Sample calculation of audit duration

Manufacturer: Date:

Initial Audit (Stage 1 + Stage 2) Surveillance #1

MDSAP Process Number of Tasks Number of Time per Number of Time per
per Process Applicable Tasks to Process Applicable Tasks to Process
be Audited (hh:mm) be Audited (hh:mm)

Management 11 2 1:12 2 0:57

DMA&FR 3 1 0:35 3 1:24
MA&I 16 2.3 1:27 4 2:01
MDAE&ANR 2 1 0:38 4 2:01
D&D 17 23 8:03 43 12:02
P&SC 29 22 16:08 4 2:20
Purchasing 16 3 0:45 3 0:36
Sub-Total 94 54.3 28:48 63 21:24

Additional time, as deemed

necessary by the Auditing 5:00
Organization, including for Stage 1 if
applicable (hh:mm)
Adjustment (%) 10% 2:52 22% 5:48
Total (hh:mm) 31:41 32:12

Duration of Audit (mandays) 3 days and 8 hours 4 days and 0 hours

n of audit duration
AO's personel

Surveillance #2 Recertification (without Stage 1)

Number of Time per Number of Time per

Applicable Tasks to Process Applicable Tasks to Process
be Audited (hh:mm) be Audited (hh:mm)

3 1:26 3 1:26
2 0:56 2 0:56
3 1:31 3 1:31
3 1:31 3 1:31
4 1:07 3 0:50
22 12:54 3 1:45
3 0:36 3 0:36
40 20:02 20 8:36

12:00 1:23

22% 7:02 -2% - 00:11

39:05 9:47

4 days and 7 hours 1 days and 2 hours

Manufacturer:
Date:
AO's person:

Task#

Process: Management
1 Verify that a quality manual, management review, and quality management system procedures and instructions have
been defined and documented.
2 Confirm top management has documented the appointment of a management representative. Verify the
responsibilities of the management representative include ensuring that quality management system requirements
are effectively established and maintained, reporting to top management on the performance of the quality
management system, and ensuring the promotion of awareness of regulatory requirements throughout the
organization.

3 Verify that a quality policy and objectives have been set at relevant functions and levels within the organization.
Ensure the quality objectives are measurable and consistent with the quality policy. Confirm appropriate measures
are taken to achieve the quality objectives.

4 Review the manufacturer’s organizational structure and related documents to verify that they include provisions for
responsibilities, authorities (e.g., management representative), personnel, resources for infrastructure,
competencies, and training to ensure that personnel have the necessary competence to design and manufacture
devices in accordance with the planned arrangements and applicable regulatory requirements.

5 Determine the extent of outsourcing of processes that may affect the conformity of product with specified
requirements and verify the proper documentation of controls in the quality management system.

6 Confirm the organization has determined the necessary competencies for personnel performing work affecting
product quality, provided appropriate training, and made personnel aware of the relevance and importance of their
activities on product quality and achievement of the quality objectives. Ensure records of training and competencies
are maintained.
7 Verify that management has committed to and has responsibility for overall risk management
planning, including ongoing review of the effectiveness of risk management activities ensuring that policies,
procedures and practices are established and documented for analyzing, evaluating and controlling product risk
throughout product realization.
8 Verify that procedures have been defined, documented, and implemented for the control of documents and records
required by the quality management system. Confirm the organization retains records and at least one obsolete copy
of controlled documents for a period of time at least equivalent to the lifetime of the device, but not less than two
years from the date of product release.

9 Verify that management reviews are being conducted at planned intervals and that they include a review of the
suitability and effectiveness of the quality policy, quality objectives, and quality management system to assure that
the quality management system meets all applicable regulatory requirements.
10 Confirm that management has identified and ensured the applicable device marketing authorization and facility
registration processes have been followed and that appropriate documents have been submitted to the applicable
regulatory authorities in the markets in which the devices are offered for commercial distribution.
11 At the conclusion of the audit, a decision should be made as to whether top management has demonstrated the
necessary commitment to ensure a suitable and effective quality management system is in place and being
maintained and whether the effectiveness of the system has been communicated to personnel.

Process: Device Marketing Authorization and Facility Registration

1 Verify the organization has complied with regulatory requirements to register and/or license device facilities and
submit device listing information in the appropriate jurisdictions where the organization markets or distributes
devices.
 2 Confirm the organization has received appropriate device marketing authorization in the regulatory jurisdictions
where the organization markets its devices.

3 Verify the organization has arranged for assessment of the change (where applicable) and obtained marketing
authorization for changes to devices or the quality management system which require amendment to existing
marketing authorization.

Process: Measurement, Analysis and Improvement

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.

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 thees 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.

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.

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.

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 non- conformities or potential nonconformities encountered.

