1. PURPOSE

This procedure ensures that policies, procedures, work instructions, forms, and templates are accurately identified, reviewed, and maintained. Each document undergoes a documented review for accuracy, compliance, and completeness, with a revision history to track changes and periodic reviews to maintain relevance.

2. SCOPE

This procedure applies to all Arrow International policies, procedures, work instructions, forms, and templates associated with both the Quality System (QS) and Environmental Management System (EMS). Translations of watermarks or other document markings may be used as needed.

3. RESPONSIBILITIES

3.1 Document Approvers

• Ensure document content sufficiently describes the intended process.
• Assess impact on their functional area, including training requirements.
• Provide approval, indicating compliance with established requirements.

3.2 Subject Matter Specialists

• Offer expertise to Document Owners, reviewers, and approvers as needed for accurate content.

3.3 Approvers of this Procedure

• Document Control is responsible for the procedure and approval is required from Document Control and Quality Assurance.

4. DEFINITIONS

• Approval Date: Date of final Document Approver’s signature; training can commence post-approval.
• Document Owner: Functional area responsible for document content and revisions.
• Issue Date: Date the revision becomes effective and available for use.
• Training Hold: Period between Approval Date and Issue Date for training purposes.

5. PROCEDURE

5.1 Request to Change a Document

1. Initiate Revision: Document Owner requests a copy of the current document from Document Control.
2. Document Changes: Apply changes, using redline tracking where applicable.
3. Submit Change Request: Complete change request form with redline copy attached; specify approvers and required translations.

5.1.1 Identification of Approvers

• Policies: Approved by Executive Committee and Document Owner.
• Procedures, Work Instructions, Forms, and Templates: Approved by Document Owner, functional manager, and QA/RA manager.
• Administrative Changes: Approved by Document Owner, relevant expert, and QA representative.

5.1.2 Cover Document for Forms and Templates

A cover document records revision history and signatures for blank forms/templates; it accompanies the document through the approval process.

5.2 Review and Approval of the Document

5.2.1 Electronic Signatures

Documents may be approved electronically if using a validated system for signatures.

5.2.2 Hand-Written Signatures

For hand-written approvals, Document Control circulates an original, unstamped copy for signatures within a designated time frame.

5.2.3 Approval by Change Order

Documents may be approved via Change Order, noted in the revision history.

5.2.4 Facsimile or Scanned Approval Signatures

If unavailable for a physical signature, approvers may fax or scan a signed approval page, provided an original follow later.

5.2.5 Timely Approvals

Approvers review documents promptly, communicating any needed changes to the Document Owner. If delays occur, the next level manager is notified to expedite review.

5.3 Training and Issuing

1. Training Requirements: If needed, Document Control applies a “training hold” watermark to the document.
2. Issuing Document: Post-training, Document Control finalizes the document’s Issue Date, creates a PDF, and distributes it to points of use.

5.4 Periodic Review of Documents

All QS documents are reviewed every three years for accuracy, with updates or confirmations of no changes noted in the revision history.

5.5 Obsolete Documents

1. Update Headers and Revision History: Replace “Issue Date” with “Obsolete Date.”
2. Approval Process: Obsolete documents require the same approvers as prior revisions.
3. Issuing Obsolete Document: Label with “OBSOLETE” in headers, archive electronic versions, and retrieve all copies.

6. APPROVALS

Functional Area:

• Document Owner
• Document Control
• Quality Assurance

7. REVISION HISTORY

Revision Level / Issue Date: 1.0

Change: Initial Version

8. APPENDICES

N/A

This procedure provides a structured approach for maintaining quality system documents, ensuring regulatory compliance, document accuracy, and accessibility.

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