3

CE Certificate And Its Compliance Audit?

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?

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?

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  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.

Medical Devices

Which Type Of Products Need CE Certification?

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

For getting CE certification in Nigeria for your products just reach Qualitcert experts they will help you to acquire CE mark certificate.

5

TOP 5 Factors To Get ISO CERTIFIED For Health Care Industry?

ISO standard works through its channel of connections to its members to bring together the foremost international expertise and disseminate it globally. By implementing ISO standards, organizations and companies make a proactive commitment to the principles of quality, transparency, accountability and safety. ISO standards make it easier to compare health services, exchange information, aggregate data and safeguard the privacy of an individual’s health. Health care Industry, Regulators & Consumers are benefited by ISO Standard.

Followed Sectors who covers under ISO standard for healthcare industry:

Dentistry of healthcare products
Assistive products
informatics
Optics Chinese medicine
Equipment for transfusions
Infusions and injections
organization management
Medical devices Surgery
Sterilization
Health
Traditional
Implants for surgery
Healthcare

Factors to get ISO certificate:

1: Ensure quality and safety in the treatment of patients.

2: Identify and manage risk to patients, staff and the organization.

3: Determine, manage, monitor and improve complex and interrelated processes.

4: Implement best practice routines and procedures.

5: Comply with relevant international and national legal requirements.

Qualitcert services is one of the few best ISO certification consulting company in Saudi Arabia, Nigeria, Kenya, Oman, UAE, Philippines, Kuwait, and Iraq. Country and area doesn’t matter in the universe every one gives more important about their health and go for hygienic products. So make sure to certify your medical devices, Medical labs, Hospitality usages with ISO 13485 certification in Saudi Arabia and ISO 17025 certification in Saudi Arabia. For more details connect with Qualitcert experts.

3

How To Get Ce Certificate In Nigeria?

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.

CE marking conformity assessments services from Qualitcert helps achieve compliance, helps to determine which EU directive &standards apply to products, safe deriving of products under EU, helps in achieving CE MARK certification to your products.

Our service includes

• Detailed explanation of CE-marking process

• Conformity assessment

• Verification of product design, specification

• Production supervision and sample testing

• Technical file preparation

• Helps in issuing CE mark Certificate

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 Nigeria . We are transnational ISO certification consultants with clients in India, USA, UK, India, Kuwait, Middle East, Europe, Africa, Australia, Singapore, Hong Kong, UAE, Qatar, Oman, Russia etc.. We provide quick, result oriented and easy to implement consultation and training for CE certificate.

ISO 9001 certification in Iraq

Main Benefits Of ISO 9001 CERTIFICATION ?

In the current marketplace many small and medium business owners feel that they cannot afford ISO certification, but fact is any industry irrespective of size and manpower (a company with single owner & one employee) are eligible to get ISO 9001 certification in Saudi Arabia and globally. As ISO 9001 indicates quality, its required everywhere.

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 best ISO certification consulting company in Saudi Arabia, Oman, Kuwait, Jordan, Lebanon, Nigeria, and Kenya. We offer Services like ISO 9001, ISO 14001, ISO 22000, ISO 27001, ISO 45001, ISO 13485, HACCP, and CE Mark certification. For more details please feel free to reach us.

ISO 45001 certification

How To Get ISO 45001 Certification In Iran?

ISO 45001 is the first international standard proposing a framework for the management of Occupational Health and Safety (OH&S). ISO 45001 aims to help organizations to keep safeguarding their employees (health & safety) from accident, serious injuries and near miss.

ISO 45001 Implemented based on following principles

1: Continual improvement using the PDCA model

2: Process-based approach to increase the expected result

3: Management by risks (and opportunities) to help control activities and reduce the impacts and undesired effects.

FIVE GOOD REASONS TO OPT FOR ISO 45001

• To know how to identify your risks

• To reduce accident rates and the related costs

• To boost awareness among all personnel

• To adopt a simplified approach

• To Improve Company brand image and safeguard employees

Qualitcert services is the best ISO certification consulting company in Iran, Iraq, Philippines, Saudi Arabia, Oman, Kuwait, and Nigeria. ISO 45001 certification in Iran is easy now with Qualitcert representatives those whose are helping globally. Are you looking take ISO certification services with less effort reach Qualitcert experts.

22000 1

How To Get ISO 22000 Certification In Iran?

