[Audio] We are here to provide a briefing and training on conducting Internal Audits (Q-M-S--). Our presentation will cover the requirements and provide explanations of each element. We will also discuss the Medical Device Single Audit Program (M-D-S-A-P) and its audit elements. Our aim is to give you a comprehensive understanding of the internal audit process and how to effectively conduct internal audits in your organization. We believe that this knowledge will help you improve the quality and safety of your medical devices and enhance patient care.. 

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Internal Audit (QMS) – Briefing and Training

Prepared by   	: Noor Azreen Binti Mohd Anuar Revision date	: 24/06/2024 Reference	: JB-05-202 Internal Audit Management Procedure,00066410 CORP PROC AUDIT (CONDUCT/HOST)

[Audio] Internal audits must be conducted according to a documented procedure to ensure the ongoing effectiveness and conformity of the Q-M-S-. The frequency of audits may vary depending on the organization's size complexity and risk profile. Audit criteria and scope should be defined including ISO 13485 requirements regulatory requirements organizational policies objectives and processes. Competent auditors should be selected to assess the Q-M-S and identify areas for improvement. Audit results should be documented including non-conformities and opportunities for improvement. Follow-up activities should be conducted to verify the effectiveness of corrective actions and close identified non-conformities to ensure the Q-M-S continues to meet ISO 13485 requirements and organizational objectives over time.. 

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The organization shall conduct internal audits at planned intervals to determine whether the quality
management system:
a) conforms to planned and documented arrangements, requirements of this International Standard,
quality management system requirements established by the organization, and applicable
regulatory requirements;
b) is effectively implemented and maintained.
The organization shall document a procedure to describe the responsibilities and requirements for
planning and conducting audits and recording and reporting audit results.
An audit program shall be planned, taking into consideration the status and importance of the processes
and area to be audited, as well as the results of previous audits. The audit criteria, scope, interval and
methods shall be defined and recorded (see 4.2.5). The selection of auditors and conduct of audits shall
ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.
Records of the audits and their results, including identification of the processes and areas audited and
the conclusions, shall be maintained (see 4.2.5).
The management responsible for the area being audited shall ensure that any necessary corrections
and corrective actions are taken without undue delay to eliminate detected nonconformities and their
causes. Follow-up activities shall include the verification of the actions taken and the reporting of
verification results.
Further information can be found in ISO 19011.
NOTE

[Audio] Medical device manufacturers are invited to attend a briefing and training on the Internal Audit (Q-M-S--) process. The presentation is known as JB-05-202. M-D-S-A-P is a regulatory audit that simplifies the process for manufacturers and ensures compliance across multiple countries. Participating authorities include the F-D-A (U S ) Health Canada and other regulatory agencies. The audit covers various aspects such as management device marketing authorization facility registration measurement and improvement medical device adverse events design and development production and service controls and purchasing. By attending this audit manufacturers can improve safety and oversight of their products and services while ensuring regulatory compliance.. 

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CHAPTER 1: MANAGEMENT CHAPTER 2: DEVICE MARKETING AUTHORIZATION AND FACILITY REGISTRATION  CHAPTER 3: MEASUREMENT, ANALYSIS AND IMPROVEMENT  CHAPTER 4: MEDICAL DEVICE ADVERSE EVENTS AND ADVISORY NOTICES REPORTING  CHAPTER 5: DESIGN AND DEVELOPMENT (NA) CHAPTER 6: PRODUCTION AND SERVICE CONTROLS  CHAPTER 7: PURCHASING

Medical Device Single Audit Program (MDSAP)

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[Audio] The process flow for conducting an effective internal audit is presented outlining the steps that an auditor must follow. The auditor proceeds to conduct the audit following the guidelines provided in ISO 19011 and any other relevant procedures and standards. Once the audit is completed any nonconformities found are submitted to the Q-S-E department which documents the audit findings and escalates any nonconformities in SmartSolve. This process is designed to ensure systematic and effective audits which helps improve the quality and efficiency of management systems.. 

