Product Certification & CE Marking – Factory Assessment | Accredify Global

Product Certification & CE Marking – Factory Assessment | Accredify Global

Introduction to Product Certification & CE Marking

Product certification is a third-party verification process ensuring that a product meets specific quality, safety, and regulatory standards before reaching the market. Through factory assessment, businesses can demonstrate that their manufacturing processes align with international compliance requirements.

CE Certification, on the other hand, is mandatory for products sold in the European Economic Area (EEA), indicating conformity with EU safety, health, and environmental regulations.

With 80% of global consumers prioritizing certified products, Accredify Global helps businesses achieve product certification quickly and efficiently.

European Union is currently a political and economic organization consisting of 28 member states with a total population of more than 500 million. One of the four basic freedoms granted by this union is the free movement of goods.

CE Marking signifies that the products meet all the requirements of the EU technical regulations and can be circulated among the member states of the EU without facing any technical barriers.

Accredify has accreditation for product certification empowering it to evaluate test reports and production systems to BS/IEC/EN standards as a third party.

Accredify assessor's has experience in numerous fields to evaluate the test reports and to assess the production system. Currently we are doing in almost all electronics/electrical/construction products /machineries.

Accredify covers different types of standards for this service. Please contact us to know whether your product can be certified against IEC/EN standards or not by Accredify.

What is Product Certification Through Factory Assessment?

Product certification through factory assessment ensures that both the product and the manufacturing process comply with international standards. It includes:

  • On-site factory inspection to assess quality control systems
  • Product testing to verify compliance with regulatory standards
  • Documentation review to ensure manufacturing consistency
  • Ongoing surveillance audits to maintain certification
  • Compliance with standards within your industry
  • Execution by factory trained technicians
  • Reduced risk of non-compliance during audits
  • Lower cost of compliance than other solutions
  • Equipment ready-for-use when you need it
  • Acceptance tests for Retail customers that your product is ready to be installed in the store with connectivity to all critical business systems
Industries that require factory assessment-based product certification include:
  • ➤ Electronics & electrical appliances.
  • ➤ Medical devices & healthcare products.
  • ➤ Automotive & machinery manufacturing.
  • ➤ Consumer goods & toys.
  • ➤ Industrial equipment & construction materials.

Benefits of Product Certification Through Factory Assessment

Any business prioritizing workplace safety and employee well-being can benefit from ISO 18001 certification. It is ideal for:

  • ✅ 50% lower risk of product recalls & safety failures
  • ✅ Increased global market access & regulatory compliance
  • ✅ Stronger supply chain trust & customer confidence
  • ✅ 30% reduction in production defects & inconsistencies

