ISO 9001 Quality Management System: A Beginner’s Guide

Everything you need to know about ISO 9001: QMS elements and standards, the methods and 7 principles of quality management, difference between ISO 9000 and ISO 9001, why ISO 9001 certification is better than ISO 9001 conformity, and ISO 9001 certification requirements

Published 27 Aug 2021

What is ISO 9001?

ISO 9001 is a global industry standard that specifies requirements and best practices for a quality management system (QMS). The current ISO 9001 standard is ISO 9001:2015. It’s used by over a million organizations worldwide across all industries and sizes.

Being ISO 9001 certified means an organization is able to demonstrate the ability to consistently deliver products and services that meet and exceed customer and regulatory expectations. Conformity to ISO 9001 also means that the organization has an established QMS.

What is a Quality Management System?

A QMS is the documentation of an organization’s processes and plans for achieving quality objectives. It should be tailored to the organization and to the needs of its customers. 

An effective quality management system enables organizations to consistently deliver high-quality products, resulting in happier customers and better business overall. A QMS also helps make processes more efficient, leading to less time and effort wasted on non-essential tasks and allowing teams to focus on high-impact activities instead. 

Elements of a Quality Management System

Quality management systems have these nine elements: quality policy and objectives, quality manual, organizational structure and responsibilities, data management, processes, customer satisfaction with product quality, continuous improvement, and document control.

Quality Policy and Quality Objectives

A quality policy is an official statement of the organization’s commitment to quality and its strategy for promoting, maintaining, and improving quality. To ensure alignment with quality policies, organizations set specific business goals or quality objectives. Both quality policies and quality objectives are standard requirements of ISO 9001. 

Organizations can use the quality policy and quality objective below as an example:

  • Quality Policy: Guarantee client’s satisfaction
  • Quality Objective: Maintain at least 95% client satisfaction

Quality Manual

A quality manual is a document containing the rationale for implementing a quality management system and an overview of the organization’s quality procedures. If a QMS standard such as ISO 9001 is one of the reasons for QMS implementation, then its requirements should be included in the quality manual. 

Organizational Structure and Responsibilities

With any major project, clearly assigning tasks and stating project ownership is a must. As a quality management system is a major project, the same rules should apply. For upper level management, allocating a quality-focused responsibility to each member of the organization helps facilitate a smoother and more well-rounded QMS implementation.

Data Management

Since documentation is a core component of a quality management system, data management or the effective handling of documents and information should be a top priority of organizations looking to create, improve, or implement their QMS. Data management entails defining data sources, collecting data from these sources, organizing data collected, storing organized data for easy access and understanding, and analyzing data to find the insights needed for improvement.

Processes

Documenting, understanding, and evaluating the processes of an organization are key steps to preparing for an ISO 9001 audit, whether it be internal or conducted by a third party for ISO 9001 certification. Any process affecting the quality of products and services has to be monitored through the quality management system.

Customer Satisfaction with Product Quality

To provide proof of customer satisfaction with product quality and demonstrate the organization’s ability to meet and exceed customer needs, it’s first necessary to figure out exactly how to measure customer satisfaction. One option is to conduct customer satisfaction surveys, which can be accomplished through email, on the organization’s website, or via an on-site digital kiosk. 

Continuous Improvement

One of the topics covered in ISO 9001’s approach is a requirement to drive improvement. In simple terms, this means that organizations planning on getting ISO 9001 certified have to take concrete action towards improving quality. Continuous improvement takes this a step further, as it requires organizations to not only improve, but to continue improving. 

Quality Instruments

Aside from assessing customer satisfaction with product quality, another way of measuring quality is to use quality instruments. A quality instrument is any machine or equipment built for testing products or aspects of its production against specific criteria. In the food industry, a temperature sensor can be considered a quality instrument since food often has to be stored at a certain temperature for its quality to be preserved.

Document Control

Though document control and data management are closely related, what makes document control different is that there is a greater focus on recordkeeping. The goal of data management, on the other hand, is to collect the necessary information from the data gathered. 

What are the 7 Quality Management Principles?

