The Medical Device Single Audit Program (MDSAP) is a certification program for the quality management system (QMS) of manufacturers who sell medical devices. MDSAP audit checklists help ensure compliance with ISO 13485:2016 and the verification of this by regulatory authorities. The MDSAP Audit Checklist is used to assess the readiness of medical device manufacturers for a MDSAP certification.
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4.1.1 Is objective evidence available to demonstrate that the MDSAP site has adequate infrastructure needed to implement the quality management system and to maintain its effectiveness?
4.1.2 Has the MDSAP site available resources to enhance customer satisfaction by meeting customer requirements?
4.1.3 Are personnel performing work affecting quality competent on the basis of appropriate education, training, skills, and experience?
4.1.4 Has the MDSAP site determined the necessary competence for personnel performing activities affecting product quality?
4.1.5 Are personnel who have been assigned QMS responsibilities qualified and deemed competent based on skills, experience, and education & training requirements?
4.2 Support – Internal Communication
MDSAP Quality Manual – Support - Section7.4 Communication
4.2.1 Is there communication between various levels and functions with respect to the processes of the management system?
5.1 Operation – Operational planning and control
MDSAP Quality Manual – Operation, Section 8.1 Operational planning and controlMDSAP Audit Procedures and FormsMDSAP Assessment Procedures and FormsMDSAP products and services: Assessment documentation, audit reports and manufacturer certificates
5.1.1 Has the MDSAP site planned and developed the processes needed for their products and services?
5.1.2 Is objective evidence available to demonstrate that the MDSAP site’s management ensures that the MDSAP staff uses defined procedures for performing work, for assuring work is reproducible, and for maintaining information integrity?
5.2 Operation – Release of Product and Services
MDSAP Quality Manual – Operation, Section 8.6 Release of products and servicesMDSAP Audit Procedures and FormsMDSAP Assessment Procedures and FormsMDSAP products and services: Assessment documentation, audit reports and manufacturer certificates
5.2.1 Does MDSAP measures and monitors product and services characteristics to verify that product and services requirements have been met?
5.2.2 Is there objective evidence that product and services acceptance criteria have been met?
5.2.3 Do records identify the person authorizing release of the products and services?
5.2.4 Are all specified activities performed before product release and service delivery?
5.2.5 If there are instances in which all specified activities have not been performed before product release or service delivery, has a relevant authority, or as appropriate the customer, been informed and approval gained?
5.3 Operation – Control of Non-conforming outputs
PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective ActionMDSAP Quality Manual – Operation, Section 8.7 Control of nonconforming outputs
5.3.1 Does each MDSAP site- ensure that a non-conforming output is identified and controlled to prevent unintended use or delivery?
5.3.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:
a. Assignment of responsibility for halting work where appropriate and ensuring work resumption upon resolution of non-conformity:
b. Making appropriate disposition on a non-conforming output:
c. When necessary, notifying the customer of the non-conformance.
5.3.3 Is non-conforming output corrected and subjected to re-verification after correction to demonstrate conformity?
5.3.4 When non-conforming output is detected after delivery or use has started, is appropriate action taken regarding the consequences of the non-conformity?
6.1 Performance Evaluation and Improvement – General
6.5.1 Does top management review the quality management system at planned intervals (at least annually), to determine the fitness and effectiveness of the quality system in achieving the stated quality objectives?
a. Does management review include management as well as the quality system manager?
6.5.2 Do management reviews include at a minimum:
a. Suitability of policies and procedures?
b. Changes that could affect the quality management system?
c. Outcome of recent audits?
d. Status of corrective and preventive actions and follow-up from prior management reviews?
e. Customer complaints/feedback?
f. Process performance?
g. Product conformity, including product related customer requirements?
h. Recommendations and opportunities for improvement?
i. Resources and staff training?
6.5.3 Do reviews evaluate the need to change the quality management system, including quality policy and quality objectives?
6.5.4 Are management reviews recorded to include:
a. Summary of findings
b. Decisions and actions related to improvement of the effectiveness and efficiency of the quality management system and its processes
c. Improvements related to customer requirements
d. Determination of resource needs
6.5.5 Are management reviews maintained and subsequent actions assigned, planned and monitored to completion?
6.6 Performance Evaluation and Improvement - Improvement – Nonconformity and Corrective Action
6.7.1 Is the site engaged in continual improvement of its work products, processes and services according to an established procedure?
6.7.2 Analysis of Data: Are appropriate data collected and analyzed to determine quality management system suitability and effectiveness, and to identify possible improvements?
6.7.3 How are data analyzed to provide information and identify opportunities for improvement on:
a. Customer satisfaction and/or dissatisfaction?
b. Conformance to customer requirements?
c. Characteristics of processes, products, and trends of quality characteristics?
d. Contractors’ performance?
6.7.4 Is there objective evidence available to demonstrate that the site’s management has created an environment that empowers and encourages staff to actively seek opportunities for improvement of performance in processes, services and products?
6.7.5 Are processes to achieve continual improvement of the quality management system planned and managed?
6.7.6 How is continual improvement of the quality management system facilitated through use of:
a. Quality policy?
b. Quality objectives?
c. Internal Audit results?
d. Analysis of data?
e. Corrective actions?
f. Management reviews to include reviews of corrective action reports, audit reports, and customer feedback?
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Please note that this checklist template is a hypothetical example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.
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