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.

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.

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.

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.
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 that 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.

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.
12 Confirm that the manufacturer has made effective arrangements for gaining experience from the post-production
phase, handling complaints, and investigating the cause of nonconformities related to advisory notices with provision
for feedback into the Measurement, Analysis and Improvement process. Verify that information from the analysis of
production and post-production quality data was considered for amending the analysis of product risk, as
appropriate.
 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.

14 Verify that the organization has defined and documented procedures for the notification of adverse events. Confirm
adverse event reporting is performed according to the applicable regulatory requirements.

15 Confirm that the manufacturer has made effective arrangements for the timely issuance and implementation of
advisory notices. Confirm that reporting of advisory notices is performed according to the applicable regulatory
requirements.
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.

Process: Medical Device Adverse Events and Advisory Notices Reporting

1 Verify that the organization has a process in place for identifying device-related events that may meet reporting
criteria as defined by participating regulatory authorities. Verify that the complaint process has a mechanism for
reviewing each complaint to determine if a report to a regulatory authority is required. Confirm that the organization’s
processes meet the timeframes required by each regulatory authority where the product is marketed.

2 Verify that advisory notices are reported to regulatory authorities when necessary and comply with the timeframes
and recordkeeping requirements established by participating regulatory authorities.

Process: Design and Development

1 Verify that those devices that are, by regulation, subject to design and development procedures have been
identified.
2 Select a completed (where applicable) design and development project for review.
3 Verify that the design and development process is planned and controlled. Review the design plan for the selected
design and development project to understand the design and development activities; including the design and
development stages, the review, verification, validation, and design transfer activities that are appropriate at each
stage; and the assignment of responsibilities, authorities, and interfaces between different groups involved in design
and development.

4 For the device design and development record(s) selected, verify that design and development procedures have
been established and applied. Confirm the design and development procedures address the design and
development stages, review, verification, validation, design transfer, and design changes.

5 Verify that design and development inputs were established, reviewed and approved; and that they address
customer functional, performance and safety requirements, intended use, applicable regulatory requirements, and
other requirements including
those arising from human factors issues, essential for design and development. Verify that any risks and risk
mitigation measures identified during the risk management process are used as an input in the design and
development process.

6 Confirm that the design and development inputs are complete, unambiguous, and not in conflict with each other.

7 Review medical device specifications to confirm that design and development outputs are traceable to and satisfy
design input requirements. Verify that the design and development outputs essential for the proper functioning of the
medical device have been identified. Outputs include, but are not limited to, device specifications, specifications for
the manufacturing process, the quality assurance testing, and device labeling and packaging.

8 Verify that risk management activities are defined and implemented for product and process design and
development. Confirm that risk acceptability criteria are established and met throughout the design and
development process. Verify that any residual risk is evaluated and, where appropriate, communicated to the
customer (e.g., labeling, service documents, advisory notices, etc.).
 9 Confirm that design verification and/or design validation includes assurances that risk control measures are
effective in controlling or reducing risk.

10 Verify that design and development validation data show that the approved design meets the requirements for the
specified application or intended use(s). Verify that design validation testing is adjusted according to the risk of the
product and element being validated.

11 Verify that clinical evaluations and/or evaluation of the medical device safety and performance were performed as
part of design validation if required by national or regional regulations.
12 If the medical device contains software, verify that the software was subject to the design and development process.
Confirm that the software was included within the risk management process.
13 Verify that design and development changes were controlled, verified (or where appropriate validated), and
approved prior to implementation. Confirm that any new risks associated with the design change have been
identified and mitigated to the extent practical.

14 Verify that design reviews were conducted at suitable stages as required by the design and development plan.
Confirm that the participants in the reviews include representatives of functions concerned with the design and
development stage being reviewed, as well as any specialist personnel needed.

15 Verify that design changes have been reviewed for the effect on products previously made and delivered, and that
records of review results are maintained.
16 Determine if the design was correctly transferred to production.
17 Determine, based on the assessment of the design and development process overall, whether management
provides the necessary commitment to the design and development process.

Process: Production and Service Controls

1 Verify that the product realization processes are planned, including any necessary controls, controlled conditions,
and risk management activities required for the product to meet the specified or intended uses and the statutory and
regulatory requirements related to the product. Confirm that the planning of product realization is consistent with the
requirements of the other processes of the quality management system and performed in consideration of the quality
objectives.

2 Review production processes considering the following criteria. Select one or more production processes to audit.
3 For each selected process, determine if the production and service process is planned and conducted under
controlled conditions (…)
4 Determine if the organization has established documented requirements for product cleanliness including any
cleaning prior to sterilization, cleanliness requirements if provided non-sterile, and assuring that process agents are
removed from the product if required.

