What are the ISO 9001 Requirements?

Originally published by Schellman.

When seeking ISO 9001 certification, part of that road to compliance will be aligning your required quality management system (QMS) with the key clauses (4-10) within the standard, each of which focuses on a specific facet of that management system—context, leadership, planning, support, operation, performance evaluation, and improvement.

Each of those clauses contains specific requirements you’ll be required to meet before your QMS can be certified, and as an experienced Certification Body with accreditation from ANAB and UKAS, we’ve worked closely with many an organization to navigate these complexities before. Now, we’re going to provide you with a starting baseline.

In this article, we’ll break down each of ISO 9001’s clauses 4-10 in detail along with some basic strategies for compliance with their requirements. Afterward, you’ll have a better idea of what will be expected of your quality management system as you get started in building it out.

What are the Key Clauses of ISO 9001?

Before we dig into clauses 4-10, we should briefly acknowledge their predecessors—clauses 1-3. Similar to other ISO standards, these are more general and provide the background information you’ll need when implementing the requirements outlined in clauses 4-10:

• Clause 1: Scope
  • Defines the boundaries and applicability of the ISO 9001 standard
• Clause 2: Normative References
  • Includes other guidance or standards that can help in your work to align with ISO 9001
• Clause 3: Terms & Definitions
  • Establishes common terminology used in the framework to facilitate consistent implementation of the standard across organization

Context of the Organization (Clause 4)

Every organization’s QMS should be tailored to its needs, but to do that first requires—as Clause 4 does—a very complete understanding of your specific context, including things like your strategic business objectives, relevant risks, and your customer expectations.

How to Get Started with Compliance:

• In defining the scope—or boundaries of your QMS—determine which of your existing processes, activities, and locations are included.
• Identify and document factors that could impact your QMS, including market trends, regulatory requirements, technological advancements, competitive pressures, organizational culture, resources, current capabilities, and performance metrics.
• Determine and document the needs of all relevant stakeholders regarding your products or services, quality standards, delivery schedules, and communication preferences.
• Develop and document a quality policy that reflects your organization's commitment to meeting those needs, complying with applicable regulations, and continually improving your products, services, and processes. (Also communicate that policy to your organization.)

Leadership (Clause 5)

Due to its holistic nature, your QMS will stretch across many facets of your organization, which means leadership must get involved and remain involved in its implementation and maintenance.

How to Get Started with Compliance:

• Top management should:
  • Contribute to the establishment of your quality policy, its communication to your wider organization, and its integration into your overall business process and strategies
  • Provide and assign adequate resources, support, and direction for the QMS by visibly championing quality initiatives, promoting a culture of continuous improvement, and actively engaging in QMS activities—including regular reviews of the QMS’s effectiveness

Planning (Clause 6)

Integrating your QMS into established processes so that it achieves what you need it to—and so that it is set up to endure and improve—will take careful planning.

How to Get Started with Compliance:

• Identify measurable quality objectives that are consistent with your organization's strategic direction and quality policy.
• Conduct a comprehensive risk assessment to identify those that may affect your ability to achieve your quality objectives and develop related mitigation strategies.
• Develop detailed procedures—including those addressing the implementation of changes to the QMS and contingency plans for any deviations—to ensure the effectiveness of QMS processes and achievement of quality objectives.
• Define roles, responsibilities, and authorities for executing planned activities and ongoing monitoring of their progress.
• Establish metrics and targets for the effectiveness of QMS activities and achievement of quality objectives.
• Maintain accurate records of all these planning activities and ensure that this documented information is accessible, up-to-date, and effectively communicated to relevant stakeholders.

Support (Clause 7)

Where ISO 9001 requires resources, they don’t just mean adequate personnel, infrastructure, technology, and financial resources to support your QMS—the framework also mandates a certain level of competence, awareness, communication, and documented information as part of that support.

How to Get Started with Compliance:

• Identify the knowledge, skills, and competencies required for personnel involved in QMS-related activities and assign/hire them—that includes providing any necessary training for your existing relevant workforce—and document the mechanisms used to verify these competencies.
• Establish and use effective communication channels within the organization to facilitate the flow of information related to the QMS, including the importance of individual contributions to the QMS, policies, procedures, instructions, and feedback.
• Develop and maintain documented information necessary for the effective planning, operation, and control of QMS processes—make sure that information is accurate, up-to-date, accessible, and properly controlled through designed procedures for such.

Operation (Clause 8)

Arguably the most critical of ISO 9001’s clauses, these requirements address quality within your design, development, and production/service provision processes through effective, efficient, and agile implementations.

How to Get Started with Compliance:

• Establish a robust design process that integrates customer inputs, risk assessments, and lessons learned from previous projects to ensure quality.
• Implement advanced manufacturing technologies such as automation, robotics, and advanced analytics that can help improve the efficiency, consistency, and quality of production processes, identify trends, and predict potential quality issues before they occur.
• Develop a robust supplier management process that includes a rigorous qualification threshold, performance monitoring, and risk management, along with contingency plans and alternative sourcing strategies should you need them. (You might consider Supplier Relationship Management (SRM) systems and blockchain-based supply chain platforms to improve transparency, traceability, and collaboration with external partners.)

Performance Evaluation (Clause 9)

In relation to Clause 10, which stresses improvement, Clause 9 requires internal audits, management review, monitoring of customer satisfaction, and regular analysis of your QMS to drive that improvement.

How to Get Started with Compliance:

• Implement a systematic approach to collecting, recording, and analyzing performance data to evaluate the effectiveness and efficiency of QMS processes, product/service conformity, and customer satisfaction, among any other relevant metrics.
• Conduct regular internal audits against ISO 9001 requirements.
• Review QMS performance data and customer feedback to evaluate the effectiveness of the QMS and identify opportunities for improvement.

Improvement (Clause 10)

Though taking a systemic approach to quality management through the establishment of a QMS is a big step, ISO 9001 requires that you remain vigilant and seek opportunities to further enhance customer satisfaction while also adapting your QMS to any changing circumstances or objectives.

How to Get Started with Compliance:

• Develop processes for identifying, documenting, and addressing nonconformities as well as those for the implementation of necessary corrective actions to prevent recurrence.
• Continuously monitor and review your QMS to identify opportunities for the improvement of its suitability, adequacy, and effectiveness.
• Establish mechanisms for capturing and implementing improvement ideas from employees and stakeholders.

Getting ISO 9001 Certified

While these compliance strategies are by no means comprehensive, they will make for a good start in addressing the requirements of each of these key clauses within ISO 9001 as you build out your QMS. If we could offer one last tip, it would be to document everything as you go through these planning and implementation motions, as not only will that be key for compliance but it’ll also help streamline your operations.