What is ISO 9001? Quality Management System (QMS) Standards

The International Organization for Standardization created ISO 9001 to provide an archetypal standard for quality management systems (QMS) worldwide. The most up-to-date version of the framework is ISO 9001:2015, which highlights the importance of risk-based thinking and decision-making to improve output and product quality.

Utilized by organizations of all sizes and across most major industries, ISO 9001 helps streamline operations and align day-to-day processes with strategic objectives. ISO 9001 also enables organizations to develop frameworks that help guarantee customer satisfaction and brand excellence.

Keep reading to discover ISO 9001’s fundamental principles, the core elements of a QMS, and how ISO 9001 benefits organizations of all sizes.

What is a Quality Management System?

Generally, a QMS is a formalized system organizations use to document the processes and procedures installed to ensure brand quality and meet customer expectations. Understanding the ins and outs of a QMS is essential to understanding the role ISO 9001 standards play.

Core Elements of a QMS

While all quality management systems will vary slightly depending upon an organization’s industry, size, status, and product reputation, most comprehensive QMSs are comprised of the following core elements:

1. Quality Policy and Objectives: A quality policy (or quality manual) is a statement of intent created by an organization that defines its commitment to quality and sets measurable quality objectives.
2. Standardized Processes and Procedures: Standardizing its processes and procedures allows an organization to ensure activities are carried out consistently and effectively and lead to predictable outcomes.
3. Document Control: All documentation, including print resources (product manuals, records, etc.) and electronic files, is scrutinized to guarantee accuracy and informational relevance when read.
4. Resource Management Principles: To ensure the delivery of quality products, most QMS include principles to manage human, infrastructure, and environmental resources that directly affect business operations.
5. Product Realization Audits: All comprehensive quality management systems will include internal audits for every step of the product realization process (from design to delivery).
6. Quality Metrics: A comprehensive QMS will include mechanisms to measure different metrics that reveal product quality (customer satisfaction, return rate, product conformity, etc.). The QMS will also likely guide the organization to implement corrective actions when product or system flaws are detected.
7. Continuous Improvement: All effective quality management systems promote a culture of continuous improvement by highlighting the need to refine processes and dial in methodologies continually over time and as the business and products it offers grow or change over time.

Benefits of a QMS

When an organization implements a QMS, it affects every aspect of its performance. Overall, comprehensive quality management systems can:

• Improve an organization's reputation,
• Increase customer satisfaction,
• Increase customer confidence,
• Increase the likelihood of repeat business,
• Improve cost-efficiency,
• Streamline compliance processes,
• Reduce waste,
• Prevent production and distribution mistakes,
• Lower costs,
• Facilitate opportunities for sustained success,
• Energize and engage staff,
• Provide organizational direction,
• Promote the importance of taking preventive actions,
• Communicate the need for continuous improvement and consistent results

Why is ISO 9001 Important?

ISO 9001 is one of five publications in the ISO 9000 Standards Series. All five of these standards focus on quality management systems. ISO 9001 is unique because ISO designed it to integrate seamlessly with other management system standards, as it utilizes ISO’s “High-Level Structure” (HLS).

Organizations implementing ISO 9001 will also witness many tangible benefits that can help them increase their bottom line and improve their reputation.

The Fundamental Principles of ISO 9001

ISO created ISO 9001 to help organizations establish policies that elevate their QMS and help them meet customer needs while improving overall performance. The seven fundamental quality management principles (QMPs) of ISO 9001 include:

• Customer focus
• Leadership
• Engagement of staff
• Process approach
• Continuous improvement
• Risk-based thinking
• Relationship management

The High-Level Structure (HLS) of ISO 9001

Introduced alongside the most recent iterations of ISO 9001, the HLS (sometimes referred to as Annex SL) revolutionized ISO’s entire suite of standards. By standardizing the structure of each of its frameworks, ISO has made it easier for organizations to pursue multi-standard certifications and facilitate integrated compliance across disciplines such as information security, business continuity, quality management, etc.

The primary features of ISO’s HLS include:

• Unified 10-Clause Structure
• Standard Text, Terms, and Definitions
• Consistent Vocabulary

Who Utilizes ISO 9001?

