Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program and MDSAP Audit Cycle. Please check out for the link below.

Medical Device Single Audit Program - Part 1

In today's blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) Management Process Audit

MDSAP is a common Medical Device auditing program followed by countries like Australia, USA, Brazil, Canada and Japan. Therefore it is important for every healthcare professionals who wish to market their product in the above mentioned countries to know in detail about MDSAP.

Let's get into the topic.

MANAGEMENT PROCESS AUDIT

The purpose of auditing the management process is to ensure whether the top management demonstrated a necessary commitment to establish a effective quality management system. There are totally 11 tasks to be performed during management process audit. The tasks are as follows.

Task 1: QMS Planning, Implementation, Changes and Quality Manual.

Task 2: Management Representative.

Task 3: Quality Policy and Quality Objectives.

Task 4: Organizational Structure, Responsibility, Authority and Resources.

Task 5: Extent of Outsourcing.

Task 6: Personnel Competency and Training.

Task 7: Risk Management Planning and Review.

Task 8: Document and Record Controls.

Task 9: Management Reviews.

Task 10: Distribution of Devices with Appropriate Marketing Authorization.

Task 11: Top Management Commitment to Quality.

Let’s discuss in detail about each task.

Task 1: QMS Planning, Implementation, Changes and Quality

Manual

Confirm QMS planning is done to ensure all processes are identified, documented, implemented, monitored and controlled in order to confirm to applicable regulatory requirements. Verify whether changed in QMS are managed to maintain the conformity of QMS. Verify that the quality manual is documented.

When there is a change in QMS to continue to be effective, quality planning in this regard should satisfy clause 7.1. of ISO 13485;2016.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 4.1.1, 4.1.2, 4.1.3, 4.1.4, 4.2.2, 5.4.2.

FDA: 21 CFR 820.20.

TGA: TG(MD)R Sch3 P1 1.4(4).

ANVISA: RDC ANVISA 16/2013: 2.1, 5.6.

MHLW/PMDA: MHLW MO169: 5, 7, 14.

Task 2: Management Representative

Verify whether Top Management has documented the appointment of Management Representative. Verify the responsibilities of Management representative. Ensure that responsibilities include reporting to top management on the performance of organizations QMS and promotion of applicable regulatory requirements throughout the medical device organization.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 5.5.2.

FDA: 21 CFR 820.20(b).

TGA: TG(MD)R Sch3 P1 1.4(5)(b)(ii).

ANVISA: RDC ANVISA 16/2013: 2.2.5.

MHLW/PMDA: MHLW MO169: 16.

Task 3: Quality Policy and Quality Objectives

Check whether quality policy and objectives are set for all functions and levels of medical device organization. Ensure that quality objectives are measurable and in accordance with quality policy. Confirm the measures taken to achieve quality objectives.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016. Clause 5.3, 5.4.1.

FDA: 21 CFR 820.20(a).

TGA: TG(MD)R Sch3 P1 1.4(5)(a).

ANVISA: RDC ANVISA 16/2013: 2.2.1.

MHLW/PMDA: MHLW MO169: 12, 13.

Task 4: Organizational Structure, Responsibility, Authority and

Resources

Check the medical device organizations structure and related documents to ensure that they include provisions for authorities, responsibilities, infrastructure, competencies and training to ensure that the personnel employed should have the necessary competence to design and manufacture medical devices in accordance with applicable regulatory requirements.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 5.1, 5.5.1, 5.5.2, 6.1, 6.2.

FDA: 21 CFR 820.20(b), 820.25.

TGA: TG(MD)R Sch3 P1 1.4(5)(b).

ANVISA: RDC ANVISA 16/2013: 2.2.2, 2.2.3. 2.2.4, 2.3.

MHLW/PMDA: MHLW MO169: 10, 15, 16, 21, 22, 23.

Task 5: Extent of Outsourcing

Check that the critical suppliers list is current and accurate. Specify the extent of outsourcing with respect to applicable regulatory requirements. Verify the documentation of controls in organizations QMS.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.5, 4.2.1.

FDA: 21 CFR 820.50.

TGA: TG (MD)R Sch3 P1 1.4(5) (b)(iii), (d)(ii).

ANVISA: RDC ANVISA 16/2013: 2.5.

MHLW/PMDA: MHLW MO169: 5, 6

Now I hope you have acquired some knowledge about MDSAP Management Process Audit. We will discuss in detail about remaining tasks of management process audit in our future blogs.

NOTE: Dear friends!!!... Please do comment a topic related to Biomedical, so that we can discuss it in future blogs.

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