Tags Posts tagged with "Do I need ISO 9001"

Do I need ISO 9001

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ISO Benefits Your Business - ISOUpdate.com

Standards, certification, testing and inspection help businesses to reduce costs, increase productivity and access new markets. ISO 9001 certification aims towards continual improvement based on a system of constant feedback and action, which works with your company’s goals and missions to help you achieve company objectives and targets. But, how does ISO 9001 certification benefit your business goals?

Improve Company Performance through Improved Operational and Product Quality and Consistency

Consistency refers to decreased variation in operations and, subsequently, your product. Deviations from desired results should result in upper management not just questioning what went wrong, but how their process allowed for the mistake to be made. With a properly implemented management system, steps and controls are in place to prevent such occurrences. When implemented correctly, your management system should allow for seamless production and effective practices that reduce downtime, confusion, and non-conforming products from reaching the customer.

Consider your quality management processes the well-built foundation that your business is built on and grows upon. Controls are built upon objectives, data metrics, and procedure flexibility, the interaction of all these variables should contribute to a well-established Quality Management System, which should, in turn, improve the quality and consistency of the product.

Interested in learning about real-world applications and successes of ISO Certifications? Read these Case Studies on Improving Company Performance through ISO Standards

Expanding Market Opportunities and Customer Base through Improved Overall Quality of Products and Services

Your organization is constantly striving to improve your processes, adapting and accommodating to a forever changing global landscape and increase in international competition. Implementation of ISO 9001 provides your organization with a guideline for success, and measures to report against to prove your growth. Using a process approach to business, ISO 9001 enables your organization to focus on quality and consistency in your outputs while decreasing waste and increasing efficiency. The reduction, or elimination, of variation and improved consistency results in more efficient procedures that are less wasteful than their previous counterparts. In a case study from Shogyo International, the company leveraged the management system and ISO 9001 to qualify for projects they previously were not able to and to eliminate tedious practices like lengthy questionnaires. They also gained understanding, specifically with regards to nonconformities – when a customer requests corrective action, they now understand what process to follow. ISO 9001 also allowed Shogyo to gain better control of their vendor’s nonconformities, which in turn allowed them to track and monitor trends.

Shogyo International predicted that this increase in market potential and decrease in inefficient practices would result in over $200k in increased sales volume. “Given the reduction in their employees spending less time filling out long questionnaires during bids, they are already saving about $6,000 per year, enabling the business to recover their investment in ISO 9001 certification in less than 2 years.” Source

Interested in learning more about real-world applications and successes of ISO Certifications? Read these Case Studies on Expanding Market Opportunities through ISO Standards

Better Understand Production Procedure

ISO 9001 requires your organization to provide detailed and effective documentation of processes as well as identification of affecting external factors and appropriate courses of action or metrics. With increased attention to procedures, best practices, and improvement, organizations using ISO 9001 see dramatic increases in the understanding and effectiveness of their processes, and how to better them.

Utilizing ISO 55001, one organization improved its risk management and reliability, with work delivered more efficiently towards higher ‘risk to operations’ activities, reducing reactive work by nearly 40%. The organization saw more focus delivered to continuous improvement activities, enabling even more benefits to be realized and saw a 41% reliability improvement over 36 months with their certification. –Source


“Conformity assessment has a range of strands, all of which contribute to giving people confidence and assurance in using and buying products and services. These strands include testing, inspection, certification and accreditation. – Source

They can help to:

  • Build customer confidence that your products are safe and reliable;
  • Meet regulation requirements, at a lower cost;
  • Reduce costs across all aspects of your business; and
  • Gain market access across the world.

If you are interested in learning about how ISO 9001 can help your organization, speak to a local industry professional today:

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What is ISO 9001? - ISOUpdate.com

What is ISO?

ISO, or the International Organization for Standardization, is a non-governmental international organization that develops, through consensus, voluntary, market-relevant international standards with the aim of supporting innovative thinking and practices and providing solutions to global challenges. Through international standards, ISO provides specifications for products, services and systems to ensure quality, safety and efficiency, and are instrumental in facilitating international trade.

In short, ISO sets a standard for how companies produce their product or service and manage their organization to ensure that what you expect from an organization is what you receive. Download the information PDF from ISO here to learn more about the history of ISO. 

Creating and implementing a Management System (MS) first requires choosing a standard, or set of requirements, to structure your system upon. Consider this the solid foundation that your MS is built on.

These standards are the key to creating an MS that properly delivers its promise to establish and improve upon efficiency and excellence. One such standard is ISO 9001, the internationally accepted standard for Quality Management Systems.

What is a Quality Management System?

Organizational operations are typically dictated by ideas centered on their customers. This includes customer satisfaction and customer service, as well as the need for offering products or services that meet certain standards and requirements that customers expect.

A Quality Management System, or QMS, is a compilation of diverse business processes that aims to fulfil customer requirements and deliver customer satisfaction. The QMS is a formal list of procedures, policies, responsibilities and organizational goals to ensure the organization is efficient and effective. The QMS aids a company’s aspirations towards improving efficiency and lowering costs, streamlining processes, creating organization-wide direction for employees and reducing wasted time, money and manpower.

