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ISO 9001 explained in plain English. Learn how to get ISO 9001 certified.
Published January 27th, 2021
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:
iAuditor ISO 9001 Checklist
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.
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.
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).
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:
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.
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:
Here are 6 steps to help you get ISO 9001 certified:
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.)
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.
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.
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.
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.
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.
Here are the 5 benefits of having an ISO 9001 certified QMS:
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.
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.
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.
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.
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 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.
Use this ISO 9001:2015 checklist to eliminate non-conformities and their root causes.
SafetyCulture staff writer
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