ISO 13485 Standards: Understanding the Requirements and Automating Compliance

With a global reach, ISO 13485 (2003) standards1 require the support for and the implementation and maintenance of a quality management system in all medical device environments that wish to achieve ISO 13485 Certification.

You're On Your Own …Sort Of…


The ISO 13485 quality management system is of the utmost importance since it helps to shape and mold devices that are safe and effective for customer use. However, like most regulations and standards, ISO 13485 requirements do not spell out every step of the process. Therefore, no quality management system is--or will be--created equal, so it's those medical device company representatives that most clearly define their quality documentation and objectives while simultaneously rendering those objectives to reality who will reap the greatest benefits.

A Brief Highlight of ISO 13485


Let's quickly highlight the most important aspects of ISO 13485 and then proceed to suggestions for the automation of ISO 13485 standards.

Management/Executive Responsibilities


Most explanations of ISO 13485 will start by explaining the requirements of the quality management system itself but the true starting point for any quality management system is the man or woman that sits at the head of the company table. Yes, quality can be delegated to a quality representative or to an entire quality department but when responsibility is parsed down to its core, it's the upper management representatives (i.e., the executives) who have the most power to ensure the success of a quality management system. According to clause 5 of the ISO 13485 standards, upper management representatives carry the weight of the following responsibilities:

• Promoting quality throughout the company;



• Identifying customers requirements;



• Promoting customer requirements and their company's responsibility to meet those requirements;



• Developing a quality management system;



• Supporting those who have also been given responsibility for the development of their quality management system;



• Defining quality objectives;



• Providing the necessary resources required for quality purposes;



• Implementing a quality management system;



• Providing resources to those who have also been given responsibility for the implementation of the quality management system;



• Encouraging employees to meet all quality management system requirements.
  
  
• Maintaining their quality management system;



• Performing reviews for the purpose of directly discussing quality management issues;



• Providing resources that allow those who have been delegated to be responsible for quality to maintain the quality management system;



• Expecting and encouraging employees to identify and recognize customer requirements;



• Defining his or her company's quality policy;



• Defining quality objectives;



• Planning for the development, implementation, improvement and modification of his or her company's quality management system.



• Etc.

There are many more requirements that could be discussed in regard to the responsibilities assigned to management by ISO 13485 but for the purposes of this paper the responsibilities already mentioned above are sufficient to show that the automation of 13485 can to a large degree save medical device companies months--if not years--of planning and administration time.

System Requirements


ISO 13485 (Clause 4) standards discuss the quality management system itself. These requirements are essential for ISO 13485 compliance but are also basically essential to other standards or regulatory requirements such as those prescribed by ISO 9001:2008, 21 CFR 820, etc. In other words, these requirements are very basic to the development, understanding and maintenance of quality management systems.

The Clause 4 requirements include the following:

• The creation and development of a quality management system;



• The identification of those processes that will keep the quality management system functioning;



• The description of all processes associated with quality management;



• The implementation of the quality management system;



• The implementation of all of the processes identified within the quality management system;



• The effective control of the quality management system processes;



• The maintenance of the quality management system;



• The effective monitoring of all processes associated with quality management;



• The effective maintenance of all processes associated with quality management;



• The development of quality management system documentation including documents for quality system implementation, a file for every type or model of each medical device and a file for every related service;



• The preparation of a QMS manual;



• The documentation of QMS procedures;



• A description of how QMS processes interact with each other;



• The control of QMS documentation;



• The approval of documentation associated with quality management before that documentation can be distributed;



• The maintenance of QMS records.

Resource Requirements


Resources are required for all worthwhile endeavors and achieving ISO 13485 certification is no exception. Clause 6 of the 13485 requirements include the following:

• The identification of resource requirements for the quality management system in question;



• The identification of resources that are needed and that will be needed to continually support the quality management system;



• The identification of those resources that will be necessary to satisfy customer requirements;



• The identification of those resources that will be needed to satisfy regulatory requirements;



• The provision of resources for the quality management system including all phases of system development (i.e., support, implementation and maintenance);



• The utilization of personnel who are competent for QMS purposes;



• The responsibility to ensure that the competent personnel have received the correct training;



• The identification of training needs;



• The establishment of assessment procedures related to training needs;



• The delivery of training programs;



• The evaluation of training programs;



• The maintenance of competence records;



• Etc.
  
  

There are also many additional requirements that are inclusive in clause 6 (mostly regarding infrastructure and work environment stipulations) that will not be discussed in this paper.

Automation: Applications for Streamlined ISO 13485 Management


As you've looked over the basic requirements for meeting ISO 13485 standards you've probably noticed a few trends emerge. Most of the requirements mentioned above for example could be categorized into the following categories:

• Heavy Management Responsibility



• Document Control (centralized controls, securities, etc.)



• Document Management (routing, version controls, etc.)



• QMS Process Controls



• QMS Trending



• Training



• Reporting

All of these categories to the great glee of many executives and quality management personnel are fully capable of being streamlined and automated with web-based technologies. MasterControl, a software developer of QMS, GxP Process, Audit and Document Control technologies provides solutions that streamline management responsibilities as well as responsibilities related to document control/management, QMS process management, QMS trending, training and reporting.

How Does it Work?


MasterControl lightens the burdens of medical device management executives by first providing the projects, collaboration and document control solutions that allow executives (from virtually anywhere in the world) to get online and plan from the initial development of the QMS throughout the implementation and maintenance phases. MasterControl can also provide an audit trail that allows project managers to see what has been accomplished, when and by whom. Document control systems allow management representatives (again from virtually anywhere in the world) to create QMS-related documents, collaborate with their colleagues on these documents, route and approve documents and set them up for training procedures and automated exams. In short, MasterControl can shave months--if not years--off the time that goes into the administration of QMS planning and document control.

Addressing the System Requirements


In terms of the requirements for the quality management system itself, MasterControl streamlines the automation of these developed processes by providing document management and control for all policies, manuals and other documentation associated with quality management (or any other type of file for that matter). MasterControl also streamlines the automation of collaborative processes so that management and quality representatives can discuss QMS documentation and edit it with full audit trail capabilities and version controls. MasterControl process controls (i.e., controls for customer complaints, audits, deviations, nonconformance events, change control and CAPAs) also serve to automate the quality management system itself! Tracking and trending features--along with audit trails also allow users to effectively monitor and maintain the quality management system without missing essential information. In addition to these automation benefits, MasterControl provides solutions especially designed to meet the needs of DHR control, medical device labeling, etc.

Addressing the Resource Requirements


Addressing resource requirements with MasterControl is a wonderful experience and one that saves additional time! Planning to meet resource requirements again can be managed with projects, collaboration and document control modules (these modules are launched from one web-based platform) and the training module allows users from anywhere in the world to be trained, tested and proved competent (via an audit trail) for compliance needs. Competence records are also fully controlled in the centralized document repository.

Conclusion


In short, MasterControl can take a medical device company's need for ISO 13485 compliance and help make it an automated reality. To learn more about MasterControl, please feel free to contact a MasterControl representative by calling 1.800.825.9117 or by emailing info@mastercontrol.com.

References


(1) All references to ISO 13485 information in this article have been paraphrased from information that was extracted from the following website: http://www.praxiom.com/iso-13485.htm

Marci Crane is the Lifeline Publications Editor at MasterControl, Inc. in Salt Lake City, Utah. To learn more about achieving consistent compliance with ISO 13485 standards, please contact a MasterControl representative to learn more about MasterControl's web-based software solutions for document control, BOM management, audit control, PLM management and training management.