Understanding ISO 9001:2015 Documentation: What's required?

The ISO 9001:2015 Quality Management Systems Standard serves as a critical tool for any organisation committed to enhancing its operational performance and credibility.?

Understanding and interpreting the management system requirements for ISO 9001:2015 is essential for businesses aiming to implement an effective Quality Management System (QMS) for Certification. This is a challenging part of the Certification-readiness process, as developing the required documentation that both fulfils the standard requirements while also meeting the unique operational needs of the business can be quite a complex task. In this article, we'll explore the documentation requirements that ensure your processes meet the requirements of the ISO 9001:2015 standard while also meeting your business needs. You’ll learn: - What comprises a QMS? Principles and Clauses

- How to meet the ISO 9001 clauses and requirements?

- What documentation is needed?

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What comprises a QMS? Principles and Clauses

A Quality Management System (QMS) is a framework to document processes, procedures, and responsibilities for achieving quality policies and objectives. To achieve Certification to ISO 9001:2015, organisations must develop and implement a management system that meets the requirements of the ISO Standard, supported by the necessary documented information.

A well-implemented QMS helps coordinate and direct a business’s activities to meet customer and market needs, and continually improve its effectiveness and efficiency.?

The ISO 9001:2015 Quality Management System Standard presents seven core principles and 10 clauses. While the seven principles guide the overall management approach, the specific requirements for documentation and system implementation are found in Clauses 4 through 10 of the standard. In Australia, you can purchase the licensed version of the standard via the Standards Australia website.?

Expert Tip: Download the ISO 9001:2015 - Quick Check to go through the overarching standard requirements. This mini assessment will provide some insight into the current state of your Management System. Complete the checklist, send it back to [email protected], and we will plan with you the best approach for your organisation to address the missing items to get you ready for Certification!

ISO 9001:2015 is built on seven core principles that guide organisations in establishing an effective Quality Management System. These principles are:

• Customer Focus, which emphasises meeting customer needs and enhancing satisfaction;?
• Leadership, ensuring that leaders create unity of purpose and direction;?
• Engagement of People, promoting employee involvement at all levels for better performance;?
• Process Approach, which focuses on managing activities as interconnected processes;?
• Improvement, driving continual enhancement of the organisation’s systems;?
• Evidence-based Decision Making, using data and analysis for informed decisions; and?
• Relationship Management, fostering mutually beneficial relationships with suppliers and stakeholders.?

These principles are not the actual requirements for the Management System documentation, but they are the foundation for the requirements.

Read More:

To learn more about the process and steps to achieve Certification to ISO Standards, check out this article: How to Achieve ISO Certification: A Comprehensive Guide

The ISO 9001:2015 requirements outline the criteria for establishing, implementing, maintaining, and improving a Quality Management System (QMS). The standard is broken down into 10 clauses. Out of those, clauses 1 to 3 are guidelines and definitions, while the actual requirements clauses are across clauses 4 to 10.

• Clause 4 - Context of the Organisation: Organisations must understand internal and external factors that impact their goals, and identify relevant interested parties and their needs as input to establishing an effective management system.
• Clause 5 - Leadership: Top management must demonstrate leadership and commitment to the QMS, establish relevant policies, and assign roles and responsibilities for the key areas and functions.
• Clause 6 - Planning: Organisations are required to assess risks and opportunities, set quality objectives with measurable targets, and plan changes to maintain the effectiveness of the QMS.
• Clause 7 - Support: This includes providing necessary resources, ensuring competence of personnel, maintaining internal and external communications, and controlling documented information.
• Clause 8 - Operation: Organisations must plan and control processes to meet product and service requirements, manage external providers, and implement processes for handling nonconforming outputs.
• Clause 9 - Performance Evaluation: Monitoring and measuring processes, conducting internal audits, and reviewing QMS performance through management reviews are required to ensure the system's effectiveness.
• Clause 10 - Improvement: Organisations must identify and act on opportunities for improvement, address nonconformities, and take corrective actions to continually enhance the Management System.

How to meet the ISO 9001 clauses and requirements?

The clauses of the ISO 9001:2015 standard are not prescriptive, and don’t specifically tell you what to develop and implement. Rather, they are open and flexible so organisations of any industry, size, and scope can implement them.?

