MDSAP Audit Checklist - Free Editable PDF | Lumiform

MDSAP audit checklist template

About the MDSAP audit checklist template

Using an MDSAP audit checklist is an effective way to streamline your compliance processes. This checklist is structured to cover key areas such as management responsibility, resource management, and product realization. By following this organized approach, you can ensure that all regulatory requirements are met efficiently.

An MDSAP audit checklist benefits you by providing a clear framework for audits, reducing the risk of overlooking critical compliance areas. This structured approach enhances your audit efficiency, saving time and resources. Additionally, it helps you identify gaps in your processes, allowing for proactive improvements.

By using a template like the MDSAP audit checklist, you can optimize your workflows and ensure that your organization consistently meets international standards. This not only boosts your credibility with stakeholders but also facilitates smoother operations, ultimately contributing to your business’s success.

Key elements of an MDSAP audit checklist template

Understanding the key elements of an MDSAP audit checklist template is essential for optimizing your compliance documentation. Here are the main components:

Management responsibility: Ensures that leadership is actively involved in maintaining compliance. This section helps you track management’s commitment to quality and regulatory standards by requiring documentation of management reviews, policy updates, and strategic planning. It emphasizes the role of top management in setting the tone for compliance culture.
Resource management: Focuses on the allocation and adequacy of resources such as personnel, infrastructure, and work environment. This ensures your organization has the necessary tools and skills to meet regulatory requirements efficiently. It involves assessing training needs, maintaining equipment, and ensuring a safe work environment, which are crucial for sustaining operational effectiveness.
Product realization: Captures the entire process from design to delivery, ensuring that all stages of product development align with international standards, minimizing the risk of non-compliance. This section includes design controls, supplier management, and production processes, ensuring products meet quality expectations and regulatory criteria.
Measurement, analysis, and improvement: Critical for continuous improvement, this section involves monitoring performance, analyzing data, and implementing corrective actions. It includes tracking key performance indicators, conducting audits, and managing corrective and preventive actions. This proactive approach enhances your organization’s ability to maintain compliance and improve overall quality by addressing issues before they escalate.

When to use the MDSAP audit checklist template

Using an MDSAP audit checklist template is crucial in several scenarios to enhance your compliance efforts. If your organization is preparing for an upcoming MDSAP audit, this template ensures you cover all necessary requirements efficiently. It’s also beneficial when you’re integrating new processes or products, as it helps align them with international standards.

In contexts where regulatory compliance is critical, such as expanding into new markets or maintaining certifications, the checklist serves as a comprehensive guide. This proactive approach minimizes risks and ensures consistent adherence to regulations. Additionally, during internal audits, the template helps identify gaps and areas for improvement, allowing you to address issues before they escalate.

By using the MDSAP audit checklist template, you can streamline your workflows, ensure thorough preparation, and maintain a high standard of compliance across your organization.

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Preview of the template

Quality Management System - Scope

1.1.1 Is objective evidence available to demonstrate that each site has defined, planned, and implemented MDSAP QMS quality management system?

1.1.2 Has each site improved the effectiveness of its QMS through the use of quality objectives, audit results, analysis of data, corrective and preventive actions, and management review?

1.1.3 Has each site identified the processes needed to implement MDSAP throughout the organization?

1.1.4 Have criteria and methods been established to ensure that the operation and control of these processes are effective?

1.1.5 Has a quality manager been appointed with defined responsibility and authority for ensuring that the management system related to quality is implemented?

1.1.6 Are processes measured, monitored, and analyzed with appropriate actions taken to achieve planned results and continual improvement?

1.2 Quality Management System Documented information

1.2.1 Are documents required for the quality management system properly controlled and managed?

1.2.2 Has each site implemented the MDSAP QMS P0002 in the following aspects:

a. Developing, reviewing and approving documents for adequacy before they are issued?

b. Reviewing, updating as necessary?

c. Re-approving changed documents to ensure adequacy prior to use?

d. Identifying and maintaining the current revision of documents?

e. Ensuring current documents remain legible, readily identifiable and retrievable?

f. Identifying and controlling documents of external origin?

g. Notifying staff of new, revised or cancelled documents?

h. Archiving superseded or obsolete documents?

i. Preventing unintended use of obsolete documents retained for any purpose?

1.2.3 Has the established MDSAP Quality Manual been implemented, including:

a. Scope of quality system, details and exclusion justifications?

b. MDSAP QMS Procedures?

c. Sequence and interaction of processes or reference to them?

1.2.4 Are records properly managed and controlled?

1.2.5 Has each site implemented the MDSAP QMS P0007 in the following aspects:

a. Identification?

b. Recording and error correction?

c. Electronic record identification and back up?

d. Access?

e. Retention?

f. Disposal?

g. Archiving?

1.2.6 Do the record control procedures cover reports, correspondence, and technical records, i.e. collection reports, analytical worksheets, equipment data recordings, etc.?

