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.

ISO 9001 Jordan

What Is An ISO 9001 Audit And Its Procedure

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 ISO 9001 mainly focus on quality in management system, the ISO 9001 audit is an essential part of becoming and staying ISO 9001 certified. It will help you:

  • Ensure your Quality Management System complies with the ISO 9001 standard
  • Identify and address any issues with your Quality Management System
  • Identify potential improvements to your system
  • Ensure your organization takes appropriate action to meet its quality objectives.

There are three types of audit they are:

1st party audit : – Internal Audit

2nd party Audit:- Supplier Audit, Contractors Audit etc..

3rd party Audit :- Certification Audit, Financial Audit etc..

ISO 9001 Certification awarded once company underwent a complete audit process, it happens only in 3rd party audit. It has two stages

Document Review: First, auditors check whether procedural documentation meets ISO 9001 requirements.

Process Review: The main part of the audit process consists of checking actual business activities against documentation and looking for discrepancies.

The three ways audits can be conducted are:

On-site audits are performed in full days. The number of days needed for an audit depends on several factors including size, complexity, risk, and nature of an organization. The International Accreditation Forum (IAF) has provided guidelines for registrars to calculate audit time.

Remote audits may be performed via web meetings, teleconferencing or electronic verification of processes. Remote audits are less common and typically not as effective as on-site audits.

Self-audits do not always mean an internal audit.

  • Steps involved in audit process
  • Appoint the Right Auditors
  • Use Forms and Checklists: Audit Checklist, Audit Report Form, Attendance Roster
  • Standardize the Audit Assessment
  • Hold a Closing Meeting with Auditees
  • Get Feedback from Auditees

Qualitcert helps you in auditing process for both internal audit and external audit. ISO 9001 auditing in Saudi Arabia is easy with Qualitcert. For any queries to get ISO certified contact us

ISO 45001 certification

Why Do We Go For Iso Consultation?

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Consultant & consultation both plays a vital role in achieving an ISO certification also, consultants helps providing solutions for problems.  The present market is competitive and demanding for quality products and services that deliver exceptional customer experience. Getting globally recognized as a “quality first” brand can be the key to achieving a competitive edge in today’s growing global marketplace. If you are considering certification, choosing the right ISO Consultant is a critical decision that will determine how efficiently and seamlessly your certification process will take place. The right consultant can also change how fast you achieve certification.

Hence companies going for ISO certification in Kenya should not forget to hire a consultant or outsource the project for consultation to understand the effectiveness of the system.

 

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. For any standards of ISO certification in Nigeria, Kenya, Saudi Arabia, Oman, UAE. Jordan, Lebanon, Iraq, and India reach Qualitcert experts.

5

ISO 13485 Certification Process And Its Cost?

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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.