What is the ISO 9001 QMS?

11 April 2018

A QMS, or Quality Management System, is basically a suite of business processes designed to generate continuous improvement in quality and ensure customer expectations are met or exceeded. There are many ways to set up a Quality Management System, but the best known and most widely implemented is the one defined by ISO 9001.

It's important to understand that a Quality Management System is not the same as quality control – a QMS is vastly more inclusive and designed to improve quality from the ground up. A QMS impacts all activities that directly and indirectly affect quality: it affects all company processes and employees, and extends out to the supply chain and customer interactions. The benefits of a Quality Management System are numerous but typically include increased profitability, higher quality products and services, and improved customer satisfaction. See our article about the benefits of ISO 9001 to gain a broader understanding.

ISO 9001 Consultants

Continuous improvement (sometimes also referred to as continual improvement) is one of the core objectives of an ISO 9001 QMS.

Quality management principles

Seven principles form the foundation of an ISO 9001 Quality Management System; collectively they represent a platform on which company-wide improvements can be implemented and realized. They apply as much to product-based providers as to those delivering services; their relative importance will obviously vary from company to company, and can be expected to change over time.

The interactive table below explains each of the seven quality management principles. To learn more, just click on any of the principles you want to read about. The tips and advice accompanying each principle are provided for the benefit of small business owners about to get started on their journey towards ISO 9001 implementation.

ISO 9001 Customer Focus

Customer focus

The key objective of an ISO 9001 Quality Management System is to meet customers' requirements while simultaneously trying to exceed their expectations. The most obvious benefits include better customer satisfaction and loyalty (along with an expanded customer base), more repeat business and improved company reputation, increased revenue and market share.

What you can do?

Set company and departmental goals linked specifically to customer needs and expectations; ensure that staff at all levels within the company are aware of these needs and expectations.

Monitor customer satisfaction and take corrective action where necessary. Quickly addressing problems (regardless of their relative importance) almost always leads to improved customer satisfaction.

Maintain active relationships with customers and view interactions with them as a chance to learn and create more value for them. Consider their future needs, too, as this will help your company adapt and retain its edge.

ISO 9001 Leadership

Leadership

Characteristics of good leadership typically include vision, courage, integrity and planning. In the context of an ISO 9001 system, strong leadership involves aligning the organization to the needs of the market and evolving a culture in which staff are motivated to pursue the company's strategic objectives. Strong, focused leadership ensures better communication throughout the company, along with improved coordination of operational processes and continual improvement of the QMS.

Tips: what you can do

Cultivate a work environment that's fair and honest, and ensure all employees are familiar with the company's mission and strategic objectives. Ensure too that people within the organization are committed to quality and awarded due recognition for their contributions.

Lead by example: managers must be good examples of those who can "walk the talk" rather than simply "talk the talk". Senior management (which ISO refers to as top management) must take responsibility for managing and directing the QMS rather than simply showing commitment to it.

Training should be provided where appropriate and an environment cultivated in which staff are encouraged to seek greater responsibility and autonomy

ISO 9001 Engagement of People

Engagement of people

ISO (the International Organization for Standardization) defines "people" as senior managers, mid-level executives, supervisors, employees and other ancillary staff. Engaging people throughout the company leads to better organizational efficiency and effectiveness, and increased job satisfaction. Additional benefits include enhanced trust in the company (as well as increased motivation and commitment), better collaboration and teamwork.

Tips: what you can do

Make sure all people are made aware of the relevance and importance of their individual contributions. Specifically, people must understand and appreciate the extent to which they impact on the effectiveness of the Quality Management System and resulting organizational performance. Encourage collaboration, knowledge sharing and teamwork activities; give people sufficient room to grow and develop from their mutual interactions.

People should be encouraged to evaluate themselves and their performance. This type of self-assessment is surprisingly empowering: not only does it give people an opportunity to see for themselves what they're doing well, it also helps them identify areas for improvement.

Company-wide surveys are an excellent way to assess both job satisfaction and the extent to which people believe the organization is achieving its quality objectives. The results of these surveys should be communicated back to the relevant people and appropriate action taken where necessary.

ISO 9001 Process Approach

Process approach

This principle stresses that in order to achieve predictable results, company-wide activities must be viewed as a collection of interrelated processes which together form a robust Quality Management System. The process approach spawns greater consistency, more efficient use of resources and less barriers between different functions. Ultimately, effective process management leads to improved performance and increased corporate efficiency.

Tips: what you can do

First, the objectives of the QMS must be defined, along with the processes required to fulfill them. This involves determining inputs and outputs, and the people responsible for managing them. It's then necessary to assess the extent to which processes are interrelated and how the outcome of one process can affect other processes in the organization.

At all times information and statistical data must be available to operate and improve the processes. This information should also be used to monitor and evaluate the performance of the QMS.

Risk management is very important: first, potential risks must be determined (possibly with a SWOT analysis); second, actions must be taken to counter the impact any such risks may have on individual processes and the Quality Management System.

ISO 9001 Improvement

Improvement

A steadfast, company-wide commitment to improve spawns a environment in which innovation can thrive; customer satisfaction is enhanced; internal and external risks can be anticipated, identified and addressed; and process performance becomes more effective and efficient.

Tips: what you can do

Seek improvement by inviting people to examine procedures and processes with a fresh perspective. In other words, encourage people to think "outside the box". Invite critical commentary and feedback, and work collaboratively to find new, improved solutions; always reward innovation and creativity.

Throughout the company, implement projects designed to promote improvement – provide employee education and/or training where necessary. Inspire people to broaden their goals or objectives, and cultivate a culture in which continuous improvement is considered a corporate norm.

