Quality management system

What a quality management system is

A quality management system (QMS) is not a folder, a program or a certificate. It is a set of agreements on who is responsible for what, how we work, how we know we are doing it right, what we do when something goes wrong and how we learn from it. Every company has a system in some form; the question is whether it is organised and demonstrable or scattered across folders and people’s heads.

The most widely used framework for a quality management system is ISO 9001:2015. ISO 14001 (environmental management) and ISO 45001 (occupational health and safety) share the same structure, so companies often run them as one integrated system. A longer explanation with practical examples is in What is a QMS and what does a quality management system make easier.

The principles of ISO 9001

ISO 9001 is based on the seven quality management principles of ISO 9000: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management. In practice the standard rests on three concepts:

Process approach

You understand work as linked processes with inputs, outputs, owners, resources and KPIs, not as separate departments. Clause 4.4 requires you to determine processes, their interactions and how they are controlled. How to map and improve processes is covered in Business process optimisation as the foundation of company quality.

The PDCA cycle

Plan, do, check, act. The structure of the standard follows this cycle:

Risk-based thinking

Clause 6.1 requires you to determine risks and opportunities from the context of the organisation and the expectations of interested parties, and to plan actions proportionate to their potential impact. The standard does not prescribe a method; a likelihood and consequence matrix is common.

Building blocks of the system

• Documentation (clause 7.5): documented information that is identified, approved, available and protected, with a clear valid version.
• Internal audits (clause 9.2): a planned audit programme showing whether the system works as documented.
• Corrective actions (clause 10.2): from nonconformity through root cause analysis to verified effectiveness.
• KPIs (clause 9.1): measurable objectives and process monitoring as the basis for management decisions.
• Risks and opportunities (clause 6.1): a register with owners, ratings and actions.
• Training and competence (clause 7.2): who needs to know what, and evidence that they do.
• Management review (clause 9.3): top management reviews system results at planned intervals and decides on improvements.

How these building blocks lead to certification and what the cost is made of is described on the ISO 9001 certification page. Why the standards pay off and where subsidies come in is summarised in the guide to ISO quality standards.

What a digital quality management system means

Any system can be run on paper and in Excel. A digital system does not change what the standard requires; it changes the cost of meeting it: how much time you spend finding the valid version, retyping reports, collecting data for the management review and chasing deadlines. In a digital system:

• every document has one valid version, an approval and an acknowledgement trail,
• deadlines (revisions, calibrations, actions, risk reviews) remind the owner automatically,
• an audit finding becomes an action with a deadline, not a line in a report,
• management review inputs are assembled from data that already exists,
• you show the auditor a screen or a printout, not folders.

That is how the E-kakovost QMS platform works: modules for documents, audits, actions, risks, KPIs, training, equipment and other building blocks, with data flowing between them.

Platform modules, one by one

Each module has an article explaining the requirement of the standard and a short video recorded in the application:

• The Audits module: an internal audit without days of typing up the report
• The Documents module: one valid version
• The Equipment module: calibration cycle, maintenance and breakdowns in one place
• The Actions module (CA/PA): from a failure to its root cause

Where to go next

• What is a QMS and what does a quality management system make easier?Seven situations from practice and a comparison of paper, Excel and a digital QMS.
• ISO quality standards: what, why and howISO 9001, 14001 and 45001 in brief, with a note on subsidies.
• Business process optimisationThe process approach in practice.
• ISO 9001 certificationProcess, timeline, costs and common mistakes.
• ISO 14001 consultingEnvironmental aspects, legislation and the life cycle perspective.
• E-kakovost QMS platformAll modules, data security and a free consultation.