ISO 27716 - COSMETICS - GOOD MANUFACTURING PRACTICES

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The Faster the Growth
The Higher the Quality Risks

The cosmetics industry in Asia is experiencing rapid expansion, with double-digit growth rates recorded annually. However, amid this accelerated growth, many organizations have yet to make adequate investments in robust quality management systems—resulting in significant risks, including:

Product recalls – Products affected by microbiological contamination, formulation errors, or inaccurate labeling

Reputational damage – Long-term negative impacts on consumer trust and distributor confidence

Export barriers – Products rejected in the EU, the United States, Japan, and South Korea due to stringent regulatory and conformity requirements

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A COMPREHENSIVE SOLUTION FOR
SAFE COSMETIC MANUFACTURING

ISO 22716:2007 is an international standard framework for Good Manufacturing Practices (GMP) specifically developed for the cosmetics industry. It covers the entire manufacturing chain—from raw material procurement and equipment operations to finished product inspection.

Compliance with ISO 22716 enables organizations to establish a standardized production system that ensures product quality and safety, while effectively facilitating access to global markets.

THE PRACTICAL VALUE OF ISO 22716:2007
FOR ORGANIZATIONS

Enhanced product credibility

The application of international standards enables organizations to demonstrate that their products are safe, stable, and consistently compliant with quality requirements—from the first batch to the last.

Export compliance

Many markets, including the EU, Japan, and South Korea, require ISO 22716 certification as a prerequisite for placing cosmetic products on the market.

Reduced legal and regulatory risks

Compliance with GMP guidelines helps minimize manufacturing non-conformities, reducing the risk of product recalls or penalties related to hygiene, traceability, and labeling requirements.

A solid foundation for advanced system integration

ISO 22716 provides an ideal foundation for organizations to expand into other management systems such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management), or ESG-related frameworks.

Strengthened brand image

Demonstrates a commitment to transparency and professionalism across the entire manufacturing process, building trust among consumers, business partners, and domestic and international distributors.

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Enhanced product credibility

The application of international standards enables organizations to demonstrate that their products are safe, stable, and consistently compliant with quality requirements—from the first batch to the last.

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Export compliance

Many markets, including the EU, Japan, and South Korea, require ISO 22716 certification as a prerequisite for placing cosmetic products on the market.

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Reduced legal and regulatory risks

Compliance with GMP guidelines helps minimize manufacturing non-conformities, reducing the risk of product recalls or penalties related to hygiene, traceability, and labeling requirements.

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A solid foundation for advanced system integration

ISO 22716 provides an ideal foundation for organizations to expand into other management systems such as ISO 9001 (Quality Management), ISO 14001 (Environmental Management), or ESG-related frameworks.

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Strengthened brand image

Demonstrates a commitment to transparency and professionalism across the entire manufacturing process, building trust among consumers, business partners, and domestic and international distributors.

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ESTABLISHING A RELIABLE GMP SYSTEM
BASED ON 15 CORE PRINCIPLES

ISO 22716 establishes a comprehensive GMP system that ensures quality control throughout the entire manufacturing chain—from raw materials to finished products. All 15 principles operate in alignment with the PDCA cycle, enabling continual improvement and effective adaptation to market demands.

  • 1

    Personnel system

  • 2

    Premises and facilities

  • 3

    Manufacturing equipment

  • 4

    Raw materials and packaging materials

  • 5

    Production management

  • 6

    Finished products

  • 7

    Quality control laboratory

  • 8

    Control of non-conforming products

  • 9

    Waste management

  • 10

    Management of subcontracted activities

  • 11

    Deviation management

  • 12

    Complaints and product recalls

  • 13

    Change control

  • 14

    Internal audit

  • 15

    Documentation and records management

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WHICH ORGANIZATIONS REQUIRE
ISO 22716 CERTIFICATION?

ISO 22716 is designed for organizations involved in the manufacturing, packaging, and distribution of finished cosmetic products and does not apply to raw material manufacturers.

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Manufacturing facilities and brand owners:<br>Including OEMs, ODMs, and domestic or independent brands seeking to standardize operations and expand market access.
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Contract manufacturers:<br>Engaged in filling, packaging, and labeling activities, ensuring GMP compliance throughout the entire process.
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Warehousing and distribution organizations:<br>Responsible for the storage, handling, and distribution of products, ensuring product quality is maintained until reaching the end consumer.

ARES VIETNAM
Accompanying Cosmetic Organizations Toward International Markets

An international GMP certification organisation with comprehensive implementation capabilities, supporting organizations in standardising their systems, enhancing credibility, and optimising operational efficiency.

