1

Measurement, Analysis and Improvement 

Process 

CAPT Kimberly Lewandowski - Walker 

Senior Regulatory Officer 

Center for Devices and Radiological Health 

U.S. Food and Drug Administration
Course Prerequisites

• Successful completion of the following MDSAP training 

modules is a prerequisite to this course: 

– Introduction to the MDSAP Program 

– Overview of the MDSAP Audit Process 

– MDSAP: Management Process 

– MDSAP: Device Marketing Authorization and Facility 

Registration Process
Learning Objectives

• Explain the Measurement, Analysis and Improvement process 

• Describe the purpose of auditing the Measurement, Analysis 

and Improvement process 

• Discuss the expected outcomes from audit of the Measurement, 

Analysis and Improvement process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Learning Objectives

• Explain the Measurement, Analysis and Improvement process 

• Describe the purpose of auditing the Measurement, Analysis 

and Improvement process 

• Discuss the expected outcomes from audit of the Measurement, 

Analysis and Improvement process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Measurement, Analysis and 

Improvement Process

• Process activities that are one of the most important 

activity in the quality management system 

• Identifies existing and potential causes of product and 

quality problems 

• Identifies causes so that appropriate and effective 

corrective or preventive actions can take place 
Measurement, Analysis and 

Improvement Process

• Collects and analyzes information 

• Identifies and investigates existing and potential causes of 

product and quality problems 

• Takes appropriate and effective corrective or preventive action 

to prevent recurrence or occurrence 

• Verifies or validates the corrective and preventive actions 

• Communicates corrective and preventive action activities to 

responsible people 

• Provides relevant information for management review 

• Documents the activities performed 
Learning Objectives

• Explain the Measurement, Analysis and Improvement process 

• Describe the purpose of auditing the Measurement, Analysis 

and Improvement process 

• Discuss the expected outcomes from audit of the Measurement, 

Analysis and Improvement process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
MDSAP Audit Sequence
Purpose of Auditing

• Purpose of auditing the Measurement, Analysis and 

Improvement process is to: 

– Verify that information related to products, processes, or the 

quality management system is collected and analyzed to 

identify nonconformities 

– Verify that problems and potential problems are investigated 

– Take appropriate and effective corrective and preventive 

actions
Learning Objectives

• Explain the Measurement, Analysis and Improvement process 

• Describe the purpose of auditing the Measurement, Analysis 

and Improvement process 

• Discuss the expected outcomes from audit of the 

Measurement, Analysis and Improvement process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Expected Outcomes

As a result of the audit of the Measurement, Analysis and 

Improvement process, objective evidence will show whether the 

organization has: 

A. Defined, documented, and implemented procedures for 

measurement, analysis and improvement that address the 

requirements of the quality management system standard 

and participating MDSAP regulatory authorities 

B. Identified, analyzed, and monitored appropriate sources of 

quality data to identify nonconformities or potential 

nonconformities and determined the need for corrective or 

preventive action 
Expected Outcomes

As a result of the audit of the Measurement, Analysis and 

Improvement process, objective evidence will show whether the 

organization has: 

C. Ensured investigations are conducted to identify the 

underlying cause(s) of nonconformities and potential 

nonconformities, where possible 

D. Implemented appropriate corrective action to eliminate the 

recurrence, or preventive action to prevent the occurrence,

of product or quality system nonconformities, 

commensurate with the risks associated with the 

nonconformities or potential nonconformities encountered
Expected Outcomes

As a result of the audit of the Measurement, Analysis and 

Improvement process, objective evidence will show whether the 

organization has: 

E. Reviewed the effectiveness of corrective action and 

preventive action 

F. Utilized information from the analysis of production and 

post - production quality data to amend the analysis of 

product risk, as appropriate
Learning Objectives

• Explain the Measurement, Analysis and Improvement process 

• Describe the purpose of auditing the Measurement, Analysis 

and Improvement process 

• Discuss the expected outcomes from audit of the 

Measurement, Analysis and Improvement process 

• Explain the audit tasks to include: 

– Description and related Clauses and Regulations

– Country - specific requirements and assessment of conformity 

– Links to other MDSAP processes 
Task 1

1. Verify that procedures for measurement, analysis and improvement 

which address the requirements of the quality management system 

standard and regulatory authorities have been established and 

documented. Confirm the organization maintains and implements 

procedures to monitor and measure product conformity 

throughout product realization, as well as procedures that provide 

for mechanisms for feedback to provide early warnings of quality 

problems and the implementation of corrective action and 

preventive action. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 8.1, 8.2.1, 8.2.6, 8.5; 

TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f); RDC ANVISA 16/2013: 

5.3.1, 7.1, 7.2; MHLW MO169: 6, 54, 55 - 1, 58, 59, 62, 63, 64 (Old: 6, 

54, 55, 58, 59, 62, 63, 64); 21 CFR 820.100(a)]

MDSAP Audit Approach
Task 1

• Additional country - specific requirements: Brazil 

(ANVISA); and United States (FDA) 

• Assessing conformity: 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 1

16
Task 2

2. Determine if appropriate sources of quality data have been identified for input into 

the measurement, analysis and improvement process, including customer 

complaints, feedback, service records, returned product, internal and external 

audit findings, and data from the monitoring of products, processes, 

nonconforming products, and suppliers. Confirm that data from these sources are 

accurate and analyzed using valid statistical methods (where appropriate) to 

identify existing and potential product and quality management system 

nonconformities that may require corrective or preventive action. Information 

from the organization’s analysis of quality data should be used to inform the audit 

team’s decision as to specific complaint records to review in Task 12, and products 

and processes to audit during the Design and Development, Production and 

Service Controls, and Purchasing processes. 

Clause and Regulation: [ISO 13485:2016: 7.5.4, 8.1, 8.2.1, 8.2.6, 8.4; TG(MD)R 

Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f); RDC ANVISA 16/2013: 7.1.1.1, 9.1; MHLW 

MO169: 43, 54, 55-1, 58, 59, 61 (Old: 43, 54, 55, 58, 59, 61); 21 CFR 820.100(a)]

MDSAP Audit Approach
Task 2

• Additional country - specific requirements: None 

• Assessing conformity: 

– Review the previous audit report if there is one 

– Consider reviewing service records again 

– Sample raw quality data 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 2

18
Task 2

• Links: 

– Purchasing

ØDuring the audit of the Purchasing process 

o Consider selecting suppliers to audit that have 

corrective action indicators of nonconformities 

with supplied components or processes
Task 3

3. Determine if investigations are conducted to identify the 

underlying cause(s) of detected nonconformities, where 

possible. Confirm investigations are commensurate with the 

risk of the nonconformity. 

Clause and Regulation: [ISO 13485:2016: 8.5.2; TG(MD)R Sch3 

P1 1.4(3)(a),(b), (5)(b)(iii),(f), TG(MD)R Sch1 P1 2; RDC ANVISA 

16/2013: 2.4, 6.5.1, 7.1.1.2; MHLW MO169: 63; 21 CFR 820.100 

(a)(2)]

MDSAP Audit Approach
Task 3

• Additional country - specific requirements: None 

• Assessing conformity: 

– Select records of investigation where nonconformity has a 

higher risk of adversely affecting: 

ØThe finished device’s ability to meet its essential design outputs 

ØThe safety and efficacy of the product 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 3

21
Task 4

4. Determine if investigations are conducted to identify the 

underlying cause(s) of potential nonconformities, where 

possible. Confirm investigations are commensurate with the 

risk of the potential nonconformity. 

Clause and Regulation: [ISO 13485:2016: 8.5.3; TG(MD)R Sch3 

P1 1.4(3)(a),(b), (5)(b)(iii),(f),TG(MD)R Sch1 P1 2; RDC ANVISA 

16/2013: 2.4, 7.1.1.1; MHLW MO169: 64; 21 CFR 

820.100(a)(2)]

MDSAP Audit Approach
Task 4

• Additional country - specific requirements: None 

• Assessing conformity: 

– Select records of investigation where the potential 

nonconformity has a higher risk of adversely affecting: 

ØThe finished device’s ability to meet its essential design outputs 

ØThe safety and efficacy of the product 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 3: Measurement, 

Analysis and Improvement, under task 4

23
Task 5

5. Confirm that corrections, corrective actions, and preventive actions 

were determined, implemented, documented, effective, and did 

not adversely affect finished devices. Ensure corrective action and 

preventive action is appropriate to the risk of the nonconformities 

or potential nonconformities encountered. 

