N. Law & Associates Company Limited

No. Q-011 -- Requirement of ISO 9001 in Calibration and Internal Audit

Q :

We are a metal work product manufacturing firm in Hong Kong. We have two
questions relating to ISO 9001 as shown below. Please answer ASAP :

a) If we have discovered 20 nonconformities in the quality management system,
will it affect our Certification Audit which will take place one month from now.

b) If we have just finished the calibration of all our test equipment, will it cause any
problems because we were using non-calibrated equipment before.

A :

We would like to answer as follows :

a) No problems if these 20 nonconformities are not major nonconformities which
will affect your company's ability to fulfil the certification requirement a month later.
Auditor will look at how you correct the problems and how to prevent their

b) No problems if you can confirm that all test equipment works well by showing
acceptable calibration certificates. However, if any equipment is found to out-of-
calibration in the recent calibration, then you need to assess its use in the past
and take actions accordingly.