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Neftis Laboratorios renews ISO certifications accrediting the company’s quality and efficiency model

30 March, 2022 · 3 minutes of reading

Neftis Laboratorios is certified under two ISO standards accrediting that the cosmetic products and medical devices we manufacture are in line with an international standard of quality, safety and efficacy: UNE-EN ISO 22716 on Good Manufacturing Practices for Cosmetic Products and UNE-EN ISO 13485 on Medical Devices - Quality Management System.

The two standards are complementary, and acquiring both certifications means having all our internal processes audited and enables us to offer a global quality perspective in all our areas.

Since our foundation, we have always considered quality standards to be of the utmost importance. To ensure that we maintain this rigour and quality, which are an integral part of who we are as a company, we have our quality system audited annually by independent certifying bodies.

UNE-EN ISO 22716 Good Manufacturing Practices for Cosmetic Products

The International Organization for Standardization (ISO) published the ISO 22716 Standard in 2007 as a guideline for Good Manufacturing

Practices for Cosmetic Products. This standard implements Article 8 of European Regulation 1223/2009 on cosmetic products. The ISO 22716 Standard combines the benefits of Good Manufacturing Practices (GMP) and the implementation of a management system as a tool for driving continuous improvement all throughout the cosmetic product development process.

Neftis Laboratorios was one of the first Spanish companies to be certified under this ISO standard in 2014. The certification provides guidelines for manufacturing, packaging, control, storage and shipment.

Compliance with this certification ensures the quality of the products and of all the materials that make them up, as it controls the quality of all parts of the production chain. This allows Neftis Laboratorios to have all our internal processes audited, offering a global quality perspective in all our areas and achieving a final product with the expected quality levels according to the design.

UNE-EN ISO 13485 Medical Devices Quality Management System

This international standard supplements Annex IX of European Regulation 2017/745 on Medical Devices, which proposes a conformity assessment system based on a quality management system and the assessment of technical documentation.

The ISO 13485 Standard focuses on management of processes and their risks, continuous improvement and fulfilling client needs and expectations. In complying with this standard, we at Neftis Laboratorios demonstrate our capacity to provide medical devices that consistently meet client requirements as well as the applicable regulatory requirements.

Neftis Laboratorios achieved this certification in 2016, under the scope of subcutaneous sterile injectable devices and sterile and non-sterile devices for topical use. Compliance with this standard ensures the efficacy and safety of the medical devices at all stages of the product life cycle, ensuring that they have been developed using a high-quality process that is risk-free to the end user, since each step of the chain is perfectly assessed, controlled and subject to strict checks.

Renewal of Neftis Laboratorios certifications

Working with harmonised standards, such as the ISO standards, involves complying with all the essential requirements to obtain a high-quality contract manufacturer product.

Our annual audits under these ISO standards position us in the industry as a contract manufacturer partner that prioritises product quality over all else, enabling us to create commercial relationships based on an established level of quality and, as a result, a high level of client confidence and satisfaction.

The renewal of the certifications is validation of our work over more than 20 years and consolidates our company’s commitment to quality to guarantee efficient and professional work. We will always strive for continuous improvement in our processes to provide our clients with excellent service.

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