What is ISO 9001?
ISO 9001 is an internationally recognized standard that sets out the requirements for a consistent Quality Management System (QMS). This system provides a framework for organizations to ensure they have a systematic approach to consistently creating and delivering high-quality products.
Here are some key points about ISO 9001:2015:
It applies to all parts of an organization, including product development.
It emphasizes a customer-focused approach.
It promotes continuous improvement in processes.
It helps organizations meet regulatory requirements.
While achieving ISO 9001 certification is not mandatory, it demonstrates a company's commitment to quality and can be a valuable asset for customer trust and business growth.
ISO 9001 Engineering and Product Development
ISO 9000 is often associated with excellence in manufacturing, since it emphasizes quality and reinforces consistency. With ISO 9001, the quality management system extends to all aspects of a company, including engineering and product development.
A product development manager feels the pressure of juggling project priorities while meeting product specs that hopefully represent customer need. Following a well-defined product development process aligned with ISO 9001:2015 has significant benefits for product development managers. This structured approach ensures that customer needs are central to each stage of development, leading to products that truly meet their expectations and boost satisfaction. Furthermore, a clear process minimizes rework and avoids costly errors, ultimately reducing development time and keeping projects on budget. The framework also fosters improved communication and collaboration within the development team, ensuring everyone is working towards the same goals. This streamlined approach leads to fewer errors and consistently high-quality products, giving your company a competitive edge in the marketplace.
This article presents a general product development process as it is described in ISO 9001. The process is shown in flowchart form and is intended to reinforce a robust product development system that is customer focused and quality based. With adaptation for specific company needs, the flowchart can be utilized by companies of all sizes.
The 7-Phases of Product Development
After years of product development, from consumer products to industrial machines, I realize there is no ‘one size fits all’ development method. Every company has a different culture and will need to develop a process that works best in their environment. There are, however, a basic set of checks and balances to ensure that products are developed consistently and with a quality outcome. I have summarized these steps in a set of flowcharts that can be used as the basis for a 9001:2015 product development process.
The process is divided into 7 phases:
Feasibility
Project Planning
Stage 1 Design (Product Concept Design)
Stage 2 Design (Product Preliminary Design)
Stage 3 Design (Product Detailed Design)
Verification and Validation
Product Release
Phase 1: Feasibility
The following flowchart represents the Feasibility phase of the design process.
Phase 2: Project Planning
The following flowchart represents the Project Planning phase of the design process.
Phase 3: Stage 1 Design
The following flowchart represents the Stage 1 Design or Product Concept Design phase of the design process.
Phase 4: Stage 2 Design
The following flowchart represents the Stage 2 Design or Product Preliminary Design phase of the design process.
Phase 5: Stage 3 Design
The following flowchart represents the Stage 3 Design or Product Detailed Design phase of the design process.
Phase 6: Verification and Validation
The following flowchart represents the product Verification and Validation phase of the design process.
Phase 7: Product Release
The following flowchart represents the Product Release phase of the design process.
The Role of Documentation
Strong documentation and record keeping are cornerstones of a successful ISO 9001:2015 compliant product development process. This focus on capturing information plays a critical role in several ways:
Improved Consistency and Repeatability: Detailed documentation of processes, decisions, and specifications ensures consistency across projects. This eliminates the need to "reinvent the wheel" and allows new team members to quickly understand established practices.
Enhanced Traceability and Root Cause Analysis: Maintaining clear records of activities, changes, and test results enables traceability throughout the development cycle. If an issue arises, this documented history facilitates root cause analysis, allowing for targeted corrective actions and continuous improvement of the development process.
Knowledge Transfer and Learning: Documented knowledge from past projects serves as a valuable resource for future endeavors. Lessons learned and best practices can be readily accessed and applied, accelerating development and fostering innovation.
Demonstrating Compliance: Thorough documentation serves as evidence that your product development process adheres to ISO 9001 standards. This can be crucial during audits and provides peace of mind that your quality management system is functioning effectively.
Remember: Every Company is Different
Again, every company has different development requirements and may distribute the steps into different stages or not need as many design stages, but understanding the basic requirements and implementing a process is the your first step to ensuring consistent product development and quality. This flowchart will need to be modified to fit the needs of your company and your products.
Striper Solutions LLC, Your Product Partner
With over 30 years development experience and more than a decade providing consulting services, Striper Solutions has demonstrated a commitment to excellence and integrity in developing new products. Embracing a shift to regulatory compliance allows us to focus on a critical area of product development with the dedication and quality our customers need.
See more at www.striperllc.com
Commentaires