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JB-05-202 Internal Audit Management Procedure Rev N

< Internal
Audit
Process>
I .Prepare anrual
intemal auiit plan
& scheme
aldit plan &
3.Cceuni cat ion
4. O*ning meeting
before audit
5. Cmduct
7. Prepue audit
S. Closhg
meet ing
NCR/CAPA
report (if appliable)
9Approve audi t
report
10. Distribute
NQ/CAPA r90rt
II. Rcøt cause analyze
and detercine
containmenVcorrection
æ•.d corrective action
audi t
14. Close NCR/CAPA
report archive
12. Cmduct
Containm.ent/
ccrrætion and
corrective action
3. Verify effetiveress
of corrective action

[Audio] During the audit process the Team Lead holds numerous responsibilities. These include coordinating with the auditee and the audit team to establish the audit schedule executing the audit and preparing the audit checklist. The Team Lead must also ensure that any N-C-R C-A-P-A or RA is verified before closing the action item and that effective communication is maintained with the Lead Auditor and audit team. Furthermore the Team Lead must promptly address any concerns or issues raised by the audit team to ensure that the audit is conducted in accordance with the audit scheme and within the time frame.. 

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Lead Auditor Coordinate Internal Audit (Preparation, Opening until closing audit) Prepare Annual audit plan, Audit Strategy, Internal Audit Scheme, Internal Audit Quality System Report, Audit Checklist Compile Audit Checklist from Team lead.  Issue NCR/CAPA and RA if any and close the NCR accordingly
 Team Lead (Rotate - at least once every year) Make arrangement with respective auditee and audit team on audit schedule and do invitation Conduct audit, complete audit checklist accordingly, Compile audit checklist by audit team and submit to Lead Auditor Clarify with Lead Auditor for any issue or concern raise by audit team. To ensure audit done according to audit scheme within audit time frame. Ensure NCR/CAPA (if any) is verified effective.
 Auditor Conduct Audit according to arrangement make by Team Lead Complete audit checklist for team lead compilation Support team lead to ensure audit team task completed within audit time

[Audio] We conducted an internal audit of the Recruitment & Training process in the Human Resources department. The audit report was submitted to Q-S-E including audit findings recommendations and corrective actions. The audit report was reviewed by the Quality Assurance team to ensure compliance with ISO 13485:2016 standard. The audit was conducted in accordance with the procedure number 6610 and the audit findings were recorded using the JB-05-403 Internal Audit Checklist. Auditors identified conformities and nonconformities during the audit and the audit report was acknowledged by the auditee for major minor opportunities for improvement good practices and no findings.. 

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[image] Audited Process: Recruitment & Training
Department: H uman Resources
A uditor.
MN C = (Major non conformity) NC = (M inor non conformity)
Internal Audit Checklist
Audit Date: 20/1/2022
Audit Time:
OFI
Responsible: Miza, Sebastian
(Opportunity tor improvement) GP = (Good practice) NF=No finding
IS013485
No.
Clause
Additional
requirement I
Regulation
Related
Document
A udit Question
Verity previous Audit finding or any
CAPA/NCR raise pass 6 months
A udit Evidence
MNC/NC/
OFI/GP/NF
Acknowledged by
auditee (applicd)le for
MNC/NC/OFI)
It any
b Recmihent,
geEctDi1 & Temjwalbw accoxling b HR
pncedue

[Audio] The procedure number referenced in the presentation is 6610. The checklist is created based on relevant documents standards and the M-D-S-A-P audit approach and IA strategy. It should contain at least 2 – 3 questions from the M-D-S-A-P audit model for each group. Audit evidence should align with the audit question. If you ask to audit 3 samples write down the details of those 3 samples in the audit evidence. If you ask about the person in charge or training please write down the employee no. or position and date of training of the audited person. Sample you take should be from the passed 6 months as Internal audit happens twice yearly. Please ensure that the correct standard ISO13485:2016 clause is addressed in each row especially for other requirements than ISO13485:2016. You may address the respective clause in the column Additional requirement/regulation column. Address C-A-P-A or N-C-R number in the audit checklist – Q-S-E will give you the final copy of NCR/CAPA for printing and sign off.. 

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Checklist is created based on relevant documents, standards and MDSAP Audit approach and IA strategy. Checklist should contain at least 2 – 3 questions from MDSAP audit model for each group. Audit Evidence should align with audit question. Especially when you take the question from MDSAP model audit. Example 1:  If you asking to audit 3 samples then write down the details of those 3 samples in Audit evidence.  Example 2: If you asking about person in charge or training, please write down the employee no. or position and date of training of audited person. Example 3: Sample you take should from passed 6 months as Internal audit happen twice yearly Please ensure correct standard ISO13485:2016 clause is address in each row especially for other requirement than ISO13485:2016, you may address the respective clause in the column “ Additional requirement/regulation” column. Address CAPA or NCR number in Audit checklist – QSE will give you final copy of NCR/CAPA for printing and sign off. Hence kindly ensure the NCR/CAPA number is define in audit checklist too. Please ensure the finding in the NCR report similar with your audit checklist. Especially on the audit finding description.