According to the ISO, implementing a quality management system will be much easier if the organization follows the 7 quality management principles, which are also the primary elements of total quality management (TQM).

  1. Customer focus: attracting and retaining customers by meeting, exceeding, and adapting to their needs 
  2. Leadership: unified direction and purpose across the organization, from high-level management to employees, a culture of internal collaboration 
  3. Engagement of people: empowering employees to be their best at work leads to better value for your customers. Staff should have sufficient training, support, and resources to do their job well. 
  4. Process approach: seeing activities as processes that connect and function within a system, ensuring that everyone is familiar with the organization’s processes and how it all works together to drive business
  5. Improvement: sustaining an ongoing focus on improvement even as time goes on, being proactive when it comes to building innovation, and reacting to internal and external changes as they evolve and manifest in different ways
  6. Evidence-based decision making: establishing, measuring, and acting on quality metrics for greater ROI and efficiency
  7. Relationship management: identifying and effectively managing key stakeholder and supplier relationships through an established plan

Quality Management Methods

TQM is a quality management method focused on combining the processes, systems, and strategies of an organization with customer-based definitions of quality through strong internal collaboration. Other well-known quality management methods are Lean, Six Sigma, and Kaizen. 

Though the Lean method has many tools, the ones used for quality management are PDCA and 5 Whys. PDCA is a problem-solving technique that stands for Plan-Do-Check-Act, while 5 Whys is a root cause analysis technique that involves asking the question “why” five times. 

Six Sigma, on the other hand, has two main methodologies, DMAIC and DMADV. DMAIC, which stands for Define-Measure-Analyze-Improve-Control, is used for existing processes, while DMADV is used for new processes and stands for Define-Measure-Analyze-Design-Verify.

Kaizen is a Japanese term usually translated as continuous improvement, which is also one of the elements of a quality management system. Similar to the Lean method, there are many Kaizen tools, the most prominent of which is Gemba. Gemba or “the real place” is the act of seeing where the actual work happens by performing a Gemba walk

Types of QMS Standards

QMS standards can be divided into two types. The first type of QMS standards is the ISO 9000 series, which contains ISO 9001, ISO 9004 (for sustaining the ISO 9001 certified QMS), and ISO 19011 (guidelines from the ISO 9001 Auditing Practices Group). The second type of QMS standards is industry specific and includes ISO 13485 and IATF 16949.

ISO 13485 is the QMS standard for the manufacturing, distribution, servicing, and disposal of medical devices. Organizations with ISO 13485 certification are recognized to produce medical devices that are at par with industry standards. ISO 13485 certification is also a prerequisite for manufacturers that want to get certified for the Medical Device Single Audit Program (MDSAP).

IATF 16949 was developed by the International Automotive Task Force (IATF), a global group of organizations in the automotive industry that aims to build consensus on benchmarks for product quality and processes in the automotive supply chain. Members of IATF require their suppliers to be IATF 16949 certified

ISO 9001 Certification 

Both conformity to ISO 9001 and ISO 9001 certification can be used by an organization to claim that its QMS meets ISO 9001 requirements. An organization can claim conformity to ISO 9001 through a legally binding declaration or statement based on the organization’s own internal audits. ISO 9001 certification, on the other hand, is an assessment conducted by a third-party, who then issues a certificate of conformity.

Why ISO 9001 Certification is Important

Here are the 5 benefits of having an ISO 9001-certified QMS:

Improve the Quality of Products and Services

By analyzing the processes involved in the provision of products and services, you can take control of your operations and ensure consistent quality output. 

As ISO 9001 certification requires an independent third party audit, your processes will be well-scrutinized and recommendations on how to further develop the quality management system of your organization will be provided.

Meet the Requirements of Potential Business Partners

Some vendors require ISO 9001 certification before engaging in business. By meeting ISO 9001 requirements and getting certified, you can attract more business partners that are likely ISO 9001 certified themselves as well as expand into new markets.