Clause and Regulation: [ISO 13485:2016: 8.2.1, 8.2.5, 8.3.1,8.5.2, 

8.5.3; TG(MD)R Sch1 P1 2, TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), 

(f); RDC ANVISA 16/2013: 2.4, 6.5, 7.1.1.3, 7.1.1.4, 7.1.1.5; MHLW 

MO169: 55 - 1, 57, 60 - 1, 63, 64 (Old: 55, 57, 60, 63, 64); 21 CFR 

820.100(a)(3), 820.100 (a)(4), 820.100(a)(6), 820.100(b)]

MDSAP Audit Approach
Task 5

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that the decision not to take corrective action was 

made using risk based decision 

– Look for problems or trends that continued or began after 

the actions were implemented 

Detailed information on country - specific requirements and 

how to assess conformity for this audit task can be found in the 

MDSAP Audit Approach, Chapter 3: Measurement, Analysis 

and Improvement, under task 5

25
Task 5

•Links: 

–Medical Device Adverse Events and Advisory 

Notices Reporting

Ø Determine whether any of the organization’s 

corrective actions require reporting to 

participating MDSAP authorities
Task 6

6. When a corrective or preventive action results in a design 

change, verify that any new hazard(s) and any new risks are 

evaluated under the risk management process. 

Clause and Regulation: [ISO 13485:2016: 7.1, 7.3.9; TG(MD)R 

Sch1 P1 2; RDC ANVISA 16/2013: 2.4, 4.1.10; MHLW MO169: 26, 

36-1 (Old: 26, 36); 21 CFR 820.30(i), 820.30(g)]

MDSAP Audit Approach
Task 6

• Additional country - specific requirements: None 

• Assessing conformity: 

Detailed information on how to assess conformity for this 

audit task can be found in the MDSAP Audit Approach, 

Chapter 3: Measurement, Analysis and Improvement, under 

task 6

28
Task 6

•Links: 

–Design and Development

Ø When necessary, confirm that design controls 

were applied to the change 

Ø Evaluate design changes as part of its risk 

management activities
Task 7

7. When a corrective or preventive action results in a process change, 

confirm that the process change is assessed to determine if any new 

risks to the product are introduced. Verify the manufacturer has 

performed revalidation of processes where appropriate. 

Clause and Regulation: [ISO 13485:2016: 4.1.2, 4.1.4, 4.1.6, 4.2.1, 7.1, 

7.5.2, 7.5.6, 7.5.7; TG(MD)R Sch1 P1 2; Sch3 P1 1.5(4); RDC ANVISA 

16/2013: 2.4, 5.6, 7.1.1.4; MHLW MO169: 5 - 2, 5 - 4, 5 - 6, 6, 26, 41, 45, 

46 (Old: 5, 6, 26, 41, 45, 46); 21 CFR 820.100(a)(4), 820.100(a)(5), 

820.70(b), 820.75(c)] 

MDSAP Audit Approach
Task 7

• Additional country - specific requirements: Australia (TGA); 

Canada (HC); and Japan (MHLW) 

• Assessing conformity: 

– Review evaluation of the process change to determine if 

revalidation is needed 

– Consider selecting suppliers for evaluation during audit of the 

Purchasing process that performed production and process 

changes 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 7 

31
Task 7

• Links:

– Production and Service Controls 

ØDuring audit of Production and Service Controls: 

o If the corrective action or preventive action involves 

changing a production process, consider selecting this 

process for evaluation

– Purchasing 

• During audit of Purchasing: 

o Consider selecting suppliers for evaluation that performed 

production and process changes 
Task 8

8. Verify that controls are in place to ensure that product which does 

not conform to product requirements is identified and controlled to 

prevent its unintended use or delivery. Confirm that an appropriate 

disposition was made, justified, and documented and that any 

external party responsible for the nonconformity was notified. 

Clause and Regulation: [ISO 13485:2016: 8.3.1, 8.3.2; TG(MD)R Sch3 

P1 1.4(5)(b)(iii); RDC ANVISA 16/2013: 6.5, 7.1.1.6; MHLW MO169: 

60-1, 60-2 (Old: 60); 21 CFR 820.90(a)]

MDSAP Audit Approach
Task 8

• Additional country - specific requirements: None 

• Assessing conformity: 

– Select a sample of records involving nonconforming product 

that was in stock or returned 

– Confirm that the decision to use nonconforming product was 

made using risk based decision making 

– Select records of nonconforming products where the 

nonconformity has a higher risk of adversely affecting: 

Ø The ability of the finished device to meet its essential design outputs 

Ø The safety and efficacy of the product. 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 8 

34
Task 9

9. Confirm that when nonconforming product is detected after 

delivery or use, appropriate action is taken commensurate 

with the risk, or potential risks, of the nonconformity. 

