EU RoHS 2 directive was introduced in 2013 and restricts the use of certain hazardous substances in electronic equipment. RoHS 2 (Directive 2011/65/EU) extended the original RoHS 2002/95/EC regulations, which were introduced in 2002.

The substances banned under RoHS are Lead (Pb), Mercury (Hg), Cadmium (Cd), Hexavalent Chromium (Cr VI), Polybrominated Biphenyls (PBB), Polybrominated Diphenyl Ethers (PBDE), Di-ethyl hexyl Phthalate (DEHP), Butyl Benzyl Phthalate (BBP), Di-butyl Phthalate (DBP) and Di-isobutyl phthalate (DIBP).

RoHS compliance is essential if anyone wants to sell any kind of electronic products in the EU and European Economic Area (EEA) market.

The following product categories are impacted under the RoHS Directive:
✔ Category-1: Large household items which includes refrigerators, washers, stoves, air conditioners.
✔ Category-2: Small household products - vacuum cleaners, hair dryers, coffee makers, irons.
✔ Category-3: Computing & communications products like computers, printers, copiers, phones, satellite TV, cell tower equipment, antennas.

There are many other products that are followed till Category-11.

By getting the RoHS compliance certificate, your company gets the following benefits:
     Prevention and elimination of hazardous substance in your product.
     Improves the reliability and efficiency of your product.
     Products assures to safe for use.
     Increase the consumers trust in your product.
     Create long-term business relationships with clients in the EU.

Our experts have extensive knowledge and experience and are fully versed in every aspect of the regulations. Our efficient compliance testing for RoHS standard supports you to confidently take your product to market fast.

dsj offers a one-stop solution designed to assist you with the complex processes of RoHS CE compliance.

REACH Certification

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REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. It entered into force 1st June 2007 onwards. REACH is a European Union regulation, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals. REACH establishes a procedure for collecting and assessing information on the properties and hazards of substances.

REACH applies to all chemical substances those used in industrial processes as well as those found in our daily used household products such as paints, cleaning products, clothes, furniture and electrical appliances etc.

REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.

In general, under REACH you may have one of these roles:

✔ Manufacturer: If you manufacture chemicals, either to use yourself or to supply to other people, then you will probably have some important responsibilities under REACH.

✔ Companies established outside the EU: If you are a company established outside the European Union, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.

✔ Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be raw materials of individual chemicals or a mixture for sale or finished products such as clothes, furniture or plastic goods items.

✔Downstream users: Most of the companies use chemicals, sometimes even without realizing it, therefore you need to check your obligations. If you handle any chemicals in your industry then you might have some responsibilities under REACH.

Manufacturers and importers must be aware of the fact that the REACH standards are subject to constant change and follow the latest compliance requirements.

dsj offers a one-stop solution for services to ensure that your production and distribution system support the compliance with REACH legislation.

Corporate Trainings

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We provide trainings on,

✔ ISO 9001:2015 - Quality Management System

✔ ISO 14001:2015 - Environmental Management System
✔ ISO 45001:2018 - Occupational Health Safety Management System
✔ ISO 13485:2016 - Quality Management System – Medical Devices
✔ Quality Improvement Techniques
✔ Risk Analysis
✔ Total Quality Management
✔ 5'S' at Workplace
✔ Kaizen Methodology
✔ Lean Management
✔ Failure Mode & Effects Analysis

GMP Implementation

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Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

The main risks are:
 Unexpected contamination of products, causing damage to health or even death.
 Incorrect labels on containers, which could mean that patients receive the wrong medicine.
 Insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

GMP covers all aspects of production from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.

There must be a systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.

WHO has established detailed guidelines for good manufacturing practices? Many countries have formulated their own requirements for GMP based on WHO GMP.

NABL Implementation

National Accreditation Board for Testing and Calibration Laboratories (NABL) is an accreditation body, with its accreditation system established in accordance with ISO/ IEC 17011 “Conformity Assessment - Requirements for Accreditation bodies accrediting conformity assessment bodies.”

NABL is signatory to ILAC as well as APLAC Mutual Recognition Arrangements (MRA) for accreditation of Testing including Medical and Calibration laboratories. NABL has been established with the objective of providing Government, Industry Associations and Industry in general with a scheme of Conformity Assessment Body’s accreditation which involves third-party assessment of the technical competence of testing including medical and calibration laboratories, proficiency testing providers and reference material producers.

Benefits of NABL :
     Compliance of laws is assured by getting NABL certification.
     Superior expertise in the calibrating procedure.
     Improved customers & satisfaction and loyalty.
     Brand identification and impact in domestic and global markets.
     Reducing re-testing of items saves time and money.
     Improved lab procedures and feedback control.

dsj adopts a results-oriented approach for the effective system implementation in your organization, by preparing documentation to obtain the NABL accreditation to your organization.

5’S deployment is a systematic form of visual management incorporating everything from the floor to operational manuals. It is a standardized process when implemented appropriately creates and maintains organization safe, clean and efficient.

