CE Marking

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) since 1985.

CE marking is also found on products sold outside the EEA that are manufactured in, or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to people who are not familiar with the European Economic Area.

CE marking is described as a trade passport because it enables the free movement of products within the European market.

According to EU legislation, the EU Member States are not allowed to restrict the placing on the market of CE marked products, unless such measures can be justified on the basis of evidence of the non-compliance of the product. CE marking does not indicate that a product was made in the European Union. The CE mark also is not a quality mark. The CE marking is the manufacturer's declaration that the product meets the requirements of the applicable EC directives.

Seven steps to follow CE Mark on the product:

  • Determine the applicable CE directives/regulations
  • Identify the applicable European harmonized standards
  • Identify which essential requirements of the CE marking directive/regulations apply to the product
  • Identify which requirements of the European harmonized standards apply to the product
  • Conduct and document the conformity assessment against the essential requirements and the requirements from the standards
  • Risk analysis to critical products
  • Provide the user with the information required to use the product safely
  • Ensure consistency of production, thus proving the assessed sample and the production are identical
  • Prepare a document that are necessary to show compliance with all relevant requirements – Technical File.
  • Draw up and sign a Declaration of Conformity
  • Affix the CE mark to your product

GMP (Good Manufacturing Practice)

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product. The main risks are: unexpected contamination of products, causing damage to health or even death; incorrect labels on containers, which could mean that patients receive the wrong medicine; insufficient or too much active ingredient, resulting in ineffective treatment or adverse effects.

GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process - every time a product is made.


WHO has established detailed guidelines for good manufacturing practices? Many countries have formulated their own requirements for GMP based on WHO GMP.



IATF 16949

ISO/TS 16949 was originally created in 1999 to harmonize different assessment and certification schemes worldwide in the supply chain for the automotive sector. The primary focus of the IATF 16949 standard is the development of a Quality Management System that provides for continual improvement, emphasizing defect prevention and the reduction of variation and waste in the supply chain. The standard, combined with applicable Customer-Specific Requirements (CSR’s), define the QMS requirements for automotive production, service and/or accessory parts.

IATF 16949:2016 is an independent QMS standard that is fully aligned with the structure and requirements of ISO 9001:2015. Therefore, the IATF 16949 cannot be implemented alone as a stand-alone document, but must be implemented as a supplement and in conjunction with ISO 9001:2015. IATF 16949 standard provides guidance and tools for companies and organizations who want to ensure that their products consistently meet customer requirements and that quality and customer satisfaction are consistently improved.

All requirements of IATF 16949 are applicable unless suppliers do not provide product design related functions. Requirements are generic and are intended to be applicable to any supplier providing design and development, production and, when relevant, assembly, installation and services of automotive related products, including products with embedded software.


Benefits of IATF 16949

  • Demonstrate its ability to consistently provide products that meet customer and applicable statutory, regulatory and product safety requirements.
  • Defines overall context, who is affected and what they expect from system.
  • Clearly states objectives and identifies new business opportunities
  • Gives assurance to sustain existing customers & increases customer loyalty, add new clients and increase business
  • Expand into new markets, as some sectors and client requires effective implementation & certification of IATF 16949 to start business.
  • Identify and address the risks associated with your organization.
  • Work in a more efficient way to increase productivity and efficiency, bringing to reduce internal costs.
  • Become more socially responsible through the documentation and implementation of corporate responsibility polices.

HACCP

(Hazard Analysis and Critical Control Point)

HACCP stands for Hazard Analysis and Critical Control Point and it is mainly designed to identify and minimize hazards in food production. In other words, HACCP is a process in which food safety is addressed by the analysis and control of biological and physical hazards. It is a global recognized standard for food safety and provides high credibility to the potential clients.

HACCP define for the prevention of hazards not for the finished product inspection it helps to provide guideline to the organization on how to analysis the hazards and how to reduce or control them for human consumption. The main objective of HACCP is process and makes the product safe. The Preventive approach of HACCP is helps to improve the food management system as well as improve the quality management system.

HACCP Principle

HACCP approaches 7 principles

  • Conduct a hazard analysis.
  • Determine the critical control points.
  • Establish critical limits.
  • Establish a system to monitor control of the CCP.
  • Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control
  • Establish procedures for verification to confirm that the HACCP system is under control.
  • Establish documentation concerning all procedures and records appropriate to these principles and their application.

Benefits of HACCP

  • Consistent Improve food quality and food safety management system.
  • Improve the market value of the organization.
  • Reduce risk in food production system.
  • Develop team work among the employees.
  • Time saving and cost saving process.
  • It helps to ensure that you are compliant with the law.
  • Commitment to produce safe and quality food for human consumption.

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