Clause and Regulation: [ISO 13485:2016: 8.3.3, 8.5.2; TG(MD)R 

Sch1 P1 2, TG(MD)R Sch3 P1 1.4(3)(a),(b), (5)(b)(iii), (f); RDC 

ANVISA 16/2013: 2.4, 7.1.1.8; MHLW MO169: 60 - 3, 63 (Old: 60, 

63); 21 CFR 820.100(a)]

MDSAP Audit Approach
Task 9

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that the control and actions to be taken on 

nonconforming products detected after delivery or use was 

determined 

– Confirm decisions are made using adequate risk justification 

Detailed information on how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 3: Measurement, 

Analysis and Improvement, under task 9 

36
Task 9

• Link: 

– Medical Device Adverse Events and Advisory 

Notices Reporting

ØConfirm that the appropriate MDSAP regulatory 

authorities have been notified, as necessary
Task 10

10. Verify that internal audits of the quality management system are 

being conducted according to planned arrangements and 

documented procedures to ensure the quality management system 

is in compliance with the established quality management system 

requirements and applicable regulatory requirements, and to 

determine the effectiveness of the quality system. Confirm the 

internal audits include provisions for auditor independence over 

the areas being audited, corrections, corrective actions, follow - up 

activities, and the verification of corrective actions. 

Clause and Regulation: [ISO 13485:2016: 6.2, 8.2.4; TG(MD)R Sch3 P1 

1.4(5)(b)(iii); RDC ANVISA 16/2013: 7.3; MHLW MO169: 22, 23, 56; 21 CFR 

820.22, 820.100]

MDSAP Audit Approach
Task 10

• Additional country - specific requirements: None 

• Assessing conformity: 

– Interview auditors and ask 

ØHow are audits conducted 

ØHow long audits typically last 

ØWhat documents are typically reviewed 

Detailed information on country - specific requirements and 

how to assess conformity for this audit task can be found in the 

MDSAP Audit Approach, Chapter 3: Measurement, Analysis 

and Improvement, under task 10

39
Task 10

• Links: 

– Management

ØDuring the audit of the Management process, 

the audit team should confirm that the output 

of internal audits is an input to management 

review.
Task 11

11. Determine if relevant information regarding nonconforming 

product, quality management system nonconformities, 

corrections, corrective actions, and preventive actions has 

been supplied to management for management review. 

Clause and Regulation: [ISO 13485:2016: 5.6.2; TG(MD)R Sch3 

P1 1.4(5)(b)(iii); RDC ANVISA 16/2013: 2.2.6, 7.1.1.7; MHLW 

MO169: 19; 21 CFR 820.100 (a)(7)]

MDSAP Audit Approach
Task 11

• Additional country - specific requirements: None 

• Assessing conformity: 

– Select a recent, significant corrective or preventive action 

– Determine which records or information regarding the event 

was submitted for management review 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 11 

42
Task 11

• Links: 

– Management

ØDuring the audit of the Management process: 

o Confirm that the status of corrective and 

preventive actions is an input to management 

review 
Task 12

12. Confirm that the manufacturer has made effective arrangements for gaining 

experience from the post - production phase, handling complaint, and investigating 

the cause of nonconformities related to advisory notices with provision for feedback 

 into Measurement, Analysis and Improvement process. 

Select records of complaints for review that represent the highest risk to the user or 

have the largest impact on the ability of the device to meet its essential design 

outputs. 

Verify information from the analysis of production and post - production quality 

data was considered for amending the analysis of product risk, as appropriate.

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.2.3, 7.5.4 (a) 8.2.1, 8.2.2; TG(MD)R 

Sch1 P1 2, Sch3 P1 1.4(3), 1.4(5)(b)(iii) &1.4(5)(f); RDC ANVISA 16/2013: 7.2; CMDR 

57 - 58; MHLW MO169: 6, 29, 43, 55 - 1, 55 - 2, 62 (Old: 6, 29, 43, 55, 62); 21 CFR 

820.198]

MDSAP Audit Approach
Task 12

• Additional country - specific requirements: Australia (TGA); 

Brazil (ANVISA); Canada (HC); Japan (MHLW); and United 

States (FDA) 

• Assessing conformity: 

– Review complaints and customer feedback 

– Review the analysis of complaint data and postmarket surveillance 

activities 

– Select one or more complaint failure modes 

Detailed information on country - specific requirements and how to assess 

conformity for this audit task can be found in the MDSAP Audit Approach, 

Chapter 3: Measurement, Analysis and Improvement, under task 12 

45
Task 12

• Links: 

– Medical Device Adverse Events and Advisory 

Notices Reporting 

ØDuring the review of complaints and feedback: 

o Confirm that individual medical device reports 

were made to the appropriate regulatory 

authorities when necessary. 

– Design and Development 

– Production and Service Controls 
Task 13

13. Where investigation determines that activities outside the 

organization contributed to a customer complaint, verify that 

records show that relevant information was exchanged 

between the organizations involved. 

