ISO 9001: Quality Management System

What is ISO 9001?

ISO 9001 is an international standard that sets out the requirements for a quality management system (QMS) that an organization must meet to align its operations with internationally recognized requirements. The current version is ISO 9001:2015, and a 2024 amendment added a requirement for the organization to consider whether climate change is a relevant issue for its business.

ISO 9001 is suitable for any organization that wants to improve the way it is managed, regardless of size or industry. The purpose of the standard is to make the organization more effective by applying a process approach.

The ISO 9000 family of standards consists of:

ISO 9000 — Fundamentals and vocabulary

Introduces the concept of a quality management system and the terminology used in the other standards in the family.

ISO 9001 — Requirements

The criteria you must meet if you want to operate in line with the standard and obtain a certificate. This is the only standard in the family against which a company is certified.

ISO 9004 — Guidelines for achieving sustained success

Guidelines that top management uses as a framework for steering the organization, taking into account the needs of all interested parties, not just clients. It is not used for certification but for developing the system afterward.

ISO 9001 principles

A quality management system under ISO 9001:2015 is based on seven quality management principles:

1. Customer focus — meeting customer requirements and striving to exceed their expectations.
2. Leadership — management sets the direction and creates the conditions in which quality objectives can be achieved.
3. Engagement of people — competent, engaged employees at every level of the organization.
4. Process approach — activities are managed as interrelated processes that form a single system.
5. Improvement — continual improvement as a permanent objective of the organization.
6. Evidence-based decision making — decisions are based on the analysis of data and information.
7. Relationship management — managing relationships with suppliers and other interested parties.

The principles draw on the collective experience and knowledge of experts worldwide who take part in Technical Committee ISO/TC 176 (Quality management and quality assurance), which is responsible for developing and maintaining the ISO 9000 family of standards.

Who is ISO 9001 for?

ISO 9001 is suitable for any organization that wants to improve the way it is managed, regardless of size or industry. ISO 9001 is also compatible with other management system standards, such as ISO 45001 (occupational health and safety) and ISO 14001 (environmental management). They share the same structure, so they can be implemented as one integrated system.

The advantage of the process approach is that it connects individual processes, departments and their interactions. Defining the inputs and outputs of every process and the resources it needs gives you a basis for planning and a way to measure customer satisfaction. This model increases client confidence in the product or service and leads to a stronger market position.

Benefits of implementing ISO 9001

ISO 9001 specifies the core requirements for a quality management system that an organization must meet to show that it consistently delivers products and services that satisfy customer requirements and applicable legislation.

Benefits of implementing ISO 9001:

• greater trust from existing and, above all, prospective clients,
• improved business capability and productivity,
• focus on achieving business objectives and meeting client expectations,
• achieving and maintaining a consistent level of product and service quality,
• higher client satisfaction,
• assurance that the desired level of quality has been achieved and is being maintained,
• opportunities to enter new markets and grow your share of existing ones,
• the ability to take part and compete in tenders.

What implementing ISO 9001 looks like

1. Gap analysis — we compare how the company currently works with the requirements of the standard and determine what is already in place and what needs to be introduced.
2. Plan and documentation — we define the quality policy and objectives, processes, responsibilities and the documented information the standard requires, tailored to the way you work, not the other way around.
3. Rollout and training — employees start following the new procedures, and we train them and monitor how the system works in practice.
4. Internal audit — we check whether the system works as intended and resolve nonconformities before the certification body finds them.
5. Management review — management evaluates the system's results and decides on improvements, a mandatory step before certification.
6. Certification audit — an accredited certification body carries out a two-stage audit. We are with you throughout the audit and help you address any findings.

For most companies the whole process takes two to three months, depending on the size of the company and its existing documentation.

If you are interested in implementing an ISO 9001 quality management system in your company, you can request a quote or contact us by phone or by email at office@eqsint.com.