“Harry Miller Corp underwent a Re-Assessment Audit earlier this month for compliance to the ISO 9001:2008 Quality Standard. Based on the results of this audit it has been determined that the management system is effectively implemented and meets the requirements of the standard. Therefore, a recommendation for continuing certification has been submitted to SAI-Global review team. The Audit was performed by Lew Atkinson, an accredited lead auditor for SAI-Global, an internationally accredited registrar. Our entire Quality management system was audited for Major non-conformances, Minor non-conformances, and Opportunities for Improvement (OFI’s).
ISO 9001:2008 Audit Findings and Recommendations
The audit went very well, there were no major / minor non-conformances in our system, and a few opportunities for improvement. OFI’s included 2 minor recommendations for procedure rewrites and a recommendation to review the outside calibration records and to make appropriate comments regarding calibration findings.
The auditor’s conclusion was that we are to be recommended for a new Certification to ISO 9001:2008 for the next 3 years.
Particular Strengths in Our Processes
The auditor found several strengths within our system, and specifically mentioned:
- Good comments on the company website regarding the ISO certification process.
- Very good internal audit program – well ‘customized’ to business risks/priorities (and including detailed audit planning & development of checklists). Some good observations & OFIs were documented.
- Good Management Reviews – including overall content, tracking of quality costs & “pre-review” of topics.
- Good (on-going) follow-up of Management Review Action Items.
- Good analysis of reasons for batch errors (e.g., multiple format for graphical presentation).
In 2018, we will then be registering for the new standard, ISO 9001:2015, which is expected to be released next month. There will be changes with the new standard, primarily involving the onset of much more activity dealing with “risk assessment” of processes by companies, more involvement by top management, and less emphasis on documented procedures, and more on recorded data. We will be implementing those changes, once received, over the 3 year period.
Thanks to all involved in the daily operations that are all linked to the Quality Management System in place; and for contributing to the success of that system! Let’s strive to make the system work even better over the next 3 years!
Nick Ariano, Vice President
Harry Miller Corp