How many businesses know that the complexity of quality control can actually be simplified? A significant number of companies globally apply ISO 9001 Quality Management System – a system which not only enhances operational efficiency but also demands specified documented information.
The essence of ISO 9001 lies in its requirement for documented information which comprises various manuals, procedures, and records. These elements allow an organization to demonstrate its commitment to quality and compliance, and to measure success. With ISO 9001, organizations can streamline their operations and foster a culture of continual improvement.
ISO 9001 necessitates the preservation of specific documented information, providing evidence of adherence to its requirements. This includes quality policy, quality objectives, scope of the quality management system, documented procedures & records required by the standard, and results of management review. Individual companies may expand the list based on operational needs.
Understanding the Documentation Requirements of ISO 9001
ISO 9001, the international standard for Quality Management Systems (QMS), prescribes certain documented information to be maintained for effective implementation and operation of QMS. Adequate preparation and management of such documented information serve as a key factor in achieving ISO 9001 certification.
Key categories of required documents
The ISO 9001:2015 standard introduces the term ‘documented information’ and replaces the terms ‘documents’ and ‘records’. The standard defines two categories of documented information: those necessary for the operation of the QMS and those required for the effectiveness of the QMS.
Broadly, the documented information required by ISO 9001 can be segregated into four categories: Policy and Objectives, Manual, Procedures, and Records. Effective record-keeping helps an organization track its performance towards quality goals, and the procedures in place help to maintain consistency in operations.
Besides these, the organization is also required to maintain additional documented information necessary for the effectiveness of the QMS. This can be workplace instructions, forms, plans, protocols, etc. These details are needed for planning, operation, and control of processes.
Familiarizing yourself with these requirements is essential in understanding ‘What Documented Information is Required by ISO 9001?’. They provide the basis for evidence demonstrating that the organization is adhering to the requirements and guidelines set forth by ISO 9001.
Specifications of Documented Information
ISO 9001:2015 mandates particular specifications for the various kinds of documented information required. This includes regulatory compliance documents, internal and external audit results, records of non-conformities and corrective actions, and reports or results from management reviews.
Frequently, the standard uses phrases such as ‘the organization shall retain documented information,’ indicating when a record must be retained. In other instances, ‘the organization shall maintain documented information,’ implying the necessity to keep a particular type of document consistently updated and accessible.
However, ISO 9001:2015 does not dictate the method, format, or medium that should be used to maintain this information. This flexibility allows organizations to choose efficient and suitable means in accordance with their operational processes and culture.
Moreover, the standard only requires an establishment to show that their QMS meets the specifications. This provides opportunities for innovation, improvement, and functionality in how organizations decide to structure their QMS.
Exploring Types of Documented Information for ISO 9001:2015
Mandatory Records and Documents
While the ISO 9001:2015 standard does away with the need for a formal quality manual and documented procedures, there are still mandatory records and documented information that organizations need to maintain. An understanding of these is integral to answer the query ‘What Documented Information is Required by ISO 9001?’
These mandatory records and documents can be broken down into seven broad categories: Scope of the QMS, Quality Policy, Quality Objectives, Criteria for Evaluation and Selection of Suppliers, Records of Training, Skills, Experience and Qualifications, Evidence of Fitness of Monitoring and Measuring Equipment, and Records of Product and Service Conformity.
As implied by the names, these various categories cover different aspects of the organization’s QMS. For instance, the quality policy is a formalized statement from management that outlines the overall intentions and direction of an organization related to its quality performance. This policy must be communicated and understood within the organization.
To further categorize, these documents can be regarded as system-level documents, process-level documents, and records. System-level documents include the QMS charter and SOP, while process-level documents comprise SOPs and work instructions required to guide the operation of processes.
Control of Documented Information
ISO 9001:2015 also specifies requirements for controlling documents that are needed for planning, operation, and control of the organization’s processes–so-called ‘documented information.’
This involves ensuring that documents are properly identified and described (e.g., a title, date, author, reference number), they are reviewed and approved for suitability and adequacy, they are available where and when they are needed, and they are adequately protected (e.g., from loss of confidentiality, improper use or loss of integrity).
