Business Management System: Requirements 00-BMS-002

Transcription

1 Business Management System: Requirements 00-BMS-002

2 Preface This document defines the applicability of International s requirements to the Business Management System (BMS) processes implemented at GM Nameplate (GMN). The sources of these requirements include: ISO 9001:2015; Quality Management Systems Requirements. AS 9100D:2016; Quality Management Systems Requirements for Aviation, Space, and Defense Organizations. ISO 13485:2016; Medical devices Quality management systems Requirements for regulatory purposes. These requirements are identified by clause and sub-clause. The application of each clause or sub-clause to a process, document, or other documentation is identified by a or a n/a. A clause or sub-clause applies where indicated by a. A clause or sub-clause does not apply where indicated by a n/a. Many of the requirements apply to more than one process or document. The following matrices reflects the primary reference that is most relevant to the standards requirement. This document is to be used to bridge the Business Management System (BMS): Manual, 00- BMS-001 to the Business Management System (BMS): Procedures, 00-BMS-003 documents. 00-BMS-002 Rev. 3 Page 1 of 9

3 requirements GMN Documentation BMS Processes ISO 9001: 2015 AS 9100D BMS Manual RFQ/Quotation Order Processing APQP Manufacturing Inspection and Packaging Audit and Ship Dispositioning NC Product Document Control Audits Management Planning and Review Hiring Training Calibration Receiving Inspection Purchasing Work Instructions BMS-002 Rev. 3 Page 2 of 9

4 requirements GMN Documentation BMS Processes ISO 9001: 2015 AS 9100D BMS Manual RFQ/Quotation Order Processing APQP Manufacturing Inspection and Packaging Audit and Ship Dispositioning NC Product Document Control Audits Management Planning and Review Hiring Training Calibration Receiving Inspection Purchasing Work Instructions BMS-002 Rev. 3 Page 5 of 9

5 requirements GMN Documentation BMS Processes ISO 13485:2016 BMS Manual RFQ/Quotation Order Processing APQP Manufacturing Inspection and Packaging Audit and Ship Dispositioning NC Product Document Control Audits Management Planning and Review Hiring Training Calibration Receiving Inspection Purchasing Work Instructions BMS-002 Rev. 3 Page 4 of 9

6 requirements GMN Documentation BMS Processes ISO 13485:2016 BMS Manual RFQ/Quotation Order Processing APQP Manufacturing Inspection and Packaging Audit and Ship Dispositioning NC Product Document Control Audits Management Planning and Review Hiring Training Calibration Receiving Inspection Purchasing Work Instructions BMS-002 Rev. 3 Page 5 of 9

7 ISO 9001: AS D Clause Understanding the organization and its contet Understanding the needs and epectations of interested parties Determining the scope of the quality management system Quality management system and its processes Leadership and commitment Customer focus Policy Establishing the quality policy Communicating the quality policy Organizational roles, responsibilties, and authorities Actions to address risks and opportunities Quality objectives and planning to achieve them Planning of changes Resources People Infrastructure Environment for the operation of processes Monitoring and measuring resources Organizational knowledge Competence Awareness Communication Documented information Creating and updating Control of documented information Operational planning and control Operational risk management Configuration management Product safety Prevention of counterfeit parts Requirements for products and services Customer communication Determining the requirements for products and services Review of the requirements for products and services Changes to requirements for products and services Design and development of products and services Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes Control of eternally provdied processes, products and services Type and etent of control Information for eternal providers 00-BMS-002 Rev. 3 Page 6 of 9

8 ISO 9001: AS D Clause Production and service provision Control of production and service provision Control of equipment, tools, and software programs Validation and control of special processes Production process verification Identification and traceability Property belonging to customers and eternal providers Preservation Post-delivery activities Control of changes Release of products and services Control of nonconforming outputs Monitorying, measurement, analysis, and evaluation Customer satisfaction Analysis and evaluation Internal audit Management review Management review inputs Management review outputs Nonconformity and corrective action Continual improvement 00-BMS-002 Rev. 3 Page 7 of 9

9 ISO 13485: Clause requirements Documentation requirements Quality manual Medical device file Control of documents Control of records Management commitment Customer focus Quality policy Planning Quality objectives Quality management system planning Responsibility, authority and communication Responsibiltiy and authority Management representative Internal communication Management review Review input Review output Provision of resources Human resources Infrastructure Work environment and contamination control Work environment Contamination control Planning of product realization Determination of requirements related to product Review of requirements related to product Communication Design and development Design and development planning Design and development inputs Design and development outputs Design and development review Design and development verification Design and development validation Design and development transfer Control of design and development changes Design and development files Purchasing process Purchasing information Verification of purchased product Control of production and service provision Cleanliness of product Installation activities Servicing activities 00-BMS-002 Rev. 3 Page 8 of 9

10 ISO Business Management System: Requirements Clause 13485: Particular requirements for sterile medical devices Validation of processes for production and service provision Particular requirements for validation of processes for sterilization and sterile barrier systems Identification Particular requirements for implantable medical devices Customer property Preservation of product 7.6 Control of monitoring and measuring equipment Feedback Complaint handling Reporting to regulatory authorities Internal audit Monitoring and measurement of processes Monitoring and measurment of product Actions in response to nonconforming product detected before delivery Actions in response to nonconforming product detected after delivery Rework Analysis of data Corrective action Preventive action 00-BMS-002 Rev. 3 Page 9 of 9