03.26.2019 Robert Fenton

What An ISO 13485 Quality Manual For Medical Devices Should Look Like

An electronic quality management system (eQMS) and a defined process for compliance are critical for medical device companies. Without a clear set of organizational guidelines, you may accept unnecessary risks of inspection or low-quality products.

Producing high-quality medical devices offers a clear benefit to both patients and manufacturers. That's the reason the FDA launched the Case for Quality program and 21 CFR part 820 designed for quality improvements among medical device manufacturers. The FDA guidance is closely related to ISO 13485 guidelines for medical device quality. A quality manual is a core component of ISO 13485 and many other quality management systems in highly regulated industries.

A quality management manual guided by ISO 13485 can enable your organization to meet all applicable regulatory requirements, including FDA 21 CFR part 820, achieve certification with ISO 13485, and foster a culture of quality at your organization. Read on to learn why a quality manual isn't optional, and essential components of this critical document for device manufacturers.

Why You Need An ISO 13485 Quality Manual For Medical Devices

The quality manual for medical devices is a document required by ISO 13485, a quality management system designed for medical device manufacturers. If you are manufacturing medical devices for use in the U.S., your organization will need to prove compliance with FDA regulations. Demonstrating compliance with ISO 13485 is required for manufacturing medical devices which will be distributed internationally.

The Quality Management System consists of multiple components, including comprehensive documentation of the organization’s quality policy quality manual, procedures, work instructions, quality plans, and records.

A QMS Hierarchy

Quality guidelines are designed to capture the requirements for the quality management system and practices at the organization in a single, comprehensive document. ISO 13485 requirements for the quality manual include:

  • Describe the scope of the QMS, including any exclusions
  • List or reference QMS standard operating procedures (SOPs)
  • Describe interactions between QMS processes
  • Provide an outline of QMS documentation structure

ISO 13485 provides flexibility in how organizations choose to structure the quality manual. Procedures, work instructions, and forms can be included in the quality guidelines to satisfy these requirements. Specific characteristics hold true for a practical 13485 quality manual at any organization. Regardless of how large or mature your company is, a high-value set of quality guidelines should be a streamlined guide, carefully controlled, readily accessible, and follow a set structure. It should also address any regulations which your organization is not required to comply with and clear justification.

Related Reading: What is the Best ISO 13485 Quality Management System Software for 2019?

Streamlined Guide

When it comes to your 13485 quality manual for medical devices, bigger isn't always necessarily better. You don't want to overcomplicate your processes or create a document which is too big or cumbersome to provide value to the majority of staff members. However, the ISO standard clearly conveys that the document must be completely comprehensive and even provide clear justification for any regulations that your organization is exempt from.

Providing a streamlined user experience can be accomplished with useful tools and techniques for document management and knowledge management. Convey organizational process flow and the relationships between procedures using graphical communication tools, such as flow charts. To provide the best digital access experience possible, a sophisticated document management system designed for medical device manufacturers can provide easy-to-navigate links between documents and allow employees to click to access in-depth SOPs or related full-length policies.

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Controlled Document

Your guide should be the say-all about your quality management system. To serve as a comprehensive guide for both internal and external auditors, it should contain everything someone would need to know to understand your process and system. Depending on the scope of your QMS, this may not include a full list of SOPs. However, it should outline all applicable SOPs and regulations, and add a graphical representation of the end-to-end organizational process flow to precisely map the system.

According to Section 4.2.4 (Control of documentation) of ISO 13485:2016, documents required by the Quality Management System (QMS) should be “controlled” and “maintained” to ensure effectiveness for quality operations. The quality guidelines should address processes, procedures, and tools for document control, such as an eQMS system which meets applicable requirements for eSignatures. It should also outline policies such as:

  • Document review and approval before adoption
  • Processes for document revision and changes
  • Procedures to ensure documents are available at the point of use

An Accessible Resource

ISO 13485:2015, Section 6.1 (Provision of Resources) has no significant points of difference from the most closely related FDA requirements (820.20(b)(2) Resources). FDA language states "each manufacturer shall provide adequate resources, including the assignment of trained personnel, for management, performance of work, and assessment activities, including internal quality audits, to meet the requirements." The Quality Manual needs to be accessible to the entire team, and your organization must provide adequate training for the whole staff.

“Accessible” rarely means handing out printed copies for most manufacturers of medical devices. True accessibility to SOPs and other relevant documentation is generally better supported with a cloud-based eQMS (designed for medical device manufacturers) which can be accessed from mobile devices by a global workforce, including tablets used by lab workers. By integrating your training system with your document control system, you can meet regulatory requirements to measure training efforts and educate staff on quality standards.

Learn more in 13 Bottom Line-Boosting Benefits of a Quality Management System

Set Document Structure

The quality guidelines should follow a clearly defined logical structure, which reflects the structure of the pyramid. Use a defined approach to nomenclature and numbering procedures and create digital links between documents within your eQMS system to develop logical, simple-to-use navigation. The best structure for a set of quality guidelines is generally:

  • Scope
  • Quality Policy
  • Documented Procedures
  • Process Interactions
  • Definitions and Abbreviations
  • Organizational Structure
  • Regulations and Standards
  • Exemptions

The foundation of the quality manual should comprise the first portion of the guidelines, followed by procedures and work instructions. After definitions and rules, there should be a clear link to document records.

Exempted Regulations

Your quality manual should also provide a section for “exemptions.” This is a clear outline of any applicable regulations under FDA or international requirements that your organization is not required to comply with, and clear justification for these exemptions. For example, 13485 has a specific section on sterilization, but if your product isn't sold sterile, you don't need a set of SOPs.

Fostering A Culture of Quality

Remember the real purpose of an ISO 13485 Quality Management System Manual. It's to create a centralized document which describes the Quality Management System at a medical device manufacturing organization. If anyone, from a new employee to an external auditor, wants to understand the QMS in its entirety, this document should contain everything they need to know. Avoid creating a report which is built like a novel or a product which is too streamlined and misses critical links to need-to-know information.

By utilizing eQMS software with advanced document management features, you can satisfy regulatory requirements for document control and create a set of guidelines which are accessible for your entire workforce. A successful QMS manual should play an essential role in fostering a culture of quality.

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Published by Robert Fenton March 26, 2019
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