What is ISO 9001 and Why is it Important?

What Is ISO 9001?

ISO 9001 is the most well-known international standard for Quality Management Systems (QMS), published by the International Organization for Standardization (ISO). It is part of the ISO 9000 family of quality management standards, with the current version being ISO 9001:2015, released in 2015.

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

ISO 9001 specifically focuses on quality management system standards for enterprise-wide quality assurance. It defines requirements for creating a robust quality management system that is a uniform, well-organized, process-driven approach to governing quality and control objectives to ensure continual improvement.

The standard addresses more than just adhering to product specifications—it focuses on meeting customer needs and overall customer satisfaction. ISO 9001 encourages a process-oriented management strategy by reviewing more than 20 processes. By following the suggestions of the standard, a company can ensure that it offers high-quality products and services.

What Is The Current ISO 9001 Standard?

The current version is ISO 9001:2015, published in September 2015, which replaced the previous ISO 9001:2008 standard. Key updates in the 2015 version 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
Alignment with other newer management system standards like ISO 14001 (environmental management) and ISO 13485 (medical devices)

ISO 9000 vs. ISO 9001

It’s important to understand the distinction between these related standards:

ISO 9000 refers to the entire 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 in the ISO 9000 family that organizations can get certified by an accredited body.

The Seven Quality Management Principles of ISO 9001

At the center of ISO 9001 are seven fundamental quality management principles (QMPs) that form the backbone of the standard. These principles are not ranked in order of importance—they are all equally important, though 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. ISO 9001 evaluates an organization’s objectives and initiatives to meet customer requirements and exceed customer expectations. This principle applies to product performance as well as customer service. Customer complaints must be systematically logged and corrective action taken.

2. Leadership

Organizations succeed when their leaders establish and maintain work environments that engage people across the company to achieve quality objectives. Leaders at all levels must establish unity of purpose and direction and create conditions in which people are engaged in achieving the organization’s quality objectives.

3. Engagement of People

Competent, empowered, and engaged people throughout the organization are essential to the quality management process. This principle allows employees to be more empowered, competent, dependable, and better able to help you achieve your quality objectives and meet customer needs.

Engaging your employees also means you should respect them as individuals. Recognize their achievements, help them with personal and professional development, and constantly communicate with them. The way for your company to succeed is to retain competent employees by engaging with them.

4. 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. An organization will operate more efficiently when leaders manage and control the business processes, linking them together to form a single system.

Adopting this process approach of inputs and outputs will help your company achieve more predictable and consistent results. It will also help people focus their efforts on crucial improvement processes.

5. Improvement

Successful organizations have an ongoing focus on improvement. Continual improvement is an ongoing effort to identify new opportunities and enhance your company’s products, services, and processes. It involves constant evaluation of customer needs and process improvement activities.

In response to quality gaps, identifying the root cause and implementing sustainable corrective actions are crucial to quality assurance.

6. Evidence-based Decision Making

Decisions based on the analysis and evaluation of information are more likely to produce desired results. Competent staff members should analyze and evaluate all available data and information using the appropriate tools and methods during the decision-making process.

All this data, however, should be accurate, reliable, and secure because objective facts and proper data analysis drive the best business decisions.

7. Relationship Management

For sustained success, an organization manages its relationships with interested parties, such as suppliers. Successful companies establish relationships with relevant partners, including business associates, vendors, investors, and resellers, to ensure the continuity of the supply chain.

What Are the Requirements of ISO 9001?

To achieve and maintain an ISO 9001 certification, businesses must meet requirements based on the critical areas of the quality management system. These requirements are organized into seven key clauses:

1. Context of the Organization (Clause 4)

This clause specifies the goal and strategic direction of your company’s quality management system. It addresses:

Identifying the internal and external factors influencing your quality
Identifying your company’s stakeholders (employees, suppliers, etc.)
Recognizing your consumers’ preferences and needs

2. Leadership (Clause 5)

ISO 9001 recognizes that a successful quality management system depends on your organization’s top management’s commitment. This clause requires your management team to:

Develop a quality management system
Create quality guidelines and goals
Communicate these guidelines and goals to personnel accountable for product/service quality
Perform periodic evaluations

3. Planning (Clause 6)

A successful quality management system uses a risk-based approach and implements strategies to handle risks and opportunities. Organizations must:

Record possible threats, noting their severity and likelihood of occurrence
Make plans to avoid or mitigate unfavorable consequences
Integrate strategies to improve desired outcomes