5 Verify that the organization has determined and documented the infrastructure requirements to achieve product
conformity, including buildings, workspace, process equipment, and supporting services. Confirm that buildings,
workspaces, and supporting services allow product to meet requirements. Verify that there are documented and
implemented requirements for maintenance of process equipment
where important for product quality, and that records of maintenance are maintained.

6 Verify documented requirements have been established, implemented and maintained (…)
7 Determine if the selected process(es) and sub-process(es) have been reviewed, including any outsourced
processes, to determine if validation of these processes is required.

8 Verify that the selected process(es) has been validated if the result of the process cannot be fully verified. Confirm
that the validation demonstrates the ability of the process(es) to consistently achieve the planned result. In the event
changes have occurred to a previously validated process, confirm that the process was reviewed and evaluated, and
re-validation was performed where appropriate.
9 If product is supplied sterile:
•    Verify the sterilization process is validated, periodically re-validated, and records of the
validation are available
•    Verify that devices sold in a sterile state are manufactured and sterilized under
appropriately controlled conditions
•    Determine if the sterilization process and results are documented and traceable to
10 each
Verify that the system for monitoring and measuring of product characteristics is capable of demonstrating the
conformity of products to specified requirements. Confirm that product risk is considered in the type and extent of
product monitoring activities.

11 Verify that the processes used in production and service are appropriately controlled, monitored, and operated within
specified limits. In addition, verify that risk control measures identified by the manufacturer for
production processes are implemented, monitored and evaluated.

12 Verify that personnel are competent to implement and maintain the processes in accordance with the requirements
identified by the organization.

13 Confirm that the organization has determined the monitoring and measuring devices needed to provide evidence of
conformity to specified requirements. Verify that the monitoring and measuring equipment used in production and
service control has been identified, adjusted, calibrated and maintained, and capable of producing valid results.

14 Confirm that the organization assesses (and records) the validity of previous measurements when equipment is
found not to conform to specified requirements, and takes appropriate action on the equipment and any product
affected. Verify that the control of the monitoring and measuring devices is adequate to ensure valid
results. Confirm that monitoring and measuring devices are protected from damage or deterioration.

15 If the selected process is software controlled or if software is used in production equipment or the quality
management system, verify that the software is validated for its intended use. Software validation may be part of
equipment qualification.

16 Determine if the manufacturer has established and maintained a file for each type of device that includes or refers to
the location of device specifications, production process specifications, quality assurance procedures, traceability
requirements, and packaging
and labeling specifications. Confirm  that the manufacturer  determined the extent of
traceability based on the risk  posed by the device in the event the device does not meet specified
requirements.
17 Determine if the manufacturer has established and maintained a record of the amount manufactured and approved
for distribution for each batch of medical devices, the record is verified and approved, and the device is
manufactured according to the file referenced in task 16.

18 If the organization manufactures active or nonactive implantable medical devices, life-supporting or life-sustaining
devices, confirm that the manufacturer maintains traceability records of all components, materials, and work
environment conditions (if these could cause the medical device to not satisfy its specified requirements) in addition
to records of the identity of personnel performing any inspection or testing
of these devices. Confirm that the organization requires that agents or distributors of these devices maintain
distribution records and makes them available for inspection. Verify that the organization records the name and
address of shipping consignees for these devices.

19 Verify that product status identification is adequate to ensure that only product which has passed the required
inspections and tests is dispatched, used, or installed.
20 Verify that the organization has implemented controls to identify, verify, protect, and safeguard customer property
provided for use or incorporation into the product. Verify that the organization treats patient information and
confidential health information as customer property.
21 Verify that acceptance activities assure conformity with specifications and are documented. Confirm that the extent
of acceptance activities is commensurate with the risk posed by the device.
22 Verify that the identification, control, and disposition of nonconforming products is adequate, based on the risk the
nonconformity poses to the device meeting its specified requirements.
 23 If a product needs to be reworked, confirm that the manufacturer has made a determination of any adverse effect of
the rework upon the product. Verify that the rework process has been performed according to an approved
procedure, that the results of the rework have been documented, and that the reworked product has been re-verified
to demonstrate conformity to requirements.

24 Verify that procedures are established and maintained for preserving the conformity
of product and constituent parts of a product during internal processing, storage, and transport to the intended
destination. This preservation encompasses identification, handling, packaging, storage, and protection, including
those products with limited shelf-life or requiring special storage conditions.

25 Confirm that the organization performs a review of the customer’s requirements, including the purchase order
requirements, prior to the organization’s commitment to supply a product to a customer. Verify that the organization
maintains documentation required by regulatory authorities regarding maintenance of distribution records.

26 If installation activities are required, confirm that records of installation and verification activities are maintained.

