Our ISO 9001 Journey: Putting our Documentation to the Test: Implementation

The first step in our preparation for ISO 9001 compliance was the arduous process of documenting all of the essential procedures used within our business. That was only the beginning! After everything had been documented, we began an implementation phase which put our documented procedures to the test.

Step 1 during implementation was to provide … even more documentation:

• List of other documents used by our QMS (local instructions, SOP’s, flowcharts, etc.)
• List of external documents necessary to our QMS (applicable codes, standards, specifications, regulations, etc.)
• List of all records our company retains
• List of all suppliers
• List of all equipment
• List of full‐time personnel An organizational chart showing key positions / functions within the organization Job descriptions for key positions / functions

Next we developed a Quality System Development (QSD) checklist, which identified implementation activities required to complete our system and serve as a guide in verification activities. After this, we began to implement the processes and functions required by ISO 9001, based on our QSD checklist.

One of the most fundamental parts of demonstrating compliance with the ISO 9001:2008 standard is record keeping. In terms of our final audit: if there’s no record, the assumption is that the event never happened. It became critical during the implementation phase to begin generating and collecting various quality-related records in order to ensure there was sufficient evidence to demonstrate the ability of our QMS to achieve desired outcomes.

It also became necessary to establish a local filing area and system to maintain historical data for personnel, equipment, materials, and other items related to our QMS. The generation, collection, and control of our quality records will be an ongoing activity throughout the life of our QMS.

There were some implementation activities that required a longer period to complete. This was primarily due to dependencies that existed between activities or the need to perform an activity in a specific sequence. Some of the activities that occurred during the later stages of implementation were:

• Completion of complex projects where many processes were used
• On‐going employee training/awareness events
• Analysis of QMS‐related data (process performance, product conformance, customer satisfaction, suppliers, delivery, etc.)
• Performance of our management review
• Establishment of our Quality Objectives

At this point, we were all seeing the results of our commitment and feeling very close to our goal!

“Individual commitment to a group effort — that is what makes a team work, a company work, a society work, a civilization work.” ~ Vince Lombardi