Publisher's Synopsis
This EASY-to-understand book is ideal for all (Employees & Employers) and other people who are new to MDSAP, ISO 13485, (International Standard) who want to get more out of an established Quality Management System (QMS). Particularly for employees who just need a basic understanding of what MDSAP is and how it applies to them. This Book was written so that anyone at any level of the organization can get to the heart of the standard's requirements and how they apply to the organization quickly and simply. ISC certifies a wide range of professionals and organizations, including governmental entities, commercial businesses, and professional associations.
International Standard Certification (ISC) certification programs are based on recognized national and international compliance standards that ensure domestic and global acceptance. ISC is a certification body that Provides certification services. ISC Publishes different educational books and provides educational courses and certification services. ISC operates under industry-approved international standards and requirements and maintains integrity and impartiality while taking into account professional and public interests. International Standard Certification (ISC) provides objective evidence that a person or an organization operates at the highest level of ethical, legal, professional, and technical standards.
ISC certifies a wide range of professionals and organizations, including governmental entities, commercial businesses, and professional associations. International Standard Certification (ISC) certification programs are based on recognized national and international compliance standards that ensure domestic and global acceptance. www.iscasc.com
MDSAP The Medical Device Single Audit Program is the single audit program that covers the regulations of Australia, Brazil, Canada, Japan and USA. These regulations use the MDSAP to verify compliance to the quality systems of their national regulations and ISO 13485. The intention of the Medical Device Single Audit Program (MDSAP) is to allow competent auditors from MDSAP recognized Auditing Organizations (AOs) to conduct a single audit of a medical device organization's quality management system that will satisfy the requirements of the medical device regulatory authorities participating in the MDSAP program.
Audits performed under the MDSAP program will be process based, focusing on several defined processes, a defined method for linking those processes, and built on a foundation of requirements for risk management.
ISO 13485 MDSAP are two different programs with similar requirements but they do not duplicate each other.
MDSAP has the more stringent requirements of the two and companies that are already certified to ISO 13485 will see an increase in the number of audit days once they seek certification to MDSAP.
The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure a single audit will provide efficient yet thorough coverage of regulatory requirements.
These requirements include; Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016), the Quality Management System requirements of the Conformity Assessment Procedures of the Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch3), the Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013), the Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (MHLW Ministerial Ordinance No. 169), the Quality System
Regulation (21 CFR Part 820), and specific requirements of the medical device regulatory authorities participating in the MDSAP
program.