The standard expects organizations to control the process for creating and updating documented information. This gives an organization the liberty to structure its documents requirement according to its operational needs and expectations, provided these are within the boundaries stated by ISO 9001:2015.
In conclusion, ISO 9001:2015 demands documented information as proof of compliance with its standards. Understanding what type of documentation is necessary, and how it should be managed and controlled, can considerably ease the process of implementing a QMS in accordance with ISO 9001.
ISO 9001 Documentation Requirements
ISO 9001:2015 standard assesses the quality management systems of organizations and has specific requirements regarding paperwork. An organization must have a quality manual, documented procedures, and work instructions to demonstrate its dedication to maintaining high quality and continuous improvement.
| Document Type | Reason |
| Quality Manual | Acts as the foundation for the quality management system. |
| Documented Procedures | Shows compliance and provides employees with guidelines. |
| Work Instructions | Evidence that standards are being followed and allows for continuous training. |
While these documents provide a framework, organizations have the freedom to weigh risk against the benefits of further documentation. Additional records, like meeting minutes or audit records, might also provide evidence of ISO 9001 compliancy.
Frequently Asked Questions
If you’re looking to get ISO 9001 certification for your business, it’s important to understand the required documented information. Let’s uncover some common questions about ISO 9001 documentation.
1. Why is documented information important for ISO 9001?
Documented information is an essential part of the ISO 9001 Standard. It provides proof that an entity has established, implemented, and maintained a quality management system. It enables a company to demonstrate its commitment and adherence to the specified standards and requirements of the system.
In addition, documented information serves as a valuable tool for continual improvement as it offers a clear record of what has been done, allowing businesses to identify areas for enhancement.
2. Can you give examples of mandatory documents in ISO 9001?
Certain documentation is mandatory for ISO 9001 compliance. Examples include but are not limited to: the Quality Policy, Quality Objectives, The Scope of the Quality Management System, and the Procedures for Control of Documents and Control of Records.
Additionally, organizations need to supply evidence of the processes implemented across their operations and their level of effectiveness. This is usually in the form of records, which also serve as a tool for identifying areas of improvement during internal audits and management reviews.
3. Are there any non-mandatory documents that might still be beneficial for ISO 9001?
While it’s true that certain documents are not explicitly required for ISO 9001, they can still prove beneficial in substantiating the efficiency and effectiveness of processes. Examples might include process flow charts, work instructions, and software that assists in managing the quality management system.
These documents ensure transparency, enhance communication between various parties, increase operational efficiency, and help assess congruence with planned results, enabling the consistent delivery of quality products or services.
4. How frequent should the documented information be reviewed or updated?
Regular reviews of documented information are vital to ensure its continuing suitability, adequacy, and effectiveness. ISO 9001 does not explicitly state a frequency for these reviews, as it largely depends on the type of business, the complexity of the procedures, and the rate of change within the organization.
However, it’s a good practice to review the documented information at least annually or whenever significant changes occur within the organization’s processes, products or services, or its external business environment.
5. What happens if an organization fails to maintain or adhere to the ISO 9001 documented information?
Non-compliance with ISO 9001 documented information requirements could lead to various negative outcomes. Not only might it prevent the organization from obtaining ISO 9001 certification, but the absence of appropriate documentation can also damage the efficiency and effectiveness of the quality management system.
In the worst case, the failure to maintain proper documentation can cause a breakdown in processes, leading to errors, customer dissatisfaction, and loss of business. Therefore, adhering to the documentation requirement is vital for operational success and customer satisfaction.
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Indeed, ISO 9001 requires a range of documented information for effective implementation of quality management system. These documents include a quality policy, quality objectives, and procedure documents, where the latter helps organizations to control, operate and maintain their processes effectively. Additionally, records act as evidence of conformance to these procedures.
While these requirements might seem daunting at first glance, they are truly the backbone of a robust quality management system. They ensure that processes are organized, traceable, and consistently improved upon. Complying with these requirements reflects an organization’s commitment to quality and continuous improvement – the very essence of ISO 9001.
