System Management

System Management ISO, OHSAS, JGMP, CGMP KGMP

  1. International Organization for Standardization

– ISO 9001 Quality management systems,

Requirements, ISO 9001:2015 specifies requirements for a quality management system when an organization:

  1. a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
  2. b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of ISO 9001:2015 are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

Scope

This International Standard specifies requirements for a quality management system when an organization:

  1. a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
  2. b) aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.

– ISO 13485 Medical device, Quality management systems,

Requirements for regulatory purposes, ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.

Requirements of ISO 13485:2016 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization.

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system by monitoring, maintaining, and controlling the processes.

If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulatory requirements can provide alternative approaches that are to be addressed in the quality management system. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.

If any requirement in Clauses 6, 7 or 8 of ISO 13485:2016 is not applicable due to the activities undertaken by the organization or the nature of the medical device for which the quality management system is applied, the organization does not need to include such a requirement in its quality management system. For any clause that is determined to be not applicable, the organization records the justification as described in 4.2.2.

 

– ISO 14001 Environmental management systems,

Requirements with guidance for use, ISO 14001:2015 specifies the requirements for an environmental management system that an organization can use to enhance its environmental performance. ISO 14001:2015 is intended for use by an organization seeking to manage its environmental responsibilities in a systematic manner that contributes to the environmental pillar of sustainability.

ISO 14001:2015 helps an organization achieve the intended outcomes of its environmental management system, which provide value for the environment, the organization itself and interested parties. insistent with the organization’s environmental policy, the intended outcomes of an environmental management system include:

  • enhancement of environmental performance.
  • fulfilment of compliance obligations.
  • achievement of environmental objectives.

 

ISO 14001:2015 is applicable to any organization, regardless of size, type, and nature, and applies to the environmental aspects of its activities, products, and services that the organization determines it can either control or influence considering a life cycle perspective. ISO 14001:2015 does not state specific environmental performance criteria.

ISO 14001:2015 can be used in whole or in part to systematically improve environmental management. Claims of conformity to ISO 14001:2015, however, are not acceptable unless all its requirements are incorporated into an organization’s environmental management system and fulfilled without exclusion.

– ISO 22000

– ISO 22716

– ISO 50001

 

  1. Occupational Health and Safety Management Systems

– OHSAS 18001

 

  1. Good Manufacturing Practices

– KGMP (KOREA)

– cGMP (U.S.)

– JGMP (JAPAN)

-TGMP (THAILAND)

 

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Product Certification. – CE, FDA, CFDA, MHLW, MFDS, TFDA

  1. CE Certification

– Medical Device

– LVD & EMC

– Cosmetic

– Personal protective equipment

– Pressure equipment

– Construction Product

– Machinery

– Marine Equipment

– Recreational craft

 

  1. FDA (U.S.)

– 510K Medical Device

– Registration and Listing

– Cosmetic

 

  1. CFDA (CHINA)

– Medical Device

– Cosmetic

 

  1. MHLW (JAPAN)

– Medical Device

– Cosmetic

 

  1. MFDS (KOREA)

– Medical Device

 

  1. TFDA (THAILAND)

– Medical Device

– Cosmetic

 

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Product Testing

  1. American Society for Testing and Materials
  2. British Standards
  3. European Committee for Standardization
  4. International Electrotechnical Commission Product Testing
  5. German Institute for Standardization
  6. Restriction of Hazardous Substances
  7. Registration, Evaluation, Authorization and Restriction of Chemicals 8. Calibration

 

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Global Services

  1. Global Representative Service

 

– FDA Agent

 

– EU Representative

 

– EU Responsible person

 

– China Medical Device Responsible agent

 

– China Cosmetic Responsible agent

 

  1. Other Global Service

– Medical Device registration in EU

– Certificate of Free Sale in EU

– GMDN code – U. S. D-U-N-S number

 

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Technical Support

  1. Surveillance Care of CE Medical device (Risk Management, Clinical Evaluation, Post Market Surveillance)
  2. Cosmetic certification package (Testing, System Management, Documentation, Representative Service, Registration)
  3. Quality Management System and Technical Support
  4. Medical device IEC 60601-1 3rd consultation (Testing, Documentation)
  5. 2nd Party Audit (OEM audit)

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