Describes the companies QMS and identifies the kep applicable procsesses for the company. Can customize for your companies product and processes.

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Describes the companies QMS and identifies the kep applicable procsesses for the company. Can customize for your companies product and processes.

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FR-412-01-01  Process FMEA Form

FR-412-01-02. Design FMEA Form

FR-412-01-03  Risk Management Plan

7 pages outlining the process and requirements for identifying and evaluating risks for products designed and manufactured by the company. Includes Risk Management Planning, Risk Analysis, Risk Evaluation, Risk Controls, Risk Acceptability, Risk Management Review and Production information and review. Includes forms for FMEA's, as well as Risk Management Planning.

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FR-412-01-01  Process FMEA Form

FR-412-01-02. Design FMEA Form

FR-412-01-03  Risk Management Plan

7 pages outlining the process and requirements for identifying and evaluating risks for products designed and manufactured by the company. Includes Risk Management Planning, Risk Analysis, Risk Evaluation, Risk Controls, Risk Acceptability, Risk Management Review and Production information and review. Includes forms for FMEA's, as well as Risk Management Planning.

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Describes the requirements for the DMR including product and process specifications, QA procedures and packaging and labeling specifications.

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Describes the requirements for the DMR including product and process specifications, QA procedures and packaging and labeling specifications.

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FR-424-01-01 Document Review Form

FR-424-01-02 External Standards

FR-424-01-03 Index Quality Documents

FR-424-01-04 Document Change Request

6-page SOP plus forms defining the requirements for controlling quality management system documents. This to ensure documents are accurate, complete, maintained, approved, and stored securely and provide easy access.

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FR-424-01-01 Document Review Form

FR-424-01-02 External Standards

FR-424-01-03 Index Quality Documents

FR-424-01-04 Document Change Request

6-page SOP plus forms defining the requirements for controlling quality management system documents. This to ensure documents are accurate, complete, maintained, approved, and stored securely and provide easy access.

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Describes the requirements for GDocP required for all QMS documents and records. Applies to all documents including form completion, recording of data, revisions to data, signature format requirements etc. Also covers control of external standards and the change process for documents.

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Describes the requirements for GDocP required for all QMS documents and records. Applies to all documents including form completion, recording of data, revisions to data, signature format requirements etc. Also covers control of external standards and the change process for documents.

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FR-425-01-02 Record Disposal Form

Describes the procedure for control of all required quality records, including, hard copy & electronic, record I.D., error correction, record retention, storage and disposal.

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FR-425-01-02 Record Disposal Form

Describes the procedure for control of all required quality records, including, hard copy & electronic, record I.D., error correction, record retention, storage and disposal.

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Outlines how the company’s top management is committed to the development and implementation of the Quality Management System and its ongoing maintenance and effectiveness. Includes how top management carries out communicating throughout the organization the importance of meeting customer requirements as well as applicable regulatory requirements, establishing and communicating the Quality Policy, and Quality Objectives, conducting Management Reviews, and ensuring availability of resources.

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Outlines how the company’s top management is committed to the development and implementation of the Quality Management System and its ongoing maintenance and effectiveness. Includes how top management carries out communicating throughout the organization the importance of meeting customer requirements as well as applicable regulatory requirements, establishing and communicating the Quality Policy, and Quality Objectives, conducting Management Reviews, and ensuring availability of resources.

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FR-561-01-01 Management Review Attendance

FR-561-01-02 Management Review Minutes Template

Establishes the procedure for the planning, conducting and documenting of Management Review of the QMS by top management. This includes reviewing the continuing suitability, adequacy, and effectiveness of the QMS and ensures it satisfies the Quality Policy and Objectives.

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FR-561-01-01 Management Review Attendance

FR-561-01-02 Management Review Minutes Template

Establishes the procedure for the planning, conducting and documenting of Management Review of the QMS by top management. This includes reviewing the continuing suitability, adequacy, and effectiveness of the QMS and ensures it satisfies the Quality Policy and Objectives.

