Ombu Enterprises LLC


	Library Acceptance Sampling The OC Curve of Attribute Acceptance Plans (January, 2009 - 7 Pages) Sequential Sampling Plans (January, 2009 - 3 Pages) Establishing the AQL (September, 2009 - 2 Pages) Lot Acceptance by Attributes in MIL-STD-1916 (July, 2011 - 2 Pages) Risk Analysis Understanding Risk Priority Numbers (June, 2011 - 2 Pages) ISO 9001:2008 ISO 9001:2008 for Purchasing Professionals (March, 2009 - 69 Pages) ISO 9001:2008 Technical Corrigendum 1 (August, 2009 - 7 Pages) Useful Aids to Implementing ISO 9001 2008 (August, 2009 - 7 Pages) Outsourcing and ISO 9001 (November, 2009 - 62 Pages) Guidance on Outsourced Processes (November, 2009 - 3 Pages) Vocabulary and Definitions (October, 2011 - 2 Pages) Understanding Metrics Process Metrics (March, 2009 - 6 Pages) Worcester Section - Attribute Sampling Acceptance Sampling Exercises (April, 2009 - 1 Page) Three Views of the OC Curve (April, 2009 - 2 Pages) Acceptance Sampling Slides (April, 2009 - 72 Pages) Excel Spreadsheets Available (April, 2009 - 1 Page) CAPA Systems Preventive Action, Correction, and Corrective Action (May, 2009 - 63 Pages) Servicing, Complaints, and FDA Reporting (November, 2009 - 119 Pages) Corrective and Preventive Action Clearing up Confusion (September, 2011 - 2 Pages) ISO 13485: 2003 ISO 13485 Technical Corrigendum 1 (August, 2009 - 2 Pages) Determining Requirements Related To Products (November, 2011 - 1 Page) FDA Information Review of Post Inspection Responses (August, 2009 - 3 Pages) Notice of Information Collection for QSR (August, 2010 - 6 Pages) Ombu Comments on Notice of Information Collection for QSR (August, 2010 - 5 Pages) Managing the Supply Chain Supplier Quality Agreements for Medical Devices (May, 2010 - 85 Pages) Medical Device Quality Agreement Template (November, 2009 - 17 Pages) Supplier Quality Agreements ISO 9001 (January, 2010 - 86 Pages) Supplier Quality Agreement Template ISO 9001 (January, 2010 - 15 Pages) Supplier Quality Agreement Template ISO 9001 (January, 2010 - 15 Pages) Medical Device Regulations Medical Device Classification (February, 2010 - 79 Pages) Excel Spreadsheets and FDA Device Regulations (March, 2010 - 75 Pages) Determining the Revision Level of QSR Sections (April, 2010 - 2 Pages) Regulatory Requirements for Medical Device Calibration Programs (April, 2010 - 73 Pages) Process Validation for Medical Devices (May, 2010 - 74 Pages) Process Validation for Medical Devices GxP Article (June, 2010 - 6 Pages) Understanding �Product� in FDA�s QSR (December, 2010 - 3 Pages) Changes to QSR (December, 2010 - 6 Pages) The Matrixx Case - Analysis by Dan O'Leary (June, 2011 - 8 Pages) Understanding Standards Harmonized to the MDD (September, 2011 - 2 Pages) Excel Spreadsheet Validation with Multiple Versions (October, 2011 - 4 Pages) EU Publishes New List of Standards Harmonized to the MDD (September, 2012 - 2 Pages) UDI Final Rule Timing (May, 2013 - 1 Page) Setting the Medical Device Lifetime (May, 2013 - 3 Pages) ASQ Certification CBA CQA Comparison Chart (March, 2010 - 20 Pages) Health Care Reform Medical Device Excise Tax (April, 2010 - 1 Page) Laboratory Developed Tests Ombu Presentation at the FDA LDT Meeting (July, 2010 - 7 Pages) In Vitro Diagnostic Directive European Commission Opens Consultation on the IVDD (July, 2010 - 9 Pages) Restrictions on Hazardous Substances (RoHS) RoHS Q&A (September, 2010 - 3 Pages) Total Productive Maintenance Equipment Utilization Metrics (September, 2010 - 4 Pages) Supply Chain Certifications CPSM v CSCP: Same or Different? (September, 2010 - 18 Pages) Risk Management for Medical Devices Medical Device Risk Management Using ISO 14971 (October, 2010 - 86 Pages) Statistical Tolerancing Basic Statistical Tolerancing (November, 2010 - 5 Pages) Global Harmonization Task Force The GHTF Regulatory Model (May, 2011 - 27 Pages) Statistical Distributions Selecting Discrete Sampling Distributions (December, 2011 - 3 Pages)