ISO 9001 works for all organizations, regardless of supply chain size, industry, or economic sector. According to the ISO website, over 1 million companies across 170 countries have achieved ISO 9001 certification.

Organizations within highly regulated industries such as aerospace, medical devices, government, and automotive utilize ISO 9001 to ensure they meet customer requirements and continue to deliver high-quality products. Other sectors that leverage ISO 9001 include manufacturing, construction, retail, and wholesale.

What is the Certification Process for ISO 9001?

Organizations seeking to obtain ISO 9001 certification must scrutinize each area of their QMS. The main steps to achieving ISO 9001 certification include:

• 1. Identify Gaps With a Pre-Audit: Sometimes referred to as a gap analysis, this initial step in the certification process allows an organization to review its QMS and identify problem areas that do not meet ISO 9001 standards. This step defines what the business needs to complete before pursuing a formal certification audit.
• 2. Undergo a Formal Audit: Once an organization has completed its pre-audit and addressed its ISO-related issues, it will undergo a formal certification audit with a certification body with ISO accreditations. Typically, formal certification audits include two stages: a readiness review and a certification audit. Stage one verifies that an organization’s documentation aligns with regulatory requirements, while the second stage thoroughly examines the organization’s quality management standards.
• 3. Take Corrective Action: During this step of the process, the organization should review the certifying body’s performance evaluation and address any known findings. Here, the organizations can demonstrate their commitment to maintaining the standards of ISO 9001.
• 4. Submit for Final Review: The final step in the certification process includes documenting the organization's corrective actions and submitting for final certification review. The certifying body will review all the changes made and their effectiveness. The body will approve the ISO 9001 certification if the organization has addressed all concerns.

Benefits of ISO 9001 Certification

ISO 9001 offers a host of promising benefits. Organizations that achieve certification or who possess an ISO 9001 QMS can expect to:

• Improve efficiency by taking a holistic process approach to quality control
• Streamline operations and eliminate waste by identifying data-driven process flaws
• Increase customer satisfaction by improving product consistency and brand trust
• Increase customer retention by improving the brand’s overall reputation
• Expand business opportunities by unlocking new markets that require ISO certification
• Increase their competitive edge by outpacing other businesses in the sector
• Enhance brand image by supporting interested parties and displaying certification badges

The ISO 9000 Series

In addition to ISO 9001, the ISO 9000 series includes four additional quality management standards. Standards within the ISO 9000 series include:

• ISO 9000: Fundamentals and vocabulary
• ISO 9001: Principles and requirements
• ISO 9002: Production and installation
• ISO 9003: Quality assurance
• ISO 9004: Sustained organizational success

While all standards within the ISO 9000 series focus on different elements of quality management systems, the five standards align in several ways:

• Context of the organization: Each standard requires an organization to take account of external and internal flaws that are affecting overall performance
• Interested parties: Each standard requires an organization to identify relevant stakeholders and their needs related to quality and information security
• Ongoing monitoring: Each standard requires an organization to implement processes for continuous monitoring to maintain compliance and certification
• Management review: Each standard promotes a culture reliant on internal audits and management review. The criteria of these audits will differ, but the process to carry out the audits, utilize documented information, address concerns, and improve business continuity is the same
• Non-conformity: Each standard requires organizations to correct problems and address non-conformities

Organizations looking to take a holistic approach to quality management systems can use the entire ISO 9000 series to improve their frameworks.

Is ISO 9001 Certification Mandatory?

ISO 9001 is an essential certification in many industries, but the standard is not a legal requirement. Companies that possess ISO 9001 certification demonstrate a commitment to continuous quality improvement, which will likely improve brand reputation and brand image and coincide with a host of additional benefits.

How Can UpGuard Help With ISO 9001?

UpGuard’s attack surface and vendor risk management (VRM) products can help organizations streamline their cybersecurity programs to improve quality across all business operations.

UpGuard Vendor Risk provides organizations access to automated compliance questionnaires they can send to vendors across their supply chain. Gone are the days of wasting precious resources tracking down vendor responses. UpGuard makes it easy to ensure compliance with new and existing vendors and throughout the vendor lifecycle.

The UpGuard library includes security questionnaires focused on the following: