What is a quality management system, and how do you build one?
A quality management system (QMS) is the management structure through which an organisation defines, applies and continually improves the policies, processes, documents and records that assure the quality of its products and services. Its most widely used framework is ISO 9001. This guide covers the building blocks of a QMS, the clauses of ISO 9001, the documents you need and how to digitise quality management.
What does a quality management system do?
A quality management system makes sure work is done right every time, that errors are recorded and solved at their root cause, and that the organisation learns from experience. Customer complaints fall, processes depend on defined rules rather than individuals, and showing evidence in audits becomes easy.
What is ISO 9001?
ISO 9001 is the quality management system standard published by the International Organization for Standardization (ISO). It applies to any organisation regardless of sector or size, and describes the management structure needed to deliver products and services that consistently meet customer requirements. Organisations are certified to ISO 9001 through audits by accredited certification bodies.
The main clauses of ISO 9001:2015
In ISO 9001:2015, the first three clauses cover scope, normative references and terms. The requirements sit in clauses 4 to 10:
- 4. Context of the organisation: internal and external issues, interested parties, the scope and processes of the QMS.
- 5. Leadership: top management commitment, quality policy, roles and responsibilities.
- 6. Planning: risks and opportunities, quality objectives, planning of changes.
- 7. Support: resources, competence, awareness, communication and 7.5 documented information.
- 8. Operation: planning and design of products and services, control of suppliers, production and service provision.
- 9. Performance evaluation: monitoring and measurement, customer satisfaction, internal audit, management review.
- 10. Improvement: non-conformity and corrective action, continual improvement.
The seven quality management principles
ISO’s quality management principles underpin the standard: customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making and relationship management.
The building blocks of a quality management system.
Each block feeds the next; a gap in one weakens the whole system.
Quality policy and objectives
Top management’s approach to quality and measurable quality objectives are put in writing.
What it delivers: Everyone works towards the same goals.
Document control
Procedures, instructions and forms are managed with revision, approval and distribution rules.
What it delivers: The current, approved document is always the one in use.
Records
Inspection, training and audit results are kept as tamper-proof evidence.
What it delivers: Audits become a matter of showing records.
Non-conformity and CAPA
Problems are recorded, root causes analysed and corrective actions tracked by owner and due date.
What it delivers: The same error does not happen twice.
Internal audit and management review
Planned audits verify how the system works and management reviews the results.
What it delivers: Gaps are found before the certification audit.
Training and competence
Competences required by each role, training and document read confirmations are tracked.
What it delivers: Changes reach the shop floor correctly.
Supplier quality
Suppliers are evaluated and their non-conformities and certificates tracked.
What it delivers: Risks from outside are kept under control.
Risk and change management
The impact of process and document changes is assessed, and risks and opportunities are recorded.
What it delivers: Change does not turn into a quality problem.
Which documents does a quality management system need?
ISO 9001:2015 groups documents under “documented information” and largely lets the organisation decide which documents it needs. In practice, a quality management system usually includes:
- Scope, quality policy and quality objectives: the core information the standard requires in writing.
- Quality manual: not mandatory in ISO 9001:2015, but many organisations keep one to give an overview of the system.
- Process map and procedures: define how processes work, responsibilities, inputs and outputs.
- Work instructions: describe step by step how a task is done.
- Forms: make sure records are created in the same structure.
- Records: evidence such as inspection results, training records, internal audit reports, CAPA records and management review outputs.
The structure that manages these documents is called a quality document management system (QDMS). Revision, approval, distribution and read tracking happen here, and the controlled-copy concept is part of it.
How to build a quality management system
- Define context and scope: products and services, interested parties, the sites and processes the system covers.
- Map the processes: define core, support and management processes, their owners and interactions.
- Write policy and objectives: set measurable quality objectives and how they are tracked.
- Prepare the documents: create procedures, instructions and forms with revision and approval rules.
- Assess risks: record risks and opportunities for each process.
- Train and apply: train people, collect read confirmations and start producing records.
- Run internal audits: verify the system works and open CAPAs for non-conformities.
- Hold a management review: evaluate the results and prepare for the certification audit.
Integrated management system: different standards, one structure.
Because ISO standards share the same high-level structure, quality, environmental and health-and-safety systems can be combined into one integrated management system.
ISO 9001
Quality management: consistently meeting customer requirements.
ISO 14001
Environmental management: managing environmental impacts and obligations.
ISO 45001
Occupational health and safety: preventing and reducing risks.
IATF 16949
Quality management requirements specific to the automotive industry.
Questions to ask when choosing QMS software.
QMS software creates value when it connects documents, records and actions.
- Document control: are revision, approval, distribution and read confirmation in one flow?
- CAPA and audits: are non-conformity, root cause, action and effectiveness check connected?
- Training: does a document change turn into training and read tasks for the right people?
- Integrated management: can ISO 9001, 14001, 45001 and industry standards be managed in one structure?
- Audit trail: can you see who changed and approved what, and when, without extra effort?
- Organisation-wide: do quality documents work alongside other business documents and the ERP?
Quality management systems: common questions.
What is a quality management system (QMS)?
A quality management system is the management structure through which an organisation defines, applies and continually improves the policies, processes, documents and records that assure the quality of its products and services. Its most common framework is ISO 9001.
What is ISO 9001?
ISO 9001 is the International Organization for Standardization’s quality management system standard. It applies to organisations of any sector and size, and certification is granted through audits by accredited bodies.
What does QMS stand for?
QMS stands for quality management system. QMS software is the software that manages the system’s documents, records and processes digitally.
What is a quality document management system (QDMS)?
A quality document management system (QDMS) is the structure that manages quality documents and records with revision, approval, distribution and read tracking. M-Files QMS combines it with CAPA, audit and training processes.
Is a quality manual mandatory?
No, ISO 9001:2015 does not require a quality manual. Information such as the scope, quality policy and objectives must be documented; many organisations still keep a manual to summarise the system.
How do you get ISO 9001 certified?
The organisation builds its QMS, runs it for a period, completes internal audits and a management review, then passes an audit by an accredited certification body. QMS software makes it easier to keep the records and evidence this requires in order.
What is an integrated management system?
An integrated management system manages the requirements of several standards, such as ISO 9001, ISO 14001 and ISO 45001, with shared documents, records, audits and actions.
Let’s digitise your quality management system.
See your quality processes, from document control to CAPA, audits and training, on one platform with M-Files QMS.