Part of maintaining good quality is accountability. You have to understand which people are in charge of which processes so that there are clear lines of responsibility. Without that, tasks are left fuzzy, and no one knows who is supposed to perform certain actions.
Section 5.5 of ISO 13485 (Responsibility, authority, and communication) may not require its own procedure, but it’s still important for an organization to meet the requirements and achieve a high level of quality in its processes and products.
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The Why
Quality is not something that you can leave employees to create on their own. By establishing clear responsibilities and enabling people through authority, people are better able to produce high-quality devices and help the QMS improve.
The goal of the Management Representative is to have one person who is knowledgeable about the relevant standards and regulations and empowered to implement changes for the betterment of the QMS and the company.
Responsibility and Authority (5.5.1)
Top management must ensure that all roles within an organization are well-defined. Without roles being defined, it becomes easy to brush off aspects of a process as “not your job”.
Typically, top management delegates authority to employees through job descriptions and organizational charts. If you read our Training Requirements Guide, you know that job descriptions need to be controlled within your organization’s QMS.
Additionally, companies also list responsibilities for different processes within the relevant work instructions or SOPs. This can make it clear who will be doing each section of the process. If your organization is going this route, you can make sure responsibilities are added to documents following your document control procedure.
The Organizational Chart
An Org Chart needs to exist within a company’s QMS to show the interrelation of personnel. The level of detail and location of the Org Chart will depend on the size and needs of the company.
For example, a large company may have an Org Chart specific to roles and departments, and does not go into granular detail about who is in each role. You’ll often find this type of Org Chart in a company’s Quality Manual, but it is perfectly acceptable to have it as a standalone document referenced in the Quality Manual.
Medium and large companies may also have human resources software that can show a full Org Chart, including each employee and their manager. However, it may be difficult to access this information during an audit, and the chart would be impossible to move through if it contained thousands of employees. For this reason, a company may choose to have both the software and a department-level Org Chart built into the Quality Manual.
At smaller companies, it can be feasible to include each individual employee and their role within the Org Chart. If you are taking this approach, I highly recommend having an Org Chart as a separate document referenced in the Quality Manual. That way, you do not need to change the Quality Manual every time the Org Chart is updated.
Independence
ISO 13485 section 5.5.1 includes the statement “personnel who manage, perform, and verify work affecting quality shall ensure the independence and authority necessary to perform these tasks”.
It’s useful to think about this both from an organizational level and a specific task level.
From an organizational level, it can be detrimental for certain members of Quality to report directly under Operations/Manufacturing. The employees in Quality may feel that they can’t be honest in their role without facing career repercussions. Many times, Medical Device companies will have a separate area for Quality on their Org Chart, including the Head of Quality having a connection or “dotted-line” connection to the CEO.
However, the feasibility of this approach will depend on the size of the organization. Smaller companies may have limited managers and no employees dedicated to Quality. These companies should focus on empowering employees to point out quality concerns with their work.
At the task level, all sizes of organizations need to maintain independence for certain activities.
One of the main activities cited here is internal audits. Put simply, people should never be in a position to audit their own work. It’s also not advisable to have someone audit the work of their direct superior.
At larger companies, it can be easier to train different employees in internal audits and have them audit areas outside of their work function. At smaller companies, there may be one or no member of the organization who is qualified to lead audits, and the company should look at outsourcing its internal audit.
The Management Representative (5.5.2)
The Management Representative is a strange role that exists in organizations following a QMS. The purpose is to have one specific individual who is responsible for making sure every part of the QMS is effective, meets the standards, and is communicated to top management and the rest of the organization.
What are the duties of a Medical Device Management Representative?
The specifics of what the Management Representative does will vary depending on the size of the organization; however, here are the responsibilities laid out in ISO 13485:
- Verify that the processes needed for the QMS conform to ISO 13485 and are documented
- Inform top management of the effectiveness of the QMS and areas where it can improve
- Promote awareness of the standard and applicable regulatory requirements throughout the company
While ISO 13485 lists these as requirements for the Management Representative, it’s important to note that any or all of these tasks can be delegated to different members of the organization. However, the Management Rep has ultimate responsibility for ensuring the activities are completed.