1.2.7 Do record control procedures cover quality records such as procedures, audit reports, corrective action reports, and management reviews?

2.1 –Leadership and Commitment - MDSAP Quality Manual – Section 5.1 Leadership and Commitment

2.1.1 Has the RAC demonstrated commitment to the QMS development and improvement by:

a. Communicating to the staff the importance of meeting customer as well as regulatory & legal requirements?

b. Communicating the established quality policy and quality objectives?

c. Conducting management reviews?

d. Ensuring availability of necessary resources?

2.2 Leadership - Customer Focus

MDSAP Quality Manual – Leadership - Section 5.1.2 Customer Focus

2.2.1 Does top management ensure that customer requirements are determined and met with the goal to achieve customer satisfaction?

2.2.2 Are customers and stakeholders kept informed?

2.3 Leadership - Policy

MDSAP Quality Manual – Leadership- Section 5.2 Policy MDSAP QMS F0001.1 QMS Policy and Objectives

2.3.1 Is there an established quality policy?

2.3.2 Has top management ensured that the quality policy is communicated and understood within each site?

2.3.3 Is the quality policy included in the document control process?

2.4 Leadership - Responsibility and Authority

MDSAP Quality Manual – Leadership - Section 5.3 Organizational roles, responsibilities and authorities

2.4.1 Are functions and their interrelations within each site defined and communicated?

2.4.2 Are responsibilities and authorities defined?

2.4.3 Is an individual appointed who has the responsibility and authority for ensuring QMS establishment, implementation, and maintenance?

3.1 Planning - Strategic and Quality Planning

MDSAP Quality Manual – Section 6. Planning MDSAP QMS F0001.1 QMS Policy and Objectives

3.1.1 Are there established quality objectives?

3.1.2 Is quality management system planning carried out to meet the requirements of the quality management system and the quality objectives?

3.1.3 If applicable, is there evidence that the integrity of the quality management system is maintained during changes?

4.1 Support – Resources, Competence and Awareness

PROCEDURE MDSAP QMS P0014 – Training MDSAP Quality Manual – Support – Section 7.1 Resources, Section 7.2 Competence and Section 7.3 Awareness

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 control MDSAP Audit Procedures and Forms MDSAP Assessment Procedures and Forms MDSAP 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 services MDSAP Audit Procedures and Forms MDSAP Assessment Procedures and Forms MDSAP 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 Action MDSAP 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

MDSAP Quality Manual – Performance Evaluation, Section 9.1.1 General PROCEDURE MDSAP QMS P0004 – Risk Management PROCEDURE MDSAP QMS P0013 – Continual Improvement

6.1.1 Is objective evidence available to demonstrate that MDSAP has defined, planned, and implemented the monitoring and measurement activities needed to assure conformity and to achieve improvement?

6.1.2 Are suitable methods used to measure and monitor these key processes?

6.1.3 Are the intended purposes of the key processes quantified by process parameter specifications, by specifications for the product output of the process or by some other means?

6.2 Performance Evaluation and Improvement – Monitoring, measurement, analysis and evaluation - Customer Satisfaction - Complaints & Feedback

PROCEDURE MDSAP QMS P0011 – Complaints and/or Customer Feedback PROCEDURE MDSAP QMS P0004 – Risk Management MDSAP Quality Manual –Performance evaluation – Section 9.1.2 Customer satisfaction

6.2.1 Are complaints properly documented, investigated and resolved?

6.2.2 Is feedback other than complaints properly documented and reviewed for opportunities to improve processes, services and work products?

6.2.3 Has each MDSAP site implemented the MDSAP QMS P0011 in the following aspects:

a. Receiving, documenting and categorizing complaints and feedback about any process, internal or external, that impacts MDSAP components’ processes, services or work products?

b. Processing the complaint?

c. Determination and investigation of adverse impact?

d. For complaints with adverse impact, initiation of corrective action process to resolve the complaint or elevate the issue to the appropriate level for resolution?

e. Including complaints/feedback in audits and internal management reviews to ensure that follow-ups were effective in correcting the root causes?

f. Review to determine if actions taken in response to complaints or feedback were sufficient and appropriate?

g. Closing complaints after corrective action has been completed?

6.2.4 Is complaint data tracked and trended in the CAPA system?

6.2.5 Is customer satisfaction information recorded and monitored?

6.2.6 Is customer feedback analyzed for trends and improvements?

6.3 Performance Evaluation and Improvement – Analysis and Evaluation

MDSAP Quality Manual – Performance Evaluation, Section 9.1.3 Analysis and Evaluation PROCEDURE MDSAP QMS P0013 – Continual Improvement

6.3.1 Does MDSAP analyze data to determine the suitability and effectiveness of the quality management system?

6.3.2 Does MDSAP analyze data to identify improvements that can be made?

6.3.3 Does MDSAP analyze data to provide information on customer satisfaction?

6.3.4 Does MDSAP analyze data to provide information on conformance to product and services requirements?

6.3.5 Does MDSAP analyze data to provide information on trends?

6.4 Performance Evaluation and Improvement - Monitoring, measurement, analysis and evaluation - Internal Assessment/Audit and Continual Improvement

PROCEDURE MDSAP QMS P0008 – Internal Assessment PROCEDURE MDSAP QMS P0013 – Continual Improvement PROCEDURE MDSAP QMS P0004 – Risk Management MDSAP Quality Manual – Performance Evaluation - Section 9.2 Internal Audit

6.4.1 Are internal audits systematically conducted to monitor and determine compliance with the requirements of the MDSAP quality management system?

