5

ISO 13485 Certification Process And Its Cost?

with No Comment

In the current marketplace many small and medium business owners feel that they cannot afford ISO certification. Unfortunately, this means that they miss out on the many financial benefits of achieving ISO 13485 certification. Kwalitycert aim to provide a cost-effective way for businesses improvement to get ISO certified. This is achieved by streamlining the overall process, allowing you to apply for and obtain your certification on-time, without any hassle. This means that you’ll start saving money from the very beginning of the process, which will continue as your business adopts the practices needed to maximize your resources.

The total cost of ISO 13485 certification in Kenya depends on various factors specific to each organization and involves the following factors:

  • Your industry sector
  • How many offices you have
  • Your annual turnover
  • How many employees you have
  • Single Site or multiple site
  • Intent/1st surveillance/2nd Surveillance
  • Recertification

Kenya is receiving more investments from Europe and America thus the requirement of the compliance is very high. New Certifications that Integrate with various standards like FSSC 22000 Certification, BRC Certification are in demand this can be achieved by having the most basic certification that is skeleton for all food safety certification – ISO 22000 Certification in Kenya. ISO Certification in Kenya can also benefit with ISO 22000 as HACCP Certification in Kenya is also included in Implementation.

ISO 9001 certification consultant in Kenya 1

ISO 9001 Certification Process And Its Cost?

with No Comment

In the current marketplace many small and medium business owners feel that they cannot afford ISO certification. Unfortunately, this means that they miss out on the many financial benefits of achieving ISO 9001 certification in Kenya. Qualitcert aim to provide a cost-effective way for businesses improvement to get ISO certified. This is achieved by streamlining the overall process, allowing you to apply for and obtain your certification on-time, without any hassle. This means that you’ll start saving money from the very beginning of the process, which will continue as your business adopts the practices needed to maximize your resources.

The total cost of ISO 9001 certification depends on various factors specific to each organization and involves the following factors:

  • Your industry sector
  • How many offices you have
  • Your annual turnover
  • How many employees you have
  • Single Site or multiple site
  • Intent/1st surveillance/2nd Surveillance
  • Recertification

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.

SM Poster 3 e1712426487454

What Is Safety Audit Explain Briefly?

with No Comment

A safety audit is a structured and systematic process where all required information is collected relating to the efficiency, effectiveness, and reliability of a company’s total health and safety management system.

Safety audits are conducted mainly for two purposes :

  • To know whether the company is in compliance with safety legislation. These can be performed by representatives of a regulatory body or by the company itself.
  • To identify risk and weaknesses in their safety programs and processes. These audits are then used as a guide for designing safety plans or to identify corrective actions that should be undertaken.

Other beneficiaries from safety audits are:

  • Promote constant review of systems to ensure that they do not become weakened by habit
  • Facilitate planned improvements to programs, policies, and procedures
  • Help to identify weaknesses in human resources departments
  • Help to demonstrate management’s dedication to employee health and safety

Key elements of workplace audit:

  • Consistent regularity
  • Competent and objective auditors
  • Advanced Preparation
  • Thorough Recordkeeping
  • Perceptive Data Analysis
  • Upgrading to Modern Technology

For more details about ISO certification in Nigeria , Documentation, implementation, auditing and recertification feel free to contact us.

3

CE Certificate And Its Compliance Audit?

with No Comment

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?

with No Comment

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?

with No Comment

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?

with No Comment

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?

with No Comment

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?

with No Comment

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 ?

with No Comment

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.