Paperless |
Home | Learn more about eQMS or call for information: 719-649-4242 Hold your smartphone in landscape mode for best view | Cookies required to operate eQMS Dag nabbit Norton, stop reporting false positives - we've been online 20 years! Consider whitelisting our web address to evaluate eQMS. In your Norton, go to Security - Advanced Security - Safe Web - Exclusions, then add our web address to evaluate eQMS. |
Log In |
ISO 13485 Quality ManualTable of Contents Section 1: Welcome to (Your Co) Section 1: Welcome to (Your Company Name) The Company is a developer and producer of medical devices that include (your product description). Section 2: Company Vision and Governing Policies ... Section 3: Scope, Exclusions and Definitions 3.1 Scope 3.2 Exclusions 3.3 Definitions & Conventions Section 4: Quality Management System 4.1.1 The Company's quality system... (see the Management Process Procedure) and to meet the requirements of... The Company has... and emphasizes the importance of:
4.1.2 For each process identified in use at the Company (see the Management Process Procedure), the sequence and interaction of processes has... Every process... ... 4.1.3 Processes are...
4.1.4 The Company manages quality management system processes and procedures according... Changes ... are controlled according to the Configuration Management Procedure and are:
4.1.5 When the Company elects to outsource..., The controls for outsourced activities are... according to the Purchasing Procedure, which includes... 4.1.6 The Company controls... according to the Production Procedure, and after... Records of validations are retained and maintained according to the Control of Documented Information Procedure. 4.2 Documentation Requirements ... 4.2.1 General
The order of precedence of order-specific documentation is as follows...:
4.2.2 Quality Manual
4.2.3 Medical Device File The contents of the medical device file includes:
4.2.4 Control of Documents Documents are controlled to:
Changes to documents are... according to the Configuration Management Procedure. Obsolete documents are retained and maintained according to the Control of Documented Information Procedure. 4.2.5 Control of Records Section 5: Management Responsibility 5.1 Management Commitment
5.2 Customer Focus 5.3 Quality Policy The Company's quality policy:
5.4 Planning 5.4.1 Quality Objectives 5.4.2 Quality Management System Planning The quality system has... Subsequent major changes... are... The QMS documentation acts as... 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority Figure 2: Responsibilities and Authorities ... 5.5.2 Management Representative The Quality Manager reports directly to... The Quality Manager has the responsibility and authority to... 5.5.3 Internal Communication 5.6.1 General 5.6.2 Review Input 5.6.3 Review Output Section 6: Resource Management 6.1 Provision of Resources The processes of Management and Proposal Development and Contract Review have... Employees may submit the Request for Support form to... Resource management is addressed in the Management Process Procedure. Employees are... Personnel undergo training... according to the Training Program. All Company personnel are... according to the Training Program. The Company's training program:
The training program is defined in the Training Program. 6.3 Infrastructure Infrastructure requirements are regularly reviewed during Management Review and include a review of:
The Company utilizes maintenance routines... Records of maintenance activities are retained and maintained according to the Control of Documented Information Procedure. Monitoring and measurement equipment is controlled according to the Calibration Procedure. The Facilities Manager... IT resources are... For more on management's controls over the infrastructure, see the Management Process Procedure. 6.4 Work Environment and Contamination Control 6.4.1 Work Environment The Company:
6.4.2 Contamination Control For sterile medical devices, the Company documents:
6.5 Corrective Maintenance Section 7: Product Realization 7.1 Planning of Product Realization
7.2 Customer-Related Processes 7.2.1 Determination of Requirements Related to Product
7.2.2 Review of Requirements Related to Product Once requirements are... as defined in the Proposal Development & Contract Review Procedure, which includes:
Where the Customer provides... When product requirements are changed, the Company... according to the Configuration Management Procedure. Records... are retained and maintained according to the Control of Documented Information Procedure 7.2.3 Communication
Communication methods may include... 7.3.1 General
7.4 Purchasing 7.4.1 Purchasing Process The criteria applied for the evaluation and selection of Suppliers is:
The Company monitors Supplier performance... according to the Receiving Procedure taking into account... 7.4.2 Purchasing Information Purchasing information..., including as appropriate:
The Company... see the Purchase Order Review Work Instruction. 7.4.3 Verification of Purchased Product ..., the Company determines... according to the Management Process Procedure. ...external provider... according to the Receiving Procedure. 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision
