ISO Quality Management standards are a proven way to differentiate a company in a crowded marketplace by communicating to supply chain partners a commitment to quality processes and products. Companies adopting ISO standards or attaining certification can also benefit from reduced cycle time and inventory as well as improved customer satisfaction.
Implement a systematic quality management framework in your organization. ISO certification provides the framework for well-defined procedures for ensuring quality products. The ISO quality standard is the most well known internationally. It shows other companies you are a professional, quality-driven organization.
- Increased quality rate
- Decrease returns
- Increase customer satisfaction
- Reduce rework
- Sales tool
The world’s most popular standard for medical device quality management has been revised for the first time since 2003.
ISO 13485 is an International Organization for Standardization (ISO) standard, published in 2016, that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (both 1997), the ISO 13485 published in 1996, 20013 and ISO 13488 (also 1996).
While it remains a stand-alone document, ISO 13485 is generally harmonized with ISO 9001. A principal difference, however, is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires the certified organization to only demonstrate the quality system is effectively implemented and maintained. Additionally, the ISO 9001 requirements regarding customer satisfaction are absent from the medical device standard.
ISO 9001:2015 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. ISO 9001 is implemented by over one million companies and organizations in over 170 countries.
Quality Management Principles are:
Principle 1 – Customer Focus
Principle 2 – Leadership
Principle 3 – Engagement of People
Principle 4 – Process Approach
Principle 5 – Improvement
Principle 6 – Evidence-Based Decision Making
Principle 7 – Relationship Management
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. This is a similar process to ISO 13485 for the medical community. MTS can help you implement the required elements to obtain certification.
Six Sigma seeks to improve the quality of process outputs by identifying and removing the causes of defects (errors) and minimizing variability in manufacturing and business processes. It uses a set of quality management methods, including statistical methods, and creates a special infrastructure of people within the organization who are experts in the methods.
Each Six Sigma project carried out within an organization follows a defined sequence of steps and has quantified value targets, for example: reduce process cycle time, reduce pollution, reduce costs, increase customer satisfaction, and increase profits.