Clause and Regulation: [ISO 13485:2016: 4.1.5, 7.4.1, 8.3.1; 

RDC ANVISA 16/2013: 7.1.1.6; MHLW MO169: 5 - 5, 37, 60 - 1 

(Old: 5, 37, 60); 21 CFR 820.100(a)(6)]

MDSAP Audit Approach
Task 13

• Additional country - specific requirements: None 

• Assessing conformity: 

– Confirm that information related to quality problems or 

nonconforming product is disseminated 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 13 

48
Task 13

• Links: 

– Purchasing

ØDuring the audit of the organization’s 

Purchasing process: 

ØIf significant nonconformities are related to supplied 

product, the audit team should consider selecting 

those suppliers for evaluation
Task 14

14. Verify that the medical device organization has defined and 

documented procedures for evaluation of complaints for adverse 

event reporting. 

Confirm that decisions to not report complaints were made 

according to established procedures and a documented rationale. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.2.3, 8.2.3; TG(MD)R 

Sch3 P1 1.4(3)(c); RDC ANVISA 16/2013: 7.1.1.8, RDC ANVISA 

67/2009; CMDR 59 - 61.1; MHLW MO169: 6, 29, 55 - 3 (Old; 6, 29, 62); 

21 CFR 803]

MDSAP Audit Approach
Task 14

• Additional country - specific requirements: Refer to MDSAP 

process Medical Device Adverse Events and Advisory 

Notices Reporting 

• Assessing conformity: 

– Asses whether the complaint was evaluated 

– Confirm the appropriate reports and information was provided to 

the regulatory authority when appropriate 

– Compare the submitted reports to the associated complaint and 

complaint investigation 

– Confirm that reportable events were evaluated for corrective 

action when necessary 

Detailed information on country - specific requirements and how to assess 

conformity for this audit task can be found in the MDSAP Audit Approach, 

Chapter 3: Measurement, Analysis and Improvement, under task 14 

51
Task 15

15. Confirm that the manufacturer has made effective arrangements for 

the timely evaluation of quality problems involving distributed 

product for potential issuance and implementation of advisory 

notices. 

Select records for review of quality problems that were evaluated for 

potential issuance of advisory notices (include records where a 

decision was made not to issue an advisory notice as well as records 

of decision to issue advisory notices) and assess whether the 

organization has taken actions appropriately based on risk and 

documented the rationale. 

Clause and Regulation: [ISO 13485:2016: 4.2.1, 7.2.3, 8.3.3; TG(MD)R 

Sch3 P1 1.4(3)(c); RDC ANVISA 16/2013: 7.1.1.8, RDC ANVISA 23/2012; 

CMDR 63 - 65.1; MHLW MO169: 6, 29, 60 - 3 (Old: 6, 29, 60); 21 CFR 806. 

820.100(a)] 

MDSAP Audit Approach
Task 15

• Additional country - specific requirements: Refer to MDSAP 

process Medical Device Adverse Events and Advisory 

Notices Reporting 

• Assessing conformity: 

– Select quality issues evaluated for potential advisory actions 

– Assess whether appropriate actions were taken and decisions 

were justified based on risk 

– Assess whether the scope of the quality issue was determined 

appropriately 

Detailed information on how to assess conformity for this audit 

task can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 15 

53
Task 16

16. Determine, based on the assessment of the Measurement, 

Analysis and Improvement process overall, whether 

management provides the necessary commitment to detect 

and address product and quality management system 

nonconformities, and ensure the continued suitability and 

effectiveness of the quality management system. 

Clause and Regulation: [ISO 13485:2016: 4.1.3, 5.2, 8.1, 8.5.1; 

RDC ANVISA 16/2013: 2.2.1; MHLW MO169: 5 - 3, 11, 54, 62; 

(Old: 5, 11, 54, 62)]

MDSAP Audit Approach
Task 16

• Additional country - specific requirements: None

• Assessing conformity: 

Information on and how to assess conformity for this audit task 

can be found in the MDSAP Audit Approach, Chapter 3: 

Measurement, Analysis and Improvement, under task 16.

55
Summary

• The Measurement, Analysis and Improvement process 

is the second primary process to be audited per the 

MDSAP audit sequence. 

• The identification of existing and potential causes of 

product and quality problems is: 

– One of the most important activities in the quality 

management system 

– Carried out under the Measurement, Analysis and 

Improvement process 
Conclusion

This concludes the training module for the MDSAP 

process: Measurement, Analysis and Improvement 
58