ISO 22000 is a Food Safety Management System that can be applied to any organization in the food chain, farm to fork. Becoming certified to ISO 22000 allows a company to show their customers that they have a food safety management system in place. This provides customer confidence in the product/services of food line. This becomes more important as customers demand safe food and food processors require that ingredients obtained from their suppliers to be safe.

The ISO 22000 standard can be used by all the direct and indirect food chain stakeholders, regardless of their size or their location in the world. This includes not only animal feed and agricultural producers (livestock and/or crop production), but also manufacturers and processors, service providers, transport operators and subcontractors, warehousing and distribution, retail stores and food services, as well as organizations closely related to the sector, such as manufacturers of equipment, packaging, cleaning products, additives and ingredients.

For effective output of the food safety management system, ISO 22000 can be blend with HACCP, ISO 9001, ISO 14001 & other system management standards.

What are the key steps for implementing ISO 22000?

• Defining the background and directions

• Planning the management system: answering the who, what, where, when and how questions

• Building a solid base through good hygiene practices

• Conducting an HACCP study

• Implementing the management system

• Anticipating and managing crisis situations

• Checking the effectiveness of the management system

• Continuously improving the management system.

Qualitcert is a global ISO certification provider in Iran with their representatives worldwide. We are specialized in FSMS certification, ISO 22000 certification in Iran is very affordable, faster, and easier. We also provide ISO 9001, ISO 45001, ISO 14001, ISO 27001, HACCP, CE certifications. Are you looking for any of these services please feel free to reach us.

How to get HACCP

How To Get HACCP Certification In Iran?

Qualitcert services – we are HACCP Consultant in Iran, for providing HACCP Certification in Iran, and other major cities with the services of training, Audit, Documentation, Templates, Certify, Gap Analysis, Implementation, Registration, Consulting services at affordable cost to all organizations to get certified under Food and Safety Management System in Iran or FSMS Certification in Iran.

HACCP – Hazard Analysis and Critical Control Point is a systematic preventive approach to food safety from biological, chemical and physical hazards in production processes that can cause the finished product to be unsafe.

Top Five principles of HACCP Certification:

  1. Conduct an hazard analysis: This is the first and the foremost principle of HACCP where an analysis has to be made on identifying hazards of any sort such as chemical biological and also physical. The hazard analysis should also involve defining the preventive measures to control the hazards identified. This will be helpful at the time of HACCP audit in Erbil. And these preventive measures are applied at certain point called critical control point in order to prevent the hazards or completely eliminated.
  2. Identify critical control point: a critical control point is a point Austin or even defined as a procedure in a food manufacturing process at which control can be applied in order to prevent, eliminate or reduce to an acceptable level, the food safety hazards such as physical, chemical and biological. HACCP services in Baghdad will be helpful to complete this process. This step of principal needs and assistance of Technical consultant.
  3. Established critical limits for each critical control point: optical limit is basically nothing but a maximum or minimum value to which a physical biological and chemical hazards that can be controlled at a critical control point to prevent, eliminate or reduce any sort of hazards to an acceptable level. HACCP consultants in Basra will be an helping hand.
  4. Establish monitoring procedures: Monitoring is a good tool to ensure that the critical limits are met at critical control point. HACCP certification process in Iran will be successful only after monitoring the practice. It is all about how you will measure the effectiveness. It is very important to measure the critical limits at critical points to ensure the effectiveness of HACCP system. HACCP certification in Iran will increase the effectiveness. Any deviation from HACCP plan can be addressed immediately without any delay so that avoiding or preventing any end point errors.
  5. Establish corrective actions: If a HACCP plan is ready and all set for implementation of HACCP system, it is not that everything will be going in accordance with the plan. HACCP certification bodies in Iran will help your organization certified. Many errors including both manual and technical is a possible outcome of the implemented system. This is the practical case where it is impossible to completely eliminate the error. But the errors can be eliminated or reduced to an acceptable level of establishment of proper corrective actions. HACCP certification in Iran is a necessary tool to gain potential in the market.

HACCP in Iran is a basic requirement. Before starting the implementation of HACCP system a prerequisite programs needs to be in place and also education and training has to be provided to all the process it’s and employees of an organization to ensure that they are really well aware of the importance and significance of HACCP. The most important factor of consideration is HACCP certification in Iran. And again everything is going to end with the good result if and only if a complete plan drafted. Similarly HACCP plan plays a major role in successful implementation of the system.

Kindly contact us [email protected] to get your customized ISO certification programme developed for your organization.