ISO 9001 Clause 7.5.1 emphasizes the importance of documented information within the quality management system (QMS). Document Information includes documents that can be changed and documents that record information, also called records, that need to be retained.
Types of Clause 7.5.1 Documented Information
The volume and types of documented information necessary for the QMS can vary among organizations due to various factors:
- Mandatory Documentation: The standard requires specific documented information to ensure compliance with ISO 9001 requirements.
- Organization-Specific Documentation: The organization is responsible for identifying and maintaining additional documented information necessary for the effectiveness of its quality management system.
- Organization Size and Type of Activities: Larger organizations or those involved in more complex activities may require more extensive documentation.
- Complexity of Processes: The intricacy and interrelated nature of the processes might demand more detailed documentation to ensure effective management.
- Staff Competence: The workforce’s skill level and expertise can influence the required documentation’s extent and complexity.
Examples of Documented Information Relevant to ISO 9001:2015’s Clause 7.5.1
- Scope of the Quality Management System: A document defining the boundaries and applicability of the Quality Management System within the organization.
- Procedures and Work Instructions: Detailed step-by-step guides on how specific tasks should be performed, ensuring consistency and quality in execution.
- Quality Policy: A document outlining the organization’s commitment to quality, endorsed by top management and communicated across the company.
- Quality Objectives: Documented objectives that are specific, measurable, achievable, relevant, and time-bound (SMART) help drive continual improvement.
- Records of Internal Audits: Documents recording the process, results, and actions taken during internal audits to verify compliance and identify areas for improvement.
- Training Records: Documentation showing employee training and competence in roles that affect quality management system performance.
- Specifications and Standards: Documents specifying requirements for products, services, or processes to ensure consistency and conformity.
- Corrective Action Reports: Records detailing non-conformities, root cause analysis, and actions taken to rectify quality-related issues.
- Records: Document retention is needed to demonstrate compliance and effective operation of the QMS. These include training records, audits, corrective actions, monitoring and measurement results, etc.
These examples illustrate the breadth of documented information necessary to support and maintain an effective quality management system while aligning with ISO 9001:2015 requirements. The documents needed might vary based on the organization’s nature, operations, and processes.
ISO 9001 2015 Required Documented Information
ISO 9001:2015 requires 25 types of documents. ISO 9001 Clause 7.5 details the requirements for documented information. The mandatory documents and clause numbers are listed below.
Documented Information that needs to be Maintained
The first four documents should change over their lifetime. Documents that change must be maintained using document controls (i.e., dates, versioning, review, and approval). These are typically referred to as “documents.”
1.      4.3 Scope.
2.      4.4 QMS processes, as needed, to support the operation of processes (i.e., process maps, procedures, SIPOC or turtle diagrams).
3.      5.2.2 Quality policy (and exclusions for requirements that do not apply).
4.      6.2.1 Quality objectives.
Documented Information that needs to be Retained
The next 21 documents should not change because they are evidence of what has happened. The only time that evidence can be changed is when it is determined that the data was recorded by mistake. This could be due to the wrong date used, data in the wrong field, an incorrect reading from a measuring device, etc. In this case, use a line to strike through the incorrect data. Then, record the correct data, initial, and date the correction.
Do not erase the old data; it is evidence of the incorrect data. Evidentiary records must be retained using document controls (i.e., preserved, protected, backed up, and easily retrievable). Although ISO has changed the term to “documented information,” they are typically called “records.”
5.   7.1.5.1 Evidence of fitness for monitoring and measurement resources (calibration).
6.   7.1.5.2 Basis used for calibration or verification, where measurement traceability is a requirement and standards don’t exist.
7.   7.2 Evidence of competence (training, skills, experience, and qualifications).
8.   8.1 Confidence that the processes have been carried out as planned and to demonstrate the conformity of products and services to requirements.
9.   8.2.3.2 Results of the review of requirements related to products and services (order acceptance).
10.  8.3.2 Confirm that design and development requirements have been met.
11.  8.3.3 Design and Development Inputs.
12.  8.3.4 Design and development controls (i.e., verification, validation, reviews, tests)
13.  8.3.5 Design and Development Process Outputs (production drawings, criteria, work instructions, setup instructions, control plans, tooling specifications, etc.).
14.  8.3.6 Design and development changes.
15.  8.4.1 Results of external provider evaluations, performance, and re-evaluations.
16.  8.5.1 Characteristics of the products and services, Activities to be performed, and the results to be achieved (i.e., production orders, travelers, and design outputs from 8.5.3)
17.  8.5.2 Unique identification of process outputs, where traceability is a requirement.
18.  8.5.3 Customer property damage notice.
19.  8.5.6 Results of the review of production changes, the personnel authorizing the change, and any necessary actions.
20.  8.6 person(s) authorizing the release of products and services for delivery (final inspections).
21.  8.7.2 Actions taken on nonconforming process outputs, products, and services, including concessions obtained and the person or authority that made the decision dealing with the nonconformity.
22.  9.1.1 Evidence of results that ensure monitoring and measurement activities are implemented per the determined requirements (inspections).
23.  9.2.2 Evidence of the audit program and audit results.
24.  9.3.3 Evidence of the results of management reviews.
25.  10.2.2 Nonconformities, subsequent actions taken, and corrective action results.
ISO 9001:2015 Clause 7.5.1 Documented Information
In essence, the clause highlights the need for a minimally documented system that meets the organization’s specific requirements while meeting the prescribed standards of ISO 9001. The goal is to maintain a system that supports effective quality management without being overly burdensome or complex.
