Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE

1 Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE HAEMONETICS CORP. - COMPANY CONFIDENTIAL Before using this document, please consult Agile for the latest revision. Page 1 of 26 Global : Revision: CU Purpose This PROCEDURE provides the minimum requirements for Haemonetics Document Control and Records MANAGEMENT , including issuance, review, authorization and control. Scope This PROCEDURE applies to all world-wide facilities and organizations in Haemonetics, including corporate. This PROCEDURE applies to new documents and document revisions under the MANAGEMENT and control of documents that are part of Corporate DOCUMENTATION as well as Quality MANAGEMENT System (QMS), Design History File (DHF), Device Master Record (DMR) and Device History Records (DHR).

2 The Organization Chart is maintained by Human Resources within the Workday system on a real time basis and is not subject to the controls of this PROCEDURE . References Regulations and Standards Code of Federal Regulations 21 CFR 211 Code of Federal Regulations 21 CFR 820 Health Canada - Medical Device Regulations (MDR) European Union Medical Device Regulation 2017/745 (EU MDR 2017/745) Japanese Pharmaceutical Affairs Law ISO 13485: Medical Devices NOTE: the documents referenced above are shown without revision levels, unless specified, the most current version applies.

3 Document Document Number Haemonetics Global Quality Manual QM Document Control Policy PLY-QMS-0001 Global SOP- DOCUMENTATION Control System Templates/Forms Global SOP-Document and Part Numbering, Revisions and Naming Standards Global SOP-Record Retention and Retrieval Review and Control Process for Standards and Guidelines Drawing Formats Obsolescence PROCEDURE Engineering Drawing and DOCUMENTATION Procedures Verification of Manufacturing and Service Procedures and Instructions Global SOP-Employee Training and Training Qualification Global SOP-Good DOCUMENTATION Practices Completion of ECO Cost Impact Worksheets WI1097 Tijuana-Covina Work Instruction - Record Retention and Document Distribution WI1627 Global Work Instructions For

4 Supplier Change Notification WI1646 Global Work Instruction-Part and Document Creation, Revision And Non-Revision Controlled Workflows WI2242 Work Instruction for Robar Approved Labels WI1811 Global Work Instruction-Change Analyst WI2212 Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE HAEMONETICS CORP. - COMPANY CONFIDENTIAL Before using this document, please consult Agile for the latest revision. Page 2 of 26 Global Revision: CU Global SOP-NonConforming Event Global SOP-Label Review, Control and Inspection PROCEDURE Global SOP-Lot Numbering/Serialization PROCEDURE Device Master Record, Device History Record and Product Release PROCEDURE Lot Numbering/List Numbering For Bar Coded Bag Labels Global SOP - Design Control New Product Design And Release Process Global SOP-MDD Technical File Requirements Global SOP-Clinical Investigation Capital , Equipment and Disposables Global SOP - Temporary Change Notification SOP2529 Agile Training.

5 navigation , Basic Search And Approve/Reject TI1075 Agile PLM: Manufacturer & Manufacturer Part Creation Training TI1438 Revision and Non-Revision Controlled Approval Matrix Agile100190 Document Translation: Language Verification Form Definitions Term Definition Part Is defined as a purchased or manufactured material or good. Drawing, Manufacturer s Data Sheet or a Specification document is used to demonstrate the characteristics of the Part. Document Is defined as controlled written policy, operating PROCEDURE , inspection PROCEDURE , manufacturing PROCEDURE , specification, etc.

6 That directly or indirectly affects product quality and which forms the part of QMS, DHF, DMR or DHR Correction A change or update made to an item (part/document) to correct a clerical error or discrepancy in the content. Note: Changes made to update or revise a design or process shall follow the requirements per Item Parts and documents are referred to an Item" in Agile. IFU or DFU Instructions or Directions for Use Global Document Globally applicable DOCUMENTATION that covers processes across multiple sites and regions. Regional Document Specific regional level DOCUMENTATION that covers region specific process detail.

7 Site Document Specific facility-level DOCUMENTATION that covers site specific process detail. Translation Process of translating words or text from one language into another without altering the content. Master file The main file from which one or more translations are performed is called a master file. Approval Documented review and acceptance of the proposed change. Global SOP - DOCUMENTATION MANAGEMENT PROCEDURE HAEMONETICS CORP. - COMPANY CONFIDENTIAL Before using this document, please consult Agile for the latest revision. Page 3 of 26 Global Revision: CU Haemonetics Dictionary, Responsibilities The following section establishes roles and responsibilities for this Process.

8 Document Control is responsible for MANAGEMENT and control of this process. Document Control personnel will ensure timely review, processing, DOCUMENTATION , and release of the change in accordance with corporate and regulatory requirements. In addition, various functions and roles within Haemonetics have been assigned a set of responsibilities to ensure compliance and efficiency of the change control process. The following table describes each role or functional area s key responsibilities throughout the review. These responsibilities are not intended to be all inclusive or to exclude personnel from reviewing other aspects of the change.

9 Not all functional groups may be involved in the review and approval of a new or revised document. Agile Product Lifecycle MANAGEMENT (PLM) is an enterprise-wide software suite designed to manage product data from concept through obsolescence. Agile access is requested using the Haemo IT form located on the HaemoNet site. Document MANAGEMENT specific access includes: General Access - allows user to Navigate/Search/View/Approve/Reject Item Content Manager - allows user to create and make changes to Parts, Documents and Numbering and process Revision/Non-Revision Workflows.

10 Role Responsibilities Accounting / Finance Consider the impact of change on the cost and resources. Change Approver Assess the proposed change for compliance to this PROCEDURE , verify affected items are complete, inventory dispositions are appropriate, supporting DOCUMENTATION is included and appropriate, relative to the Approver s area of expertise. Change Initiator or delegate Prepare package including all required supporting and affected documents and to ensure their integrity, accuracy, and sufficiency. Complete required workflow forms per applicable SOPs.