What is ISO?
ISO (International Organization of Standardization) is an independent, non-governmental, international organization, based in Geneva Switzerland, which develops standards to ensure the quality, safety, and efficiency of products, services, and systems. These international standards help maintain consistency and quality across industries and nations.
ISO standards exist in many areas of industry, from environmental management (ISO 14001) and social responsibility (ISO 26000) to medical devices (ISO 13485), food safety (ISO 22000), and data security (ISO 27001). ISO standards are in place to ensure consistency. Each certification has separate standards and criteria and is classified numerically. For example, if an organization is “ISO 9001 Certified”, this means that a third party registrar has audited and certified that it meets all the requirements of the ISO 9001 standard.
What is ISO 9001?
Quality is something every company strives for and is often times very difficult to achieve. Complications concerning efficiency and quality present themselves every day in business, whether an important document cannot be found or a customer finds a product not up to their expectations. ISO 9001 was developed to give companies a roadmap for building a quality management system that increases productivity, reduces unnecessary costs, and ensures quality of processes and products.
As standards go, ISO 9001 is one of the most widely recognized in the world. It is a quality management standard that presents guidelines and requirements intended to increase business efficiency and customer satisfaction. It sets the framework for a quality management system and is the cornerstone for many industry-specific standards such as the ISO 13485 Medical Device standard, AS9100 Aerospace standard, and IATF 16949 Automotive standard. Being ISO certified reassures customers and other interested parties of your commitment to quality.
It is important to stress that ISO 9001 is not a rigid set of requirements, and that organizations have flexibility in how they implement their quality business management system. This freedom allows the ISO 9001 standard to be used in a wide range of organizations, and in businesses large and small.
What is the Annex SL?
The introduction of the Annex SL in the latest ISO 9001:2015 version, further increases the flexibility and scope of effectiveness of ISO 9001. The Annex SL is a management system format that helps streamline the creation of new standards, and makes implementing multiple standards within one organization easier. Before Annex SL even though many standards have common elements, they were described and organized differently, making it difficult for organizations to implement multiple standards. Now companies can start with ISO 9001, and then layer additional industry standards onto their existing management system as they decide to enter new markets.
What are the ISO 9001:2015 principles?
ISO 9001:2015 is based on seven principles that can be used as a framework to guide organizations, large or small, towards improved performance:
Customer Focus. Customer satisfaction as well as understanding and meeting customer requirements is crucial to success as a business. With knowledge of customer needs, resources can be allocated appropriately and efficiently. Dedication to understanding and delivering on customer requirements while hearing and acting on their complaints, creates customer loyalty and customer loyalty, of course, translates into increased business.
Leadership. A team of good leaders will establish unity and direction quickly in a business environment. They develop the vision and strategic direction of the company and create conditions in which people are motivated and empowered to achieve the company’s unified objectives.
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. Involvement of substance will lead to a personal investment in a project and in turn create motivated, committed workers. These people will tend towards innovation and creativity, and utilize their full abilities to complete a project. This ensures they are dedicated to making the improvements necessary to get the highest quality out of your processes.
Process Approach. This means identifying, understanding and managing a company’s interrelated processes as a coherent business system. This allows consistent and predictable results to be achieved more effectively and efficiently. This process approach can lower costs through the effective use of resources, personnel, and time. Cross-functional barriers are reduced (no more working in silos) and managers understand their roles and responsibilities for working toward common objectives. If a process is controlled as a whole, management can focus on goals that are important to the big picture, and prioritize objectives to maximize effectiveness.
Improvement. One of the cornerstones of iso 9001 is continual Improvement. Continual Improvement is essential to reaching the highest levels of quality and increasing efficiency throughout your organization. A company should not be satisfied with the conditions of a process at any given moment. Instead, empower employees to suggest improvements. Ask them to focus on problem solving through root cause analysis, by identifying risks and opportunities, implementing corrective and preventive actions, and looking for ways to make processes more efficient and effective. ISO 9001 was written with the business world's insatiable desire for excellence in mind, it inspires progress and a culture of continual improvement.
Evidence-Based Decision Making. ISO 9001 allows you to measure your success based on real data that is accessible, accurate and reliable. Effective decisions are based on the analysis and interpretation of information and data that is now easier to observe because you are following a standardized process. This makes data stand out and makes improvements easier to identify. As companies make this a habit, they will be able to demonstrate the effectiveness of past decisions, and become more confident in current and future decisions.
Sustained success is more likely to be achieved when a company manages relationships with all of its suppliers and partners to optimize their impact on performance. A supplier that recognizes mutually beneficial relations will be quick to react when customer needs or markets change. Work collaboratively with your suppliers on improvement and development efforts. Regardless of where you are in the supply chain, utilizing ISO 9001 allows you to communicate with a common language and a common set of quality management processes. This increases the bond and the communication connections between suppliers at all levels of your operation.
Why Obtain ISO Certification?
ISO 9001 is seen in every sector of the business world, and its success is a testament to its worth. It is a flexible standard and organizations can fulfill its requirements any way they choose. This increases ISO 9001’s scope of effectiveness, allowing a wide range of companies, large and small, to create quality management systems that match their needs. ISO Certification can help your company:
Demonstrate your commitment to quality
Meet customer requirements
Get more revenue and business from new and existing customers
Increase customer satisfaction
Increase efficiency, reduce waste and save money
Improve consistency of your operations
Develop a quality focused culture and empower your employees
Develop professional culture and better employee moral – empower employees
“Steve and Deborah have been tremendous to work with. They are very knowledgeable and had us set up to succeed from the start. Because of their advice and direction, ISO has become a great tool within our organization, rather than a burden. We were well prepared and able to pass our audits with ease. Thank you AIM” Taurus Fabrication, Grass Valley, CA
“AIM professionalism made a significant difference in our ISO certification process” GC Machining, Stockton, CA
“Just wanted to take a minute to acknowledge that Steve did great work. He was perceived very positively by the organization and the feedback I received so far from managers/ process owners is that he was extremely helpful in helping them understand the requirements and their roles in the light of the upcoming audit.
I am very pleased and satisfied with the support/ advice and consultation we received from him.
Thanks to both of you for handling this project in an informal yet effective manner, and I also greatly appreciate the flexibility you showed given the strict time constraints. " TSI Semiconductors, Sacramento, CA