ISO 9000 / ISO 9001 and ATEX Checklists
ISO 9000 / ISO 9001 and ATEX Checklists:
There are several free check sheets and questionnaires on this website including both ISO9001 and for ATEX. The ISO 9001 Check sheet is broken into sections based on sections of the standard. As part of the company internal audit plan, the entire quality system should be audited on an annual basis. This can be a monumental task if you don’t break the audit into smaller sections. There are several styles of auditing but if you doing checklist audits, then the section are a workable amount. The following Checklists can be found on this website:
Checklist ISO 9001 Section 4 - Quality system
This portion of the audit usually requires the quality manual and the quality representative. It should be very clean cut if the quality manual was written with the ISO 9001 standard in mind.
Checklist ISO 9001 Section 5 - Management
This portion of the audit usually requires the quality manual, the top management and the quality representative. I recommend auditing the CEO to make sure that they are aware of ISO program and how it affects the employees.
Checklist ISO 9001 Section 6 - Resource Management
This is the most vague portion of an internal audit. This section is short but difficult to audit because you will rely on verbiage from manages who are trained to say they have enough resources even if they don’t.
Checklist ISO 9001 Section 7 - Product Realization
This portion of the audit will require support from engineering, production, purchasing and operations. This section will require retrieval of quality records including design notebooks, work instructions and production records. This is the most time consuming portion of the annual audit.
Checklist ISO 9001 Section 8 - Measurement, Analysis and Improvementt
This includes calibration and maintenance, non-conforming materials, process monitoring and corrective and preventive actions. If there are stable systems with good records, this section can be very clean cut. The continuous improvement requirement of this section can be assumed if the company is doing all the other measurement, analysis activities.
After you have completed all the ISO section, you can audit to the additional requirements of the ATEX standard. This will only be appropriate where products for hazardous environments are manufactured.
Using the Free check sheets
Just cut and paste the check sheets onto company letterhead or a document that is personalized for your company. You can add signature and date at the top and you may want to leave space at the end for a list of personnel that you audited. There should be 3 columns in the check sheet:
- The check sheet question
- Your notes during the audit. If the area is compliant, you can simple write OK. If the area is not compliant, add as much detail in the area or add more information on a separate sheet. After the audit is complete, this information will go into the summary report for the audit.
- The identifying number for the document that was audited or was used to confirm compliance. This number is especially critical for tracking any non-conformances. If you find a non-conformance during the audit, you will write the finding in your audit summary report. The number of the document will allow the engineering or quality team to find exactly where their problem is without delay. This issues can get to be critical when you are looking at 20 different findings and no one can remember which finding is associated with which procedure
Give these documents a controlled number and save the master in a controlled area on the company computer system. You may want to change the check sheet to in the future to better fit the company. You are not technically required to number this document but it will make it easier to track and retrieve if you do.
You may want to print a copy of each, mark is as a master, and place it in the front of the internal audit notebook for reference. Then you can complete an audit in less time. Simply:
- Buy the checklist
- Complete, the checklist, sign and date it.
- Create your summary report and add them to a dated tab in the internal audit notebook.
This is the simplest way to maintain compliance to the internal auditing section of the ISO 9001 standard.
Using Check Sheets Or Checklists To Develop Procedures
If you in the process of developing new procedures, then the checklist can be very useful. Although the ISO 9001 standard describes exactly what is required, the checklist phase the same requirement as a question that must be answered by the auditor (either internal or external). The checklist also puts the standard into simpler language that can make generation of a new procedure quick and easy. If there is a question on the checklist, there should be a sentence in the procedure to address that question.