ISO 9001 Decision Making

Evidence-based decision making

Evidence-based decision making focuses on the fact that most decisions generally involve a degree of uncertainty, along with the risk of subjective interpretation and possibility of error. Better, more objective decisions are possible, however, if they stem from systematic evaluation and analysis of evidence. Decisions thus made can be implemented with far greater confidence.

Tips: what you can do

By itself, evidence-based decision making is insufficient – decisions should also be based on experience and a "gut feeling" for what's right. This tenet applies not only to senior managers but to mid-level executives and other decision-makers throughout the organization.

For obvious reasons, decisions involving evidence are only as good as the information available. Steps must be taken, then, to ensure all pertinent data is fresh, accurate and secure. This data must also be readily accessible to those who need it.

ISO 9001 Relationship Management

Relationship management

The seventh quality management principle, relationship management, describes the need for companies to manage their relationships with suppliers and other interested parties. The logic is straightforward: fair, transparent relationships lead to a better understanding of the needs and objectives of all interested parties. This in turn results in sustainable success for the organization, well-managed supply chains and improved supplier satisfaction.

Tips: what you can do

First, determine who the relevant interested parties are and their relationships with the company. These parties may include suppliers, partners, customers, investors and employees. Next, sort these relationships into some sort of order and determine whose needs are greatest and who should be given priority in terms of regular communication, feedback, etc.

Learn to distinguish between relationships that will only ever offer short-term gains and those that might offer longer-term opportunities. Prioritize accordingly, but nonetheless aim to strengthen all relationships and actively seek feedback in order to pinpoint areas for possible improvement. At the same time, recognize achievements made by suppliers (reduced delivery times, for example) and give due acknowledgement.

The PDCA Cycle

In our opinion an "unofficial" eighth quality management principle is the PDCA Cycle, a looping four-step model for continuous improvement. The letters PDCA represent Plan, Do, Check and Act. When properly implemented, the cycle is easy to understand and maintain, and one of the most effective tools for process control and continual improvement.

Plan
This initial step involves pinpointing the issues that need to be addressed. In the context of individual processes, you need to define the objective of the process and what's required to ensure harmonization with other processes it interacts with. When considering the broader picture, define the Quality Management System's objectives and the resources needed to deliver outputs in accordance with customers' requirements and expectations, and in keeping with company policies.

Show applicable ISO 9001:2015 clauses

4. Context of the organization

4.1 Understanding the organization and its context

4.2 Understanding the needs and expectations of interested parties

4.3 Determining the scope of the QMS

4.4 QMS and its processes

5. Leadership

5.1 Leadership and commitment

5.2 Policy

5.3 Organizational roles, responsibilities and authorities

6. Planning

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes


Do
This step is the implementation phase and is crucial to obtaining accurate results. Solutions to problems and/or new approaches to optimizing processes can be tried and tested.

Show applicable ISO 9001:2015 clauses

7. Support

7.1 Resources

7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

8. Operation

8.1 Operational planning and control

8.2. Requirements for products and services

8.3 Design & development of products and services

8.4 Control of externally provided processes, products and services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of nonconforming outputs


Check
This step, sometimes called the Study step, is the point in the cycle where:

  1. products or services are monitored, measured (where applicable) and analyzed to ensure they meet requirements;
  2. processes are assessed in terms of how effectively and efficiently they are operating;
  3. customer satisfaction is evaluated to make sure targets are being met or exceeded.

Show applicable ISO 9001:2015 clauses

9. Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

9.2 Internal audit

9.3 Management review


Act
The final step brings together everything that's been learned during the cycle and is the point where full-scale changes can be implemented It's important to remember that the PDCA model is an ongoing loop rather than a one-time cycle: it can be repeated as often as required to maintain company-wide continuous improvement and ensure processes are as efficient as possible.

Show applicable ISO 9001:2015 clauses

10. Improvement

10.1 General

10.2 Nonconformity and corrective action

10.3 Continual improvement


ISO 9001 PDCA Cycle

Maintaining an effective Quality Management System

Strong leadership from senior management is a key factor in successfully maintaining the QMS. Other critical factors include employee involvement, positive customer and supplier relationships, and company-wide ISO recognition. Also crucial is an emphasis on continuous improvement (and exploring fresh opportunities to achieve this) and preventive/corrective actions.

Another proven approach is for companies to implement continuous improvement initiatives. Numerous variations are possible, but typically departments within the workplace are encouraged to develop a set number of improvement projects in a specified time frame. Examples of improvement projects include training staff in corrective/ preventive action analysis, simplification of company processes, improvement of ISO 9001 forms and documentation, and evolving new approaches to product or service evaluation.

Resources
Maintaining and continually improving an ISO 9001 QMS requires sufficient resources; examples include adequate provision of equipment and infrastructure, a safe, well-managed work environment, and systems to ensure monitoring and measuring (where applicable) can be undertaken reliably and accurately. Staff must be competent to perform their designated duties, and dedicated training should be provided if required. Online courses are an excellent way to educate staff working within the Quality Management System.

The organization shall establish, implement, maintain and continually improve a Quality Management System, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

ISO, Geneva, Switzerland, 2015

How to set up a QMS?

Setting up an ISO 9001 Quality Management System is not an easy task – it requires time and diligence from senior managers and employees throughout the company. Fortunately there are numerous products and services designed to ease the burden, ranging from management consultants to online training and in-house ISO 9001 certification kits.

More information
Read more about how to implement a QMS in our guide How to get ISO 9001 certification.

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