MDSAP Audit Process Sequence

MDSAP Audit Process

The design of the Medical Device Single Audit Program (MDSAP) audit process is to ensure that a single audit provides efficient and complete coverage of regulatory requirements. These requirements include:

• Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016);
• Quality Management System Requirements of the Australian Therapeutic Goods (Medical Devices) Regulations Conformity Assessment Procedures (TG(MD)R Sch3);
• Brazilian Good Manufacturing Practices (RDC ANVISA 16/2013);
• Japanese Ordinance on Standards for Manufacturing Control and Quality Control of Medical Devices and In Vitro Diagnostic Reagents (Ministerial Ordinance No. 169 MHLW);
• Quality System Regulation for the United States (21 CFR Part 820);
• Specific requirements of medical device regulatory authorities participating in the MDSAP program.

Audit Sequence

The design and development of the MDSAP audit sequence allow for logical, focused, and efficient conduct of an audit. The MDSAP audit sequence follows a process approach and has four main processes:

• management process;
• measurement, analysis, and improvement process;
• design and development process;
• production and service control process, with links to the procurement support process.

The definition of each process includes a purpose and an outcome that are indicators of process performance. Each participating Regulatory Authority expects risk management to be the foundation for these processes, which are the requirements of a quality management system for medical device organizations. The MDSAP audit process also has two other support processes:

• Authorization for Commercialization of Devices and Registration of Installations;
• Medical Device Adverse Event Reports and Warnings.

These processes are necessary to meet the specific requirements of regulatory authorities participating in the MDSAP.

The following Figure illustrates the MDSAP audit sequence and interrelationships. The design of the MDSAP audit approach requires auditing the primary MDSAP processes in the following sequence:

(1) Management;

(2) Measurement, Analysis, and Improvement;

(3) Design and Development;

(4) Production and Service Control Processes.

Auditing the Procurement process is in conjunction with the Measurement, Analysis, and Improvement process, the Design, and Development process, and the Production and Service Controls process.

Each MDSAP audit process will require the audit team to perform audit tasks to determine whether the results of the process and the purposes of the process were achieved. Many audit tasks require verification of the availability and control of documentation and record specific to the MDSAP regulator (jurisdiction that a manufacturer intends to market its products).

MDSAP Audit Cycle

The Medical Device Single Audit Program is based on a three-year audit cycle. The Initial Audit, also known as the “Initial Certification Audit,” is a complete audit of a medical device organization’s quality management system (QMS), consisting of a Stage 1 Audit and a Stage 2 Audit. The Initial Audit is followed by a partial Surveillance Audit in each of the next two years and then a full audit, also called a “Recertification Audit” in the third year. A recertification audit may also include a Stage 1 audit if there are significant changes to the QMS that need to be adequately assessed.

Request the form for MDSAP from NCC Certificações.

Source: MDSAP AU P0002.006 – MDSAP AUDIT APPROACH