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FR-622-01-01 Training Record Form

FR-622-01-02 Training Matrix

FR-622-01-03 Job Description

FR-622-01-04 Employee Training Plan

FR-622-01-05 Facility Training Plan

5-page SOP and 5 Forms describes the general training requirements for all employees to ensure they have the knowledge, skills and abilities to perform their respective roles successfully by developing the required proficiency through various and appropriate methods of training. Forms for employee training records, training matrix for SOP’s, JD template and employee and facility training plans.

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FR-622-01-01 Training Record Form

FR-622-01-02 Training Matrix

FR-622-01-03 Job Description

FR-622-01-04 Employee Training Plan

FR-622-01-05 Facility Training Plan

5-page SOP and 5 Forms describes the general training requirements for all employees to ensure they have the knowledge, skills and abilities to perform their respective roles successfully by developing the required proficiency through various and appropriate methods of training. Forms for employee training records, training matrix for SOP’s, JD template and employee and facility training plans.

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Describes and documents the training requirements and process for the Quality Management System procedures and other appropriate QMS and Regulatory requirements. This SOP is specific to the QMS training and is used along with SOP-622-02 General Training for total training requirements.

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Describes and documents the training requirements and process for the Quality Management System procedures and other appropriate QMS and Regulatory requirements. This SOP is specific to the QMS training and is used along with SOP-622-02 General Training for total training requirements.

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Requirements for buildings, workspace and associated utilities, process equipment and essential supporting services needed to achieve conformity of product requirements, prevent product mix-ups and ensure proper handling of product.

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Requirements for buildings, workspace and associated utilities, process equipment and essential supporting services needed to achieve conformity of product requirements, prevent product mix-ups and ensure proper handling of product.

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FR-631-02-01 Equipment Log

FR-631-02-02 PM Report

Describes the general preventative maintenance requirements for the manufacturing and test equipment used at the company. Applies to only the general requirements and as required specific area or equipment procedures can be added. Equipment supplier maintenance manuals can also be used.

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FR-631-02-01 Equipment Log

FR-631-02-02 PM Report

Describes the general preventative maintenance requirements for the manufacturing and test equipment used at the company. Applies to only the general requirements and as required specific area or equipment procedures can be added. Equipment supplier maintenance manuals can also be used.

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Describes the GMP rules for all employees and visitors entering the manufacturing areas. Includes health and cleanliness requirements for employees, personal practices including clothing, hairnets, gowns, etc.

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Describes the GMP rules for all employees and visitors entering the manufacturing areas. Includes health and cleanliness requirements for employees, personal practices including clothing, hairnets, gowns, etc.

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Outlines the procedures for housekeeping throughout the total manufacturing and administration areas of the company facility. This is required to avoid contamination of product. Housekeeping as covered in this procedure is to be carried out in all areas of the facility and can be customized to suit the needs of the company.

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Outlines the procedures for housekeeping throughout the total manufacturing and administration areas of the company facility. This is required to avoid contamination of product. Housekeeping as covered in this procedure is to be carried out in all areas of the facility and can be customized to suit the needs of the company.

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Documents the requirements for the Pest Control program for the facility. Covers all areas of the facility as required and all concerned and appropriate pests.

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Documents the requirements for the Pest Control program for the facility. Covers all areas of the facility as required and all concerned and appropriate pests.

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Describes the procedures for the control of contaminated or potentially contaminated product and manufacturing equipment in order to prevent contamination of the work environment, personnel, or product.

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Describes the procedures for the control of contaminated or potentially contaminated product and manufacturing equipment in order to prevent contamination of the work environment, personnel, or product.

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This SOP describes the records required for each batch and/or run of product that was manufactured and can be customized to suit the organizations method of operations. The DHR provides evidence that the manufacturing process resulted in product that met all the requirements.

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This SOP describes the records required for each batch and/or run of product that was manufactured and can be customized to suit the organizations method of operations. The DHR provides evidence that the manufacturing process resulted in product that met all the requirements.

