Hi friends!!!

In our previous blog we had a introduction about Medical Device Single Audit Program, MDSAP Audit Cycle and Management process Audit Task 1 -5 Please check out for the link below.

Medical Device Single Audit Program – Part 1

MDSAP Audit Cycle – Part 2

MDSAP Management Process Audit – Part 3

In today’s blog we will discuss in detail about Medical Device Single Audit Program (MDSAP) Management Process Audit Tasks 6 – 11

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

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.

In our previous blog, we have discussed about Tasks 1 – 5. Now we will discuss about Task 6 – 11

Let’s discuss in detail about each task.

TASK 6: Personnel Competency and Training

Ensure that the medical device organization has defined necessary competencies for personnel’s performing activities affecting product quality. Ensure that medical device organization is providing appropriate training for personnel’s influencing the quality of the product. Make sure that medical device organization has created awareness on importance and relevance of employee’s activities with respect to product quality and achievement of quality objectives.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.2.1, 6.2.

FDA: 21 CFR 820.20(b) (2), 820.25

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

MHLW/PMDA: MO169: 6, 22, 23, 25.4

As per ANVISA Brazilian regulation, Any consultancy which is giving advice to the manufacturing firm regarding design, purchase, manufacturing, packaging, labelling, storage, installation and service should have appropriate qualification to do so. This consultancy should be contracted as a service supplier by the manufacturing firm as per RDC ANVISA 16/2013: 2.2.3.

TASK 7: Risk Management Planning and Review

Ensure that medical device organizations management has commitment for overall risk management planning. Check the management’s ongoing review for effectiveness of risk management activities including policies, practices and procedures which are documented and executed for analyzing, evaluating and controlling product risk throughout product realization. The top management should be responsible for forming the risk acceptability criteria.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.2 (b), 7.1.

FDA: 21 CFR 820.30(g).

TGA: TG(MD)R Sch1 P1 2

ANVISA: RDC ANVISA 16/2013: 2.4

MHLW/PMDA: MO169: 26.

TASK 8: Document and Record Control

Ensure that procedures for document and record control have been defined, documented and implemented for both internal and external origin documents required by QMS. Ensure that medical device organization retains atleast one obsolete copy of controlled documents for a period atleast equivalent to lifetime of the medical device which should not be less than 2 years from the date of product release.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.4, 4.2.1, 4.2.4, 4.2.5.

FDA: 21 CFR 820.40, 820.180.

TGA: TG(MD)R Sch3 P1 1.4(4).

ANVISA: RDC ANVISA 16/2013: 3.1.

MHLW/PMDA: MO169: 5, 6, 8, 9.

TASK 9: Management Reviews

Ensure that management review procedure has been documented. Ensure that management reviews are conducted at planned intervals. Ensure that management review includes the review of quality policy, quality objectives, quality management systems suitability and effectiveness to ensure that medical device organizations quality management system meets all applicable regulatory requirements.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 5.6.

FDA: 21 CFR820.20(c).

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

ANVISA: RDC ANVISA 16/2013: 2.2.6.

MHLW/PMDA: MO169: 18, 19, 20.

TASK 10 – Distribution of Devices with appropriate Marketing Authorization

Verify that only devices having appropriate marketing authorization are distribution or offered for commercial distribution in only applicable markets. Ensure that medical device organization has identified and documented the responsibilities of employees for ensuring proper registration, licensing, notification, approval information and listing. The same should be submitted to regulatory authorities.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3.

TASK 11 – Top Management  Commitment to Quality

Verify that top management has demonstrated necessary commitment to ensure the suitability and effectiveness of quality management system. Verify that the effectiveness of quality management system has been communicated to personnel.

APPLICABLE REGULATORY STANDARDS AND CLAUSE

ISO 13485:2016: 4.1.1, 4.1.4, 5.1, 5.5.3

FDA: 21 CFR 820.20(a), 820.5.

ANVISA: RDC ANVISA 16/2013: 2.1, 2.2.1.

MHLW/PMDA: MO169: 5, 10, 17.