12 easy steps to establishing your
Quality Management System

Quality Management SystemWhat is a Quality Management System?

People have different ideas of what a Quality Management System is, so to avoid any misunderstanding, here is our definition:

A Quality Management System establishes policies and objectives to direct and control an organisation with regard to quality. A Quality Management System refers to an organisation which is compliant with a standard such as ISO 13485. To be successful, it requires ongoing commitment from senior management.

1. Gain commitment from senior management

The first requirement is to ensure senior management recognise the need for a Quality Management System and are committed to supporting its creation, implementation and maintenance. They may not understand the benefits of corrective action, management reviews, measuring quality or any other processes, but it’s vital they recognise that without the goal of ISO certification, the likelihood of achieving a Quality Management System is zero.

The reason for setting up a Quality Management System is often to satisfy a client’s requirement for certification. But to be successful, it’s important management see the bigger picture of adopting standard procedures as a means to improving business performance and creating better products. A gap analysis will outline what you need to do and how to achieve.

2. Carry out a gap analysis

A gap analysis is a measure of how well your organisation conforms to a set of predetermined standards. Shortfalls in conformity are called gaps. So a gap analysis provides evidence of where an organisation needs to make improvements.

Gap analysis reports are very useful in showing where your business stands. They include a detailed account of each requirement and the degree of compliance with corresponding actions needed to close gaps.

Gap analysis reports include advice and therefore more suitable for consultants or experts to carry out. They are seldom performed by a registrar or certification company because they are not allowed to provide advice due to conflict of interest.

3. Define your processes

Process diagrams can help you define key processes and the flow of your business as well as who is responsible for each action. Include areas such as:

  • Information technology
  • Recruitment
  • Accounting
  • How quality interacts with each process such as inspection, review, or to roll-up metrics in support of quality objectives

4. Draft your quality policy

This states what your client wants from your organisation in relation to quality. It’s the foundation of your policy.

This may be straightforward for organisations with a single product and location, but can become more complex with multiple products and locations.

Multi-site organisations sometimes divide up their processes and designate them subject to quality management requirements versus those not needing to comply. These are often political decisions, but ultimately senior management will need to confirm that all employee actions contribute to the quality of its products and services.

Consider your commitment to client focus:

  • Quality – what you need to do consistently to satisfy your client?
  • Client satisfaction – What are your client’s requirements?
  • Continuous improvement – What you need to do better?

5. State your quality objectives

Explain your quality objectives to your staff. ISO requires that your quality objectives are:

  • Derived from your quality policy
  • Measureable
  • Deployed through your organisation

Include a commitment to a schedule. Without a schedule certification is unlikely to happen.

6. Define defects for each process

Defects are nonconformances that occur either as a product defect or a process defect. Each defect needs to be recoded. When defining your defects:

  • Determine transaction volume
  • Determine defects (product and process based)
  • Define how defects are recorded
  • Define how defects are charted and communicated

7. Create your documents and manage your information


  • Documents and records ISO 13485 requires
  • Documents and records your organisation requires
  • Prepare a quality manual for your QMS
  • Define scope of your organisation’s QMS
  • Outline structure of QMS documentation
  • Include QMS procedures or refer to them
  • Describe how your QMS processes interact
  • Establish a file for each medical device type or family of medical devices
  • Establish procedure to control QMS documents
  • Establish records for your organisation’s QMS

When your documentation is created, it’s important senior management remain committed and insist on complying with specified requirements, measuring processes, reviewing and taking action to improve.

8. Define your quality process

Your quality processes include:

  • Internal audit
  • Corrective and preventive actions
  • Management review, communication, and commitment process

9. Measure and monitor your performance

It’s important to collect relevant and useful data you can use to improve performance such as:

  • Quality objectives performance
  • New performance benchmarks
  • Improvement opportunities in your data by identifying trends, patters, or correlations

10. Use surveys to collect information

Develop a client satisfaction survey tool based on finding out what is important to them.

The best way to know how well you are meeting client requirements is by asking the right questions. Employ a structured process to solicit feedback. Avoid thinking you know what is important to clients and find out using a survey.

Each client should have a survey customised to their particular requirements to establish baseline data on perception of current practice. This provides a foundation for improvements and demonstrates progress as improvement plans are implemented.

Resurvey clients every year to see if scores have improved. Expectations change over time, so keeping pace with client expectations is critical to business success.

11. Keep improving business performance

Ultimately, you’re collecting data to improve business performance.
If your data shows a particular trend, then take action and select opportunities likely to make a difference.

Opportunities for improvement might include:

  • Process improvement initiatives
  • Leadership development
  • Management training
  • Staff Training
  • Performance management
  • Internal auditor competence
  • Corrective action training

12. Create customisation

Another requirement for the Quality Management System is customisation. Some organisations purchase ready-made documentation which doesn’t provide any requirements and could apply to any organisation. If there are no requirements, then there are no meaningful instructions for people to follow.

Customisation should be balanced with an eye to future organisation changes.

An organisation’s objectives are a vital part of creating a Quality Management System along with process requirements. If you want more control over returned products for servicing, then you should have detailed procedures to track returns and records.

This procedure may include creating a tracking system and process measure so that over time, management can ensure the process is meeting your objectives. On the other hand, order entry may be a highly automated simple process that can be consistently executed without a documented procedure. What to document and measure are decisions unique to every organisation. Hiring a consultant will ensure the right decisions are made.

Hiring a consultant

Many organisations struggle with process measures that don’t provide accurate information about the effectiveness of a process. Valuable resources can be wasted on process measures which do not contribute to your objectives. This is where an experienced consultant can provide valuable guidance and help you avoid expensive delays.


If you have any further questions then please email Michael.gamlen@medical-device-support.com
or call +44 207 164 6139

Device vigilance +44 1773 718882




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