The telecommunications equipment supplier I work for faced a number of challenges when it discovered that it had to be contractually obligated to become ISO 9001 certified. As mentioned in a prior article, the first challenge was in determining what needed to be done in order to pass the pending ISO audit that was just eight weeks away.
There were no real secrets to getting ready—just a lot of preparation work that involved putting all the key documentation in order. It also helped when we were finally able to get the support of the development managers, whom we relied on in order to understand their processes.
Passing an audit
To pass an audit, an organization must follow these guidelines:
- Develop a Quality Management System (QMS) manual.
- Develop the procedures required by the ISO Standard.
- Determine the additional processes and procedures that are needed by the organization to perform work and satisfy the requirements in the ISO Standard.
- Operate in accordance with the organization's documented QMS.
- Provide evidence that the organization is operating according to the QMS.
The following tips helped my development team pass an ISO audit.
Use the ISO 9001 Standard guidelines as a checklist
It shouldn’t be too much of a surprise that using the standard as a checklist is the best way to prepare. The first order of business to satisfy the ISO Standard is to develop a Quality Management System (QMS) manual. Our company was fortunate enough to have had a Quality policy manual already in place for the business unit undergoing the audit. All we needed to do was make minor modifications to the manual, scale it down a bit, and adopt it to our project.
My organization also had a dedicated Quality Council that was charged with monitoring process quality. The manager of this council had been through a number of ISO audits. At his suggestion, he played the role of auditor and ran us through a mock audit. Not every group has the luxury of such an experience, but someone who is inquisitive and has interviewed technical team members before would be a good candidate for this role.
Educate the project team in the ISO Standard
Our quality coordinator quickly prepared a synopsis of the ISO Standard and conducted a number of miniclasses lasting two hours each. He reviewed the key concepts of what the standard specifies and what we’d need to do to pass the audit.
The next step was to create the development processes. Trying to get the various functional development areas of the project team to document what they do was challenging. Collecting this documentation proved to be difficult during the entire preparation process.
The team would have been more than happy to have the quality coordinator write their processes. But the goal was to get them to think about and understand what they do in their functional area, and to understand the functions of the other development areas.
What helped with this exercise was that we had the developers use a common template for documenting each process. The key items to document were the inputs and outputs to the process and the identification of what ISO calls “quality records” for retention.
The focus of this exercise was to document only those process steps that were really necessary.
Use templates for system-related documentation
By using a template to develop our processes, there was a standard look and feel that made the review process slightly more palatable. We did not use flowcharts, common in such document processes, since we used the template. Depending on the functional area of responsibility, we mainly wanted to see process inputs, outputs, and handoffs to other groups. Another important item was to identify quality records that we’d have to produce to show we were following the processes. The templates had sections for metrics, process owner, and a glossary.
To keep all the documents generated for the audit in a central place, we utilized a Web-based project tracking system.
Use a centralized library or repository
We were able to store all of our documents in a Web-based project database tool. This provided a structured means for storing and locating key project documents, especially ISO-specific materials. We placed our ISO documents in a section we created and named “Quality Management System,” which had a subsection named “Quality Management Documents.”
During the audit, all we had to do was show the auditor a document online—there was no need to produce paper documents. The documents were always kept current by the author, and the system displayed the last time a document was updated.
During the actual audit, project team members being interviewed knew exactly where to go to find the process they were expected to follow.
Follow this advice, and there’s a good chance that your project will pass an audit as well!
Passing the ISO muster
How did your team prepare for an ISO 9001 audit? Share your tips or post a comment below.