The Company has established and retains/maintains... 7.5.1.1 Production Documentation 7.5.1.2 Control of Production Process Changes 7.5.1.3 Control of Production Equipment & Tools 7.5.1.4 Control of Work Transferred on a Temporary Basis Outside the Organization's Facilities
7.5.1.5 Control of Service Operations 7.5.2 Cleanliness of Product
If product is cleaned according to a) or b) above, the requirements.. do not... 7.5.3 Installation Activities If the agreed Customer requirements..., the Company provides... Records of medical device... according to the Control of Documented Information Procedure. 7.5.4 Servicing Activities The Company analyses records of servicing activities produced by itself and its Suppliers:
Records of servicing activities are retained and maintained according to the Control of Documented Information Procedure. 7.5.5 Particular Requirements for Sterile Medical Devices 7.5.6 Validation of Processes for Production and Service Provision Records of the results and conclusion of validation and necessary actions from the validation are retained and maintained according to the Control of Documented Information Procedure. 7.5.7 Particular Requirements for Validation of Processes for Sterilization and Sterile Barrier Systems ... 7.5.8 Identification The Company identifies... throughout product realization. If required..., the Company... according to the Production Procedure. Returned medical devices... according to the Control of Nonconformities Procedure. All products..., which is fully defined in the Production Procedure 7.5.9.1 General 7.5.9.2 Particular Requirements for Implantable Medical Devices The Company requires Suppliers... 7.5.10 Customer Property 7.5.11 Preservation of Product Special conditions required for preservation of product are controlled according to the Production Procedure and are recorded according to the Control of Documented Information Procedure. 7.6 Control of Monitoring and Measuring Equipment Equipment, tools,... according to the Production Procedure. All measuring and test equipment instruments and devices... are maintained as defined in the Calibration Procedure. To ensure valid measurement results, measuring equipment:
In addition, the Company... When computer software is used in the monitoring and measurement of specified requirements,... The specific approach and activities associated with software validation and revalidation... Records of the results and conclusion of validation and necessary actions from the validation are retained and maintained according to the Control of Documented Information Procedure. Section 8: Measurement, Analysis and Improvement 8.1 General
When applicable,... Responsible Authorities collect data for determining the acceptability of the quality management system, which may include:
8.2 Monitoring and Measurement 8.2.1 Feedback The Company's feedback process includes... Records are retained and maintained according to the Control of Documented Information Procedure. 8.2.2 Complaint Handling Justification is documented in the Request for Support form... 8.2.3 Reporting to Regulatory Authorities Records of reporting to regulatory authorities are retained and maintained according to the Control of Documented Information Procedure. 8.2.4 Internal Audit
The audit program is... Records of the audits and their results are retained and maintained according to the Control of Documented Information Procedure. The Responsible Authority for the area being audited... 8.2.5 Monitoring and Measurement of Processes The method for measuring process performance to demonstrate the ability of each process to achieve planned objectives is defined according to the Management Process Procedure. ... 8.2.6 Monitoring and Measurement of Product Evidence of conformity to the acceptance criteria is retained and maintained according to the Control of Documented Information Procedure, which... For implantable medical devices, the Company... 8.3 Control of Nonconforming Product 8.3.1 General 8.3.2 Actions in Response to Nonconforming Product Detected Before Delivery Nonconformities are processed by:
When nonconforming product is corrected, it is... according to the Control of Documented Information Procedure. 8.3.3 Actions in Response to Nonconforming Product Detected After Delivery The Company applies requirements..., which are... Records of actions relating to the issuance of advisory notices are retained and maintained according to the Control of Documented Information Procedure. 8.3.4 Rework 8.4 Analysis of Data If the analysis of data.... Records of the results of analyses are retained and maintained according to the Control of Documented Information Procedure. 8.5.1 General 8.5.2 Corrective Action Records of the results of any investigation and applied actions are retained and maintained according to the Control of Documented Information Procedure. 8.5.3 Preventive Action Records of the results of any investigation and applied actions are retained and maintained according to the Control of Documented Information Procedure. Appendix A: Company Processes and Applicable ISO 13485 Clauses
Appendix B: Company Processes and Applicable Documents
Appendix C: Outsourced Processes The following processes are outsourced and controlled as indicated:
Appendix D: Quality Objectives
Appendix E: Identification of Key Realization Processes ... 9.0 REVISION HISTORY AND APPROVAL RECORD Quality System Procedure PROPRIETARY INFORMATION - UNCONTROLLED IF PRINTED UNLESS OTHERWISE MARKED |