ISO 9001 Certification
ISO 9001:2015 is the title of a document (Standard) that outlines the requirements an organization must maintain in their quality system for ISO 9001:2015 certification. There are several different documents in the ISO 9000 family of standards, but ISO 9001:2015 is the only ISO 9000 standard that requires certification. ISO 9001:2015 is the most recent standard, and the “2015” references the year of latest revision. It was previously called ISO 9001:2008, which became obsolete September 2018.
ISO 9001 is an internationally recognized Quality Management System. You may want to read:
- What is a Quality Management System?
- Learn about the ISO 9001:2015 Requirements
- Learn about the entire ISO 9000 Family
- Learn the Steps to ISO 9001 Certification
- ISO 9001:2015 Requirements Training reviews all the clauses of ISO 9001:2015
- Steps to ISO 9001 Certification – 8 Steps to Certification
- All-in-One Package – All of the tools you will need in one simple package
- ISO 9001 Registrar – Get three quotes at one time from top registrars for FREE!
- Read our example of ISO 9001 applied to making cookies.
ISO 9001:2015 does NOT define the actual quality of your product or service. The standard helps you achieve consistent results and continually improve the process. Thus, if you can make a good product most of the time, this helps you make it all of the time. It’s just good business practices.
ISO Certification Process
ISO certification process for the majority of its management systems including ISO 9001, ISO 14001, or ISO 45001 follow a two stage process, and once granted certification, the certificate lasts 3 years before renewal.
ANAB accredited certification bodies cannot advise or provide consultancy, yet the pre-audit or gap analysis allows you to understand if your QMS is weak in certain areas. As this is not part of the formal certification process it is not a pass or fail audit, however if you do not address pre-audit findings, this could lead to nonconformances during the certification process.
Stage 1 of the audit review is the document review. This first stage is used so the registrar can review the structure of the management system through the available documentation. The goal is to verify that any mandatory requirements have been addressed within the documentation.
Stage 1 is most often conducted on site and helps plan for the stage 2 audit. This allows the auditor to tour the site and assess any unusual circumstances that may affect the audit. Although the stage 1 audit is not pass or fail, the auditor can raise nonconformances that must be addressed by the stage 2 visit. If they feel your quality management system will not be ready in time they can postpone the stage 2 audit. Note- there is a maximum time between the stage 1 and stage 2 audits, and if stage 2 is not completed within this window you will have to redo stage 1.
Stage 2- Certification Audit
Stage 2, certification audit covers all aspects of the quality management system. Registrars will take the approach to sample records to obtain objective evidence that the system is operating effectively. There is a minimum of 3 months of records and evidence for the auditors to review. Stage 2 audits are held on-site and will need to include all business areas and locations referenced in your certification scope statement. In general this stage takes longer than stage 1. There are several categories of findings for stage 2. The most serious is called a major non-conformance and these will need to be addressed before granted certification.
A scheduled program for surveillance audits are most often created at the end of the Stage 2 audit. Surveillance audits are similar to the stage 2 audits above, however they will focus on smaller sections of the management system each visit. Therefore these visits are generally shorter than the stage 2 process.
The intervals of occurrence vary depending on the complexity of your management system and your preference, but usually these fall either annually or 6-monthly. Surveillance audits are booked just as the other audits are, so there is no spot-checks or surprise visits.
ISO 9000 Certified: The Myth
“ISO 9000 Certified” is technically incorrect as ISO 9000 does not have requirements. “ISO Certified” is also incorrect, as it does not state which ISO standard you are certified to.
ISO 9001:2015 is focused on meeting customer expectations and delivering customer satisfaction so you must pay attention to the customer.
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). Meeting legal and regulatory requirements benefit the community. Read more about continuous improvement.
What is 9001 Quality Management versus General Management Systems
What is 9001 and what is not ISO 9001? ISO 9001:2015 is a quality management system, not a general management system. While ISO does actually provide general management systems that help document, organize and define how a business will run its overall operations (such as ISO 26000), these systems are rarely a requirement for certain types of commerce as ISO 9001:2015 often is.
Is 9001 a Performance Benefit?
While it is hard to prove a direct correlation between ISO 9001’s quality system and business performance, a number of studies suggest there is an association between ISO 9001 certification and financial performance. Though not solely the reason for seeking the benefits of ISO 9001 certification, there are substantive surveys showing that gaining new business was a direct result.
What is 9001’s Resource Impact?
As with most business processes, the more you do yourself, the less the cost, but the more time it may require. No matter how much external resources are utilized, there will need to be involvement by your employees and staff to varying degrees. While there is no total “do it yourself” solution, you can go a long way on ISO 9001 basic requirements by using pre-formatted materials for documentation and training. While the procedures and methods in these must be tailored to your situation, they are typically created with minimizing the changes required and maximizing the ability for others to use and comprehend them. The goal of any quality management system should not be to add unnecessary paperwork, but to make all references clear and highly usable.