ISO 9001 Frequently Asked Questions

What does a quality system look like?
What are the benefits of an ISO QMS?
How long will it take?
Who should be involved?
Should we use outside help?

How much will it cost?

What is the Process Model?
Are process flow charts required?
How many procedures are we required to write?

What records are required?
How often should we have management review meetings?
Are job descriptions required?
What is process auditing?
How often should we audit each area?

What is the Process Model?

The process model is based on the idea that an organization is a system of interlinked processes. The ISO 9001:2008 Standard is designed to manage and improve those processes. First, you identify your key processes. Second, you define quality standards for those processes. Third, you decide how process quality will be measured. Fourth, you document your approach to achieving the desired quality, as determined by your measurements. Fifth, you evaluate your quality and continuously improve.

Are process flow charts required?

Flow charts are not specifically required, but more than likely expected by your registrar. The standard requires that you identify your processes and determine the sequence and interaction of the processes. This is most easily accomplished by preparing flow charts of your product realization processes.

How many procedures are we required to write?

The standard specifically requires six procedures:

  • Control of Documents
  • Control of Records
  • Internal Audits
  • Control of Nonconforming Prod cut
  • Corrective Action and
  • Preventive Action

That may not be enough: the standard also asks that you prepare any other documents you need to for planning, operation and control of your processes. The standard also asks that you have available the work instructions you feel are necessary. The answer to how many procedures or work instructions are required: you must decide this.

What records are required by the standard?

The standard specifically requires records for the following items:

  • Management reviews
  • Education, training, skills and experience
  • Evidence that processes and product or service meet requirements
  • Review of customer requirements and any related actions
  • Design and development including: inputs, reviews, verification, validation and changes
  • Results of supplier evaluations
  • Traceability where it is an industry requirement
  • Notification to customer of damaged or lost property
  • Calibration
  • Internal audit
  • Product testing results
  • Nonconforming product and actions taken
  • Corrective action
  • Preventive action
  • Records you need to provide evidence of following your processes.

How often should we have management review meetings?

There is no specific requirement for frequency of management review meetings. We recommend quarterly meetings. This allows you to stay on top of upcoming issues and yet collect meaningful data between meetings. We have found annual meetings are not acceptable to all registrars. With annual meetings you may not be able to prevent issues or resolves issues in a timely manner. Management Review

Are job descriptions required?

No, there is no requirement for job descriptions. You are required to do two related tasks: define responsibility and authority and define competency in terms of education, experience, skills and training. Job descriptions are one way of accomplishing this. There are other ways including preparing organizational, job responsibility lists, and competency matrices.

What is process auditing?

We have received a number of questions regarding process auditing and what it means. If you are auditing your quality management system by area or department and then auditing all the applicable ISO elements while in that department, you are doing process auditing. If you are auditing your quality system by ISO elements throughout the organization you are not set up currently for process auditing. Process Auditing

How often should we audit each area?

There is no specific requirement for audit frequency. The audit schedule should be based on the importance of the area and on what previous audits have uncovered. In a new system, you will want to audit frequently, perhaps monthly, to make sure everything is implemented and working. In a mature, audits can be performed much less frequently. For a mature system (in place for several years) we recommend every six months to one year. Based on the results of your audits, you may be able to reduce the frequency for those areas that are performing well. If you start at monthly, try quarterly for awhile and see if it is working. Do not audit less than annually.

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