27 Determine if servicing activities are conducted and documented in accordance with defined and implemented
instructions and procedures. Confirm that service records are used as a source of quality data in the Measurement,
Analysis and Improvement process.
28 When appropriate, verify that risk control and mitigation measures are applied to transport, installation and
servicing, in accordance with the organization’s risk management practices.
29 Determine, based on the assessment of the production and service control process overall, whether management
provides the necessary commitment to the production and service control process to ensure devices meet specified
requirements and quality objectives.

Purchasing
1 Verify that planning activities describe or identify products to purchase and processes to outsource, the specified
requirements for purchased products, the requirements
for purchasing documentation and records, purchasing resources, the activities for purchased product acceptance,
and risk management in supplier selection and purchasing.

2 Select one or more supplier evaluation files to audit.

3 Verify that procedures for ensuring purchased product conforms to purchasing requirements have been established
and documented.
4 Verify that the procedures assure the type and extent of control applied to the supplier and the purchased product is
dependent upon the effect of the purchased product on subsequent product realization or the final product.

5 Verify that criteria for the selection, evaluation and re-evaluation of suppliers have been established.
6 Verify that suppliers are selected based on their ability to supply product or services
in accordance with the manufacturer’s specified requirements. Confirm  that the degree of control
applied  to the supplier  is commensurate with  the significance of the
supplied  product or service on the quality  of the finished device, based on risk.

7 Verify that records of supplier evaluations are maintained.

8 Verify that the manufacturer maintains effective controls over suppliers and product, so that specified requirements
continue to be met.
9 Confirm that the re-evaluation of the capability of suppliers to meet specified requirements is performed at
intervals consistent with the significance of the product on the finished device.

10 Verify that the organization assures the adequacy of purchasing requirements for products and services that
suppliers are to provide, and defines risk management activities and any necessary risk control measures. Confirm
that the manufacturer ensures the adequacy of specified purchase requirements prior to their communication to the
supplier.
 11 Verify that the organization documents purchasing information, including where appropriate the requirements for
approval of product, procedures, processes, equipment, qualification of personnel, and other quality management
system requirements.
12 Verify that documents and records for purchasing are consistent with traceability requirements where applicable.

13 Confirm that the verification (inspection or other activities) of purchased products is adequate to ensure specified
requirements are met. Confirm that the manufacturer has implemented an appropriate combination of controls
applied to the supplier, the specification of purchase requirements, and acceptance verification activities that are
commensurate with the risk of the supplied product upon the finished device.

14 Verify that records of verification activities are maintained.

15 Verify that data from the evaluation of suppliers, verification activities, and purchasing are considered as a source of
quality data for input into the Measurement, Analysis and Improvement process.

16 Determine, based on the assessment of the overall purchasing, whether management provides the necessary
commitment to the purchase process.
Number of planned tasks

Sub-Total (hh:mm)

Additional time, as deemed necessary by the Auditing Organization,

including for Stage 1 if applicable (hh:mm)

Adjustment (%) *
Adjustment (hh:mm)

Total (hh:mm)

SUMMARY

*Adjustment may be positive or negative. The rationale for any adjustment needs to be documented.
 Task

ess: Management
Verify that a quality manual, management review, and quality management system procedures and instructions have
been defined and documented.
Confirm top management has documented the appointment of a management representative. Verify the
responsibilities of the management representative include ensuring that quality management system requirements
are effectively established and maintained, reporting to top management on the performance of the quality
management system, and ensuring the promotion of awareness of regulatory requirements throughout the
organization.
Verify that a quality policy and objectives have been set at relevant functions and levels within the organization.
Ensure the quality objectives are measurable and consistent with the quality policy. Confirm appropriate measures
are taken to achieve the quality objectives.

Review the manufacturer’s organizational structure and related documents to verify that they include provisions for
responsibilities, authorities (e.g., management representative), personnel, resources for infrastructure,
competencies, and training to ensure that personnel have the necessary competence to design and manufacture
devices in accordance with the planned arrangements and applicable regulatory requirements.

Determine the extent of outsourcing of processes that may affect the conformity of product with specified
requirements and verify the proper documentation of controls in the quality management system.

Confirm the organization has determined the necessary competencies for personnel performing work affecting
product quality, provided appropriate training, and made personnel aware of the relevance and importance of their
activities on product quality and achievement of the quality objectives. Ensure records of training and competencies
are maintained.
Verify that management has committed to and has responsibility for overall risk management
planning, including ongoing review of the effectiveness of risk management activities ensuring that policies,
procedures and practices are established and documented for analyzing, evaluating and controlling product risk
throughout product realization.
Verify that procedures have been defined, documented, and implemented for the control of documents and records
required by the quality management system. Confirm the organization retains records and at least one obsolete copy
of controlled documents for a period of time at least equivalent to the lifetime of the device, but not less than two
years from the date of product release.