5'S implementation enables an organization to have a safe, clean, orderly and productive workplace. It a standardized system that aims at having everything at its designated space, thus reduces redundant time and resource in searching it later. With a proper 5'S implementation, organizations can improve their overall functions and increase productivity.

5’S training program helps organizations to perform efficiently, effectively and safely.

 SEIRI (Sorting): Eliminate all unnecessary materials including tools, parts, machines and documents. Keep only essential items and eliminate what is not required, by prioritizing things per requirements and keeping them in easily-accessible places. Everything else is stored or discarded.

 SEITON (Set in Order):There should be a place for everything and everything should be in its place. The place for each item should be clearly indicated. Organizing everything in a logical order and ergonomic locations thus making it easier for employees to reach them and complete the task in time effectively.

 SEISO (Shine): Clean the workspace and all equipment and keep it clean, tidy and organized. At the end of each shift, clean the work area and be sure everything is restored to its place. This makes it easy to know what goes where and ensures that everything is where it belongs. Spills, leaks and other messes also then become a visual signal for equipment or process steps that need attention. A key point is that maintaining cleanliness should be part of the daily work – not an occasional activity initiated when things get too messy.

 SEIKETSU (Standardization): It is one of the major parts of 5'S training program as it gives importance of work practices that should be consistent and standardized at all times. All work stations for a particular job should be identical. All employees doing the same job should be able to work in any station with the same tools that are in the allocated location in every station. Everyone should know exactly what his or her responsibilities are for adhering to the first 3 S's.

 SHITSUKE (Sustenance): Sustaining the practice maintain and review standards. Once the previous 4 S's have been established, they become the new way to operate. Maintain focus on this new way and do not allow a gradual decline back to the old ways. While thinking about the new way, also be thinking about yet better ways. When an issue arises such as a suggested improvement, a new way of working, a new tool or a new output requirement, review the first 4S's and make changes as appropriate. It should be made as a habit and be continually improved.

Trademark & I.P. Registration

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Trademark Registration is the key to protect the Intellectual Property i.e. business registered name, logo. Registering gives you brand protection and the sole legal rights to your symbol, logo, or name.

Trademark registration give benefits to both business owners as well as consumers. Trademarks allow businesses to build an identity and reputation with customers. It allows consumers to take an informed buying decision by searching brand names and avoid bad buying experiences.

Benefits of the Trademark:
     Protect Intellectual Property and gives exclusive right to goods/services the use that legal name & logo.
     Provides security in respect of infringement of the Intellectual Property.
     Facilitate badge of loyalty and affiliation.
     Enables brand recognition and brand association.
     Gain confidence to purchase products/services with consumers.

Zero Effect Zero Defect |
ZED Certification Scheme

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Hon'ble Prime Minister of India Shri. Narendra Modi urged the industry, especially the Micro, Small and Medium Enterprises (MSMEs) of India, to manufacture goods in the country with "Zero Defects" and to ensure that the goods have "Zero Effect" on the environment.

Certification Levels and Cost of Certification Zero Defect and Zero Effect (ZED) is a simple, transparent and affordable certification based on well-defined parameters of Quality, Safety, Production, Cleanliness, Energy, Environment and more. ZED certificate is valid for a period of 3 years from the date of certificate issued.

All manufacturing MSMEs registered with the UDYAM registration portal will be eligible to participate in MSME Sustainable (ZED) certification and avail related benefits.
ZED certification scheme is implemented by Quality Council of India (QCI). The ZED division is involved in flagship programs of Ministry of Micro, Small & Medium Enterprises, Ministry of Tourism, Ministry of Defence, Ministry of Housing & Urban Affairs and others.

Few objectives of ZED certification are:
     Encourage MSMEs for manufacturing of quality products by using latest tools & technology, tools with sustained upgraded processes for achievement of high quality and high productivity.
     Develop an Ecosystem for ZED Manufacturing in MSMEs, for enhancing competitiveness and enabling exports.
     Promote adoption of ZED practices and recognizing the efforts of successful MSMEs.
     Encourage MSMEs to achieve higher ZED Certification levels through graded incentives.
     Increase public awareness on demanding Zero Defect and Zero Effect products through the MSME Sustainable (ZED) Certification.
     Identify areas to improve upon, thereby assisting the Government in policy decisions and investment prioritization.

MSMEs can apply for certification at any of the following three levels:
    ✔ Certification Level 1: BRONZE (5 Parameters)
    ✔ Certification Level 2: SILVER (14 Parameters)
    ✔ Certification Level 3: GOLD (20 Parameters)

The ZED certification also recognizes the efforts of the MSMEs that have already attained specific certifications and allows a provision of exemption(s) from assessment on relevant parameter(s) for the MSMEs with existing Certifications as specified in the scheme, like ISO 9001, ISO 14001, ISO 45001 etc.

The MSME Sustainable (ZED) Certification Model presented in this document will be applicable on all sectors of the manufacturing MSMEs.

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