Chapter 1: Setting up a Quality Management System
22
The audit’s duration is based on the following guid-
ance: IAF Mandatory Document for the Application
of ISO/IEC 17021 in Medical Device Quality
Management Systems (ISO 13485)—IAF MD 9:2011.
This document suggests the number of audit days
based on the organization’s size (number of personnel)
and provides a number of factors that may be used to
increase or reduce the number of audit days (Tables 1-7
and 1-8). The duration includes offsite planning and
reporting activities.
ISO/IEC 17021 allows sampling of multi-site
organizations however, IAF MD 9:2011 does not allow
sampling of sites performing design and development
and manufacturing. Once the auditors are onsite, the
audit starts with a formal opening meeting, where the
audit’s objectives, criteria and scope are confirmed.
Communication during the audit is through the audit
team leader to the main site contact (typically the
management representative). Observers can be present
as part of the audit team, but their presence should
be communicated and agreed prior to the audit. The
manufacturer needs to provide guides for the audit
team the number should be based on the audit agenda
and the number of auditors required to meet the audit
plan objectives. The auditors will employ a number of
methods to collect and verify information, including
observing processes, interviews and reading documen-
tation. The audit team will identify and record audit
Table 1-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers
Effective Number of
Personnel
Audit Duration Stage 1 +2
(days)
Effective Number of
Personnel
Audit Duration Stage 1 +2
(days)
1–5 3 626–875 15
6–10 4 876–1,175 16
11–15 4.5 1,176–1,550 17
16–25 5 1,551–2,025 18
26–45 6 2,026–2,675 19
46–65 7 2,676–3,450 20
66–85 8 3,451–4,350 21
86–125 10 4,351–6,800 22
126–175 11 5,451–6,800 23
176–275 12 6,801–8,500 24
276–425 13 8,501–10,700 25
426–625 14 10,700 Follow progression above
Source: IAF MD9:2011
Table 1-8. Factors That May Increase or Reduce Audit Durations
Increase Decrease
Large range of devices Reduced product range
Device complexity Reduced design processes
Cannot demonstrate supplied processes’ and parts’ conformity Reduced production processes
Poor regulatory compliance
Source: IAF MD9
22
The audit’s duration is based on the following guid-
ance: IAF Mandatory Document for the Application
of ISO/IEC 17021 in Medical Device Quality
Management Systems (ISO 13485)—IAF MD 9:2011.
This document suggests the number of audit days
based on the organization’s size (number of personnel)
and provides a number of factors that may be used to
increase or reduce the number of audit days (Tables 1-7
and 1-8). The duration includes offsite planning and
reporting activities.
ISO/IEC 17021 allows sampling of multi-site
organizations however, IAF MD 9:2011 does not allow
sampling of sites performing design and development
and manufacturing. Once the auditors are onsite, the
audit starts with a formal opening meeting, where the
audit’s objectives, criteria and scope are confirmed.
Communication during the audit is through the audit
team leader to the main site contact (typically the
management representative). Observers can be present
as part of the audit team, but their presence should
be communicated and agreed prior to the audit. The
manufacturer needs to provide guides for the audit
team the number should be based on the audit agenda
and the number of auditors required to meet the audit
plan objectives. The auditors will employ a number of
methods to collect and verify information, including
observing processes, interviews and reading documen-
tation. The audit team will identify and record audit
Table 1-7. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers
Effective Number of
Personnel
Audit Duration Stage 1 +2
(days)
Effective Number of
Personnel
Audit Duration Stage 1 +2
(days)
1–5 3 626–875 15
6–10 4 876–1,175 16
11–15 4.5 1,176–1,550 17
16–25 5 1,551–2,025 18
26–45 6 2,026–2,675 19
46–65 7 2,676–3,450 20
66–85 8 3,451–4,350 21
86–125 10 4,351–6,800 22
126–175 11 5,451–6,800 23
176–275 12 6,801–8,500 24
276–425 13 8,501–10,700 25
426–625 14 10,700 Follow progression above
Source: IAF MD9:2011
Table 1-8. Factors That May Increase or Reduce Audit Durations
Increase Decrease
Large range of devices Reduced product range
Device complexity Reduced design processes
Cannot demonstrate supplied processes’ and parts’ conformity Reduced production processes
Poor regulatory compliance
Source: IAF MD9