Quality Management System Documentation Support
Today the goal of creating quality management system harmonization is still alive. Currently, ISO 9001:2015 and multiple quality management systems share a significant degree of harmonization thanks to the tireless work of the International Organization for Standardization more commonly known as ISO in Geneva Switzerland.
Different terms and methodologies have been deployed over the various years in quality assurance and control such as Parts per Million (PPM) measurements for defects, Statistical Process Controls and resulting Cpk Charts and Design of Experiment activities. However, none of the aforementioned aspects will catch your customer’s eye more, and is more appreciated that than establishing your Quality Management System (QMS) with clear and complete documentation and well defined records.
ISO 9001:2015 clause requirements 1, 4.1 – 4.4.1, 5.1.2, 6.1.1 – 6.1.2, 6.3, 7.1.6, 22.214.171.124, 8.2.1 – 8.2.4, 8.3.2, 8.4.1 – 8.4.3, 8.6, 9.1.3, 10.2.1 and 10.3 convey requirements that can invoke the customer’s involvement with your organization depending the specific departments involved and tasks in play. Customer involvement and focus are now more integral to most quality management systems.
Today customers participate in Manufacturing Readiness Reviews, New Product Introduction (NPI) Plans, Design Reviews, Site Qualification Surveys and Visits, and Design Verification or Validation activities such as Alpha or subsequent Beta Testing as well.
Your quality management system documentation is viewed both internally and externally on various occasions over time, so the documentation must be well defined and analogous to the resulting process output records used by the organization.
The Purpose of Quality Management System Documentation
Today the objectives of ISO 9001:2015 are still:
- to convey a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and
- for the amount and detail of the documentation that is required to be more relevant to the desired results of the organization’s process activities.
ISO 9001:2015 and the various other quality management systems allow each organization quite a bit of flexibility in documenting their quality management system. This enables every organization to develop the most useful and adequate amount of documentation needed. Your organization’s first goal should be to utilize your documentation as your “aide-mémoire”, a living guide to how the company controls and monitors your product and processes and secondly, to demonstrate your organization’s ability to the effectively plan and implement your processes while improving the effectiveness of your quality management system. As we work with our clients, we try to uphold this simple rule when working with quality management documentation”
Quality Management Standards such as ISO 9001, TL 9000 and ISO 45001 require a documented management system and not a burdensome system of documents. We invite your organization to learn more about why clear and complete documentation and well-defined records matter within your quality management system.