What Are the ISO 13485 Standard Operating Procedures a Small Production Company Must Comply With?
The ISO 13485 standard for maintaining the quality performance of your production and supply chain of medical devices asks companies to meet a list of clauses for compliance. The ISO 13485 standard operating procedure is nothing but a systematic process for ensuring that your system has zero non-conformance. This operating procedure is accountable for determining the improvement and subsequent readiness of a system. Quality assurance is key to obtaining customer loyalty in the industry of medical devices. To check the efficiency level and enhance the performance for achieving the ISO 13485 certification, companies need a systematic procedure. A set of standard operating systems allows the management team to take the necessary actions to minimize the differences between the system’s present activities and the desired outcome.
The standard operating procedure is often considered difficult for small companies who do not possess previous experience. With the right guidance in place and relevant resource mobilization, companies can have a seamless journey for certification. This procedure starts with establishing quality management system guidelines and ends with implementing the operating system through training, approval, and monitoring.
The present blog will list the step-by-step process for the ISO 13485 and will help companies regardless of their size. To comply with the ISO 13485, organizations must establish and maintain a comprehensive set of standard operating procedures (SOPs).
Step 1 of ISO 13485 Standard Operating Procedure
Management Responsibility
Management Review: Procedures for conducting management reviews of the QMS at planned intervals to ensure its continuing suitability, adequacy, and effectiveness.
Quality Policy and Objectives: Procedures for establishing and communicating the quality policy and quality objectives throughout the organization.
Step 2
Quality Management System (QMS) Procedures
Quality Manual: Defines the scope of the QMS, including documented procedures or references to them.
Document Control: Procedures for controlling documents required by the QMS, including creation, review, approval, distribution, and changes.
Record Control: Procedures for identifying, storing, protecting, retrieving, retaining, and disposing of records.
Step 3
Resource and infrastructure
Training and Competency: Procedures for ensuring personnel performing work affecting product quality are competent based on appropriate education, training, skills, and experience.
Infrastructure and Work Environment: Procedures for providing and maintaining the infrastructure and work environment needed to achieve conformity to product requirements.
Step 4
Product Realization
Customer-Related Processes: Procedures for determining customer requirements and ensuring customer satisfaction.
Design and Development: Procedures for controlling the design and development process, including design planning, input, output, review, verification, validation, and changes.
Purchasing: Procedures for ensuring purchased products conform to specified purchase requirements, including supplier evaluation and selection.
Production and Service Provision: Procedures for planning and controlling production and service provision, including production processes, installation activities, and servicing.
Control of Monitoring and Measuring Devices: Procedures for ensuring monitoring and measuring devices are calibrated and maintained to provide evidence of conformity to requirements.
Step 5
Supervision, analysis, and improvement
Monitoring and Measurement: Procedures for monitoring and measuring product and QMS performance, including internal audits, product inspections, and customer feedback.
Control of Nonconforming Product: Procedures for identifying, controlling, and disposing of nonconforming products to prevent their unintended use or delivery.
Corrective and Preventive Actions: Procedures for taking corrective and preventive actions to eliminate the causes of nonconformities and potential nonconformities.
Data Analysis: Procedures for collecting and analyzing data to demonstrate the suitability and effectiveness of the QMS and to identify areas for improvement.
Step 6
The additional procedures
Risk Management: Procedures for applying risk management throughout the product realization process.
Software Validation: Procedures for validating software used in the QMS, as applicable.
Traceability: Procedures for ensuring traceability of products, especially for implantable devices, including identification and control of product status.
Complaint Handling: Procedures for handling complaints, including investigation, corrective action, and reporting. To find the right professional support for obtaining the ISO 13485 quality management system standards requirements, contact us at Compliancehelp Consulting LLC. We are a premier site for achieving any ISO certification in the US. Our bespoke solutions for ISO and other global certifications are ready to make the seemingly exhausting process of accreditation, comfortable and timely. From basic consultation to audit and analysis, we will cover everything. Get help to clear your concepts regarding the clauses of any management system standard you require. Click here to learn more about the question “ISO 13485 standard operating procedure”!