Verify that management reviews are being conducted at planned intervals and that they include a review of the
suitability and effectiveness of the quality policy, quality objectives, and quality management system to assure that
the quality management system meets all applicable regulatory requirements.
Confirm that management has identified and ensured the applicable device marketing authorization and facility
registration processes have been followed and that appropriate documents have been submitted to the applicable
regulatory authorities in the markets in which the devices are offered for commercial distribution.
At the conclusion of the audit, a decision should be made as to whether top management has demonstrated the
necessary commitment to ensure a suitable and effective quality management system is in place and being
maintained and whether the effectiveness of the system has been communicated to personnel.

Number of planned tasks

Process Time
ess: Device Marketing Authorization and Facility Registration
Verify the organization has complied with regulatory requirements to register and/or license device facilities and
submit device listing information in the appropriate jurisdictions where the organization markets or distributes
devices.
 Confirm the organization has received appropriate device marketing authorization in the regulatory jurisdictions
where the organization markets its devices.
Verify the organization has arranged for assessment of the change (where applicable) and obtained marketing
authorization for changes to devices or the quality management system which require amendment to existing
marketing authorization.

Number of planned tasks

Process Time
ess: Measurement, Analysis and Improvement
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.

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 thees 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.

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.

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.

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 non- conformities or potential nonconformities encountered.

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.

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.

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.
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.
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 that 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.

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.
Confirm that the manufacturer has made effective arrangements for gaining experience from the post-production
phase, handling complaints, and investigating the cause of nonconformities related to advisory notices with provision
for feedback into the Measurement, Analysis and Improvement process. Verify that information from the analysis of
production and post-production quality data was considered for amending the analysis of product risk, as
appropriate.
 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.

Verify that the organization has defined and documented procedures for the notification of adverse events. Confirm
adverse event reporting is performed according to the applicable regulatory requirements.
Confirm that the manufacturer has made effective arrangements for the timely issuance and implementation of
advisory notices. Confirm that reporting of advisory notices is performed according to the applicable regulatory
requirements.
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.

Number of planned tasks

Process Time
ess: Medical Device Adverse Events and Advisory Notices Reporting
Verify that the organization has a process in place for identifying device-related events that may meet reporting
criteria as defined by participating regulatory authorities. Verify that the complaint process has a mechanism for
reviewing each complaint to determine if a report to a regulatory authority is required. Confirm that the organization’s
processes meet the timeframes required by each regulatory authority where the product is marketed.

Verify that advisory notices are reported to regulatory authorities when necessary and comply with the timeframes
and recordkeeping requirements established by participating regulatory authorities.
Number of planned tasks
Process Time
ess: Design and Development
Verify that those devices that are, by regulation, subject to design and development procedures have been
identified.
Select a completed (where applicable) design and development project for review.
Verify that the design and development process is planned and controlled. Review the design plan for the selected
design and development project to understand the design and development activities; including the design and
development stages, the review, verification, validation, and design transfer activities that are appropriate at each
stage; and the assignment of responsibilities, authorities, and interfaces between different groups involved in design
and development.

For the device design and development record(s) selected, verify that design and development procedures have
been established and applied. Confirm the design and development procedures address the design and
development stages, review, verification, validation, design transfer, and design changes.

Verify that design and development inputs were established, reviewed and approved; and that they address
customer functional, performance and safety requirements, intended use, applicable regulatory requirements, and
other requirements including
those arising from human factors issues, essential for design and development. Verify that any risks and risk
mitigation measures identified during the risk management process are used as an input in the design and
development process.

Confirm that the design and development inputs are complete, unambiguous, and not in conflict with each other.
Review medical device specifications to confirm that design and development outputs are traceable to and satisfy
design input requirements. Verify that the design and development outputs essential for the proper functioning of the
medical device have been identified. Outputs include, but are not limited to, device specifications, specifications for
the manufacturing process, the quality assurance testing, and device labeling and packaging.

Verify that risk management activities are defined and implemented for product and process design and
development. Confirm that risk acceptability criteria are established and met throughout the design and
development process. Verify that any residual risk is evaluated and, where appropriate, communicated to the
customer (e.g., labeling, service documents, advisory notices, etc.).
 Confirm that design verification and/or design validation includes assurances that risk control measures are
effective in controlling or reducing risk.

Verify that design and development validation data show that the approved design meets the requirements for the
specified application or intended use(s). Verify that design validation testing is adjusted according to the risk of the
product and element being validated.

