ISO 9001:2015's Clause 4.4.2 touches on the requirements for quality management system (QMS) processes, and part of this involves documented information. Documented information is crucial for the effective implementation, maintenance, and continuous improvement of these processes. While Clause 4.4.2 itself focuses on the processes within the QMS, the requirements for documented information to support these processes are embedded within the broader context of ISO 9001, particularly intersecting with Clauses 7.5 (Documented Information) and the specific requirements mentioned throughout the standard for maintaining and retaining documented information.
Here's an overview of the documented information requirements as they pertain to the processes described in Clause 4.4.2:
1. Documenting the Processes
The organization needs to maintain documented information to the extent necessary to support the operation of its processes. This includes:
- Process Descriptions: Documentation that outlines what each process does, its significance to the QMS, and how it fits within the overall process architecture of the organization.
- Responsibilities and Authorities: Clear documentation of who is responsible and accountable for each process, including how these responsibilities and authorities are defined and communicated within the organization.
2. Criteria and Methods
Organizations are required to maintain documented information necessary to ensure that processes are carried out as planned. This includes:
- Process Criteria: Documentation of the performance criteria for each process. This could be in the form of process specifications, quality objectives, or other metrics that the process must meet.
- Methods and Instructions: Documented procedures, work instructions, or guidelines on how processes should be performed to meet the set criteria.
3. Resources
Documented information regarding the resources needed for each process. This can include:
- Human Resources: Competence requirements, qualifications, training records, or other documentation supporting personnel competencies.
- Infrastructure and Environment: Documentation on the infrastructure and working environment needed for the processes to operate effectively.
4. Monitoring and Measuring
The organization must maintain documented information necessary to monitor, measure, analyze, and evaluate the performance of processes. This involves:
- Monitoring and Measurement Data: Records of monitoring and measurement results, including how data is collected, analyzed, and used for improvement.
- Analysis and Evaluation: Documentation of the analysis and evaluation of process performance and conformity to product and service requirements.
5. Control of Documented Information
Clause 7.5 details how documented information should be controlled. This includes ensuring its suitability, adequacy, and effectiveness, as well as protecting the information from loss of confidentiality, improper use, or loss of integrity. This encompasses:
- Document Creation and Update: Ensuring documented information is properly reviewed and approved before release.
- Document Distribution, Access, Retrieval, and Use: Ensuring documented information is available to those who need it and is protected as necessary.
- Retention and Disposition: Keeping records of process performance and quality management activities as evidence of conformity with requirements, and defining how long these records should be retained.
While Clause 4.4.2 itself might not list these documented information requirements in detail, understanding the context of ISO 9001:2015 makes it clear that documented information is a foundational element in establishing, implementing, maintaining, and continually improving the QMS processes. It supports traceability, accountability, and the ability to review and improve processes over time.