A Quality Management System (QMS) is a recorded and codified set of processes and methods designed to ensure the consistently high quality of your products or services. A QMS should help you meet customer expectations and any government regulations required of your industry.

ISO 9001 is the international standard for quality management systems established by the International Organization for Standardization (ISO). ISO standards address all business issues; 9001 focuses on quality control; the ISO 9001:2015 version is the most recent update.

ISO 9001 promotes a process approach to management, examining more than 20 processes. By implementing the standard’s recommendations, an organization can ensure that it provides quality products and services.

What Is The Current ISO 9001 Standard?

The current version of the ISO 9001 standard is ISO 9001:2015, published in September 2015. This latest revision replaced the previous ISO 9001:2008 standard.

Some key updates in ISO 9001:2015 include:

  • Greater focus on risk-based thinking and risk management
  • More emphasis on achieving desired outcomes that meet customer needs, not just following procedures
  • More flexibility regarding documented information requirements
  • Streamlining of the standard’s requirements to simplify implementation of ISO 9001
  • Alignment with other newer management system standards like ISO 14001 for environmental management and ISO 13485 for medical devices

Organizations certified under the previous 2008 version were given a 3-year transition period to upgrade their quality management systems to meet the 2015 requirements.

Why ISO 9001 is Important

ISO standards are globally recognized, allowing for a consistent framework for quality management regardless of your company’s location. It also makes doing business with organizations in other countries much easier since you’re working with a standard set of suggested practices. Even if your business is strictly domestic, it’s beneficial to understand ISO 9001’s requirements and how they can apply to your business.

Following a framework for your quality management can streamline the process and eliminate confusion about expectations. A framework can also improve efficiency and encourage progress while your company grows. These continuous improvements can inspire confidence among your customers, board, and other stakeholders.

Who should use ISO 9001?

ISO 9001 can benefit organizations of any size or industry. It provides a model for building an effective Quality Management System (QMS). Adoption is voluntary unless mandated by contract, customer needs, or regulatory requirements. Typically, ISO 9001 is most relevant for organizations that:

  • Want to demonstrate commitment to quality, customer satisfaction, and continual improvement
  • Seek consistency and efficiency through standardized processes across the supply chain
  • Require certification for bidding purposes or customer demands
  • Operate globally and need QMS alignment across various sites or countries
  • Want to integrate different management system standards like ISO 14001 for optimized performance

Service industries, manufacturing, healthcare, and medical device organizations often adopt ISO 9001. Some companies may start with a limited-scope certification and then expand over time.

Is ISO 9001 a legal requirement?

Mostly, ISO 9001 certification is voluntary, not a legal requirement. However, in some cases, an industry regulator may mandate certification for participation. Some government tenders and contracts also require suppliers to be ISO 9001 certified. Certification can also help companies comply with general statutory and regulatory requirements regarding product quality and safety.

ISO 9000 vs. ISO 9001

  • ISO 9000 refers to the family of standards related to quality management established by ISO/TC 176. This includes standards for fundamentals, vocabulary, training, quality systems, management review, documentation, etc.
  • ISO 9001 is the specific standard within the ISO 9000 family focused on the requirements for a QMS. It is the only standard organization that can get certified by an accredited body.
  • The full name is ISO 9001:2015, where 2015 refers to the publication year of the current version.

The Seven Quality Management Principles

Seven Quality Management Principles (QMPs) form the backbone of ISO 9001 and other ISO quality management standards. These principles can help your organization optimize its QMS.

The principles (listed below) aren’t ranked in order. Instead, they are all equally important, and their significance may vary depending on the needs and priorities of your particular organization.

  1. Customer focus. The primary focus of quality management is customer satisfaction: meeting customer requirements and striving to exceed customer expectations.
  2. Leadership. Leaders at all levels establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.
  3. Engagement. Competent, empowered, and engaged people throughout the organization are essential to the quality management process.
  4. Process approach. Consistent and predictable results are achieved more effectively and efficiently when business processes function together as a coherent system.
  5. Improvement. Successful organizations commit themselves to continual improvement.
  6. Evidence-based decision making. Decisions based on the analysis and evaluation of information are more likely to produce desired results.
  7. Relationship management. An organization manages its relationships with interested parties, such as suppliers, for sustained success.

Should I Get ISO 9001 Certification?

