CE Mark 1

How To Get CE Certification In Abu Dhabi?

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What is CE Certification?

Conformité Européene or CE Certification is a proof that the product attained the requirements set by EC Directives which was taken on European Conformity.

CE mаrkіng іѕ a сеrtіfісаtіоn mark thаt іndісаtеѕ conformity wіth hеаlth, safety, аnd environmental protection standards fоr рrоduсtѕ ѕоld wіthіn thе European economic area.

Industries that needs CE certification:

Manufacturers of the following products are recommended to get the CE Certification in Abu Dhabi as well as Globally:

  • Telecommunications equipment
  • Safety of toys
  • Recreational craft
  • Radio terminal equipment
  • Pyrotechnics
  • Pressure vessels
  • Pressure equipment
  • Personal protective equipment
  • Non-automatic weighing instruments
  • Noise emission in the environment
  • Medical devices
  • Measuring Instruments
  • Machinery
  • Low voltage
  • Lifts
  • In vitro diagnostic medical devices
  • Hot-water boilers
  • Hazardous substances RoHS 2
  • Explosives for civil uses
  • Electromagnetic compatibility
  • Eco-design of energy related products
  • Cableway installations designed to carry persons
  • Appliances burning gaseous fuels
  • Active implantable medical devices
Benefits of CE Mark Certification:

However, getting the products CE certified tends to be beneficial from the customer as well as manufacturer perspective.

  • The manufacturers gain the freedom of making their products completely available in the European economic market.
  • Customers are guaranteed about the product conformation as per the regulations set with respect to the particular directive.
  • Manufacturers can proudly say that their products are safe and healthy to be used.
  • By strictly possessing the CE Mark on the product will critically decrease the negative claims as well as liability premiums.

Qualitcert Services is one of the largest and leading CE consultants in Abu Dhabi . We are transnational ISO certification consultants with clients in India, USA, UK, India, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong Kong, UAE, Qatar, Saudi Arabia, Russia etc. We provide quick, result oriented and easy to implement consultation and training for CE certificate.

Medical Devices

How To Get ISO 13485 Certification In Italy

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Are you aiming to understand the ins and outs of ISO 13485? Are you the individual dedicated to implementation of this standard within your organization? Well, without reading the standard line by line, allow us to provide you with a “roadmap” of ISO 13485 certification in Italy requirements and structure.

The standard includes eight clauses, three of which provide guidance on the intended use of the standard. The remaining five clauses provide the framework for what is expected of organizations dedicated to medical device production. So, here’s what to expect in order to achieve compliance.

Clause 4 – Quality Management System (“Intersection”)

Clause 5 – Management Responsibility (“Highway”)

Clause 6 – Resource Management (“Roadway”)

Clause 7 – Product Realization (“Overpass”)

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

What do you achieve by calibrating measuring and monitoring equipment?

  • Restoring the accuracy of the instrument
  • Adjusting or repairing an instrument which is out of calibration
  • Minimizing uncertainty or error
  • Ensuring the reliability and consistency of the instrument
  • Keeping measurements within specification limits
  • Building trust, confidence and reliability in measurements
  • Establishing traceability of the measurement to a National / International Standard, which is a mandatory requirement for most standards.

To summarize, calibration quantifies and controls errors and uncertainties within measurement processes and brings them to an acceptable level.

Compliance to ISO 13485 requirements

A well-designed calibration program as described above helps you maintain the accuracy of your instruments. It also helps you achieve compliance with the calibration requirements set out in ISO 13485:2016; Clause 7.6 (Control of monitoring and measuring equipment).

Qualitcert is a catalyst for business and process excellence, your business and process excellence is guaranteed through ISO certification in Italy with Qualitcert

Up your business, talk to our Qualitcert masters who are available for you to coach and on how to get your business and process certified with ISO 9001, ISO 14001, ISO 45001, ISO 22000,ISO 27001,ISO 20000-1 and HACCP.

ISO 45001 certification

Health And Safety Certification For Manufacturing Industry?

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Occupational health and safety policies are essential for employees, but they are also important for customers and other stakeholders. Occupational Health and Safety Management systems certification to OHSMS 45001 is a strong sign of manufacturing company by committing to their employees’ health and safety.

Many manufacturing industry implement an Occupational Health and Safety Management System (OHSMS) as a fundamental part of their risk management strategy to address changing legislation and protect their workforce and there personnel working under their control.

ISO 45001 certification enables organizations to manage operational health and safety risks and improve performance.

ISO 45001 targets the following key areas:

  • Hazard identification, risk assessment and determining controls
  • Legal and other requirements
  • Objectives and OHS program(s)
  • Resources, roles, responsibility, accountability and authority
  • Competence, training and awareness
  • Communication, participation and consultation
  • Operational control
  • Emergency preparedness and response
  • Performance measuring, monitoring and improvement

Qualitcert helps an organization to achieve ISO 45001 Occupational Health and Safety Management System by implementing all the required procedure. Those who are looking to update your ISO 18001 to ISO 45001 we are happy to help you in each and every step. Qualitcert provides ISO 45001 certification in Saudi Arabia, UAE, Oman, Qatar, Jordan, Lebanon, and India.