Services

ISO 7101:2023 –Healthcare Quality Management System (HQMS ISO 9001:2015 –Quality Management (QMS) ISO 14001:2015 –Environmental Management(EMS) ISO 21001:2018 –Educational Organizations Management System (EOMS) ISO/IEC 27001:2022 –Information Security Management (ISMS) ISO/IEC 20000-1:2018 –IT Service Management (ITSM) ISO/IEC 42001:2023 –Artificial Intelligence Management System (AIMS) ISO/IEC 27701:2019 –Privacy Information Management (PIMS) ISO 45001:2018 –Occupational Health & Safety (OHS) ISO 22000:2018 –Food Safety Management (FSMS) ISO 50001:2018 –Energy Management (EnMS) ISO 13485:2016 –Medical Device Quality Management (MDMS) Certification Process Accredited Management System Process (AMSP) Complaint & Appeals Impartiality Policy Confidentiality & COI IMS (Integrated Management System) Policy Rules for Logo Use CE Marking & Product Certification HACCP (Codex 2023) – Hazard Analysis and Critical Control Points GMP (Updated 2023) – Good Manufacturing Practice Inspection and Testing General Data Protection Regulation (GDPR) Human Health Care HIPAA Compliance Certification Health Information Trust Alliance (HITRUST) System and Organization Controls (SOC) CMMI (Capability Maturity Model Integration) Vulnerability Assessment and Penetration Testing (VAPT) Payment Card Industry Data Security Standard (PCI DSS) Cyber Security Service ISO CEN/TS 16555-1:2013 - Innovation ISO/IEC 22301:2019 –Business Continuity Management (BCMS) ISO 44001:2017 – Collaborative Business Relationship ISO/IEC 17025:2017 –Testing & Calibration Laboratories ISO 20121:2012 – Sustainable Events Management ISO 41001:2018 - Facility Management ISO 55001:2014 – Asset Management System ISO 31000:2018 – Risk Management ISO 30301:2019 – Records Management System ISO 21001:2018 –Educational Organizations Management ISO/TS 16949:2016 –Automotive Quality Management ISO 21434:2021 –Automotive Cybersecurity Compliance AS 9100D:2016 – Aerospace Quality Management ISO 10002:2014 - Customer Complaint ISO 18788:2015 - Security Operation ISO 39001:2012 - Road Safety ISO 29001:2010 - QMS:Oil & Gas ISO 37001:2016 – Anti-Bribery Management System ISO 19650:2018 – Building Information Modeling (BIM) ISO 10004:2012 - Customer Satisfaction ISO 26000:2010 – Social Responsibility ISO 13485:2016 -Medical Device ISO 15189:2022 – Medical Laboratory ISO 22716:2007 – Good Manufacturing Practices (GMP) for Cosmetics

Product Development CE Marking

By affixing the CE Marking, the manufacturer, or its representative, or the importer assures that the item meets all the essential requirements of all applicable EU directives. CE Marking includes Construction Products, Containers, Cranes, Electrical Products and Components, Electromagnetic Compatibility (EMC), Lifts, Marine Equipment, Materials, Mechanical Products, Process Machines, Pressure equipment, Personal Protective Equipment (PPE), Telecom, Toys and Wood. Where products are subject to several directives, which all provide for the affixing of the CE marking, the marking indicates that the products are presumed to conform to the provisions of all these directives. Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R, etc...can further reduce timescales and costs.

KEY BENEFITS:
  • ➤ Opens acceptance worlwide of your products.
  • ➤ It is mandatory to understand your obligations and demonstrate compliance.
  • ➤ Combining CE marking with other certifications such as CB Scheme, USA/Canada Safety Certification, CCC, GOST-R,ROHS etc...can further reduce timescales and costs.
OUR APPROACH

One of the best ways to achieve success of a new product is to give it the best possible start, with care and attention at every stage.
Complying with the CE Marking is a critical issue when looking to launch your product on the global marketplace. Understanding the myriad of the regulation that affect your product in your target market is a key to success. Our assessment process begins with the understanding where product(s) is to be marketed, who will use the product, what are your quality expectations?
The responses help us to identify the regulatory barriers, the directives, the standards, your conformity assessment route option, etc...And to develop a rationalised compliance plan for your product range with your target markets within, as well as outside, the EU.

SCOPE OF DIRECTIVES
  • ✅ Medical Device Directive – 93/42/EEC
  • ✅ Low Voltage Device Directive – 2006/95/EC
  • ✅ Machinery Directive – 2006/42/EC
  • ✅ Construction Product Regulation – (EU) 305/2011
  • ✅ Electromagnetic Compatibility Directive – 2004/108/EC
  • ✅ Pressure Equipment Directive – 97/23/EC
  • ✅ Simple pressure vessels Directive - 87/404/EEC
  • ✅ Personal Protective Equipment Directive - 89/686/EEC

What is CE Certification?

We see capital letters CE on many products in free movement in the European Economic Area. This marking, meaning Conformity with Europe, demonstrate that the products have been audited/assessed in terms of minimum safety, health and environmental requirements. You would see CE marking on a new telephone, food processor, TV set or crayons purchased in the European Community. CE marking also indicates fair competition among manufacturers as it enforces accountability and conformity with the same requirements.

