American Society for Quality (ASQ)
Holistic Enterprise Level of Cultural Changes Are Needed!
ISO 9001:2015 Implementation and Certification
In this episode, learn key themes in the ISO 9001 revision, get advice on transitioning and training, and hear how to choose a registrar and consultant.
ISO 9000 – Quality management
ISO 9001 has been updated
ISO 9001 Quality Management Systems has recently been revised
Learn more about the revision of ISO 9001:2015
The ISO 9000 family addresses various aspects of quality management and contains some of ISO’s best known standards. The standards provide guidance and tools for companies and organizations who want to ensure that their products and services consistently meet customer’s requirements, and that quality is consistently improved.
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. In fact, there are over one million companies and organizations in over 170 countries certified to ISO 9001. (read more here)
FDA Quality Information
- Watch How Medical Device UDI Supports High-Quality Healthcare
- Compliance Policy Guide FDA Access to Results of Quality Audits
- Request for Quality Metrics
- Quality Considerations in Demonstrating Biosimilarity
- 21 CFR Part 820 Quality System Regulation
Last Updated: 2015-09-30