The Quality Program Management Review is critical and necessary for ISO 9001 certification. Not only this, but when done properly, it drives extensive improvement throughout your business. In theory, the QMS review output creates the plan for implementing, changing and improving your quality program.
During your ISO 9001 certification and monitoring audits, the auditor always examines your quality management review quality records.
Your easy to edit ISO 9001:2015 Quality Assurance Manual.
According to the ISO 9001 standard, the quality management system must be reviewed on a periodic basis. There are a couple of approaches to meeting this requirement.
If you’re starting to implement the ISO 9001 system then the review should be a semi annual meeting. Meet twice a year until your system matures. This assures your company stays on track and does not lose focus from the standard.
If your company has a mature system and does not expect many changes to the QMS operation then conduct an annual meeting.
Instead of an annual or semi annual meeting, a management weekly meeting could be used. When taking this approach, track all input and output records. During these meetings cover the inputs for the Quality Program Management Review and record the action items. You do not need to cover all input requirements during each meeting, however you must prove (provide documentation) that you do access the input requirements on a regular basis.
I recommend creating a procedure that documents the management review process. Within the procedure discuss the frequency, the required management team, the mandatory inputs, the outputs and your quality records. This makes it easier for you to assure you meet the requirement.
Note, this procedure is not absolutely necessary for ISO certification. See here for a list of required procedures. If you choose not to maintain a procedure, then be sure to keep your quality records for your auditors evaluation.
Your easy to edit ISO 9001:2015 Quality Assurance Manual.
When the ISO 9001 standard uses the word “Review”, this means that “a team analyses the inputs and the team makes the output plan”. For the review, employ a cross functional team approach.
When selecting the team members, include your senior management. I recommend taking a look at your organizational chart and select the top 2 or 3 management levels for your given location. The top 2 or 3 tiers are the people who belong on the quality management review team. Include managers of these functions during the QMS review meeting:
The team discusses and evaluates the inputs during the quality program management review. The inputs are actual quality records which accumulated since the last management review meeting. Below is a list of necessary inputs:
Your easy to edit ISO 9001:2015 Quality Assurance Manual.
The output is a list of action items that addresses the inputs. Document this on a gantt chart or a to do list. For each action item, include the following
On the final report, collect signatures of each team member and record the date of review.
Collect all the input data and the final output report and place this information into a folder or binder. Label the binder with “QMS review and the date.” Your ISO auditor will assess this package.
The auditor will ask you for the Quality Program Management Review documentation. Present the package and let him assess it. Be sure to meet your output action items. He will ask for you to provide status on the action items. The auditor will also quiz you on your inputs. He wants to know why you selected the given inputs. He wants to know if you addressed problematic inputs. In addition, the auditor will quiz the members of the review team. He wants to make sure the quality management review was a team effort.
See this list of key elements for a QA Project Plan
Key Elements for a Project Quality Management Plan
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