Cosmetics and medical devices

Over the past 10 years, Q-Point has gained extensive experience in various quality and sustainability standards within the cosmetics and medical devices sectors. Our array of services includes assistance with ISO 22716:2007 GMP Cosmetics and ISO 13485:2016 Medical Devices. We assist with:

Verification of Product Information Files and their submission to CPNP
Verification of labels and claims
Establishment and implementation of quality management systems aligned with ISO standards
Conducting internal audits
Assistance with external audits
Hygiene training for personnel
Risk analysis training for the quality team
Advice on sustainability, quality and legislation

The legislation for cosmetics is laid down in the European Cosmetics Regulation (1223/2009/EC). Cosmetic products must be thoroughly assessed for safety before being put on the market. The assessment should be documented in a Product Information File (PIF). Q-Point does not assist in the design of a PIF. For this, we would like to refer you to SkinConsult.

Certification

ISO 22716:2007 GMP Cosmetics 

Companies operating in the cosmetics sector are legally required to produce according to the GMP Cosmetics guidelines defined in ISO 22716:2007. Certification for this standard includes product guidelines on codes of conduct regarding workspaces, equipment and quality controls.

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ISO 13485:2016 Medical devices

Companies operating in the medical device industry are legally required to produce according to the GMP Medical devices guidelines defined in ISO13485:2016. Certification for this standard includes product guidelines on codes of conduct regarding workspaces, equipment and quality controls.

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EXCiPACT 

EXCiPACT is developed for companies seeking to demonstrate compliance with GMP/GDP standards in the pharmaceutical industry. The system is supported by a non-profit organisation and is based on ISO 9001:2015.

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EFfCI 

The European Federation for Cosmetic Ingredients has developed its own standard for producers of raw materials used in the cosmetics sector.

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BRCGS Consumer Products 

A standard has been developed for the cosmetic sector from the UK retail sector. The BRCGS Consumer Products standard focuses on risk mitigation and best practices.

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IFS Household and personal care (HPC) 

A standard has been developed for the cosmetics sector from the German and French retail sectors. The IFS HPC standard for household and personal care products includes a safety and quality management system suitable for the assessment of the entire production process.

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