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Describes the procedures used by the company for the handling of customer-related processes, including the determination of requirements related to the product, review of those requirements, and communication with customers.

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Describes the procedures used by the company for the handling of customer-related processes, including the determination of requirements related to the product, review of those requirements, and communication with customers.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.

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SOP to describe the process for the design and development of product labeling as well as provide guidance on the content of labeling to meet product and regulatory requirements. Applies to all levels of labeling from design, approvals & release for production.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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SOP to describe the process for the design and development of product labeling as well as provide guidance on the content of labeling to meet product and regulatory requirements. Applies to all levels of labeling from design, approvals & release for production.

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FR-739-01-01 Engineering Change Request (ECR)

This procedure along with the ECR form describes the process and requirements for controlling and approving minor design changes. Includes the process for identification and documentation of the changes, review and approval and validation of the changes as appropriate. 

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-739-01-01 Engineering Change Request (ECR)

This procedure along with the ECR form describes the process and requirements for controlling and approving minor design changes. Includes the process for identification and documentation of the changes, review and approval and validation of the changes as appropriate. 

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Outlines the process for purchasing raw materials, products, and services from approved suppliers. Includes required purchase order (P.O) information & maintain supplier files. This procedure covers the purchasing process for direct production materials and services that may impact product quality. This procedure used for all suppliers that are approved and are listed on the Approved Supplier List 
     
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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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Outlines the process for purchasing raw materials, products, and services from approved suppliers. Includes required purchase order (P.O) information & maintain supplier files. This procedure covers the purchasing process for direct production materials and services that may impact product quality. This procedure used for all suppliers that are approved and are listed on the Approved Supplier List 
     
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FR-741-02-01 Supplier Survey Form

FR-741-02-02 Supplier Approval Form

FR-741-02-03 Approved Supplier List

This 5-page SOP and 3 forms, focuses on the supplier approval process from the initial supplier survey to the documented approval, and entering on the approved supplier list. Applies to all suppliers who provide services or production materials to the company to be used in the manufacture of products for the company.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-741-02-01 Supplier Survey Form

FR-741-02-02 Supplier Approval Form

FR-741-02-03 Approved Supplier List

This 5-page SOP and 3 forms, focuses on the supplier approval process from the initial supplier survey to the documented approval, and entering on the approved supplier list. Applies to all suppliers who provide services or production materials to the company to be used in the manufacture of products for the company.

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This SOP provides a general overview of the control of the top-level manufacturing process including controls for the product. Specific procedures can be added to suit the companies’ processes. Detailed process procedures are covered under SIPOC diagrams as outlined in this procedure.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This SOP provides a general overview of the control of the top-level manufacturing process including controls for the product. Specific procedures can be added to suit the companies’ processes. Detailed process procedures are covered under SIPOC diagrams as outlined in this procedure.

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This SOP describes the requirements for the control of product labeling to ensure accuracy and to prevent mix-ups.  Applies to the control of labeling from incoming inspection, storage, release from stock to packaging department, line clearance and final inspection before release to shipping

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This SOP describes the requirements for the control of product labeling to ensure accuracy and to prevent mix-ups.  Applies to the control of labeling from incoming inspection, storage, release from stock to packaging department, line clearance and final inspection before release to shipping

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Applies to methods for preservation of product from receipt of raw materials, through production processes, storage, and shipment of final product. Includes any recommendations for warehousing of inventory including any guidelines for storage at customer locations.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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Applies to methods for preservation of product from receipt of raw materials, through production processes, storage, and shipment of final product. Includes any recommendations for warehousing of inventory including any guidelines for storage at customer locations..

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Purpose of this procedure is to describe the requirements for cleanliness of product produced by the company. Includes if product is to be cleaned prior to sterilization or if used non-sterile and cleanliness is of significance in use.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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Purpose of this procedure is to describe the requirements for cleanliness of product produced by the company. Includes if product is to be cleaned prior to sterilization or if used non-sterile and cleanliness is of significance in use.