The ISO 9001 standard is part of the ISO 9000 family of standards that address quality management. Among these, however, only ISO 9001 is eligible for certification.

Certification for ISO 9001 is not legally required, and the auditing and certification process can be costly depending on the size and scope of your organization. Still, many organizations choose to become ISO 9001 certified because they realize the significant benefits of ISO certification.

Achieving an attestation of ISO compliance from a certification body accredited by ISO’s Committee on Conformity Assessment (CASCO) demonstrates that your enterprise is serious about quality assurance. That enhances your reputation and can give you a competitive edge over non-certified organizations.

Certification also assures that your QMS is functioning at its full potential so your processes run efficiently and effectively. Your goods and services will meet customer requirements and statutory and regulatory requirements. Some clients will look specifically for certification when shopping for services; if you are not certified, you could miss out on new business.

What Are the Basic Requirements of ISO 9001?

Common ISO 9001 requirements that organizations must meet to achieve certification are the following:

  • Developing a quality policy and objectives approved by top management
  • Appointing management representatives responsible for the QMS
  • Maintaining documented information related to processes, procedures, and activities
  • Designing processes and procedures to meet product and service requirements
  • Ensuring adequate resources like staff training to operate processes effectively.
  • Conducting internal quality audits and management reviews
  • Addressing risks and opportunities through preventive action
  • Tracking and measuring performance through metrics and Key Performance Indicators (KPIs)
  • Managing nonconformities and taking corrective action when necessary
  • Continually improving the effectiveness and efficiency of the QMS

While simple in concept, satisfying these requirements takes considerable effort. Organizations must review all activities and processes to ensure they are aligned with ISO 9001 principles.

How Much Does It Cost to Get ISO 9001 Certification?

The costs to achieve ISO 9001 certification can vary considerably depending on the size and complexity of an organization. However, typical costs include:

  • Consultant fees to help establish or improve the QMS: $5,000-$20,000+
  • Initial certification audit by registrar: $1,000-$5,000+
  • ISO 9001 registration fees paid annually: $500-$2,000+
  • Internal audit, training, and maintaining the QMS: $3,000-$10,000+ per year
  • Surveillance audits by registrar to renew certification: $1,000-$3,000 every 6-12 months

Larger organizations or those with multiple sites face higher costs for comprehensive audits. Complex operations or industries like medical devices or automotive may also require more extensive audits. Many organizations find the investment worth the added assurance, efficiency, and competitive edge.

Steps For a Company to Get ISO 9001 Certified

Getting ISO 9001 certification requires careful planning and execution. Here are typical steps:

  1. Learn the Standard: Obtain copies of the ISO 9001 standard and conduct training to understand the requirements.
  2. Perform a Gap Analysis: Compare your current practices against the ISO 9001 requirements to identify areas that need implementation or improvement.
  3. Develop an Implementation Plan: Define the necessary activities, documents, resources, timelines, and responsibilities to develop your QMS.
  4. Create Required Documentation: Document your quality policy, objectives, procedures, processes, and other needed information per ISO 9001 requirements.
  5. Train Employees: Educate and inform all employees on the relevance and importance of ISO 9001 and how they contribute to the QMS.
  6. Conduct Internal Audits: Perform regular internal audits throughout the implementation process to gauge progress.
  7. Select a Certification Body: Research and select an accredited registrar to conduct your certification audit.
  8. Formal Certification Audit: The registrar performs an on-site audit to verify your QMS meets all requirements for certification.
  9. Obtain Certification: Once certified, you can promote and advertise your ISO 9001 certification to customers and stakeholders.
  10. Conduct Ongoing Surveillance Audits: Registrars perform periodic audits (usually annually) to ensure you maintain compliance.

ZenGRC Helps Organizations Maintain Compliance and Certifications

Compliance audits for ISO (or any other regulatory framework) can be confusing and labor-intensive. Understanding what is required of you, performing internal audits, and documenting your efforts can all seem daunting — but helpful resources are available.

ZenGRC is a fully integrated platform that allows you to monitor the entire life cycle of your compliance and risk management program. With ZenGRC, you can track outstanding requirements, centralize your documentation, and determine your prioritized tasks to achieve and maintain compliance.

Schedule a demo today and learn how ZenGRC can help you build your company’s compliance program.