ISO 9001 - A Beginner’s Guide
What is ISO 9001?
ISO 9001 is the international standard that specifies requirements and best practices for a QMS. 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. The latest version of the standard is known as ISO 9001:2015 and is used by over a million organizations worldwide across all industries and sizes.
ISO 9001 is a global industry standard that sets out the requirements for a Quality Management System (QMS) to help organizations improve efficiency and customer satisfaction.
This article explains in plain English the What, How and Why of establishing a QMS and achieving ISO 9001 certification. You can also download our free ISO 9001 audit checklist you can use to help plan for your certification process.
The latest version of the standard is known as ISO 9001:2015 and is used by over a million organizations worldwide across all industries and sizes.
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:
- Customer focus: meet and exceed customer needs
- Leadership: unified direction and purpose across management and employees
- Engagement of people: ensure competent and engaged staff. Employees should have sufficient training and support to do the job right
- Process approach: well understood internal processes to improve efficiency
- Improvement: proactive approach to driving improvement and adapting to changing conditions
- Evidence-based decision making: quality metrics are established, measured and acted upon to drive continuous improvement and ROI
- Relationship management: identify and effectively manage key stakeholder and supplier relationships
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 burden of going through an ISO 9001 certification process.
Here are the five main benefits of having an ISO 9001 certified QMS:
#Benefit 1: Improve the Quality of Products and Services
By analyzing the processes involved in the provision of products and services, you can take control and ensure a consistent quality offering. As ISO 9001 certification requires an independent third party audit, you can be assured that your processes will be well scrutinized.
#Benefit 2: Meet the Requirements of Potential Business Partners
There are vendors that require ISO 9001 certification before engaging in business. By meeting the 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
Great quality products and services delivered consistently equals satisfied customers.
#Benefit 4: Leadership Engagement
ISO 9001:2015 aims to have leaders actively engage in the improvement of quality and processes in the organization.
#Benefit 5: Improve Company Culture
With roles, expectations, and company direction clearly defined, employees can perform better and be more professional at work.
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.
Here are six key steps to help you get started with developing a QMS and getting 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: Prepare Project Plan
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 checklist to perform the gap analysis. Once you have identified the gaps, sketch out and implement a project plan with key timelines, parties, deliverables and responsibilities.
#Step 3: Documentation
Draft your quality policy and make it aligned 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.
#Step 5 Internal Audit:
Conduct internal audits to assess and sustain compliance with the implemented QMS. Use a digital auditing application to gather information that can help you analyze if the QMS is effective and achieving quality objectives.
#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 9001:2015 certified.
ISO 9001:2015 certification is achievable for businesses of all sizes and can be operationally and financially rewarding. To help you get started with your ISO 9001 certification process download this free digital ISO checklist from iAuditor:
Take a look at this ISO 9001 template
ISO 9001:2015 Template
Use this ISO 9001:2015 template to document plans on how to eliminate non-conformities and its root cause/s.