The International Organization for Standardization (ISO) informs thousands of industry leaders around the world about global standards for manufacturing processes, safety requirements, quality assurance, and more. Every few years, they produce updated standards that organizations need to be aware of.
When it comes to compliance, ISO certification is the stamp of approval that your manufacturing organization is maintaining a certain quality standard. It’s important to understand the ISO family of standards, known as ISO 9000, and how ISO 9001 fits into this management system.
- What is ISO 9000?
- What is ISO 9001?
- What Does ISO Certified Mean?
- ISO 9000 vs ISO 9001: Key Differences
- How to Become ISO Certified
- Tips for Successfully Completing Your ISO Certification
What is ISO 9000?
ISO 9000:2015, the latest version of a family of standards, describes the fundamental concepts and principles of quality management which are universally applicable to organizations seeking success through their management system, supply chain logistics, improving internal communications, and more.
These standards also benefit customers who seek confidence in an organization's ability to consistently provide products and services, as strengthening internal standards is reflected externally to customers.
ISO 9000:2015 specifies the terms and definitions that apply to all quality management and quality management system standards developed by ISO/TC 176.
What is ISO 9001?
In comparison, ISO 9001 is a singular measure within the body of the ISO 9000 standards. It specifies requirements for a quality management system when an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements.
This individual standard outlines a specific set of regulations that are laid out within a series of clauses. Detailed processes, including gap analysis and internal audits, must be conducted while using ISO 9001 to maintain the quality management system.
All the requirements of ISO 9001:2015 are generic and are intended to apply to any organization, regardless of its type or size, or the products and services it provides; all can benefit from following these standards and principles.
What Does ISO Certified Mean?
To be certified by the ISO means that you adhere to the expectations and qualifications of the latest standards set by the global organization. This certification signifies that your products are consistent with international requirements and that your business is updated on what those latest standards might be, which is beneficial for your company both internally and externally.
By achieving the latest ISO certification, your manufacturing organization demonstrates that it is keeping up with the latest industry standards and regulations. This is crucial for your business as your products should reflect the measures taken to create consistency and confidence in a global manufacturing market.
ISO 9000 vs ISO 9001: Key Differences
Going by how close these numbers are, one might imagine there are few distinctions between these two standards. This, however, is not entirely true.
The key difference: ISO 9000 is something you read up on and get familiar with to understand all of the other specific standards, while ISO 9001 is something that you put actions behind to implement.
ISO 9000 is essentially a collection of vocabulary and definitions for the entire quality management series, whereas the main purpose of ISO 9001 is for the business owner to take action toward more quality procedures. This allows the business owner and company personnel to see a clear difference between where they are currently and where they want to be.
How to Become ISO Certified
Individuals cannot become ISO certified -- only businesses and organizations can. It's also worth noting that ISO doesn't provide the certification—third-party organizations do. However, as you might expect, the ISO does have a Committee on Conformity Assessment (CASCO) which manages the qualifications of the certification process.
When choosing a certification body, it’s important to evaluate a few agencies to select the best fit for your organization. One of the points to consider is if that agency utilizes the latest, relevant CASCO standards and if they are an accredited body.
The timeline of certification training depends on numerous factors, including studying the requirements, level of preparation of an organization, and the size and complexity of the organization. Most can expect to receive their certification in three to six months.
Tips for Successfully Completing Your ISO Certification
An ISO certification can deliver both a competitive edge to manufacturers and help ensure the highest compliance standards available. Here are some tips to help make the certification process easier.
Tip #1: Get Prepared
Taking the extra steps to prepare is crucial when completing a certification. Meet with the appropriate members of your organization to understand where to start with documentation, employee training on new compliances, and other subsequent tasks inherent to this process. This initial step should also include making SMART goals - specific, measurable, attainable, realistic, and timely - as these goals will help everyone stay on target.
Tip #2 Implement Changes in your QMS
Once your business is ready with the documented QMS that follows the ISO 9001 requirements, you can start implementing ISO quality measures. This step puts plans into action, including relevant training for all employees with updated expectations for their roles. Implementing changes calls for the participation of your company’s staff, especially everyone who oversees or manages a process.
Tip #3: Consider Conducting an Internal Audit
The audit process can be conducted by an internal team made of quality representatives, or by professional auditors from any quality assurance agency. They will check your newly implemented QMS and ensure it is effectively operating and adhering to the ISO 9001 standard. This process should discover any discrepancies in the QMS and smooth them out for certification.
CMTC Can Help...
In late 2015, the International Organization for Standardization (ISO) published their latest edition of ISO 9001 — ISO 9001:2015. To help your manufacturing business understand the standards you need to thrive in the face of advancing technologies and increasingly complex supply chains, CMTC has created an ISO Tip Sheet to break down the details of the standard. Download it for free or reach out to our manufacturing experts today for more information!
About the Author
Eliot Dratch is a quality, lean and safety consultant who understands that U.S. manufacturing has been the economic engine that raised the living standards and built economic equity for the last 6 generations of Americans. Eliot’s work with manufacturers for his entire 30+ year career from different manufacturing sectors allows him to leverage a unique blend of experience for his clients. His goal is always to measurably improve a CMTC client’s productivity, safety and profitability.