ISO 22716 Audit Services

Pro QC is a Global Quality Assurance company that provides ISO 22716 Audit services in over 88 countries. With over 40 years of experience, tailor-made solutions and world-class auditing expertise, Pro QC is a trusted partner for cosmetic manufacturers. We help them build Quality Management Systems according to Good Manufacturing Practices (GMP) and following the ISO 22716 standard.

Pro QC’s ISO 22716 audit services answer the following needs:

  1. A company needs to audit its supplier to assess its compliance level with ISO 22716
  2. A company seeks to improve its Good Manufacturing Practices and performance
  3. A company needs support to prepare for an ISO 22716 certification audit, or maintain the certification
  4. A supplier wants to comply with client requirements

Pro QC is a strategic partner for cosmetics manufacturers and suppliers.

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ISO 22716 Audit Approach

The ISO 22716 audit services of Pro QC are conducted by highly qualified and experienced auditors. Our team is recognized in the field of cosmetics and medical devices and supports clients wanting to audit existing and potential suppliers, verify their compliance level against the standard, improve their performance, or prepare them for the final certification audit.

Our complete solutions go beyond our technical expertise and capitalize on our understanding of our client’s businesses. From small to mid-sized companies to large businesses and multi-national corporations – we have tailor-made audit and compliance solutions for every project. An experienced team of ISO 22716 consultants with years of auditing experience will establish the exact requirements and ensure that our proposed solution matches those requirements.

From the initial diagnosis to the preparation of the certification audit, Pro QC offers complete solutions considering all the quality challenges of the cosmetics industry. As an independent third-party company, our audits are based on factual observations and are impartial. We collect all the evidence on the compliance level of the audited organization and provide a high-level and comprehensive ISO 22716 audit report that includes the results, the strength/weaknesses, and the opportunities for improvements. Following the audit, our team can develop a detailed corrective action plan to reach full compliance with the ISO 22716 standard.

GMP, or Good Manufacturing Practices, is a quality assurance framework aimed at validating the compliance of the management system of companies with the requirements of international cosmetic regulations. They apply to the manufacture of drugs or cosmetic products. The requirements and characteristics of the ISO 22716 standard cover the fundamental principles of GMPs and ensure the quality of production.

ISO 22716 is an international standard for good manufacturing practices in the cosmetics industry. It describes the basic principles for implementing good manufacturing practices on a production site of finished cosmetic products. This standard provides practical and structured advice on the management of human, technical and administrative factors affecting product quality. ISO 22716 is an auditable standard. The audit provides the compliance level of a company against the requirements of ISO 22716.

Our ISO 22716 GMP audit checklist is based on the 2007 version and is comprised of:

  • Personnel
  • Personnel Hygiene and Health
  • Premises
  • Equipment
  • Calibration
  • Raw Materials and Packaging
  • Storage
  • Bulk Product Storage
  • Packing Operations
  • Quality Control Lab
  • Non-Conforming Products
  • Change Control
  • Documentation

The ISO 22716 Environmental Management System helps to:

  • Manage the quality and safety requirements of an organization’s supply chain.
  • Reduce product deviations, complaints, and recalls.
  • Control the risks and dangers associated with cosmetic products, ensuring continuous improvement.
  • Ensure compliance with legal requirements.

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Pro QC’s ISO 22716 Audit Outcomes

Audit report delivered within 72 hours after the service

Pro QC clients can expect an organized ISO 22716 GMP audit report delivered within 72 hours after the service and presented in exhaustive detail. Each report provides:

  • A summary of the audit
  • The overall audit score and compliance level with ISO 22716.
  • The compliance level for each part of the standard. Each finding is explained in clear language and color-coded.
  • The recommended corrective actions to implement.
  • Objective evidence such as photos, interviews, and examined records and documents.

Corrective action plan

The ISO 22716 Good Manufacturing Practices audit is only the first step. If the compliance level is insufficient, a CAPA plan must be developed and implemented to eliminate nonconformance and improve GMP performance sustainably. Pro QC helps organizations reach full compliance by:

  • Performing an ISO 22716 GMP Audit
  • Establishing a corrective action plan
  • Verifying corrective action implementation through detailed follow-up activities
  • Controlling performance and facilitating continuous improvement.

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Carrying out an ISO 22716 audit will ensure your company’s compliance with industry standards, improve product quality and promote operational efficiency and continuous improvement.

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