3 Reasons to Choose ARES Vietnam

GMP Experts – Global Support

A team of experts with a thorough understanding of quality and regulatory requirements in the EU, the United States, and Japan, providing in-depth advisory services to organizations.

End-to-End Services – Integrated Implementation

From initial assessments and training to documentation development and certification audits, all activities are delivered by a single dedicated team, optimizing both time and cost efficiency.

Market Access – SME Incentives

An international network of experts supports organizations in accessing global supply chains, while flexible incentive policies are applied for small and medium-sized enterprises (SMEs).

ISO 22716:2007 CERTIFICATION PROCESS
AT ARES VIETNAM

A 6-step standardised process, accompanying organisations from consulting to certification

1

CONTACT ARES VIETNAM

Please contact ARES Vietnam via our hotline or official social media channels

2

RECEIVING REQUIREMENTS

Based on the information provided by the organisation, we prepare a quotation and sign a contract

3

CONDUCT ASSESSMENT

Assess the current system and propose adjustments to operational processes

4

SUPERVISING EXPERT

Support organisations in addressing non-conformities to ensure compliance with assessment requirements

5

CERTIFICATION ISSUANCE

Organisations that meet the requirements will be granted certification through ARES Vietnam’s recommendation to the certification body

6

REASSESSMENT

During the 3-year validity period, annual surveillance must be conducted to maintain the certification

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SAMPLE ISO 22716:2007 CERTIFICATE
ISSUED BY ARES VIETNAM

ISO 22716 certificates issued by ARES Vietnam bear the IAS and IAF marks – guaranteeing their value and global recognition

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*Illustrative image of an ISO 22716:2007 certificate issued by ARES Vietnam

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EXCLUSIVE OFFERS FOR ORGANIZATIONS SEEKING
ISO 22716:2007 CERTIFICATION

ARES Vietnam supports cosmetic organizations in optimizing costs, shortening assessment timelines, and standardizing GMP systems in accordance with ISO 22716

  • Certification fee reduction for organisations implementing ISO for the first time
  • Special incentives for registration integrating two or more standards
  • Receive 10 Internal Auditor Certificates
  • Free Pre-audit Consultation – Reviewing the System Prior to Assessment
  • Priority scheduling for early assessment and support for fast certificate issuance

*Service incentives applicable to organisations registering via the Website

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FREQUENTLY ASKED QUESTIONS ABOUT ISO 22716 CERTIFICATION

  • Is ISO 22716 certification mandatory?

    ISO 22716 certification is not currently mandatory under statutory regulations. However, it is considered virtually essential for organizations intending to export cosmetic products to markets such as the EU, Japan, and South Korea.
    Holding ISO 22716 certification also plays a key role in enhancing credibility, strengthening competitive advantage, and increasing trust among business partners and regulatory authorities.

  • Does ISO 22716 apply to personal care products?

    Yes. In addition to traditional cosmetic products, ISO 22716 is applicable to personal care products such as body wash, hand wash, toothpaste, deodorants, and similar items—provided they fall within the cosmetic regulatory scope under international regulations.

  • What is the difference between ISO 22716 and ASEAN GMP? Which standard should organizations choose?

    - ISO 22716 is an international standard developed by the International Organization for Standardization (ISO) and is widely recognized and implemented globally.
    - ASEAN GMP is a cosmetic GMP framework issued by the Vietnamese Ministry of Health and is primarily applied within the domestic market.
    - The choice of standard depends on an organization’s business strategy and target markets. In many cases, organizations may implement both systems in parallel to optimize management effectiveness and meet multi-market requirements. ARES Vietnam provides tailored advice on suitable implementation roadmaps.

  • Does ISO 22716 certification support the cosmetic product notification process?

    Yes. While ISO 22716 certification does not replace the full set of documents required for product notification, it serves as a strong supporting basis that enhances credibility and can facilitate smoother and more efficient approval processes when working with regulatory authorities.

  • Is the cost of ISO 22716 certification high?

    Certification costs vary depending on the scope of operations, product lines, and the level of readiness of the organization’s management system.
    ARES Vietnam offers flexible consulting packages, with dedicated incentives for small and medium-sized enterprises (SMEs), including complimentary training and internal audit support to ensure effective implementation while optimizing costs.

  • Does ISO 22716 certification replace inspections by regulatory authorities?

    No. ISO 22716 certification does not replace inspections or audits conducted by regulatory authorities. However, implementing a system in accordance with ISO 22716 enables organizations to proactively manage risks and maintain well-prepared documentation, procedures, and compliance evidence—thereby reducing the likelihood of non-compliance and increasing confidence during official inspections.

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