In our ongoing series about the Iowa startup implementing ISO 9001 from day one, we’ve reached a crucial phase: Planning and Documentation.
This stage would prove to be the cornerstone of their success, embodying the wisdom of quality management pioneer W. Edwards Deming and the core principles of ISO 9001.
The Deming Cycle: Plan, Do, Check, Act
W. Edwards Deming (1900-1993), a titan in the field of quality management, taught us the invaluable cycle of Plan, Do, Check, Act. Our startup embraced this philosophy wholeheartedly, recognizing that thorough planning was the first step toward excellence.
What Does Planning Mean in ISO?
In the context of ISO 9001, planning goes beyond simple task scheduling. It’s about:
Identifying potential risks
Developing mitigation strategies
Establishing controls
As we often say, “Planning is knowing risks. PLAN to prevent them.”
This approach became our mantra as we dove into the planning phase. For each process, we meticulously identified risks and planned corresponding controls or mitigation strategies.
This proactive stance would prove invaluable as the company faced the challenges of rapid growth.
Documenting for Success (ISO 9001, clause 7.5)
With our risks identified and mitigation strategies in place, we turned our attention to documentation. In ISO 9001, documentation isn’t about creating paperwork for the sake of it. It’s about capturing knowledge, standardizing processes, and creating a foundation for continuous improvement.
We began with Order Processing, a critical function for any business. Here’s how we approached it:
Process Description: We wrote a detailed process, describing each task to be performed on the inputs.
Outputs and Their Fate: We clearly defined what the outputs of the process were and what happened to them next.
Sequence and Interaction (ISO 9001, clause 4.4): By mapping out the steps and their relationships, we created a clear picture of how Order Processing fit into the larger system.
Record Retention: We prescribed which records needed to be retained, both for legal compliance and ISO 9001 requirements.
This documentation serves multiple purposes:
It provides a clear guide for employees, ensuring consistency in operations.
It makes training new staff easier as the company grew.
It creates a baseline for future improvements.
It demonstrates compliance with ISO 9001 requirements.
The Power of Planning
As we progressed through each process, from design and development to supply chain management, the power of thorough planning became evident. By anticipating potential issues and designing solutions in advance, the startup was able to:
Respond quickly to challenges as they arose
Maintain quality standards even as order volumes increased
Scale operations smoothly without compromising efficiency
Build customer confidence through consistent, high-quality service
Lessons for Other Businesses
The experience of this Iowa startup offers valuable lessons for other new businesses considering ISO 9001 implementation:
Embrace Planning: Don’t rush into operations without thorough planning. The time invested upfront will pay dividends later.
Think Holistically: Consider how each process interacts with others. A systems approach leads to more efficient operations.
Document Wisely: Create documentation that adds value. Focus on clarity, usefulness, and accessibility.
Anticipate Growth: Design your processes and documentation to accommodate expansion. What works for 10 orders a day should still work for 100.
Involve Your Team: The people performing the work often have the best insights into potential risks and effective controls. Involve them in the planning process.
The story of this startup demonstrates that with proper planning and documentation, even a new business can build a robust quality management system. By embracing the principles of ISO 9001 from the outset, they created a foundation not just for certification, but for sustainable, quality-driven growth.
Debra Matthews Hampton, PE
ISO 9001, ISO 14001, ISO 45001, ISO 22000, ISO 13485
P.S. Let’s talk about how ISO 9001 can help you create a foundation for success. Contact us today for a free consultation. Call me at +1 (229) 798-0277 or email me at debra@ce-q.com to start your journey towards scalable quality management. Remember, it’s never too early to plan for success!
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