[Audio] During the internal audit (Q-M-S--) briefing and training different types of audit findings can be identified. These findings can be either conformity or nonconformity. Nonconformities occur when there is a failure to fulfill a specified requirement. This can include minor nonconformities significant failures to implement and maintain conformance to the requirements of applicable standards and several recurrent nonconformities that could result in the probable shipment of NC products. Additionally audit findings can include minor issues that could lead to major NCs failures to comply with applicable standards or legislations and single observed lapses in following on items of a company's Q-M-S--. However it is important to note that additional effectiveness or robustness might be possible with a modified approach to audit findings. Other findings such as observations comments or recommendations outside the applicable standards can also be identified. Overall our goal is to provide a comprehensive overview of the different types of audit findings and how they can help improve your company's Q-M-S-.. 

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Audit finding can indicate either conformity or nonconformity. Nonconformity: Nonfulfillment of a specified requirement

Significant failure to implement and/or maintain conformance to the requirements of the applicable standards Several minor NCs A recurrent NC Resulting probable shipment of NC products

Minor issue that could lead to a major NC A failure to comply applicable standards/ legislations Failure in some part of company’s QMS Single observed lapse in following on item of a company’s QMS

Additional effectiveness or robustness might be possible with a modified approach Other finding such as observation, comment or recommendations outside the applicable standard

[Audio] We conduct an Internal Audit briefing and training today. Our presentation JB-05-202 contains various documents related to this topic. Important documents such as the BCS JB Legal and Regulatory the Internal Audit Management Procedure and the Internal Audit Checklist will be discussed. Additionally we will be discussing the Corrective and Preventive Action Working Instruction 0301640 GOP Risk Management Procedure 0320650 and other important documents related to our internal audit process.. 

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Standard in BCS JB Legal and Regulatory - All Documents (sharepoint.com) Internal audit folder and MDSAP audit Model:  	R:\BCS\05 Quality & Regulatory\Internal Audit\2024 Internal Audit Related documents JB-05-202 Internal Audit Management Procedure JB-05-403 Internal Audit Checklist JB-05-404 Internal Audit NCR Report JB-05-312 Corrective and Preventive Action Working Instruction 0301640 GOP Risk Management Procedure 0320650 TEMPL, GOP RISK ANALYSIS_220518 00066420 CORP PROC CORRECTPREVENT ACTN

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Scene 0

We are here to provide a briefing and training on conducting Internal Audits (Q-M-S--). Our presentation will cover the requirements and provide explanations of each element. We will also discuss the Medical Device Single Audit Program (M-D-S-A-P) and its audit elements. Our aim is to give you a comprehensive understanding of the internal audit process and how to effectively conduct internal audits in your organization. We believe that this knowledge will help you improve the quality and safety of your medical devices and enhance patient care.

avatar

Internal audits must be conducted according to a documented procedure to ensure the ongoing effectiveness and conformity of the Q-M-S-.
                                     The frequency of audits may vary depending on the organization's size
 complexity
 and risk profile.
                                     Audit criteria and scope should be defined
 including ISO 13485 requirements
 regulatory requirements
 organizational policies
 objectives
 and processes.
                                     Competent auditors should be selected to assess the Q-M-S and identify areas for improvement.
                                     Audit results should be documented
 including non-conformities and opportunities for improvement.
                                     Follow-up activities should be conducted to verify the effectiveness of corrective actions and close identified non-conformities to ensure the Q-M-S continues to meet ISO 13485 requirements and organizational objectives over time.

slide2-hotlink2

Medical device manufacturers are invited to attend a briefing and training on the Internal Audit (Q-M-S--) process. The presentation is known as JB-05-202. M-D-S-A-P is a regulatory audit that simplifies the process for manufacturers and ensures compliance across multiple countries. Participating authorities include the F-D-A (U S )
 Health Canada
 and other regulatory agencies. The audit covers various aspects such as management
 device marketing authorization
 facility registration
 measurement and improvement
 medical device adverse events
 design and development
 production and service controls
 and purchasing. By attending this audit
 manufacturers can improve safety and oversight of their products and services
 while ensuring regulatory compliance.

