ISO 9001

ISO 9001 compliance becomes increasingly important in regulated industries. How does it affect documentation? Here is how...   What is Document Control?   Document control means that the right persons have the current version of the documents they need, while unauthorized persons are prevented from use.   We all handle many documents every day. These documents include forms that we fill out, instructions that we follow, invoices that we enter into the computer system, holiday schedules that we check for the next day off, rate sheets that we use to bill our customers, and many more.   An error on any of these documents could lead to problems. Using an outdated version could lead to problems. Not knowing if we have the latest version or not could lead to problems. Just imagine us setting up a production line to outdated specifications or making strategic decisions based on a wrong financial statement.   ISO 9001 gives us tools (also referred to as "requirements") that show us how to control our documents. Read more

In my last post, I described change control process in general and I mentioned that in the regulated industries, manufactures are required to use a change control procedure. I am going to describe this change control procedure in this post.   A change control procedure is usually one of standard operating procedures (SOP's). It usually includes a change control form. Some companies also use change request forms for suggested changes. This procedure usually includes the following components:   Identification   The identification of the changed device, assembly, component, labeling, packaging, software, process, procedure, manufacturing material, and any other related item or document. The change control form has blank spaces for recording this data. Read more

Change control within quality management systems (QMS) and information technology (IT) systems is a formal process used to ensure that changes to a product or system are introduced in a controlled and coordinated manner. It reduces the possibility that unnecessary changes will be introduced to a system without analysis, introducing faults into the system or undoing changes made by other users of software.   The goals of a change control procedure include minimal disruption to services, reduction in back-out activities, and cost-effective utilization of resources involved in implementing a change.   Change control is used in a wide variety of products and systems. For Information Technology (IT), it is a major aspect of the broader discipline of change management. Typical examples from the computer and network environments are patches to software products, installation of new operating systems, upgrades to network routing tables, or changes to the electrical power systems supporting such infrastructure. Read more

ISO 9001 specifies requirements for a Quality Management System (QMS) where an organization needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements.   An organization is required to establish, document, implement, and maintain a quality management system and continually improve its effectiveness.   A cornerstone of the QMS is document control. Therefore, in order for an organization to meet ISO 9001 requirements, it must have a document control system in place. Auditors pay particular attention to document control.   Document control is an essential preventive measure ensuring that only approved, current documents are used throughout the organization. Inadvertent use of out-of-date documents or not approved documents can have significant negative consequences on quality, costs, and customer satisfaction. Read more