Over PSI’s 40+ years in business, we have been committed to designing quality-made software and firmware systems to bring our customers the highest level of satisfaction. With the end-user in mind, we continue to strive for the most optimal software design of which cannot fail. To do so, we have developed a thorough Quality Management System (QMS) which incorporates various proprietary Standard Operating Procedures (SOPs). Each of our engineers are trained in these procedures and must adhere to them during development. We realized that many of our procedures mirrored those within the International Organization for Standardization and decided to participate in an audit that would ultimately lead to our ISO 9001:2015 Quality management systems — Requirements and ISO 13485:2016 Medical devices – Quality management systems – Requirements certifications. PSI remains dedicated to continual improvement of our processes and standards and striving for the highest quality of development.
ISO Certifications
THE ROAD TO ISO 9001:2015 AND ISO 13485:2016
OVERVIEW OF THE STANDARDS
ISO 9001:2015 is the international standard that specifies requirements for a quality management system (QMS). Organizations use the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements.
- Provides framework for standardized quality management systems
- Promotes a process-oriented approach
- Promotes a system where compliance is determined through evidence
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
In 2011, PSI participated in our first ISO audit consisting of an extensive review of our processes, procedures, and project records. Initially, we were solely involved in the ISO 9001 audit; however, we soon realized the need for ISO 13485. Today, we are both 9001:2015 and 13485:2016 certified. Our executive leaders and quality assurance team have committed to these audits and take internal measures to ensure we complete a successful external audit each year. PSI conducts frequent internal quality audits in which prepare our staff and catch any problematic issues prior to the external audit. Our team works tirelessly to document and prepare evidence of our continual improvement and fact-based decision making. With scheduled semi-annually management reviews, PSI’s quality policy, various objectives, client feedback and other ISO-pertinent information are assessed and remediated as necessary in preparation for the external ISO audit.
While evaluating the cost of becoming an ISO certified company, we concentrated on the benefits our business and clients would reap due to successfully completing an ISO audit. We already believed that we produced high quality services; however, adhering to ISO standards would ensure our products and services would be produced in a way that improves consistency. Consistency within development ensures product performance will rise and our client satisfaction levels would increase.
We often receive questions like “Why bother certifying to ISO standards? You already have an established customer base.” Or “Is an ISO audit really worth the money?” We’re here to tell you that these certifications have repeatedly paid off. PSI’s ISO 9001 and ISO 13485 certifications allow us to:
Produce a quality product
Although we believe our delivery was always to the highest of standards, ISO enabled our development team to adopt additional resources to improve our development processes. With a heightened focus on quality, our SOPs now guide our developers through a Software Development Life Cycle (SDLC) proprietary to our organization. PSI’s SDLC has become highly efficient as we incorporate increased functionality for each delivery.
Improve consistency in our service performance
With defined SOPs, our developers follow the same processes within each project. This development consistency ensures our high level of service is maintained throughout each unique project.
Deliver higher client satisfaction levels / Improve customer perception
Clients that would otherwise overlook a small business now realize our dedication to quality software development and best practices. Our business model combined with the additional guidance from the ISO standards yields strong customer satisfaction levels.
Improve communications, morale, and job satisfaction
Through this process, our team has streamlined our approach to communication. Each meeting is documented, confirming the appropriate parties are present. If an important stakeholder is missing, the meeting notes are captured and delivered as necessary. Providing each employee with the necessary information to execute their responsibilities is critical to the success of each project as well as employee morale and job satisfaction. We see these results each day as our employee turnover rate is very low and the majority of our team is tenured.
In conclusion, PSI is happy to announce our ISO 9001:2015 and 13485:2016 certifications. We are proud of our processes and value the certifications we have achieved. Each employee contributed to the success of our audit and we will continue to build upon our Quality Management System, ensuring the highest level of product and client satisfaction.
If you are interested in learning more about our certification process, we would be delighted to share our experience with you. Please feel free to reach out to our team as we have Lead ISO Auditors in-house, ready and available to answer your questions.