ISO 9001 certification in Iraq

How An ISO Certification Help Startups?

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The cost of implementation of ISO certification is surely a concern for most startup businesses. It is important that a startup should focus on project cost and benefit to have a clear comparison to move forward.  Let’s look into the benefits of ISO 9001 implementation to a startup enterprise.

  • The process strategy
  • The Plan-Do-Check-Act model
  • Drive your sales up using ISO 9001
  • Forming a careful approach to risk and opportunity
  • Preparation for the changes
  • Establishing aims and objectives

Common issues with startups:-

  • Lack of funding
  • Lack of business experience
  • Lack of sleep
  • Increased Stress
  • Lack of Systems

Prime Benefits for startups in achieving ISO 9001

  • Credibility and Image
  • A Powerful Marketing Tool
  • Attract Big Clients
  • Customer Satisfaction & Loyalty
  • Increased Revenue, Efficiency and Productivity
  • Consistent Delivery
  • Improved Procedures, Costs Reduction
  • Better Management & Reporting
  • Improved Decision Making & Continual Growth Culture

Qualitcert helps startup to achieve ISO 9001 Quality Management System by implementing all the required procedure. Our prices are very competitive and never make a customer unhappy. Qualitcert provides ISO 9001 certification in Nigeria, Kenya, South Africa, Iraq, and Philippines. For more queries you can reach us we are happy to assist you.

Medical Devices

Quality Of Medical Equipment ISO 13485?

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Medical device manufacturers are always working to balance the demands of meeting regulatory requirements and also a production cost, in order to produce the most reliable and safest medical devices.

A medical device quality plan is not only required by the FDA and the ISO 13485 framework, but it can help you build quality into your product and company from day one. In current scenario the regulatory bodies have become more stringent in there process to eradicate non-compliant medical devices companies in the market, hence to ensure an organization is completely compliant with requirements of regulatory suggested to have strong quality management system/ ISO 13485.

Benefits of ISO 13485 to improve the quality of medical equipment

  • Improve your company’s credibility and image
  • Improve customer satisfaction
  • Improve your processes
  • Improve decision-making
  • Create a culture of continual improvement
  • Better employee engagement
  • Expanded market access

Qualitcert cert helps an organization to achieve ISO 13485 Quality Management System-Medical Devices by implementing all the required procedure. ISO 17025 is for testing and calibrating labs and equipment’s to check their quality. Qualitcert provides ISO 13485 certification in Saudi Arabia, Oman, Qatar, UAE, Jordan, and Lebanon.

3

CE Certificate And Its Compliance Audit?

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CE marking allows company to legally market and distribute their product within the European Market, and declares that product complies with all applicable European Directives and Regulations.

Certification and compliance audit on following directives:

  • Boiler Efficiency Directive – 92/42/EEC
  • Construction Products Regulation (CPR)
  • Electromagnetic Compatibility Directive – EMC 2004/108/EC
  • Gas Appliances Directive – GAD 2009/142/EC
  • Lift Directive – 95/16/EC
  • Low Voltage Directive – LVD 2006/95/EC
  • Marine Directive – 96/98/EC
  • Measuring Instrument Directive – MID 2004/22/EC
  • Medical Devices – MDD/AIMDD/IVDD
  • Non Automatic Weighing Instruments Directive (NAWI)
  • Personal Protective Equipment Directive – 89/686/EEC
  • Pressure Equipment Directive (PED)
  • Radio Equipment & Telecommunications Terminal Equipment – RTTE
  • Structural Steel – EN 1090
  • Transportable Pressure Equipment – 1999/36/EC

Steps for CE Marking:

  • Identification of applicable directive(s) and harmonized standards
  • Identification of product-specific requirements
  • Identification of the risk and whether an independent conformity assessment (by a notified body) is necessary
  • Product Testing and check its conformity
  • Preparation of Technical Construction File (technical documentation)
  • Issue the EU Declaration of Conformity and affix the CE marking.

To get compliance audit of CE Mark certification in Saudi Arabia contact Qualitcert experts. For more details you can feel free to reach us.

 

5

What Are The Differences Between ISO 17025 And ISO 13485?

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ISO 17025 stands for TESTING AND CALIBRATION LABORATORIES. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade hence, ISO 17025 accreditation is not equivalent to ISO 13485 certification.

 ISO 13485 stands for MEDICAL DEVICES — QUALITY MANAGEMENT SYSTEMS, helps in complying with a specific quality system. ISO 17025 certified through accreditation board but ISO 13485 by certification body. Process steps involved in 17025 & ISO 13485,

ISO 17025 – TESTING AND CALIBRATION 
LABORATORIES		 ISO 13485- MEDICAL DEVICES — QUALITY 
MANAGEMENT SYSTEMS
Reviewing requests, tenders & contracts Context of the organization
Method suitability Leadership
Sampling Quality objectives
Handling items Management system documentation
Records Control of management system documents
Measurement uncertainty Control of records
Result validity Actions to address risks and opportunities
Result reporting Improvement & Corrective actions
Complaints and nonconforming work Internal audits & Management reviews
Internal audits & Management reviews

Health is wealth so nobody is going to compromise with health and hygienic products. How a customer thinks that your product is safe and hygiene, its purely depends on ISO certification they see that your product or company is certified through ISO or not. For any ISO standard contact Qualitcert experts. To know more about ISO 13485 certification in Nigeria, Kenya, Jordan, Lebanon, Saudi Arabia, Oman, and India please feel free to contact us.

