"If you can't describe what you are doing as a process, you don't know what you're doing."
William Edwards Deming - Statistician & Management Guru
Our purpose is to bring total quality assurance and ISO 9001 certification to customer-centric organizations. We work closely with management to develop a process approach, institute sound management practices and, with our client's approval, ISO 9001 (or 13485) certification to establish a quality management system. Quality training, process documentation and continuous improvement will each play a decisive role in the transformation.
Your workforce and customer both deserve defect-free products, and it's our pleasure to bring that vision to life.
Each project begins with an initial assessment. Included is a meeting with management to discuss goals, costs and timelines. If we decide to move forward, an analysis of your operation will examine the flow of information and materials, as well as the extent and effectiveness of documentation. Once your needs are understood and our suggestions have been integrated with the project plan, we'll:
The initial assessment phase will set pace and expectations for the quality management system (QMS) project. Management can announce the program and our team will proceed to the next phase.
ISO 9001 implementation involves everyone in your organization to some extent, so formally announcing the program is always a good idea. We will guide you in promoting awareness and encouraging the quality oriented process approach as a core, company-wide value.
The ISO 9001 standard specifies requirements for documenting a quality management system and maintaining records. This includes:
ISO 9001 emphasizes documented procedures as a means of encouraging an understanding and accountability to process points that can diminish quality. The documented procedures required for certification will be part of training, but you can view them in the QMS section.
Some employees will be contributing to documentation, such as work instructions, and ISO 9001 requires some limited training on the QMS and its purpose. As such, employees will need to understand quality as it's defined in their niche of the company, as well as criteria for satisfactory output.
Both your quality policy and the most relevant quality objectives must be fully communicated. These objectives provide clear expectations for everyone, documented procedures and work instructions will be tools to achieve the objectives, and process metrics will provide actionable feedback.
For those of you planning to get certified on your own, a handful of excellent ISO 9001 Training Courses are available. This is strongly recommended for ISO 9001 beginners.
After conducting an internal audit to the satisfaction of a management review, your registrar, a third party who issues the final certification, will send an ISO auditor for a rigorous inspection. Any non-conformities identified will be resolved before the auditor returns for the final inspection to issue your ISO 9001 certificate.
Learn more about the timing and scope of ISO 9001 Audits.
Certification is a declaration of progress and will open up new opportunities. It will reduce operating costs by minimizing scrap and rework expenses, expose new markets and underpin a culture of continuous improvement.
ISO 9001 is an important milestone, but not the end of your efforts. A plan for post certification maintenance of the QMS will go through review and approval so that your company can remain in conformance with the standard and protect your certificate.
Upon certification, you can incorporate ISO 9001 status into your marketing and branding materials. New opportunity awaits, and you'll have the process and prestige to seize it.
More resources to acquaint you with ISO and the certification process.