Many companies venturing into the medical device field are often intimidated by the task of developing an ISO 13485 - FDA QSR compliant quality system. They are also concerned whether they are, or will, meet the regulatory requirements in the markets they intend to penetrate.
Such concerns are healthy for a company. The fact is when you manufacture or design medical devices there is a higher level of responsibility associated with those activities. There is also a need for the culture of the company to respect and utilize the quality system you put in place to govern your company.
What is a quality system really? Simply put, it boils down to documented instructions on how to perform individual tasks with the necessary regulatory requirements embedded within. Every company has processes that they have developed and follow, regardless of whether or not those processes are documented. The main difference between manufacturing "ash trays" and "medical devices" is the manner in which you document the process. Documenting medical device manufacturing or design processes does not need to be complicated.
Like many people I enjoy reading a good book in my downtime. However, I do want my employees reading a book every time they need instruction on how to perform a certain task. Individual quality system procedures need to be clear, precise, limited to the task at hand and meet the regulatory requirements. The ideal procedure, from my perspective, is one that a new employee can read, understand and execute with minimal support. Naturally, some processes are more complex than others, but the concept remains the same. Keep it simple so they can follow!
ISO 13485 Quality System Products
What's a blog without a pitch! Our quality system products were developed to help companies quickly achieve their goal of ISO 13485 certification and FDA QSR compliance. Our quality system products are designed to allow companies to focus on implementation and training instead of dedicating resources for quality system development.
Our approach to quality system development has always been centered around efficiency. The main reason being that if a company is not competitive in today's global economy then a quality system becomes a moot point.
Quality systems developed piece-meal often become a confusing web of overlapping documents that are difficult to maintain and exhaust valuable resources during training and utilization. However, by applying forethought to a quality system structure and content a quality system can be an asset not a burden.
A Modular Implementation Approach
The term modular has been used to describe a plethora of products. Therefore, the word modular evokes a variety of responses. A.P. Lyon uses the term modular to describe the logical grouping of carefully crafted procedures that align with ISO 13485 elements (e.g. Section 4.0, 5.0, 6.0, etc.).
Organizing individual procedures into modules or strategic groups merely provides us, or our customers, the ability to install an entire quality system following a logical sequence. This approach incorporates the lessons learned after installing quality systems in multiple locations around the world. This becomes increasing important when installing a system in an organization already engaged in manufacturing operations in order to minimize interruptions and better manage resource requirements.
Organizing individual procedures into modules or groupings also enables us, or our customers, to rapidly extract specific standard operating procedures needed to address a quality system "gap" identified in an existing quality system.
A quality system is merely the sum of all its operating procedures. We have carefully created each of our standard operating procedures in a manner that meets applicable regulatory requirements while maintaining the flexibility to efficiently adopt them into various organizational structures and activities.
How to Install Our Quality System Products?
The process begins by first defining your company objectives, understanding the nature of your products and services, and identifying the markets you currently, or intend to, operate within (e.g. US, Europe, Canada, Etc.). It is also important to understand any current or future product design activity your company is engaged in and the anticipated regulatory pathways needed for product approval for various countries (e.g. PMA, 510(k), CE, etc.).
Define your organizational structure. Every company has varying amounts of resources and different organizational structures. As an example, a start-up company may have limited internal resources and may leverage outside resources or consultants to fill resource gaps. A start-up's internal resources may wear several "hats" within the organization. Larger companies typically have a structure that includes additional layer(s) of managers for various departments and often break departments into specific areas of focus and responsibility. Regardless of the size of the company the underlying fundamental roles and areas of expertise remain basically the same for most western companies. Many Asian companies may have a similar basic organizational structures but departmental authority will vary.
Why is establishing organizational structure important to install our products? All of our products are framed around an assumed organizational structure. Our Standard Operating Procedures may contain within them certain departmental responsibilities, authority and approval flow/processes. The nature of various activities will require varying levels of relevant expertise having input in a particular process. Establishing your organizational structure in advance allows you to simply modify the responsibilities section of our procedures to align with your unique organizational structure and company policies.
Specifically, How are Our Quality Systems Installed?
Quality System Gap Assessment. Where do we stand? The first step of system integration is to understand the company's overall business objectives and activities, such as product design, classification of products, and type of any services provided. For a company with an existing quality system a "gap assessment" should be conducted on current processes and systems (including understanding any undocumented processes). Any "gaps" are measured against ISO 13485 and FDA QSR requirements. The organizational structure and activities are also documented during this assessment phase.
Quality Manual Development. All of our quality system products come with an ISO 13485:2016 compliant quality management system manual. However, our quality manual assumes a company is engaged in design, manufacture, distribution, etc. If there is an element of the quality manual that does not apply to your company the manual can be modified. The quality management system manual encapsulates the company's activities, the regulations and standards the company intends to comply with, the documentation hierarchy, quality policy and organizational responsibilities.
Align Departmental Responsibilities. Our quality system products made assumptions as to the organizational structure. As the system is employed those assumptions are aligned with your specific organizational structure and departmental titles, areas of responsibility, and approval flow. Depending on the situation some of the standard assumptions will either be combined or broken into departmental groups or sub-groups or any other combination you want.
Specification numbering and linkage. Our quality system products utilize an our own numbering system to identify and cross link procedures. When a company elects to use their own unique numbering system a temporary spreadsheet cross referencing the two numbering systems (current and proposed) can be created and the old assigned numbers can be swapped out in a controlled manner to preserve document linkage.
Integration of specific / unique process steps. Our standard operating procedures can be easily aligned with unique company process steps and/or authority to align with a company's practices and or policies.
Facility and Process Considerations. Each facility will have some level of uniqueness to consider for incorporation into the quality management system (e.g. environmental controls, process equipment, clean rooms, etc.). Our quality system products address multiple scenarios, but if there is a need for additional procedures to incorporate into your system we have a broad library of procedures to assist with addressing any gap.
Project Management. One of the greatest advantages of how we have structured our quality systems is the ability to manage the overall implementation with well structured milestones that align with our quality system modules / procedure groupings. The installation sequence and priorities, resources training and development, and the transition from installation to utilization can be measured and documented.
How Long Does it Take to Install a Quality System?
On average most of our quality systems are fully implemented in 5-6 weeks. It is really a function of how many resources you can dedicate to support the effort and your internal goals and priorities. Our customers are often ISO 13485 certified in as little as 3 months!
The bottom line is we have done a lot of the heavy lifting for you already and our quality system products to help you achieve 85-90% of your goal from day one. My job is to communicate to the medical device community that a solution exists to help companies achieve their goal of ISO 13485 certification and FDA QSR compliance.
Thank you for reading this far!
Please feel free to email any questions to email@example.com or give us a call at 978-340-3820. Please take a moment to review all of our products at www.aplyon.com