Key Differences Between ISO 9001 And ISO 13485 Compliance

The International Standards Organization (ISO) is a stalwart in data compliance and has launched many globally harmonized security frameworks since its inception in 1947. The Organization publishes standards in several areas, including corporate reliability, length measurements, information security systems, and quality management. These standards specify requirements, specifications, directions, and other instructions.

This blog will evaluate two of ISO’s popular security standards — ISO 9001 and ISO 13485. While ISO 13485:2016 outlines requirements for the quality management systems (QMS) of manufacturers engaged in manufacturing medical devices and related services, ISO 9001 specifies requirements for general quality control systems (QMSs). This article will focus on several aspects of the compliance process, including documentation control, quality assessments, risk management, and more — and how ISO 13485 and ISO 9001 differ based on them. Let’s get started.

But first, let’s define the two standards.

What is ISO 9001?

The ISO 9001 compliance framework helps businesses produce new services or products in adherence with the guidelines outlined for a quality management system (QMS), irrespective of company size and industry. The most recent iteration of the standard was updated and made available in 2015, following its initial introduction in 1987.

The purpose of ISO 9001 is to offer processes for recording and assessing elements like organizational structure, roles, and procedures necessary for a successful quality management system. The standard provides guidance and details on a range of QMS aspects, including:

General standards for planning and documenting in QMSs;
Workforce, workplace, and other resources management;
Leadership involvement and management duties;
Product lifecycles — from conception to realization; and,
QMS assessments, encompassing audits and remedial measures.

What is ISO 13485?

ISO 13485 specifies the requirements and processes for quality management systems in the medical devices business. The emphasis on patient safety through standardizing medical device development and manufacturing procedures and putting such procedures into practice to comply with relevant legal requirements is noteworthy.

Additionally, if you are considering CE marking in the EU, ISO 13485:2016 certification is a reliable method to show the caliber of your QMS. Similarly, in most global markets, ISO 13485 certification is recognized as evidence of a superior quality QMS for the medical devices industry.

The ISO 13485 guidelines are not only useful for implementation, but they also offer a method for a comprehensive audit to gauge how well the quality system is working. The standard gives the manufacturer more assurance that they will be able to meet and stay in compliance with regulations regularly. Additionally, it can aid in reducing unexpected events and malfunctions that could compromise patient safety and harm the manufacturer’s reputation.

Note: The foundation of ISO 13485 is the ISO 9001 quality management system certification, which is available to businesses in various sectors. However, because the pharmaceutical and medical device industries have special requirements, some of the ISO 9001 criteria require more work to apply. To address these needs, ISO 13485 was created.

Now, let’s see some similarities between ISO 9001 and ISO 13485.

Similarities Between ISO 9001 and ISO 13485

Here are the similarities between ISO 9001 and ISO 13485:

The goal of both standards is to assist businesses in creating and maintaining an efficient quality management system.
Both standards concentrate on bringing products to life by satisfying consumer wants.
Significant attention is paid to risk assessment and mitigation in both standards.
Plan-Do-Check-Act cycles are used by both ISO 9001 and ISO 13485 to ensure quality proactively.
Both highlight the need for infrastructure and staff ability to produce high-quality results.

Now, let’s delve into the differences between ISO 9001 and ISO 13485.

Differences Between ISO 9001 and ISO 13485

While the ISO 9001 standard generally applies to various industries, the ISO 13485 guidelines only pertain to medical devices and software used as a medical device (SaMD), such as manufacturing.

Here are some other notable differences between ISO 9001 and ISO 13485:

Documentation Control

When it comes to documentation, ISO 13485 is stricter than ISO 9001. It calls for the system documentation to include regulatory papers (such as comprehensive product specifications, production process descriptions, and installation and maintenance procedures).

Distribution of Stakeholder Responsibilities

ISO 9001 permits organizations to assign quality control tasks to other managers without being bound by those designations, but ISO 13485 mandates that a medical device manufacturer designate a single member of the management team to be in charge of the QMS.

Risk Management

While risk management techniques are also a focus of ISO 9001, ISO 13485 offers a basic framework integrated with risk management to guarantee patient safety.

The development of risk management documentation is the main focus of ISO 13485, which mandates that a medical device maker keep records of the risk management procedure throughout the device’s production. Furthermore, the standard requires medical device manufacturers to examine customer complaints and set up post-sale monitoring to ensure the product meets the stated quality standards.

Quality Requirements

ISO 9001 prioritizes a culture that typifies quality by customer satisfaction. On the other hand, ISO 13485 strongly emphasizes customer safety and sets down certain safety standards, in addition to fostering a culture of quality. These safety guidelines include sterility during manufacture, assembly, and packing of individual medical devices, installation, inspection, and shelf life.

Resource Allocation

It is specified in both ISO 13485 and ISO 9001 that you must have adequate control over your resources to deliver products that meet the necessary standards. This covers having access to the appropriate tools, structures, trained staff, and IT resources. However, per ISO 13485, an organization engaged in the complete medical device production cycle must record the health and hygiene standards for staff clothing, keep an eye on the production environment, and create contingency plans for contaminated products.

ISO 9001 and ISO 13485 Compliance Readiness with Akitra!

Establishing trust is a crucial competitive differentiator when courting new SaaS businesses in today’s era of data breaches and compromised privacy. Customers and partners want assurances that their organizations are doing everything possible to prevent disclosing sensitive data and putting them at risk, and compliance certification fills that need.

Akitra offers an industry-leading, AI-powered Compliance Automation platform for SaaS companies. Using automated evidence collection and continuous monitoring, together with a full suite of customizable policies and controls as a compliance foundation, our compliance automation platform and services help our customers become compliance-ready for the ISO 9001 compliance framework and other security standards like SOC 1, SOC 2, HIPAA, GDPR, PCI DSS, ISO 27001, ISO 27701, ISO 27017, ISO 27018, NIST CSF, NIST 800-53, NIST 800-171, FedRAMP, CCPA, CMMC, SOX ITGC, and more such as CIS AWS Foundations Benchmark, Australian ISM and Essential Eight etc. In addition, companies can use Akitra’s Risk Management product for overall risk management using quantitative methodologies such as Factorial Analysis of Information Risks (FAIR) and qualitative methods, including NIST-based for your company, Vulnerability Assessment and Pen Testing services, Trust Center, and AI-based Automated Questionnaire Response product to streamline and expedite security questionnaire response processes, delivering huge cost savings. Our compliance and security experts will provide customized guidance to navigate the end-to-end compliance process confidently. Akitra Academy provides easy-to-learn short video courses on security, compliance, and related topics of immense significance for today’s fast-growing companies.

The benefits of our solution include enormous savings in time, human resources, and cost savings, including discounted audit fees with our audit firm partners. Customers achieve compliance certification fast and cost-effectively, stay continuously compliant as they grow, and can become certified under additional frameworks using a single compliance automation platform.

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