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FR-756-01-01 Protocol Template

This procedure outlines the minimum requirements for validation or revalidation of manufacturing processes in order to provide documented evidence that each specific process will consistently yield product meeting all quality and design specifications.  Procedure covers; master validation plans, IQ, OQ and PQ validations. The procedure is focused on Process Validations, however the protocol format included with this SOP is the same for both process and design validations.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-756-01-01 Protocol Template

This procedure outlines the minimum requirements for validation or revalidation of manufacturing processes in order to provide documented evidence that each specific process will consistently yield product meeting all quality and design specifications.  Procedure covers; master validation plans, IQ, OQ and PQ validations. The procedure is focused on Process Validations, however the protocol format included with this SOP is the same for both process and design validations.

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This procedure outlines the minimum requirements for validation or revalidation of software and computer systems. Applies to all applications in quality assurance and manufacturing processes and applicable to marketed products in order to provide documented evidence that each specific software and hardware will consistently yield results and meet all quality and design specifications.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This procedure outlines the minimum requirements for validation or revalidation of software and computer systems. Applies to all applications in quality assurance and manufacturing processes and applicable to marketed products in order to provide documented evidence that each specific software and hardware will consistently yield results and meet all quality and design specifications.

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SOP to describe the requirements for the identification of raw materials through to final product and for the traceability of those products. Applies to incoming raw materials, work in progress and final product. It covers all batches and lots of final product.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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SOP to describe the requirements for the identification of raw materials through to final product and for the traceability of those products. Applies to incoming raw materials, work in progress and final product. It covers all batches and lots of final product.

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FR-761-01-01 Equipment Calibration Log

FR-761-01-02 Calibration Record

This SOP defines the requirements for the calibration and control of all inspection and test equipment used in the manufacture and quality inspection and test of products and processes. This procedure applies to all aspects of the control of inspection and test equipment/instruments, from the purchase of new equipment, through the equipment identification, scheduling of calibration, and control and reaction if any equipment is found to be out of calibration.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-761-01-01 Equipment Calibration Log

FR-761-01-02 Calibration Record

This SOP defines the requirements for the calibration and control of all inspection and test equipment used in the manufacture and quality inspection and test of products and processes. This procedure applies to all aspects of the control of inspection and test equipment/instruments, from the purchase of new equipment, through the equipment identification, scheduling of calibration, and control and reaction if any equipment is found to be out of calibration.

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To describe the feedback processes implemented by the company to monitor information relating to whether the organization has meet customer requirements and used as one of the measures of the effectiveness of the quality management system.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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To describe the feedback processes implemented by the company to monitor information relating to whether the organization has meet customer requirements and used as one of the measures of the effectiveness of the quality management system.

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FR-822-01-01 Customer Complaint Report

FR-822-01-02  Complaint Log

Procedure to describe the complaint handling processes for complaints received for the companies products. Covers from receiving the complaint, through the investigation process, trending, CAPA's as required, and closure.

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FR-822-01-01 Customer Complaint Report

FR-822-01-02  Complaint Log

Procedure to describe the complaint handling processes for complaints received for the companies products. Covers from receiving the complaint, through the investigation process, trending, CAPA's as required, and closure.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This procedure is for the notification to Regulatory Authorities, if required by applicable regulatory requirements, customer complaints that meet specified reporting criteria of adverse events or issuance of advisory notices.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This procedure is for the notification to Regulatory Authorities, if required by applicable regulatory requirements, customer complaints that meet specified reporting criteria of adverse events or issuance of advisory notices.

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FR-824-01-01 Audit Checklist

FR-824-01-02 Audit Plan

This procedure describes the process for planning, conducting, and reporting of internal Quality Management System audits to evaluate the compliance and effectiveness of the Quality Management System against the requirements of International Standards, appropriate Regulatory requirements and the company requirements. Also includes identifying opportunities for improvement and forms for audit checklist and audit plan.  

