Quality System
Process and Equipment Certification and Validation
We can support companies in the medical device, IVD, cosmetics, and other sectors that require assistance in developing, maintaining, and/or auditing their Quality Management System (QMS) or Information Security Management System, as well as those of their suppliers.
Our services ensure compliance with the main quality and information security certification schemes, and cover all validation activities typically required in these industries, including Process Software Validation, Equipment Validation, Process Validation
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ISO 13485 and ISO 9001 Quality Systems
Developing the Quality Management System for a manufacturer of Medical Devices or IVDs, a distributor, or any company seeking certification in compliance with ISO 13485 or ISO 9001.
QMS for International Markets: MDSAP, 21 CFR 820, BGMP
Developing the Quality Management System for a company operating in the Medical Device or IVD sector, seeking certification under the MDSAP scheme or compliance with 21 CFR 820 for the U.S. market or BGM requirements for Brazil.
Information Security Management Systems (ISO 27001)
Developing the Information Security Management System for a company seeking certification in compliance with ISO 27001, while also supporting compliance with the NIS2 Directive, which involves medical device manufacturers.
Cosmetics Management Systems (ISO 22716)
EN ISO 22716 defines the Guidelines for the production, control, storage, and shipment of cosmetic products.
Internal audits, supplier audits, and support during third-party audits
The independence and competence of Auditors are requirements of every certification scheme, and a thorough understanding of the assessment criteria used by Certification Bodies and Authorities is essential to effectively support the company during Audits.
Equipment Validation
Preparation of protocols (IQ, OQ, PQ) and assistance with verifying results and preparing reports.
Process and Quality System Software Validation
We support the company in the validation of software used in production processes and within the Quality System, such as spreadsheet validation, management software, and similar applications.
Process Validation
Drawing up protocols (e.g. packaging, sterilization, washing, etc.) and assisting with verification of results and preparation of reports.