What is ISO 9001?
ISO 9001 is the international standard for a quality management system (“QMS”). In order to be certified to the ISO 9001 standard, a company must follow the requirements set forth in the ISO 9001 Standard. The standard is used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement.
A few details about ISO 9001:
There are several different documents in the ISO 9000 family of standards, but ISO 9001 is the only standard in the 9000 series that requires certification. Typically, an entire organization will seek certification, but the scope of the QMS can be tailored to improve performance at a particular facility or department. The current version is ISO 9001:2015, which was published in September of 2015 (thus the: 2015).
- It does NOT matter what size your organization is: 1 person or 1 million people. See ISO 9001 Implementation for Small Businesses
- It does NOT matter what industry you are in (service or manufacturing) – it can be a restaurant, consultancy, manufacturing company, government entity, etc. There are other standards based upon ISO 9001 for a few specific industries.
- It is NOT a standard for products. It does not define product quality. This is a process-based standard: you use it to control your processes, then your end product should meet the desired results.
- It is NOT a personal Standard – a person cannot get certified to ISO 9001, instead an organization or company becomes certified. Individuals, however, CAN become an ISO 9001 Certified Lead Auditor after a 5 day training course. This then allows them to audit other companies.
- There is no such thing as “ISO Certification” or “ISO 9000 Certification”, only ISO 9001 certification.
- It is NOT a membership group – An organization cannot “join” ISO 9001. To become ISO 9001 certified, your organization must
- Follow the steps to implement an ISO 9001 quality management system.
- Then a Certification Body (CB or Registrar) audits the performance of your organization against the latest version of the ISO 9001 Requirements. If you pass this audit, the Registrar issues an ISO 9001 Certificate demonstrating that your organization is Registered to ISO 9001 for a three year period. (See Who is able to grant certification)
- Finally, the organization must be re-certified every three years in order to maintain their ISO 9001 certification status.
The Definition of ISO 9001 Certification
“ISO 9001 Certified” means an organization has met the requirements in ISO 9001, which defines an ISO 9001 Quality Management System (QMS). ISO 9001 evaluates whether your Quality Management System is appropriate and effective, while forcing you to identify and implement improvements.
Continuous improvement assures your customers benefit by receiving products/services that meet their requirement, and that you deliver consistent performance. Internally, the organization will profit from increased job satisfaction, improved morale, and improved operational results (reduced scrap and increased efficiency).
What is ISO 9001:2015 (Current Version)?
ISO 9001:2015 is the current version of the ISO 9001 standard which outlines the requirements an organization must maintain in their quality system for ISO 9001:2015 certification. ISO 9001 is explained in detail above. It is the most recent version of the standard which included several changes from ISO 9001:2008 including:
- Adaption/adoption of the new ISO structure (Annex L) to align with other standards including ISO 14001, ISO 45001, etc.
- Enlarging the relationship between organizations and quality management systems
- ISO 9001:2015 promotes a process approach in order to produce the sought after quality outcomes
- Presents requirements for quality performance in the organization’s strategic planning
- Greater emphasis on top level management for ownership of the QMS
- Less prescriptive requirements compared to previous versions
- The main focus is on customer satisfaction
- Straightforward terminology throughout the standard
Why a new version?
ISO regularly reviews all standards to ensure they are up-to-date and continue to be relevant for the needs of organizations around the world. The last major revision of ISO 9001 was in 2008. While that might not seem like such a long time ago, the exponential increase in the availability of technology, products, and services for consumers, as well as the size and complexity of the global supply chain, have meant that ISO needed to make 9001 meet several new requirements. Customer demands on products and services, and the impact on the brand reputations of those companies that can meet them, grow each day, and ISO 9001 needed to meet these enhanced expectations.