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ISO Regulations

Why is ISO required?

You need consider the following three points regarding why ISO is required and what relation it has with pharmaceutical application.

  1. ISO indicates global conformity,

    which should be considered for the revision of pharmaceutical law.

  2. ISO is a standardized certificate for quality assurance

  3. ISO documentations and procedures are efficient for risk management (related to pharmacist)

    and manual management.

Pharmaceutical law (including law regarding medical devices) is released to regulate jobs/product influencing the human life, and therefore, it is related to ISO 9001 of quality management (ISO13485 for medical devices). Also, considering environmental factors, ISO14001 should be considered.

Our office offers the full services covering approval and licensing as well as consultation, and even further for infrastructuring

Consultation Services

  1. ISO management and support

    → Consultation services based on professional knowledge on pharmaceutics and law

  2. Business affiliation using ISO

    → More business affiliations can be available like securing distribution channel for manufacturer or seller.

Manual Documentation (Simplified procedure service is available.)

  1. Documentation for quality management (including QMS manual)

  2. Restructuring procedures/work flows

  3. Documentation for risk management

    (Including risk management related to medical devices defined in JIS T 14971)

Lectures (Following topics are available.)

  1. The relation between revision of pharmaceutical law in 2005 and ISO

  2. Certification for ISO13485:2003

  3. Quality management system

  4. Licensing/Approval

  5. JIS T 14971:2003 [Application of risk management to medical devices]

  6. Personal information protection in pharmaceutical law (Enforcement of pharmaceutical affairs law

    regarding medical devices, which has taken effect since 25th Dec, 2014)

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