The first responsibility is setting up and/or maintaining the QMS. If there are needed procedures, they should be written or reviewed by the Management Representative or a designee. The maintenance of the QMS is also supported by the Management Representative’s involvement in internal audits.
The second responsibility is most often done through the Management Review Meeting. The Management Rep can either prepare the information and lead the entire review, or they can delegate information gathering and the presentation to different employees. Either way, the Management Rep must be involved and participate in the Management Review.
The third responsibility comes down to training. The training for employees should go beyond specific work duties and include information on how activities help meet the QMS and regulatory requirements. The Management Rep should also ensure that the Quality Policy and different Quality Objectives are communicated throughout the organization.
Who can be the Management Representative?
Per the standard, the Management representative must be a member of management. They do not necessarily need to be an executive, but if they are not, they should be a manager who reports to an executive.
As usual, the person who will be the Management Rep will depend on the organization. A company may have a Quality Manager or Quality Director that acts as the Management Rep. It could alternatively have a more Regulatory-specific position that includes the Management Rep duties.
However, at smaller companies, there may not be a specific member of the organization who is focused on Quality. In these situations, it is acceptable to have a different member of the management team identified as the Management Rep.
However, there are a couple of difficulties in this situation. The first is that it is critical that there are no conflicts of interest between the responsibilities of being the Management Rep and their other responsibilities. This can make it difficult for a manager of Operations, especially a manager of Operations who does not have a background in Quality, to be the Management Rep.
The second is that a Management Rep outside of Quality may not have the necessary expertise to understand the requirements of the role.
No matter the situation, the Management Rep should have significant experience and training related to Quality requirements (sign up for the newsletter below).
If someone outside of Quality/Regulatory is going to be the Management Rep, they should be given outside training to help them succeed in the role. It’s crucial for the Management Rep to have the appropriate knowledge and authority to be respected by other members of the management team.
How is the Management Representative identified?
I’ve seen companies use two approaches to identifying the Management Representative.
The first is a callout in the Quality Manual, Org Chart, or Management Review procedure, either to a specific person or a title (e.g. the Quality Manager is appointed as the Management Representative).
The second is a formal document stating the responsibilities of the Management Rep, signed by the Management Rep and a member or members of top management.
Can there be more than one Management Representative?
There can only be one Management Representative for a QMS.
At larger companies, there may be more than one Management Rep throughout the entire organization, but this is only applicable if the company has different Quality Management Systems that each have their own ISO 13485 certificate.
Internal Communication (5.5.3)
The last part of ISO 13485 section 5.5 is focused on communication, which is often taken for granted within organizations.
Two-sided communication is necessary to maintain a successful QMS. Top management and the Management Rep must disseminate information about the effectiveness of the QMS and related goals throughout the company.
At the same time, anyone in the company should be able to communicate feedback and offer improvements related to the QMS. The feedback should be encouraged by top management and reviewed seriously and efficiently by the correct people.
One piece of advice for encouraging employees to make suggestions about processes and the QMS is that it should not feel like homework. If employees have to navigate to a hard-to-find area in the company’s intranet or fill out a detailed form, they will be less likely to offer feedback.
The types of two-way communication will vary by company but can include meetings, feedback sessions, suggestion drop boxes, emails, posters, and more. Everyone in the company should know that top management is committed to the organization’s quality.
Wrapping Up
Quality starts with people understanding their roles and how they can contribute to products and the system. To conform to ISO 13485 section 5.5, an organization needs to have a documented organizational chart with clearly defined roles and responsibilities. They should also appoint a Management Representative who has responsibility for the Quality System and communicates the effectiveness of the QMS to other members of management and throughout the organization.
If you have any questions, please leave a comment. If you found this article helpful, be sure to sign up for the newsletter below and review the rest of our articles, which cover ISO 13485 requirements in-depth.