The Similarities and Differences Between ISO 9001 and ISO 13485

- April 30, 2021

ISO 9001 is a set of standards that ensures the quality of products and services, general. ISO 13485 Certification is similar to ISO 9001 Certification in the sense of ensuring quality, however, its scope is limited to all those industries that are involved in the manufacture, distribution, or retail of medical devices.

Read this entire article to know about the similarities and differences between ISO 9001 and ISO 13485 Standards

SIMILARITIES BETWEEN ISO 9001 AND ISO 13485

Both help in achieving the organization’s quality management system
Both focus significantly on risk assessment and mitigation.
Understanding the customer’s expectation to deliver quality products.
Both ISO 9001 Certification and ISO 13485 Certification use the Plan-Do-Check-Act cycle.
Both ISO 9001 and ISO 13485 focus on the competencies of employees and infrastructure for quality.

DIFFERENCES BETWEEN ISO 9001 AND ISO 13485

The medical manufacturers are required to adopt several in addition to the requirements of ISO 9001 Certification to ensure quality products. Let us have a look at these differences:

QMS

Additional areas within which ISO 13485 Certification exceeds ISO 9001 Certification are associated with documentation and records controls.

Include regulatory documents with system documentation (4.2)
A file identifying product specification documents should be included in QMS (4.2)
A Device master record to be maintained (4.2)
Review and approval of changes in QMS documentation by the original approver or another designated individual with adequate information about the background (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/. SIS Certifications is the best certification body. With more than 15000 satisfied clients in over 55 countries. if you looking for ISO 9001 and ISO 13485 Certification in Morocco or other Certifications then you can contact SIS Certifications.

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