samis instruments ISO and CNC certificate
At Samis Instruments, quality, safety, and global standards are at the core of everything we do. We take great pride in announcing that our company has been awarded both the ISO 12528:2016 certificate and the CNC (Conformity ‘n Compliance) certificate of compliance. These certifications prove our commitment to manufacturing and exporting high-quality orthopedic, surgical, veterinary, and dental instruments. Both certificates confirm that our products are manufactured under strict quality management systems, following European and international standards.
The ISO 12528:2016 certificate has been issued by Alberk QA Akademi, a well-known and respected international certification body. This certificate shows that our quality management system meets the requirements of ISO 13485:2016, which is the global standard for medical devices. It confirms that our manufacturing processes are controlled, safe, and reliable. The ISO certificate was issued on 10th June 2024 and will remain valid until 10th June 2025, as long as we continue to follow the required standards. This certification ensures that all our instruments are made with a focus on safety, cleanliness, and accuracy, which is essential in the medical field.
In addition to ISO, we also proudly hold the CNC Certificate of Compliance. This certificate proves that our products follow the rules of the Medical Devices Directive 93/42/EEC, as updated by Directive 2007/47/EC. It shows that our instruments are compliant with the CE marking requirements. The CE marking is a legal necessity for selling medical devices in the European market. This means that our products are safe for use and meet all the essential health and safety guidelines required by the European Union.
According to the CNC certificate, our instruments are classified as Class I reusable, non-powered, and non-measuring devices, which means they are made to be used multiple times and do not contain any electronic parts or measuring tools. The certificate was issued on 25th March 2025 and will be valid until 24th March 2026. It was issued after a thorough review of our technical documentation, proving that we have followed all necessary steps for safety, design, and performance.
Our factory is located in Block C Commercial Area, Citi Housing Society, Sialkot, Punjab 51410, Pakistan, where all instruments are produced under the supervision of trained professionals using the best available materials and technologies. These certifications are not only documents — they are a mark of trust for our customers worldwide, especially doctors, surgeons, hospitals, and medical distributors who rely on us for precise and safe tools.
At Samis Instruments, we believe in continuous improvement and transparency. That’s why we’ve made it easy for anyone to verify our certificates.
In conclusion, our ISO and CNC certifications reflect our ongoing efforts to meet international quality and compliance standards. We are dedicated to producing instruments that are not just functional, but also safe, certified, and trusted by professionals around the globe. When you choose Samis Instruments, you choose reliability, quality, and compliance.

