Introduction to Quality Management

Why do we need a Quality Management System (QMS)?

• We must meet the regulatory requirements for all products that we sell.
• We need to meet customer expectations by producing high quality and consistent products that are SAFE.     
• A QMS enables us to demonstrate through evidence that we are producing products that meet the required reliability and test criteria.
• We are using controlled manufacturing methods. 
• We take action if there is a problem (through a managing non-conformity procedure).
• We consider risk throughout the design and development process etc.
• We monitor device performance. 
• We audit what we are producing to continuously improve our ways of working/device.

ISO 13485:2016

For medical devices the QMS ISO standard that is often used is ISO 13485. This international standard specifies the requirements for a QMS where an organization needs to demonstrate its ability to provide medical devices and related services. It is split into different clauses:

• Clauses 0-3 are:
  • Introduction to a QMS 
  • Scope
  • Normative references 
  • Terms and definitions 
• Clause 4 relates to the Quality Management System 
• Clause 5 relates to Management Responsibility 
• Clause 6 relates to Resource Management 
• Clause 7 is Product Realisation 
• Clause 8 is Measurement, Analysis and Improvement

ISO 13485-QMS requirements example documents

• A strategy for regulatory compliance and procedures for modifications to the device
• Identification of and addressing applicable General Safety and Performance Requirements (GSPR's)
• Responsibility of management
• Resource management, including selection and control of suppliers and sub-contractors
• Risk management
• Clinical evaluation including Post Market Clinical Follow-up
• Product realisation, including planning, design, development, production and service provision
• UDI assignments and labelling
• Setting-up, implementation and maintenance of a post-market surveillance system
• Communication with competent authorities, notified bodies, other stakeholders
• Processes for reporting of serious incidents
• Management of corrective and preventative actions and verification of their effectiveness
• Processes for monitoring and measurement of output, data analysis and product improvement

A QMS is usualy structured like the diagram below: 

Top Level Policies

• These are a series of higher levels documents that cover all areas of the QMS.
• They detail how we ensure compliance to regulations, legislation and standards. 
• All documents within the QMS should comply to top level policies. 

Processes

• These are documents which are instructions on how to conduct a particular action. This can include manufacture instructions or methods of how to conduct an internal audit or management review.
• We must carry out actions as they are described in these documents. 

Forms/Records

These are records that form the actual evidence that we have followed a process/policy in a compliant way. They also provide traceability.

Types of Records

Examples include:

• In the development stage, the data generated shows that the device is fit for purpose and has met the regulations for use.
• During manufacturing, we note how we tested the manufactured product.
• To evaluate our suppliers a record is taken of approved suppliers.
• We also have compliant handling records to document investigations. 

Document control

Is a key requirement in a QMS. All Quality Systems documents must be controlled as part of the Quality Management System.

All controlled documents have:

• Unique document numbers
• Revision numbers
• Numbered pages

All individuals working within a QMS have te responsibility to ensure good document control is maintained for traceability purposes. You can find out more about document control here. 

Audits

• Audits are required to demonstrate compliance as well as continuous improvement of the QMS and device.
• Internal audits will be carried out on a regular basis as part of ISO 13485:2016. 
• External audits are carried out by external bodies such as The British Standards Institute (BSI) to ensure that compliance to ISO 13485:2016 is maintained.
• You should expect audits to be a regular occurrence when working/managing a QMS.

Operating a QMS

1. Keep it simple and start small
2. Start early to get people used to 'processes'
3. Only introduce processes that are needed - you need to maintain and use them
4. Ensure management reviews cover QMS requirements