Dear Healthcare Professional:
Recent activity in the North American endoscopy market has created confusion and at times misinformation regarding the repair of endoscopes by 3rd party independent repair facilities.
At Total Scope, Inc. we can only speak of our documented processes and share information with you, the healthcare professional, regarding those systems and requirements. Total Scope Inc. is an ISO 13485 :2016 certified repair facility. Total Scope was the first independent repair facility in the United States to be ISO certified and has been ISO certified for 21 successive years. Total Scope Inc. adheres to stringent standards in the repair and parts procurement process for each and every endoscope.
In recent publications the FDA has announced its plan to migrate from QSR to ISO 13485:2016. This migration will provide our customers with further reassurance that our repair processes are in alignment with the FDA’s expectations.
In an effort to support your understanding of our requirements and accurate information regarding Total Scope Inc. we offer these brief but important ISO documentation requirements for process, acquisition of parts and quality assurance.
• Under 6.3 Infrastructure and 6.4 Work Environment, we are required to document the requirements for infrastructure and work environment needed to achieve conformity to product requirements. (product requirements are defined as OEM specifications)
• Under 7.2.1 Determination of requirements related to product and 7.2.2 Review of requirements related to product, we are required to review and document product requirements and ensure applicable regulatory requirements are met. We need to identify and ensure user training as well. (product requirements are defined as OEM specifications)
• Under 8.2.6 Monitoring and measurement of product, we are required to monitor and measure the characteristics of the product to verify that product requirements have been met. Evidence of conformity to the acceptance criteria shall be maintained. (product requirements are defined as OEM specifications)
In addition to the ISO standards that Total Scope Inc. follows for each and every product, there are additional requirements that Total Scope Inc. meets and follows as part of its certification. Total Scope Inc. must also meet the standards of the FDA Quality System Regulation 21 CFR 820.
Thank you for your interest in Total Scope Inc. as an independent endoscope and instrument service provider. If you have any questions regarding this information please contact our President, Denis Kennedy at 800-471-2255 and he will meet your needs.