Verify that clinical evaluations and/or evaluation of the medical device safety and performance were performed as
part of design validation if required by national or regional regulations.
If the medical device contains software, verify that the software was subject to the design and development process.
Confirm that the software was included within the risk management process.
Verify that design and development changes were controlled, verified (or where appropriate validated), and
approved prior to implementation. Confirm that any new risks associated with the design change have been
identified and mitigated to the extent practical.

Verify that design reviews were conducted at suitable stages as required by the design and development plan.
Confirm that the participants in the reviews include representatives of functions concerned with the design and
development stage being reviewed, as well as any specialist personnel needed.

Verify that design changes have been reviewed for the effect on products previously made and delivered, and that
records of review results are maintained.
Determine if the design was correctly transferred to production.
Determine, based on the assessment of the design and development process overall, whether management
provides the necessary commitment to the design and development process.
Number of planned tasks
Process Time
ess: Production and Service Controls
Verify that the product realization processes are planned, including any necessary controls, controlled conditions,
and risk management activities required for the product to meet the specified or intended uses and the statutory and
regulatory requirements related to the product. Confirm that the planning of product realization is consistent with the
requirements of the other processes of the quality management system and performed in consideration of the quality
objectives.

Review production processes considering the following criteria. Select one or more production processes to audit.
For each selected process, determine if the production and service process is planned and conducted under
controlled conditions (…)
Determine if the organization has established documented requirements for product cleanliness including any
cleaning prior to sterilization, cleanliness requirements if provided non-sterile, and assuring that process agents are
removed from the product if required.

Verify that the organization has determined and documented the infrastructure requirements to achieve product
conformity, including buildings, workspace, process equipment, and supporting services. Confirm that buildings,
workspaces, and supporting services allow product to meet requirements. Verify that there are documented and
implemented requirements for maintenance of process equipment
where important for product quality, and that records of maintenance are maintained.

Verify documented requirements have been established, implemented and maintained (…)
Determine if the selected process(es) and sub-process(es) have been reviewed, including any outsourced
processes, to determine if validation of these processes is required.
Verify that the selected process(es) has been validated if the result of the process cannot be fully verified. Confirm
that the validation demonstrates the ability of the process(es) to consistently achieve the planned result. In the event
changes have occurred to a previously validated process, confirm that the process was reviewed and evaluated, and
re-validation was performed where appropriate.
If product is supplied sterile:
•    Verify the sterilization process is validated, periodically re-validated, and records of the
validation are available
•    Verify that devices sold in a sterile state are manufactured and sterilized under
appropriately controlled conditions
•    Determine if the sterilization process and results are documented and traceable to
each
Verify that the system for monitoring and measuring of product characteristics is capable of demonstrating the
conformity of products to specified requirements. Confirm that product risk is considered in the type and extent of
product monitoring activities.

Verify that the processes used in production and service are appropriately controlled, monitored, and operated within
specified limits. In addition, verify that risk control measures identified by the manufacturer for
production processes are implemented, monitored and evaluated.

Verify that personnel are competent to implement and maintain the processes in accordance with the requirements
identified by the organization.

Confirm that the organization has determined the monitoring and measuring devices needed to provide evidence of
conformity to specified requirements. Verify that the monitoring and measuring equipment used in production and
service control has been identified, adjusted, calibrated and maintained, and capable of producing valid results.

Confirm that the organization assesses (and records) the validity of previous measurements when equipment is
found not to conform to specified requirements, and takes appropriate action on the equipment and any product
affected. Verify that the control of the monitoring and measuring devices is adequate to ensure valid
results. Confirm that monitoring and measuring devices are protected from damage or deterioration.

If the selected process is software controlled or if software is used in production equipment or the quality
management system, verify that the software is validated for its intended use. Software validation may be part of
equipment qualification.

Determine if the manufacturer has established and maintained a file for each type of device that includes or refers to
the location of device specifications, production process specifications, quality assurance procedures, traceability
requirements, and packaging
and labeling specifications. Confirm  that the manufacturer  determined the extent of
traceability based on the risk  posed by the device in the event the device does not meet specified
requirements.
Determine if the manufacturer has established and maintained a record of the amount manufactured and approved
for distribution for each batch of medical devices, the record is verified and approved, and the device is
manufactured according to the file referenced in task 16.

If the organization manufactures active or nonactive implantable medical devices, life-supporting or life-sustaining
devices, confirm that the manufacturer maintains traceability records of all components, materials, and work
environment conditions (if these could cause the medical device to not satisfy its specified requirements) in addition
to records of the identity of personnel performing any inspection or testing
of these devices. Confirm that the organization requires that agents or distributors of these devices maintain
distribution records and makes them available for inspection. Verify that the organization records the name and
address of shipping consignees for these devices.