slide3-hotlink20

The process flow for conducting an effective internal audit is presented
 outlining the steps that an auditor must follow. The auditor proceeds to conduct the audit
 following the guidelines provided in ISO 19011 and any other relevant procedures and standards. Once the audit is completed
 any nonconformities found are submitted to the Q-S-E department
 which documents the audit findings and escalates any nonconformities in SmartSolve. This process is designed to ensure systematic and effective audits
 which helps improve the quality and efficiency of management systems.

slide4-hotlink8

During the audit process
 the Team Lead holds numerous responsibilities. These include coordinating with the auditee and the audit team to establish the audit schedule
 executing the audit
 and preparing the audit checklist. The Team Lead must also ensure that any N-C-R
 C-A-P-A
 or RA is verified before closing the action item and that effective communication is maintained with the Lead Auditor and audit team. Furthermore
 the Team Lead must promptly address any concerns or issues raised by the audit team to ensure that the audit is conducted in accordance with the audit scheme and within the time frame.

We conducted an internal audit of the Recruitment & Training process in the Human Resources department. The audit report was submitted to Q-S-E
 including audit findings
 recommendations
 and corrective actions. The audit report was reviewed by the Quality Assurance team to ensure compliance with ISO 13485:2016 standard. The audit was conducted in accordance with the procedure number 6610
 and the audit findings were recorded using the JB-05-403 Internal Audit Checklist. Auditors identified conformities and nonconformities during the audit
 and the audit report was acknowledged by the auditee for major
 minor
 opportunities for improvement
 good practices
 and no findings.

slide6-hotlink2

The procedure number referenced in the presentation is 6610.
                                     The checklist is created based on relevant documents
 standards
 and the M-D-S-A-P audit approach and IA strategy.
                                     It should contain at least 2 – 3 questions from the M-D-S-A-P audit model for each group.
                                     Audit evidence should align with the audit question.
                                     If you ask to audit 3 samples
 write down the details of those 3 samples in the audit evidence.
                                     If you ask about the person in charge or training
 please write down the employee no. or position and date of training of the audited person.
                                     Sample you take should be from the passed 6 months as Internal audit happens twice yearly.
                                     Please ensure that the correct standard ISO13485:2016 clause is addressed in each row
 especially for other requirements than ISO13485:2016.
                                     You may address the respective clause in the column Additional requirement/regulation column.
                                     Address C-A-P-A or N-C-R number in the audit checklist – Q-S-E will give you the final copy of NCR/CAPA for printing and sign off.

slide7-hotlink8

During the internal audit (Q-M-S--) briefing and training
 different types of audit findings can be identified. These findings can be either conformity or nonconformity. Nonconformities occur when there is a failure to fulfill a specified requirement. This can include minor nonconformities
 significant failures to implement and maintain conformance to the requirements of applicable standards
 and several recurrent nonconformities that could result in the probable shipment of NC products. Additionally
 audit findings can include minor issues that could lead to major NCs
 failures to comply with applicable standards or legislations
 and single observed lapses in following on items of a company's Q-M-S--. However
 it is important to note that additional effectiveness or robustness might be possible with a modified approach to audit findings. Other findings such as observations
 comments
 or recommendations outside the applicable standards can also be identified. Overall
 our goal is to provide a comprehensive overview of the different types of audit findings and how they can help improve your company's Q-M-S-.

We conduct an Internal Audit briefing and training today. Our presentation
 JB-05-202
 contains various documents related to this topic. Important documents such as the BCS JB Legal and Regulatory
 the Internal Audit Management Procedure
 and the Internal Audit Checklist will be discussed. Additionally
 we will be discussing the Corrective and Preventive Action Working Instruction 0301640
 GOP Risk Management Procedure 0320650
 and other important documents related to our internal audit process.

 Standard in BCS JB Legal and Regulatory - All Documents (sharepoint.com) Internal audit folder and MDSAP audit Model:  	R:\BCS\05 Quality & Regulatory\Internal Audit\2024 Internal Audit Related documents JB-05-202 Internal Audit Management Procedure JB-05-403 Internal Audit Checklist JB-05-404 Internal Audit NCR Report JB-05-312 Corrective and Preventive Action Working Instruction 0301640 GOP Risk Management Procedure 0320650 TEMPL, GOP RISK ANALYSIS_220518 00066420 CORP PROC CORRECTPREVENT ACTN