ISO 9001 certification consultant Nigeria

What Are Reasons To Go Under ISO 9001 Certification?

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ISO 9001 comes under the family of ISO 9000 series and it is the only standard in the 9000 series that requires certification. ISO 9001 stands for Quality Management System, when a company is ready to go for certification doesn’t matter how big it is and irrespective of manpower i,e company with one employee are eligible to get the ISO 9001 standard certificate.  It doesn’t matter what industry you are in (service, trading, food or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government, schools, etc.

There are 10 Major Reasons where do us Need ISO 9001 Certification:- 

●Meet Customer Requirements

●Get More Revenue and Business from New Customers

●Improve Company and Product Quality

●Increase Customer Satisfaction with your Products

●Describe, Understand, and Communicate Your Company Processes

●Develop a Professional Culture and Better Employee Morale

●Improve the Consistency of Your Operations

●Focus Management and Employees

●Improve Efficiency, Reduce Waste, and Save Money

●Achieve International Quality Recognition

Qualitcert services is one of the global consulting company for ISO certification standards. Various services that we serve ISO 9001, ISO 14001, ISO 27001, ISO 45001, ISO 22000, ISO 13485, HACCP, and CE in different countries are ISO 9001 certification in Nigeria, Kenya, Jordan, Lebanon, Saudi Arabia, Oman, UAE, South Africa, and India.

CE Mark 1

Which Type Of Products Need CE Certification?

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CE marking is a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). In the global market there are more than 20 sectoral product directives requiring CE marking, but it is not limited to, products such as electrical equipment, machines, medical devices, toys, pressure equipment, Personal protective equipment(PPE’s), wireless devices and construction products.

CE marking applies to the following product groups:

Active implantable medical devices
Appliances burning gaseous fuels
Cableway installations designed to carry persons
Construction products
Eco-design of energy-related products
Electromagnetic compatibility
Equipment for use in potentially explosive atmospheres (ATEX)
Explosives for civil uses
Hot-water boilers
Household refrigerators and freezers
In vitro diagnostic medical devices
Lifts
Low voltage
Machinery
Measuring instruments
Medical devices
Noise emission in the environment
Non-automatic weighing instruments
Personal protective equipment
Pressure equipment
Pyrotechnics
Radio equipment and telecommunications terminal equipment
Recreational craft
Restriction of hazardous substances in electrical and electronic equipment
Safety of toys
Simple pressure vessels		 CE marking does not apply to items such as:
Chemicals
Pharmaceuticals,
including cosmetics
Foodstuffs

We are one of the leading Certification, Assessment and Training services company. We partner with our clients to help them systematically optimize and transform businesses .Our strategic innovation and key business growth strategies help businesses progress constantly.

Every organization must combine ISO requirements, technology and human skills, to Excel. Our diverse, global experience brings in solid industry expertise and helps anticipate the clients’ changing business needs through a winning- edge services. We use a unique delivery model across all industry verticals to deliver the results that help our clients surge ahead of competitors.

Getting your business certified with CE certification in Saudi Arabia will not only attract and maximize business in the market, but also empowers human resource and creates compelling processes

CE Mark 1

What Are The ISO Standards Need To Acquire For Oil And Gas?

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ISO/TS 29001:2020

Petroleum, petrochemical and natural gas industries — Sector-specific quality management systems — Requirements for product and service supply organizations, this standard mainly focus on focuses on the oil and gas supply chain. The ISO/TS 29001 standard is based on ISO 9001, it helps in improving the defects and the reduction of variation and waste from service providers. They also provide global consistency and improved assurance in the supply quality of goods and services from providers.

Advantages of having ISO 29001 standard,

  • To focus global market and to increase contracts and prospects
  • Commitment to industry best practice to stakeholders
  • Improve the way you manage risk and improve performance
  • Streamline your operations to improve quality and reduce waste
  • Better communication and regular assessment leads to continual improvement

Re-Design your system, create raving fan clients. Transform your business , Go Global

We’re a leading Certification, Assessment and Training company, We are one of the leading Certification, Assessment and Training services company. We partner with our clients to help them systematically optimize and transform businesses .Our strategic innovation and key business growth strategies help businesses progress constantly.

Every organization must combine ISO requirements, technology and human skills, to Excel. Our diverse, global experience brings in solid industry expertise and helps anticipate the clients’ changing business needs through a winning- edge services. We use a unique delivery model across all industry verticals to deliver the results that help our clients surge ahead of competitors.

Getting your business certified with ISO standards will not only attract and maximize business in the market, but also empowers human resource and creates compelling processes. We do provide different standards like ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 27001, HACCP, and CE Mark certification in Saudi Arabia, UAE, Oman, India, Jordan, and Nigeria.