This flexibility allows organisations to develop a Management System to suit their organisation, operations, and processes. However, the clauses can also be difficult to interpret by those not familiar with the Standard.?

Expert Tip: Many businesses struggle with interpreting the flexible ISO clauses, leading to costly delays and failed audits. Expert consultants like us at ISO Certification Experts help tailor the Management System to meet both the ISO requirements and your business needs, ensuring a smooth certification process. Book a Free Strategy Session to ensure your QMS is on track.

What documentation is needed?

Documented information is a core component of the ISO 9001:2015 standard, referring to all information that the business is required to control and maintain. It encompasses all forms of information that the company needs to operate, the evidence of results achieved, and knowledge that must be disseminated and/or preserved.?

The documented information will include policies, procedures, forms, templates, records, and so on, which will make up your Management System. These documents need to be effectivelyproperly managed and controlled, and can be in any format or media and from any source.

Read More Check out this article to learn more about Management Systems: What is a Management System? What does it mean?

• Documentation Control

Controlled documented information in a QMS is about ensuring that all parts of the Management System are verified, approved by the relevant owners and managers, and that correct versions are utilised by the team. To do so, documents need to be properly identified, monitored, and used.??

The role of controlled documented information in a QMS is multifaceted and crucial for several reasons:?

• Consistency and Traceability: Documented information provides a concrete method for maintaining consistency across an organisation’s practices and procedures. It helps trace the steps taken in any process, from start to finish, ensuring that activities are carried out in a controlled and reproducible manner.

• Effective Communication: Documentation serves as a reliable source for communicating necessary information across the business, ensuring that all team members are aware of processes, changes, and updates.
• Proof of Implementation: Documented information acts as evidence in audits and also in investigations if something goes wrong, demonstrating that operations are in accordance with processes and meeting the Standard requirements, as well as customer, industry or other compliance requirements.
• Knowledge Sharing: Documentation is instrumental in sharing valuable knowledge within a business. This can include best practices, lessons learned, and operational insights, which are vital for training purposes and enhancing the overall quality culture.

• Types of Documentation for a Qualityan ISO 9001:2015 Management System

The ISO 9001:2015 standard requires organisations to maintain and retain various types of documents to ensure quality processes are carried out effectively. Understanding the different categories of documented information can help organisations effectively manage their Quality Management System (QMS). Here's an overview of the types of documentation typically required to meet ISO 9001:2015 requirements:

• Quality Policy and Objectives: This foundational documentation states the business’s intentions and direction regarding quality as formally expressed by top management. It includes specific quality objectives and targets that are relevant and measurable.
• Scope of the QMS: A document that defines which parts of the organisation the QMS covers, detailing any exclusion(s) from the standard requirements and the justification for such exclusion(s), ensuring clarity and transparency.
• Processes and Procedures: These workflows, commonly presented in flowcharts or step by step tutorials, outline the systematic processes and procedures for all critical aspects of the organisation’s operations. They ensure consistency and control over activities like sales, production, and service delivery, providing a clear roadmap for execution and quality assurance.
• Records and Evidence: These could include records that demonstrate that processes have been performed as planned and that products and services meet customer and regulatory requirements. Other examples are records of employees’ education certificates which demonstrate that they meet the position description qualification needs.
• Performance Data: Performance metrics, dashboards and other reports, which can include audit results, corrective action reports, and performance evaluations. These help with measuring the effectiveness of the QMS and guide continual improvement.
• External resources: Examples include documented regulatory requirements, industry requirements, standards and supplier manuals, which need to be controlled and maintained to ensure the correct information is referred to.

Proper management of these documents ensures that everyone in the organisation has access to current and relevant information, facilitating effective decision-making and allowing the QMS to function optimally.

Expert tip For effective QMS documentation, you should maintain a consistent format across all the documentation. Use standardised identification and clear language, incorporating visual aids and cross-references to clarify and connect information. Robust Quality Management System documentation fosters confidence among stakeholders and solidifies the organisation’s commitment to quality. Meticulous management of QMS documentation facilitates quick access to necessary information and enhances operational efficiency and effectiveness, driving sustainable business success.

As ISO consultant experts, we can help you achieve Certification to ISO 9001:2015 first-time by setting up your Management System not only to meet the standard requirements for Certification, but also customised to your organisation’s needs to take your business to the next level. Call us now on 1300 614 007 or book your online FREE Strategy Session to discuss your options.