CE (Conformité Européenne) Certification is a mandatory requirement for products entering the European market. It confirms that a product:

  • ✔ Meets EU safety, health, and environmental protection standards
  • ✔ Is manufactured under a compliant quality management system
  • ✔ Can be freely marketed within the European Economic Area (EEA)

Who Needs CE Certification?

CE marking applies to over 25 product categories, including:

  • ➤ Medical devices & personal protective equipment (PPE).
  • ➤ Electrical & electronic appliances.
  • ➤ Machinery & industrial equipment.
  • ➤ Construction products & building materials.
  • ➤ Toys & consumer goods.

Why CE Certification is Important for Businesses?

With more than €500 billion in trade within the EU market, CE certification ensures:

  • ✅ Legal access to 30+ European countries
  • ✅ Enhanced product credibility & reduced import restrictions.
  • ✅ Increased consumer trust & brand reputation
  • ✅ Compliance with EU Directives & market requirements.

The CE Certification Process: Step-by-Step

  • 1️⃣ Identify the Relevant Directive – Determine which CE directive applies to your product.
  • 2️⃣ Perform Product Testing & Risk Assessment – Conduct laboratory tests to verify compliance.
  • 3️⃣ Implement Factory Assessment – Ensure manufacturing processes align with CE standards.
  • 4️⃣ Compile the Technical File – Maintain documentation of product compliance & test results.
  • 5️⃣ Issue the CE Declaration of Conformity – Declare compliance and affix the CE mark on the product.
  • 6️⃣ Undergo Periodic Audits & Market Surveillance – Ensure continued compliance with CE regulations.

Checklist for Product Certification & CE Marking

  • ✅ Verify compliance with industry-specific international standards
  • ✅ Conduct factory assessment & production quality audits
  • ✅ Perform independent product testing & safety evaluations
  • ✅ Establish a technical file with required documentation
  • ✅ Obtain a Certificate of Conformity from a Notified Body (if required)

Is CE Certification Mandatory?

Yes, CE marking is legally required for products entering the European Economic Area (EEA). Selling non-CE-certified products in the EU can lead to:

  • ➤ Legal penalties & import restrictions.
  • ➤ Product recalls & safety non-compliance issues.
  • ➤ Loss of market credibility & trade opportunities.

For exporting to non-EU markets, other regional certifications (such as UKCA, FCC, or UL certification) may also be required.


Cost of Product Certification & CE Marking

The cost of certification varies depending on the size and complexity of the organization. However, the investment can lead to significant energy cost savings and improved energy efficiency.

On average, CE certification costs range from $5,000 to $25,000, while factory assessment-based product certification varies between $10,000 and $50,000, depending on scope.


PDCA Cycle | Accredify Global

  • Plan – to think that what do we need to achieve in our organization
  • Do – to execute a planned action which will help us achieve the required objective
  • Check – monitor against the standards) (policies, objectives, requirements)
  • Action – finally implementing what has been rechecked.

ISO CERTIFICATION. 3 STEPS. 30 DAYS. DONE !! | ACCREDIFY GLOBAL

Accredify Global, we follow a structured and transparent ISO certification process to help businesses achieve international compliance efficiently. Our streamlined approach ensures a hassle-free experience from initial consultation to final certification..

3. Audit Review & Certification

  • Objective: Validate your management system through an external audit and achieve certification.
  • Actions:
    • Conduct an internal audit to ensure readiness for the certification audit, utilizing Accredify Global's auditing tools and resources.
    • Schedule and undergo an external audit with Accredify Global's accredited certification body.
    • Address any non-conformities identified during the audit with support from Accredify Global's consultants.
  • Outcome: Successful certification and ongoing compliance with the ISO standard, with continuous support and guidance from Accredify Global.