Verify that product status identification is adequate to ensure that only product which has passed the required
inspections and tests is dispatched, used, or installed.
Verify that the organization has implemented controls to identify, verify, protect, and safeguard customer property
provided for use or incorporation into the product. Verify that the organization treats patient information and
confidential health information as customer property.
Verify that acceptance activities assure conformity with specifications and are documented. Confirm that the extent
of acceptance activities is commensurate with the risk posed by the device.
Verify that the identification, control, and disposition of nonconforming products is adequate, based on the risk the
nonconformity poses to the device meeting its specified requirements.
If a product needs to be reworked, confirm that the manufacturer has made a determination of any adverse effect of
the rework upon the product. Verify that the rework process has been performed according to an approved
procedure, that the results of the rework have been documented, and that the reworked product has been re-verified
to demonstrate conformity to requirements.

Verify that procedures are established and maintained for preserving the conformity
of product and constituent parts of a product during internal processing, storage, and transport to the intended
destination. This preservation encompasses identification, handling, packaging, storage, and protection, including
those products with limited shelf-life or requiring special storage conditions.

Confirm that the organization performs a review of the customer’s requirements, including the purchase order
requirements, prior to the organization’s commitment to supply a product to a customer. Verify that the organization
maintains documentation required by regulatory authorities regarding maintenance of distribution records.

If installation activities are required, confirm that records of installation and verification activities are maintained.
Determine if servicing activities are conducted and documented in accordance with defined and implemented
instructions and procedures. Confirm that service records are used as a source of quality data in the Measurement,
Analysis and Improvement process.
When appropriate, verify that risk control and mitigation measures are applied to transport, installation and
servicing, in accordance with the organization’s risk management practices.
Determine, based on the assessment of the production and service control process overall, whether management
provides the necessary commitment to the production and service control process to ensure devices meet specified
requirements and quality objectives.

Number of planned tasks

Process Time

Verify that planning activities describe or identify products to purchase and processes to outsource, the specified
requirements for purchased products, the requirements
for purchasing documentation and records, purchasing resources, the activities for purchased product acceptance,
and risk management in supplier selection and purchasing.

Select one or more supplier evaluation files to audit.

Verify that procedures for ensuring purchased product conforms to purchasing requirements have been established
and documented.
Verify that the procedures assure the type and extent of control applied to the supplier and the purchased product is
dependent upon the effect of the purchased product on subsequent product realization or the final product.

Verify that criteria for the selection, evaluation and re-evaluation of suppliers have been established.
Verify that suppliers are selected based on their ability to supply product or services
in accordance with the manufacturer’s specified requirements. Confirm  that the degree of control
applied  to the supplier  is commensurate with  the significance of the
supplied  product or service on the quality  of the finished device, based on risk.

Verify that records of supplier evaluations are maintained.

Verify that the manufacturer maintains effective controls over suppliers and product, so that specified requirements
continue to be met.
Confirm that the re-evaluation of the capability of suppliers to meet specified requirements is performed at
intervals consistent with the significance of the product on the finished device.

Verify that the organization assures the adequacy of purchasing requirements for products and services that
suppliers are to provide, and defines risk management activities and any necessary risk control measures. Confirm
that the manufacturer ensures the adequacy of specified purchase requirements prior to their communication to the
supplier.
 Verify that the organization documents purchasing information, including where appropriate the requirements for
approval of product, procedures, processes, equipment, qualification of personnel, and other quality management
system requirements.
Verify that documents and records for purchasing are consistent with traceability requirements where applicable.
Confirm that the verification (inspection or other activities) of purchased products is adequate to ensure specified
requirements are met. Confirm that the manufacturer has implemented an appropriate combination of controls
applied to the supplier, the specification of purchase requirements, and acceptance verification activities that are
commensurate with the risk of the supplied product upon the finished device.
Verify that records of verification activities are maintained.
Verify that data from the evaluation of suppliers, verification activities, and purchasing are considered as a source of
quality data for input into the Measurement, Analysis and Improvement process.

Determine, based on the assessment of the overall purchasing, whether management provides the necessary
commitment to the purchase process.
Number of planned tasks
Process Time
Sub-Total (hh:mm)

Additional time, as deemed necessary by the Auditing Organization,

including for Stage 1 if applicable (hh:mm)

Adjustment (%) *
Adjustment (hh:mm)

Total (hh:mm)

SUMMARY

Duration of audit (man-days)

stment may be positive or negative. The rationale for any adjustment needs to be documented.
 Planning

Initial Surv. #1 Surv. #2 Recertification

(Stage 1 + Stage 2)

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

11 11 11 11
6:36 5:16 5:16 5:16

1 1 1 1
 1 1 1 1

1 1 1 1

3 3 3 3
1:45 1:24 1:24 1:24

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
 1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

