Creating a Quality Management System (QMS) that fulfills the requirements of the ISO 9001:2008 Standard or AS9100 Standard can seem like a daunting task. But it doesn’t have to be. Creating a QMS should be done like all projects. Priorities need to be established, responsibilities determined, and milestones set. What priorities? What are the key milestones? How do I get started?
AM&T has helped many small and medium sized businesses move from having no real QMS to becoming ISO 9001 or AS9100 certified. It is a process that usually takes about twelve months, but it can be done in less for very small companies. A project typically includes establishing all the required elements of the ISO/AS Quality Management System and assisting in getting it off ground functionally.
One way to establish priorities and milestones is to use the organization of the ISO 9001:2008 & AS9100 QMS Requirements itself as a proforma project plan.
The ultimate goal, however, of a QMS, is continual improvement. So, to gain the benefits of improvement, an organization has to be committed to maintaining and modifying the system over time to best suit its needs. Creating the QMS is just the beginning.
Creating an Implementation Plan
The best approach is to treat your ISO implementation as a project, starting with a project plan that estimates the resources needed (people, materials, expertise) and the project timeline from beginning until the certification audit. We might begin with a gap assessment, which provides input into the project plan. A gap assessment is just as the name describes – comparing current systems and documentation to what is needed for a system that is ISO 9001 or AS9100 compliant. If you don’t feel comfortable with the QMS Standard, then perhaps the first step is ISO training for you and members of the project team.
The project team includes key members from the quality department along with representatives from other departments like Sales & Marketing, Design & Development, Human Resources, Production, and Accounting. The members provide valuable input to the QMS development project about systems and processes, they divide up tasks and actions items, and assist in distributing important information throughout the organization. But remember, involving a team can also take more time as you wait for meetings in order to make decisions and followup on actions. So be sure to build such delays into your project plan.
Now that a plan is in place, the hard work begins.
The current version of AS 9100 aligns the standard with ISO 9001:2008 and has extra requirements regarding Regulatory Compliance and the following aerospace-sector specific requirements:
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Design phase, design verification, validation and testing processes
Reliability, maintainability and safety
Approval and review of subcontractor performance
Verification of purchased product
Product identification throughout the product’s life cycle
Product documentation
Control of production process changes
Control of production equipment, tools and numerical control machine programmes
Control of work performed outside the supplier’s facilities
Special processes
Inspection and testing procedures
Methods, resources and recording
Corrective action
Expansion of the internal audit requirements in ISO 9001:2008
First article inspection
Servicing, including collecting and analysing data, delivery, investigation and reporting and control of technical documentation
Review of disposition of non conforming product
As a result, ISO 9001:2008 is totally encompassed within AS 9100 with these additional requirements applied specifically addressing aviation safety concerns. It is also the only standard which considers the role of the Regulatory Authorities and so many of the “add-ins” are directly traceable to FAA Regulations FAR Part 21 (Certification Procedures for Products and Parts), Part 39 (Airworthiness Directives) and Part 45 (Identification and Registration Marking).
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