ISO 9001 - A Beginner’s Guide

ISO 9001 explained in plain English. Learn how to get ISO 9001 certified.

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Published January 27th, 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.

This article will discuss the following:

What Does ISO 9001 Mean?

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. 

ISO 9001 Certification vs Conformity

Both conformity to ISO 9001 and ISO 9001 certification can be used by an organization to claim that its QMS meets ISO 9001 requirements. However, ISO certification is a much higher level of compliance and better supports an organization’s claim than conformity to ISO 9001 only.

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

What is the Difference Between ISO 9000 and ISO 9001?

ISO 9001 is one of the core standards within the ISO 9000 series. ISO 9000 can also refer to the companion document introducing the fundamental concepts used in the ISO 9000 series. Other ISO 9000 core standards are ISO 9004 (for sustaining the ISO 9001 certified QMS) and ISO 19011 (guidelines from the ISO 9001 Auditing Practices Group). 

What is a Quality Management System (QMS)?

A QMS is a documented system that outlines the processes and responsibilities for achieving an organization’s quality and continuous improvement objectives. A QMS should be internally developed and tailored to the organization and its customer’s needs. ISO recommends that an effective QMS should be designed to achieve the following 7 quality management principles:

  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

A documented QMS does not have to be aligned or certified with ISO 9001 to achieve a company’s quality and improvement objectives. Each business should weigh the benefits and disadvantages of going through an ISO 9001 certification process.

What are the Primary Requirements of ISO 9001?

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 9001:2015 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.

Benefits of Being ISO 9001 Certified

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

Benefit #1 Improve Product Quality

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.

Benefit #2 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.

Benefit #3 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.

Benefit #4 Leadership Engagement

ISO 9001:2015 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. 

Benefit #5 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.

iAuditor ISO 9001 Quality Management Software

iAuditor by SafetyCulture is an award-winning quality management software that streamlines internal and third-party audits. iAuditor automates compliance monitoring and has built-in risk assessment, which is in line with ISO 9001’s risk-based or preventative approach to quality.

With iAuditor, organizations can implement safe and efficient quality management systems and prepare for ISO 9001 certification easily

Author

Sare Hawes

SafetyCulture staff writer