16 16 16 16
10:08 8:06 8:06 8:06

1 1 1 1

1 1 1 1

2 2 2 2
1:16 1:00 1:00 1:00

1 1 1 1
1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1
 1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
1 1 1 1

17 17 17 17
5:57 4:45 4:45 4:45

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
 1 1 1 1

1 1 1 1

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1

29 29 29 29
21:16 17:00 17:00 17:00

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

1 1 1 1
 1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1
1 1 1 1

1 1 1 1

16 16 16 16
4:00 3:12 3:12 3:12
50:58 40:46 40:46 40:46

0:00 0:00 0:00 0:00

50:58 40:46 40:46 40:46

Initial Surv. 1 Surv.2 Recertification

(Stage 1 + Stage 2)

6 days + 3 hours 5 days + 1 hours 5 days + 1 hours 5 days + 1 hours

Instructions for Completing Audit Time Calculation

Two (2) options are available to determine an audit duration. When using this form, Auditing Organizations are expected to u

Tab: Audit Duration Calculation #1

This worksheet requires the user to specify the number of tasks to be completed for each process
If duplicate tasks are required, the task can be counted more than once.

Tab: Audit Duration Calculation #2

This worksheet requires the user to specify each applicable task, by indicating:
0
1
The appropriate digit (2, 3, 4, …) if the audit requires the task to be accomplished more than once (e.g. increase th

This worksheet is nine (9) pages long. It can also shown as a one page Synthetic View, hiding the details of the tasks.
On the top right corner of the worksheet, two buttons allow to toggle from expanded to synthetic view.
ting Organizations are expected to use one tab, not both.

ed more than once (e.g. increase the sampling rate)

ng the details of the tasks.

ynthetic view.
 0 3 3 0 6
1 87654 3 2 5
2 2 3 4 4 product = 192
3 345678 3 6 3
8888
4 1 3 8 2
5 7.5 3 10 1
6 5 3 12 0
Summary 21 87672.5 21 42 21 result = 87777.5

A E I M
B F J N
C G K O Today 1/16/2026
D H L P
 Spanned cell for
seven rows and five columns
centered horizontally and vertically

During editing cell

insert new line by Ctrl+Enter

Names
87777.5
87777.5
0
87777.5
 12/31/2010 31/12/10 2:30 PM 14:30:20
Friday, December 31, 2010 31/12/10 14:30 02:30:20 PM
31/12 31/12/10 2:30 PM 14:30
31/12/10 31/12/10 14:30 2:30 PM
31-XII. 14:30:20
[Link].10 2:30:20 PM
31-XII-10 30:20.0
XII-10 14:30:20
prosinec 10
31. prosince 2010
31/12/10 12:00 AM
31/12/10 0:00
31/12/2010
31-XII-2010
 12/31/2010 2:30 PM
31-Dec-10 2:30:20 PM
31-Dec 14:30
Dec-10 14:30:20
31/12/10 2:30 PM 30:20
12/31/2010 14:30 30:20.0
31. prosince 2010 ###
Friday, December 31, 2010 14:30:20
31/12
2:30:20 PM
a d g
b e h
c f i 3 3

2 sd

f 43 asd
65778 s ss ss 34
213 s
df 1 8
sad ds d
123

df asd asd
a

23 23
1
s
sdf
sdf f 1 sdf 312
12 123

3 54

12

sd f
 sd

sd as
sdf
12 1a 12
325
3 12 1 sd
f f 12 d
s 989 1 323
sd
897 f
3 df
sdfsdf

asd
3 12 sdf
a

3 12 1 1
asd

123 fs
 12 678
f
8d
fsdf 8
12 s
8908089

12

1
sdf
Fixed Fixed
Fixed Level 0 1 1 2 2 2 1
0
1 Fixed
1
2
2
1
0
0
0
3
3
2
2
1
1
0
0
1
2
2
2
1
2
2
2
1
0
1 2 2 2 1 0 0 1 2
2 2 1 1 1 1 1 0
 89627.5
Relative 15 40 65
55 1 6 11 16
60 2 7 12 17
65 3 8 13 18
4 9 14 19
5 10 15 20
15 40 65

Resized
rotated
HTML - Rich text editor Floating  float
images image
color font style size index index shadow background Gradient Gradient Gradient
border Pattern Pattern Line
R 270
R 90

R5

R 130 Top right Bottom left

0

Border Border Border Border

 1/16/2026

21 55
22 60
23 65
24
25
Absolute
89627.5

Cropped
transparent
float image
Gradient Color Error 1/0 #DIV/0!
Line Line Error name #N/A
R 90

R 130 Error syntax 0

Border 87777.5 87777.5 87777.5