ISO 13485 – Quality Management System Requirements

Section 4.0 through to section 8.0 of the ISO 13485 standard, specifically focusses on the requirements of the Quality Management System. These sections are as follows:

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Section 4.0 – Quality Management System Requirements
Section 5.0 – Management Responsibility
Section 6.0 – Resource Management
Section 7.0 – Product Realization
Section 8.0 – Measurement, Analysis, and Improvement

These processes need to be effectively implemented to ensure compliance with the intent of the ISO 13485 standard.


The Quality Management System (QMS).

The QMS needs covers a range of activities such the performance of internal audits, the implementation of an effective corrective and preventative action system, the holding of regular (annual or bi-annual) management reviews, the establishment of a system to gather and analysis customer experiences, the generation, updating and control of documentation, etc..

Critical processes need to be identified, defined, documented, their performance monitored and efforts made by management to drive continued improvement.


Management Responsibility.

Management need to demonstrate a commitment to implementing an effective quality management system by establishing processes, ensuring the processes are adequately resourced, by continually monitoring process performance and by driving process and product improvement.

Management need to implement effective risk analysis and risk management to ensure customer and organizational risks are understood and minimized.

There needs to be a clear customer focus, customer expectations and experiences need to be communicated and understood throughout the organization and back into the supply chain.

Management will define a Quality Policy, which clearly outlines commitment and aspirations for quality.

The above will be delivered via continued quality planning.


Resource Management.

When determining resource requirements, management need to consider people requirements, infrastructural requirements, the work environment, information needs, supplier and partner requirements, natural resource requirements, financial requirements, etc., …  Without adequate resources, it will not be possible to support an effective quality management system.

When management determine people resource requirements, they will need to understand the skills levels, experiences and competences of staff required by the organization.

Infrastructure will focus on buildings, land, energy, utility requirements in order to be able to deliver a product or service which will meet customer expectations.

The work environment relates to a need to ensure appropriate process equipment is provided, have processes been established to ensure equipment can operate as expected, are capabilities aligned with customer expectations.


Product Realization.

Product realization relates to ensuring appropriate processes and resources are in place to ensure that the product or service is appropriately planned-out, customer expectations are clearly understood and are communicated to those responsible for designing, creating and delivering the product. The design and development processes are effectively established, there is a controlled purchasing process in-place. The production and service functions are defined and controlled. If and when non-conformances arise, there are processes in-place to identify and control any such non-conformances. The delivery processes are established.

There are also appropriate record generation, record review and record retention processes established.


Measurement, Analysis & Improvement.

Wherever there is a test, inspection, monitoring or analytical step within a process, the objective is to assure product or process conformance to expectations, to ensure adherence to procedure and specification and to demonstrate continual improvement.

Measurement, analysis and improvement applies to customer experiences, where the customer expectations need to be understood, the performance of the product post market release is recorded, and actions are taken if deviations to expectations and specifications are identified.

Where non-conformances arise throughout the process, non-conforming products needs to be segregated, investigated, root causes understood and actions taken to prevent recurrence. Similarly where process non-conformances arise, which could lead to non-conformances to customer requirements, actions need to be implemented to address.

On a continual basis data needs to be collected and reviewed to enable management to understand performance of the quality management system trends across the organization. The data needs to feed into the management reviews which in turn will influence strategic and operational decision making.

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