4. Support (Clause 7)

This clause demands that your organization offers appropriate resources to execute an effective quality management system, including:

Efficient working environments
Strong infrastructure
Effective human resources management

5. Operation (Clause 8)

The operation section defines your organization’s work to produce and supply products and services to your clients. Your procedures should outline:

The specifications and quality goals of your goods or services
The procedure manuals, papers, and tools your staff require
Monitoring, inspection, or testing required to verify quality
The guidelines governing the production and preservation of your records

6. Performance Evaluation (Clause 9)

This clause mandates your company to measure and analyze its operations, then document the results to:

Show that it meets the standards of ISO 9001
Check if it is using all components of its quality management system
Encourage continuous improvement in quality management

7. Improvement (Clause 10)

The standard’s final clause emphasizes continual improvement inside a corporation. Measures should be implemented to:

Improve services and goods for the company’s benefit
Improve client satisfaction by better matching consumer demands
Identify situations when processes fail to meet their objectives and adjust them accordingly

Common ISO 9001 Basic Requirements

Beyond the seven clauses, organizations must meet these common requirements to achieve certification:

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

Who Should Use ISO 9001?

ISO 9001 can benefit organizations of any size or industry. It’s typically 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 for optimized performance

The standard is commonly adopted by:

Software as a Service (SaaS) businesses
Manufacturing companies
Healthcare organizations
Service companies
Data centers
IT managed services providers
Financial services companies
Payment processors
HR and payroll processors
E-commerce platforms
CRM platforms
Customer service providers

Is ISO 9001 a Legal Requirement?

In most cases, ISO 9001 certification is voluntary, not a legal requirement. However, there are exceptions:

In some cases, an industry regulator may mandate certification for participation
Some government tenders and contracts require suppliers to be ISO 9001 certified
Certification can help companies comply with general statutory and regulatory requirements regarding product quality and safety

Benefits of ISO 9001 Certification

The benefits of implementing ISO 9001 and achieving certification include:

Customer satisfaction: Meeting customer requirements and exceeding expectations enhances customer loyalty
Organizational oversight: Better governance and management of systems and data
Improved vendor management: Enhanced ability to select and monitor service providers
Stronger risk management: More robust processes for identifying and mitigating risks
Regulatory alignment: Better positioning to meet other regulatory requirements
Competitive advantage: Differentiation in the marketplace
Enhanced customer trust: Proof of properly secured client data
Operational improvements: Insights for more efficient and secure operations
Stronger financial stability: Documentation, evaluation, and improvement of internal controls
Market share and new opportunities: Faster response to opportunities, expanded market share, and regulatory compliance
Engagement of people: Building a more competent and motivated workforce

Should I Get ISO 9001 Certification?

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

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. This 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 specifically look for certification when shopping for services; if you are not certified, you could miss out on new business.

Steps For a Company to Get ISO 9001 Certified

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

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

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.

Why Is ISO 9001 Important?

ISO standards are recognized worldwide. Doing business globally is much easier when dealing with a standard set of established practices and expectations. Even if your company is entirely domestic, understanding ISO 9001 regulations and how they might apply to your company is valuable.

A quality management framework helps you increase market share, implement quality fundamentals, and drive improvement activities. It’s a valuable roadmap to becoming a world-class organization. The internal and external audits required for maintaining ISO 9001 certification hold your organization accountable for its quality management principles.

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.

Streamlining ISO 9001 Compliance with Management Software

Compliance audits for ISO (or any other regulatory framework) can be confusing and labor-intensive. Understanding requirements, performing internal audits, and documenting your efforts can all seem daunting.

Instead of using spreadsheets, consider adopting compliance management software like RiskOptics ROAR or ZenGRC to streamline activities for all your compliance frameworks. These tools offer:

Cross-mapping standard requirements across multiple compliance frameworks
A single source of truth to ensure your organization is prepared for audits
Revision-controlled policies and procedures in a document repository
Workflow management features with easy tracking, automated reminders, and audit trails
Insightful reporting and dashboards providing visibility to gaps and high-risk areas
Monitoring for the entire life cycle of your compliance and risk management program

Conclusion

Implementing ISO 9001 is a challenging but rewarding task that can transform how your organization approaches quality management. By understanding the standard’s principles and requirements and following a structured approach to implementation and certification, you can enhance customer satisfaction, improve operational efficiency, and gain a competitive edge in your industry.

Whether you’re just beginning to explore ISO 9001 or are well along in your certification journey, the commitment to quality management principles will yield significant benefits for your organization, your customers, and your stakeholders.

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