What are the similarities and differences between ISO 9001 and ISO 13485 Certification

Both ISO 9001 and ISO 13485 are similar in a sense that they both provide a set of standards to ensure the quality of products and services. However, whereas ISO 9001 certification can be applied to any industry irrespective of its sector, ISO 13485 certification is industry- specific and can only be applied to those organizations that are involved in manufacture, distribution, or retail of medical devices.

Let us find out the similarities and differences between these two standards.

SIMILARITIES BETWEEN ISO 9001 AND ISO 13485

• The primary goal of both the standards is the implementation of Quality Management System in an organization.
• Risk assessment, its prevention as well as mitigation is their primary focus.
• Delivery of quality products by understanding customer’s expectations.
• Both ISO 9001 and ISO 13485 utilize management strategies such as Plan-Do-Check-Act cycle.
• These standards focus on the competency of employees as well as processes to ensure quality.

DIFFERENCES BETWEEN ISO 9001 AND ISO 13485

There are certain additional requirements that the organizations dealing with medical devices are required to fulfil. These additional requirements are listed in ISO 13485. Let’s have a look at them.

QMS

Additional areas in which 13485 exceeds 9001 are related to documentation and records controls.

• Inclusion of regulatory documents along with with system documentation (4.2)
• The QMS should include a file that has product specification documents (4.2)
• The organizations are required to maintain a device master record (4.2)
• The original approver must review and approve the changes in QMS documentation. It can also be done by any designated individual who possesses adequate information about the system (4.2)
• Designation of data retention standards by the manufacturer that is based on product lifetime and regulatory requirements (4.2)

RESPONSIBILITY OF MANAGEMENT

The following are the additional requirements for the medical device manufacturers when it comes to allocating roles and responsibility to the management:

• The management team is responsible for quality policy and a framework for QMS review (5.3)
• Management should verify and measure the QMS goals and compliance (5.4)
• Defined responsibilities for each member for managing, performing, and verifying the QMS (5.5)
• Assignment of responsibilities by the management for the purpose of maintaining QMS standards (5.5)
• Regulatory updates (5.6)

There are several other differences that exist between ISO 9001 and ISO 13485. To know more about these standards or to apply for either of these certifications, visit https://www.siscertifications.com/.

It must be noted that the International Organization for Standardization does not certify, it just publishes the ISO standards. An external body performs the certification. SIS Certifications is one such body which has a reputation for being one of the best in the world. Our vast pool of auditors is recognized for their expertise in comprehensively auditing the compliance of your management systems against the required standards and awarding you with the certifications at the end. The smoothness in the process, our integrity, and our commitment to deadlines make us stand apart from other certification bodies.