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-824-01-01 Audit Checklist

FR-824-01-02 Audit Plan

This procedure describes the process for planning, conducting, and reporting of internal Quality Management System audits to evaluate the compliance and effectiveness of the Quality Management System against the requirements of International Standards, appropriate Regulatory requirements and the company requirements. Also includes identifying opportunities for improvement and forms for audit checklist and audit plan.  

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This SOP outlines the process for managing a USA FDA facility inspection and describes activities that should be carried out to facilitate and manage the inspection. Applies to all personnel involved in the implementation and coordination of the Quality Management System. This procedure covers the preparation, reporting, and procedures to follow prior to, during, and following an inspection by the U.S. Food and Drug Administration (FDA).

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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This SOP outlines the process for managing a USA FDA facility inspection and describes activities that should be carried out to facilitate and manage the inspection. Applies to all personnel involved in the implementation and coordination of the Quality Management System. This procedure covers the preparation, reporting, and procedures to follow prior to, during, and following an inspection by the U.S. Food and Drug Administration (FDA).

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SOP to outline the requirements and procedures for the monitoring and measurement of processes and product as well as the requirements for the analysis of collected data. The analysis of appropriate data is used to demonstrate the suitability, adequacy and effectiveness of the QMS

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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SOP to outline the requirements and procedures for the monitoring and measurement of processes and product as well as the requirements for the analysis of collected data. The analysis of appropriate data is used to demonstrate the suitability, adequacy and effectiveness of the QMS

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FR-831-01-01 NC Form

FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-831-01-01 NC Form

Describes the actions required when nonconforming product is detected after delivery or when use has started. Provides a general overview of actions to be taken and specific activities are documented in other relevant procedures.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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Describes the actions required when nonconforming product is detected after delivery or when use has started. Provides a general overview of actions to be taken and specific activities are documented in other relevant procedures.

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Describes the procedure for reworking and/or sorting product that is found to be nonconforming to required specifications and/or requirements. Covers all rework or sorting of any nonconforming production materials and products and applies to all departments and employees involved in the rework or sorting process. The terms rework and sorting are often used interchangeably but as per this procedure there is a clear difference in application and requirements.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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Describes the procedure for reworking and/or sorting product that is found to be nonconforming to required specifications and/or requirements. Covers all rework or sorting of any nonconforming production materials and products and applies to all departments and employees involved in the rework or sorting process. The terms rework and sorting are often used interchangeably but as per this procedure there is a clear difference in application and requirements.

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FR-851-01-01 CAPA Form and FR-851-01-02 CAPA Log

Outlines the corrective and preventive action process to identify and implement changes required to ensure and maintain the continued suitability, adequacy and effectiveness of the QMS.  It defines the requirements for collecting and analyzing information based on appropriated statistical methodology for corrective and preventive actions, from detection and reporting of nonconformities, through the investigation, correction, corrective or preventive action and checking of effectiveness after implementation. Applies to nonconforming and potentially nonconforming raw materials, product in process, final product, customer complaints or feedback, manufacturing process nonconformance as well as QMS nonconformances.

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FR-731-01-01 Phase Review Form

FR-731-01-02 Design Review Form

Procedure defines the design and development process for products designed and manufactured by the company. Applies to all product design and development steps and activities including, design planning, design inputs, design outputs, design reviews, verification and validation and final design transfer.
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FR-851-01-01 CAPA Form and FR-851-01-02 CAPA Log

Outlines the corrective and preventive action process to identify and implement changes required to ensure and maintain the continued suitability, adequacy and effectiveness of the QMS.  It defines the requirements for collecting and analyzing information based on appropriated statistical methodology for corrective and preventive actions, from detection and reporting of nonconformities, through the investigation, correction, corrective or preventive action and checking of effectiveness after implementation. Applies to nonconforming and potentially nonconforming raw materials, product in process, final product, customer complaints or feedback, manufacturing process nonconformance as well as QMS nonconformances.

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