Drive Customer Satisfaction

High quality products and services delivered consistently brings customer satisfaction and loyalty to the forefront, creating a ripple effect that results in the business acquiring other clients and partnerships. Gain actionable insights and data on customer satisfaction through this product survey template.

Leadership Engagement

ISO 9001 aims to have leaders actively engage in the improvement of quality and processes in the organization. By providing opportunities for leaders to identify gaps in performance and spearhead new initiatives to address them, ISO 9001 increases the organization’s overall efficiency. 

Improve Company Culture

With roles, expectations, and company direction clearly defined, employees will perform better and be more professional at work. Getting ISO 9001 certified may also boost company morale as it is a worthwhile achievement and recognition of their efforts.

Achieving ISO 9001 certification can be a significant investment in time and resources. As a result, organizations that become ISO 9001 certified often hold a competitive advantage within their industries.

What are the Primary Requirements of ISO 9001 Certification?

ISO 9001 does not define the exact requirements for products and services, but is rather a measure of the overall quality management of an organization. Aside from a QMS, the other primary requirements of ISO 9001 are the following:

  • Top management commitment to quality
  • customer focus
  • Adequacy of resources
  • Employee competence
  • Process management (for production, service delivery, administrative, and support)
  • Quality planning
  • Design of products and services
  • Processes to resolve customer complaints
  • Corrective actions
  • Requirement to drive improvement 
  • Requirement to monitor customer perceptions about the quality of products and services

How to Get ISO 9001 Certified

Here are 6 steps to help you get ISO 9001 certified:

Step 1: Get Buy-in

Gather and agree on implementing a QMS at both management and staff level. Clearly communicate the objective and purpose to staff (e.g. whether to improve overall efficiency, customer satisfaction, bid for new work, etc.)

Step 2: Gap Analysis

Conduct a gap analysis in order to find out to what extent your company is already meeting ISO 9001 requirements and where the emphasis of your implementation efforts should be. Use a digital checklist to perform the gap analysis for better data visibility.

Step 3: Planning

Once you have identified the gaps, sketch out and implement a project plan with key timelines, parties, deliverables and responsibilities. Draft your quality policy and align it with ISO 9001 standards. Prepare the required documents and records. 

Step 4: Implementation

Implement your ISO-aligned QMS in your organization. Make sure that all employees are aware why the QMS is being implemented and how it will benefit them. Though it can be difficult to get everyone on board, an efficient QMS helps employees increase their productivity with minimal effort by allowing them to focus on the metrics that matter. 

Step 5: Internal Audit

Conduct internal audits to assess and sustain compliance with the implemented QMS. Use an internal audit checklist to gather information that can help analyze if your QMS is effective and achieving quality objectives. Aside from being valuable sources of data, internal audits can also act as test runs for the actual ISO 9001 certification.

Step 6: Get Certified

Find a reputable independent certification body that will visit and perform site audits to determine if your company can be ISO 9001 certified. Check if the certification body uses the relevant CASCO (ISO committee on conformity assessment) standard.

iAuditor as ISO 9001 Quality Management Software

iAuditor by SafetyCulture is an award-winning quality management software used by 1 million workers in 26,000 organizations across 85 countries. iAuditor is a GetApp Category Leader and Software Advice Frontrunner in quality management. It has the following key features for improving quality management processes:

  • Get a snapshot of how your QMS is performing in the analytics dashboard and filter data by date, location, site, user, or response to drill down further into the strengths and weaknesses of your quality management system
  • Convert existing paper documentation of your QMS into digital templates that are easy to access and edit after you’ve made changes or improvements to your QMS
  • Create, assign, and complete corrective and preventive actions on a mobile device for always on-the-go continuous improvement and team collaboration
SafetyCulture Content Specialist

Zarina Gonzalez

Zarina is a content writer and researcher for SafetyCulture. She enjoys discovering new ways for businesses to improve their safety, quality, and operations. She is working towards helping companies become more efficient and better equipped to thrive through change.

Zarina is a content writer and researcher for SafetyCulture. She enjoys discovering new ways for businesses to improve their safety, quality, and operations. She is working towards helping companies become more efficient and better equipped to thrive through change.