Compliance/Requirements
Partners Through Change, Inc. (PTC) facilitates the process by which an organization complies with industry standards/regulations or adheres to requirements. PTC provides the following services:
 These training files are in
Adobe PDF format. You may
need to download and install
the
free Acrobat Reader plugin
to view and print the files |
- Training
- Gaps Analysis/Assessments
- Project Management
- Pre-assessment Audits
- Documentation
- General Consulting (subject matter expertise)
Industry Standards/Adherence to Requirements
PTC does not provide certification or registration services; rather we aid an organization in meeting the certification standards and regulations of its particular industry. The standards/regulations that PTC can currently provide support for (in the form of the aforementioned services) are listed below:
- Quality Management Systems
- AS 9100 Schedule B - aerospace
- ISO 13485 - medical devices
- CMDR - Canada's medical device regulations
- European Medical Device Directives
- ISO 9001-general business
- TL 9000 - telecom
- ISO/TS 16949 - automotive
- Other
- CE Marketing
- ISO 14001 (environmental)
- US FDA (e.g. 1271 - tissues, 820 - medical devices,
Part 11 - electronic signatures)
- EMAS - Environmental Management Audit Scheme
- Sarbanes - Oxley Act (SOX) - corporate accountability
- Australia's Therapeutic Goods Administration
(both tissues and devices)
- Performance Excellence Award Programs
|