A properly implemented QMS will help your company meet organizational requirements and achieve your vision, as well as satisfy your customers by fulfilling their expectations.

Who Needs ISO 9001?

The nature of ISO 9001 is to provide guidelines for quality management systems that aren’t specific to any single industry or category of work. Because of this, ISO 9001 can be used by any organization, in any industry.

ISO 9001 is currently used by over 1.5 million organizations in 191 countries, and the nature of ISO 9001 means it is inclusive to all sizes of organizations. Whether your organization has 2 workers or 2 million, ISO 9001 will improve your business through a process approach and increased efficiencies.

It is important to note that ISO 9001 is not a product standard. It does not define product quality.  This is a process-based standard: you use it to control your processes so that your end product will meet your desired outcomes. https://the9000store.com/what-are-iso-9000-standards/what-is-iso-9001/

Understanding the diverse nature involving risks and the specific requirements of certain industries, ISO 9001 has a small group of sector-specific applications for the standard, including:

ISO 13485Medical Devices

ISO 17582Electoral organizations at all levels of government

ISO 18091Local government

ISO/TS 22163Business management system requirements for rail organizations

ISO/TS 29001Petroleum, petrochemical and natural gas industries

ISO/IEC 90003Software Engineering

Your organization should consider achieving ISO 9001 certification if your organization wants to:

  • gain international credibility;
  • work with international suppliers;
  • improve the consistency of operations;
  • improve the company or product quality;
  • increase customer satisfaction and trust;
  • focus management and employees;
  • reduce waste and save money

How Can my Organization become ISO 9001 certified?

ISO does not directly provide certification for any standards. But, if it is not possible for an organization to be certified by ISO, who awards the certifications?

Organizations must use third-party Management Systems Certification Bodies to achieve certification for an ISO standard.

Certification Bodies Role in Certification to ISO 9001

The Committee on Conformity Assessment (CASCO) is the ISO committee that works on issues relating to conformity assessment. CASCO develops policy and publishes standards related to conformity assessment, it does not perform conformity assessment activities. Countries have governing bodies that provide accreditation to Certification Bodies. An accredited Certification Body (CB) has achieved accreditation from an Accreditation Body.

Finding an accredited Certification Body for standards like ISO 9001 can be done either by contacting the National Accreditation Body in your region or by visiting the International Accreditation Forum (IAF) https://www.iaf.nu/.

If your Certification Body is not accredited to ISO 17021 by an IAF Member Accreditation Body, your ISO 9001 certification will not be internationally recognized.

These factors must be taken into consideration before settling on an organization of your choosing for the certification of your company. When you are looking into organizations who are certified to ISO 9001, or at Certification Bodies to issue your ISO 9001 certificate, do your due diligence and ask if they are accredited to ISO 17021 and a member of the IAF. Most accredited Certification Bodies will advertise their accreditation on their website, so look out for the IAF logo.

What are the Requirements for ISO 9001 Certification?

Before your organization can begin the steps towards certification, your QMS must be in place and functioning. It is at this stage that you could consider bringing in an ISO consultant to assess your organization and provide industry experience and expertise for implementing your system.

Once your system is in place, and effective, an auditor from your selected Certification Body will perform a Stage 1 audit to determine your readiness for a Stage 2 Certification Audit. During your Stage 1 Audit, your Certification Body will review your management system’s documented information, evaluate site-specific conditions and have a discussion with employees. The auditor will determine if objectives, KPI’s or significant aspects are in place and understood. They will review the scope of the QMS and obtain information on your processes and operations, equipment in use, levels of control established, as well as applicable statutory or regulatory requirements. Internal audits and management reviews will be evaluated to ensure they are being planned and performed and the overall level of implementation of the management system will be assessed to determine if you are ready to move forward with the Stage 2 Certification Audit.

The Stage 2 Audit evaluates the implementation and effectiveness of the organization’s management system. During this audit, the Certification Body will determine the degree of compliance with the standard’s requirements and report any non-conformances that the organization will have to correct before the certificate of registration can be issued. If the Stage 2 audit is successful, the organization’s management system will be certified. http://isoupdate.com/resources/exploring-stage-1-and-stage-2-audits/

How Much Does ISO 9001 Certification Cost?

Because ISO 9001 certification is issued by an external Certification Body, the exact cost associated with the certification does vary. Accredited Certification Bodies must follow strict requirements for quoting certification activities. These costs are based on an organization’s employee count, the level of risk associated with the product/service being provided under the management system, and how many locations are being certified.

There are two types of costs associated with the certification: implementation and certification.

Implementation of a QMS that conforms ISO 9001 may be quite costly depending on your current practices, the nature of your business, your process design and employee awareness.


The general opinion of standards and certification is that the benefits outweigh any and all costs involved with audits and implementation. As a guide, a recent study undertaken through the American Society for Quality (ASQ) showed that for every $1 spent on your QMS, you could expect to see an additional $6 in revenue, a $16 reduction in costs, and a $3 increase in profits. On average, they saw that quality management reduced costs by 4.8%

Learn more about the ROI of Quality