Question:
What are the European guidelines on the minimum number of assessment days to be spent by the registrar at each company?
Answer:
The table below shows the minimum amount of audit days that should be spent on initial assessments, annual surveillances and re-assessments every third year. The number of days include all necessary activities such as document review and reporting, but not travel time associated with assessments and surveillances against the ISO 9001:2000 standard.
The variations in time spent on each assessment depend on the type of business and line of production. The table should be read in conjunction with the Guidelines to Clause 10 of EN 45012.
Number of Employees |
Initial Assesment |
Annual Visits |
Re-Assessment Visits |
1 - 4 |
2.0 |
1.0 |
1.5 |
5 - 9 |
2.5 |
1.0 |
1.5 |
10 - 14 |
3.0 |
1.0 |
2.0 |
15 - 19 |
3.5 |
1.0 |
2.0 |
20 - 29 |
4.0 |
1.5 |
3.0 |
30 - 59 |
6.0 |
2.0 |
4.0 |
60 - 99 |
7.0 |
2.0 |
4.0 |
100 - 249 |
8.0 |
2.5 |
5.0 |
250 - 499 |
10.0 |
3.0 |
6.0 |
500 - 999 |
12.0 |
4.0 |
8.0 |
1000 - 1,999 |
15.0 |
5.0 |
10.0 |
2,000 - 3,999 |
18.0 |
6.0 |
12.0 |
4,000 - 7,999 |
21.0 |
7.0 |
14.0 |
8,000 + |
24.0 |
8.0 |
16.0 |
| Source: "Quality Systems Update," Volume 5, Number 4 |
Return to previous page
