Who (or What) is ISO
ISO 9001 is a global management system standard which provides a framework of requirements and processes which ensure that products and services consistently meet customer requirements and expectations. ISO 9001 benefits to just about any organization are numerous and can impact the organization through every function and department. The ISO 9001 standard requires organizations to determine its operating and support processes, constantly measure performance against established criteria, and identify and act on opportunities to improve products, services, and organizational performance. Let’s take a closer look at what ISO is and ISO 9001 benefits.
Based in Geneva Switzerland, ISO is the International Organization for Standardization, a standards body with representation from over 160 countries. Since its inception in 1947, ISO has established and published well over 20,000 standards for numerous industries, products, and services including manufacturing of products, water and air quality, component specifications, food safety, aerospace, healthcare, medical device, transportation, environment, and many others. Each country has its own established standards group which then provides representation to ISO during the development and approval of various standards. In the United States, the main group is the American National Standards Institute (ANSI).
Many people have probably seen an ISO standard referenced on various purchased products but didn’t realize what they were looking at. For the most part, ISO is more of a business to business thing, but it does significantly impact our everyday lives. For example, photographers who experienced the pre-digital photography age probably remember buying film with different speed ratings for interior, exterior, or other photo needs. These film speeds where based on an ISO standard and included numbers such ISO 100, ISO 400, and ISO 800 film speeds for different applications. These are still relevant today, but are either an automatic or manual setting within many of the digital cameras on the market.
ISO 9001 and Related Standards
ISO 9001 is a general management system standard with application to just about every industry and company type. This includes both manufacturing and service organizations, small and large, for-profit and not-for-profit, etc. ISO 9001 is intended for use as a general management system standard, however, ISO also publishes or aligns with a range of other management system standards which use ISO 9001 as a foundation but are focused on specific industries such as:
- ISO 29001: Petroleum and Natural Gas
- ISO 13485: Medical Device Manufacturing
- ISO 90003: Software Development
- IATF 16949: Automotive Manufacturing
- TL 9000: Telecommunications
- AS 9100: Aerospace
The origin of ISO 9001 can be traced back to the 1950’s and the DOD standard MIL-Q-9858 along with similar standards adopted by Britain. British Standards Institution (BSI) further refined the standard with the BS 5750 series of documents in the late 1970s. ISO then first published ISO 9000 in 1987 which was followed by the 1994 revision which really began to gain traction in the business world and started the major certification revolution that we have today. Following the 1994 release, ISO continued to issue ISO 9001 revisions in 2000, 2008 and the current 2015 standard which became fully implement in September 2018.
ISO 9001 Quality Management Principles
ISO 9001 is universal in nature and can be used by any organization type or size, regardless of market or industry. This includes not-for-profits, service-oriented companies, and even a company with only one employee. The standard is grounded in the following fundamental principles (from ISO document “Quality Management Principles”):
- Customer Focus: The primary focus of quality management is to meet customer requirements and to strive to exceed customer expectations.
- Process Approach: Consistent and predictable results are achieved more effectively and efficiently when activities are understood and managed as interrelated processes that function as a coherent system.
- Engagement of People: Competent, empowered and engaged people at all levels throughout the organization are essential to enhance its capability to create and deliver value.
- Improvement: Successful organizations have an ongoing focus on improvement.
- Evidence-based Decision Making: Decisions based on the analysis and evaluation of data and information are more likely to produce desired results.
- Relationship Management: For sustained success, an organization manages its relationships with interested parties, such as suppliers.
We highly recommend that you take a little time to download and read the ISO document “Quality Management Principles” to better understand these core ISO principles, ISO benefits, and the value they can bring to your organization. The processes developed through the EBS eCoach ISO 9001 Learning System will incorporate all of these principles in the final management system structure.
Value and Benefits of ISO 9001
With approximately 1.5 million organizations in over 170 countries currently certified to ISO 9001, it’s hard to argue against the results and success of the standard. While some companies have expressed negative experiences with ISO 9001, we often attribute these experiences to poor implementation of the standard and ineffective or absent management system leadership.
The ISO 9001 benefits and the value that organizations receive from ISO 9001 can vary greatly and is dependent on numerous factors. Some of the greater benefits include:
- Increased customer satisfaction & loyalty
- Enhanced organization & product brand reputation
- Increased revenue and market share
- Increased operational performance & efficiency
- Improved profitability
- Increased employee productivity
- Improved communication (internal & external)
- Enhanced product or service innovation
- Improved supply chain performance
Implementing the right management system, the right way, for the right reasons will inevitably result in overall improvement in many facets of the organization.
ISO 9001 and Supporting Publications
Unfortunately, the ISO 9001 standard isn’t free and the revenue generated from the sale of this and other ISO standards continues to fund the improvement of these documents and development of new standards. If you intend to implement ISO 9001 within your organization, you will need to purchase the standard which is available from these sources:
In addition to the ISO 9001 standard, ISO has also published a number of supporting reference documents which provide additional information, guidance, and explanation for ISO 9001. The following documents are supplemental to and/or referenced by the ISO 9001:2015 standard but are not required for ISO 9001:2015 certification. All documents are available from the ISO website store as well other online sources. The eCoach ISO 9001 Learning and Coaching system provides a comprehensive list of reference and support documents for ISO 9001. Here are a few of the many available reference documents:
- ISO 9000:2015 – Quality Management Systems-Fundamentals and Vocabulary (purchase required)
- ISO 9004:2009 – Managing for the Sustained Success of An Organization-A Quality Management Approach (purchase required)
- ISO/TS 9002:2016 – Quality Management Systems-Guidelines for the Application of ISO 9001:2015 (purchase required)
- ISO SME Handbook – ISO 9001:2015 for Small Enterprises, What to Do? Advice from ISO/TC 176 (purchase required)
- ISO/TC 176/SC2/WG23/N156 – ISO 9001:2015 The Process Approach(free download)
- ISO/TC 176/SC2/N1284 – Risk-Based Thinking in ISO 9001:2015 (free download)
- ISO 9000 Glossary – Guidance on selected words used in the ISO 9000 family of standards(free download)
- How Change Is Addressed Within ISO 9001:2015(free download)
- ISO 9001:2015 Revision Frequently Asked Questions (FAQs)(free download)
- ISO 9001 – What Does It Mean In The Supply Chain?(free download)
Hopefully understanding the history, structure, value, and ISO 9001 benefits helps demystify the standard somewhat and provides a little comfort moving forward with implementation and certification. Future articles will continue to dissect the ISO 9001 standard and start defining a working plan for ISO 9001 implementation. Our next article will take a high-level view of the ISO 9001 standard contents and explain the requirements from an executive point of view.