To date, I have assisted ten clients in obtaining their ISO 9001:2015, 14001:2015, AS9100D and IATF16949:2016 certification in the automotive, aerospace and manufacturing sectors. I am currently working with seven various registrars . This article will outline the common areas where corrective actions have been issued from your Registrar during an audit.
Majority of the registrars have been forth coming and stated that they are learning the new standards along with all their clients and this is a great opportunity to discuss the interpretation of the changes. Based on my experience, the auditor will need to be assured that you have fulfilled the new requirements by providing evidence on the following:
1. Section 4.1- Organizational context
The auditor requires evidence that you have analyzed the internal and external issues of your organizational context. Ensure you have covered the notes in 4.1.
2. Section 4.2 - Interested parties
Do you have evidence that you have determined the needs, expectations, reason of interest of the relevant interested parties and whether they are internal or external? How will you monitor these parties?
3. Section 4.3 - Scope
Does your documented information detail your scope and boundaries of your quality management system?
4. Section 5 – Leadership
Can you provide evidence of top management involvement in your quality management system
5. Section 6 – Risk and Opportunity
It is better that your risks and opportunities are documented using a FMEA or excel format. Have you reviewed the risks and opportunities for your organizational context and for all your processes?
A final question: As an organization, have you provided the necessary training to ensure competence to the new standards and to create a documented road map for your registrar. If you have, then you will have a successful transition.