ISO 13485

Quality Objectives Register

Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements.

Fully Customizable Audit Ready Instant Download
Standard
ISO 13485
Document Type
Register
Format
DOCX
Language
English
Tags
ISO 13485, Medical Devices, Register

This register records the Quality Objectives of your organisation for the period the year. ISO 13485:2016 clause 5.4.1 requires Top Management to ensure that quality objectives, including those needed to meet applicable regulatory requirements and requirements for product, are established at relevant functions and levels within your organisation, and that they are measurable and consistent with the Quality Policy.

What's Inside

  • Policy-to-Objectives Linkage
  • Company-Level Quality Objectives
  • Objective Definitions
  • Baselines, Targets and Status
  • Departmental and Process Objectives
  • Action Plan Summary
  • Monthly Performance Tracking
  • Comments on Amber / Red results and actions taken

ISO 13485 Alignment

Supports ISO 13485:2016 requirements, including Clause 5.4.1. It fits with the rest of the QEHS Vault ISO 13485 document set.

Format

Supplied as a fully editable Microsoft Word (.docx) file. Add your organisation’s name, logo and details, then use it straight away. Instant download after purchase.

Key Benefits

  • Professional, ready-to-use QEHS document designed to support effective implementation, documentation, and ongoing compliance with applicable management system requirements