6.4.2 Has each MDSAP site implemented the MDSAP QMS P0008 in the following aspects:

a. Implementation of responsibilities for management?

b. Implementation of responsibilities by the quality system manager?

c. Implementation of responsibilities for auditor?

6.4.3 Are audits carried out by trained and qualified personnel?

a. Are audits conducted by people other than those who performed activities being audited?

b. Are records of auditor training and/or qualifications maintained and available?

6.4.4 Are audits conducted in accordance with planned scope and schedules, taking into account the results of previous audits?

6.4.5 Are audit findings documented on the appropriate forms and reports, according to documented procedures?

6.4.6 Does management take timely corrective action on deficiencies found during audits?

In the event the audit discloses a problem with incorrect procedures or invalid processes, is immediate corrective action taken?

6.4.7 Do follow-ups verify and document corrective action implementation and effectiveness?

6.4.8 Is the final audit report, with resolutions, submitted to management for final approval?

6.4.9 Is the audit closed after final approval of the audit report from management?

6.5 Performance Evaluation and Improvement - Management Review

PROCEDURE MDSAP QMS P0005 – Management Responsibility and Management Review PROCEDURE MDSAP QMS P0013 – Continual Improvement PROCEDURE MDSAP QMS P0004 – Risk Management MDSAP Quality Manual –Performance Evaluation - Section 9.3 Management Review

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

PROCEDURE MDSAP QMS P0009 – Nonconformity and Corrective Action PROCEDURE MDSAP QMS P0013 – Continual Improvement PROCEDURE MDSAP QMS P0004 – Risk Management MDSAP Quality Manual – Improvement - Section 10.2 Nonconformity and corrective action

6.6.1 Does each MDSAP site identify, document, investigate, track and correct the causes of non-conformances?

6.6.2 Has each MDSAP site implemented the MDSAP QMS P0009 in the following aspects:

a. Identifying non-conformities, including those contained in customer complaints?

b. Investigation to examine the extent?

c. Determining the root cause of non-conformity to prevent recurrence?

d. Determining and implementing corrective actions needed?

e. Implementing corrective actions appropriate to the magnitude of the problem?

f. Recording results of corrective actions?

g. Reviewing corrective actions taken to determine their effectiveness?

h. Stopping work if necessary until the non-conformance is addressed?

i. Approval of by the initiator’s immediate manager of the correction action?

j. Closing the corrective action when there is objective evidence that the action is completed and effective?

6.6.3 Do procedures require that processes/services/work products will not be used until the problem is resolved and verified by the appropriate manager and quality system manager?

6.6.4 For corrective actions initiated due to complaints, are customers contacted to confirm their concerns have been met prior to closing corrective actions?

6.6.5 Do procedures ensure relevant information on corrective actions is reviewed during audits and submitted for management review?

6.7 Performance Evaluation and Improvement - Improvement - Continual Improvement

PROCEDURE MDSAP QMS P0013 – Continual Improvement MDSAP Quality Manual – Improvement, Section 10.3 Continual Improvement

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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Frequently asked questions

What is the purpose of an MDSAP audit checklist?

An MDSAP audit checklist helps ensure compliance with international regulatory standards for medical devices. It provides a structured approach to audits, reducing the risk of missing critical compliance areas and ensuring that all regulatory requirements are met efficiently, which can alleviate the stress of complex audits.

How can an MDSAP audit checklist improve my compliance process?

An MDSAP audit checklist streamlines your compliance process by organizing all necessary tasks and documentation. It helps you identify gaps and areas for improvement, allowing for proactive adjustments. This structured approach not only saves time but also enhances the accuracy and effectiveness of your audits.

Who should use an MDSAP audit checklist?

Quality assurance managers, regulatory compliance officers, and internal auditors in medical device companies should use an MDSAP audit checklist. It ensures that all aspects of the quality management system are thoroughly evaluated, helping organizations maintain compliance and avoid costly regulatory issues.

What are common challenges when using an MDSAP audit checklist?

Common challenges include ensuring comprehensive coverage of all regulatory requirements and keeping the checklist up-to-date with changing standards. Overcoming these challenges requires regular reviews and updates of the checklist, along with ongoing training for staff to ensure they understand and effectively use the checklist.

This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.