ISO 22716:2007 Good Manufacturing Practices (GMP) Certification Standard for Cosmetic Products

The content of ISO 22716:2007 Guidelines on Good Manufacturing Practices for Cosmetic Products has been approved and accepted by a number of regulatory bodies around the world. For example the International Cooperation on Cosmetic Regulation (ICCR) – a joint effort by the USA, the European Union, Japan and Canada – agreed in their July 2008 meeting to implement ISO 22716 in their respective regions, wherever possible. Regulators of several of these ICCR regions have decided to act accordingly. In the USA, it was proposed that the Food & Drug Administration (FDA) modify its current guidance. In addition, the EU is amending its existing European Committee for Standardisation (CEN) standard to incorporate the ISO 22716 standard. The Japan Chemical Industry Association (JCIA) has adopted ISO 22716 and advised the regulators in the government to act accordingly. Finally, in a meeting in late 2006 the ASEAN Consultative Committee for Standards and Quality (ACCSQ) agreed to recognise the forthcoming ISO 22716 as equivalent to the ASEAN Cosmetic GMP guideline, which was published in 2003. Each of these regions has its own regulations that have to be adhered to for any cosmetic products being brought to the market. It is from these regulations that their guidelines are generated. GMP is referred to within each country’s regulations but it is also an essential element to meeting the requirements throughout.

This standard was last reviewed and confirmed in 2017. Therefore this version remains current.



Certification Process

The certification process includes following major steps. For further details kindly see procedure for certification system in the download section.

  1. Application/Enquiry
    Client submits the application form to KBS (Application for Certification).
  2. Review of Application by KBS
    KBS reviews the application to check if the requisite services can be provided and accordingly prepares the quotation/ estimate and the contract (Certification audit contract).
  3. Audit planning
    Once the contract is signed, KBS makes the audit programme and inform the client.
  4. Assessment
    Initial certification includes two stages assessment. Recertification includes only one stage. The assessment is carried out by the team at the sites against the applicable criteria. The report is provided to client identifying the compliancelevel includingany nonconformities.
  5. Verification of Non-conformities
    Client submits the implemented or proposed action based on the classification of non-conformity. KBS reviews the actions.
  6. Certification Decision
    KBS takes certification decision based on the report submitted by the audit team. If decision is in favour of grant of certification, a Certificate is Issued to the client.
  7. Surveillance assessment
    Surveillance assessment are held as per the periodicity defined and agreed. First surveillance within 12 months from the date of the stage 2 audit. Certificate is maintained based on the outcome of the surveillance audit and compliance with the requirements. First Surveillance within 12 months from the date of certification decision date.
  8. Recertification
    Before expiry of the certificate, recertification is planned and conducted.