Key requirements of ISO 13485?
Certification to the ISO 13485:2016 QMS standard is not necessarily a requirement of the ISO 13485; however, companies can benefit from the standard without actual certifying to the ISO 13485 standard. Having a certificate of ISO 13485 will add value to the Organisation and assure trust for customers. The ISO 13485 standard is divided into 8 sections; the first 3 are introductory and the last 5 are the necessary and important requirements of the QMS.
- Section 4 – Quality Management System – General QMS, documentation, and quality control requirements
- Section 5–Management Responsibility –Implementing and maintaining and planning QMS, review and ensure customer satisfaction
- Section 6–Resource Management –Controlling the resources including human resources, infrastructure, building, environment
- Section 7–Product Realization –Planning, designing, and creating the product
- Section 8–Measurement, Analysis, and Improvement –Monitoring and measuring the results, corrective and preventive actions (CAPA)
There are various elements when it comes to implementing and getting certified to ISO 13485 standard, especially for the PCBA manufacturing in the medical sector.
- Documented quality control process for manufacturing of medical devices
- Full understanding of quality regulations for medical device
- Traceability of documented processes and materials.
- Analysis and improvement
Benefits associated with ISO 13485 include:
In addition to cutting cost and saving time, there are a plethora of benefits in implementing ISO 13485 2016 QMS standard:
- Enhancing customer satisfaction – ISO 13485 aims to fulfill customer needs by assessing them and ensuring client retention, which is a major need of the QMS standard itself.
- Improving the process – Create an environment for improvement by identifying and eliminating waste within the process, reducing errors and reworks, and thereby facilitating greater efficiency.
- Continual improvement culture – A major benefit of implementing the medical device standard is to adopt a culture of continual improvement. By doing so, Organizations and their employees can focus on new ways to improve and develop better products and strategies.
- Brand building – Certification to the ISO 13485 standard implies that your Organisation takes quality very seriously and brings trust in your customers.
- Informed decision making – By making use of facts and figures, it is easier to have clarity and are in better control of your decisions
- Employee engagement – Employees become more engaged in their work when they understand their roles and focus on delivering quality products and services, bringing improved productivity.
How to get ISO 13485:2016 Certified
The below listed six steps can brief you to get certified for ISO 13485 standard:
- Planning – In addition to producing a quality manual, quality planning is required. To begin the process, your company might hire an expert ISO consultant and a certification agent.
- Performing – Upon planning your requirements, you need to ensure your organization is meeting the regulatory requirements specified.
- Implementing – Implementing design controls is an essential step to getting certified to ISO 13485.
- Documenting – keeping track of training, effectiveness, and competency procedures.
- Managing – Implementing management processes like CAPA (Corrective & Preventive Actions) will help in getting certified.
Certification audit – Certification body performs Stage 1 and stage 2 audits to get your organization to be certified to ISO 13485 Requirements.
Omnex Certificate Accreditation – Exemplar Global QM, AU & TL/ Omnex
Omnex follows Exemplar Global, a worldwide recognized “Training Provider and Examiner Certification Scheme (TPECS)”, and depending on the courses and examination you have chosen to become qualified.
The courses offered by Omnex comprises three separate Exemplar Global Competency Units with the following objectives:
Exemplar Global-QM (Understanding the QMS requirements)
Exemplar Global-AU (Understanding the Auditing requirements)
Exemplar Global-TL (Understanding the Lead Auditing/Team Leader requirements)
Omnex can help you conduct an ISO 13485 Discovery Analysis (or Assessment) or conduct a Best-In-Class assessment to assist your organization in making process improvements that result in Efficiency and savings.
Omnex will conduct a Discovery Analysis during an initial assessment. Omnex will study your current processes to see the gaps in the systems as well as review Best-In-Class practices depending on the scope of the assessment. Omnex assessments always focus on savings and improvements within the organization. On the last day of the assessment, feedback and planning will be provided to the customer team. An implementation plan, team, and next steps are completed as a part of the Discovery Analysis. Of course, this can also be conducted at the beginning of an implementation, when the standard is revised or when the customer is ready for an overhaul of their systems.
If an organization receives an FDA 483 or a citation, the first thing Omnex will do is conduct a comprehensive assessment and determine overall organization risk. Based on the findings a comprehensive improvement plan will be developed. Some of the FDA findings and Omnex improvements are as follows:
- Quality unit deficiencies equate to QMS improvements that introduce prevention-based tools.
- Batch failure investigations equate to the better disciplined problem-solving methodologies
- "Lack of follow up" procedures could point to two areas that need work one is Top Management and their follow-through capabilities QOS/BOS and/or second, organization-wide follow-through using the discipline of process, product and system audits.
- Escalation is something that can be built into multiple processes in the QMS. Sure-fire methods to institute escalation processes are by implementing an EwIMS that has programmed into it "reminders" and "escalation".
Omnex's core strengths are spelled out in the 16 methodologies in which we specialize. Each of these practices is Best-In-Class practice that can be implemented based on the needs of a specific organization in any industry.