Clause 7.1 of ISO 9001:2015 covers the resources needed to establish, implement, maintain, and continually improve the QMS. It addresses people, infrastructure, environment for the operation of processes, monitoring and measuring resources, and — new to the 2015 revision — organizational knowledge.
7.1.1: General — People
Determine and provide the persons necessary for effective implementation of the QMS and for the operation and control of its processes.
7.1.3: Infrastructure
Determine, provide, and maintain the infrastructure necessary for the operation of processes. This includes buildings, utilities, equipment (hardware and software), transportation, and information and communication technology.
7.1.4: Environment for the Operation of Processes
Determine, provide, and maintain the environment necessary for processes. This can include physical factors (temperature, humidity, cleanliness, lighting, noise), social factors (non-discriminatory, calm, non-confrontational), and psychological factors (stress-reducing, burnout prevention, emotionally protective).
7.1.5: Monitoring and Measuring Resources
When monitoring or measurement is used for evidence of conformity, determine and provide the resources needed to ensure valid and reliable results. Measurement equipment must be calibrated or verified at specified intervals, identified for calibration status, and safeguarded from adjustments that would invalidate results. Retain appropriate documented information as evidence of fitness for purpose.
7.1.6: Organizational Knowledge
This is an entirely new requirement in ISO 9001:2015. Determine the knowledge necessary for the operation of processes and to achieve conformity of products and services. This knowledge must be maintained and made available to the extent necessary. When addressing changing needs and trends, consider current knowledge and determine how to acquire or access any additional knowledge needed.
Best Practices
- Maintain a calibration schedule for all monitoring and measuring equipment
- Create a knowledge management plan identifying critical knowledge areas
- Document tribal knowledge before key personnel depart
- Use preventive maintenance software to track infrastructure and equipment maintenance
- Capture lessons learned from projects, incidents, and audits
Common Pitfalls
- Ignoring the organizational knowledge requirement as too vague
- Not maintaining calibration records for measuring equipment
- Failing to plan for knowledge transfer when employees leave
- Not considering the work environment’s impact on product quality
Related Ecesis Solutions
Document Management
Version-controlled procedures and records
Audits & Inspections
Schedule, conduct, and track audit findings
Nonconformity Tracking
Report, investigate, and resolve nonconformities
Training Management
Track competence requirements and records
Change Management
Structured review of planned changes
Compliance Obligations
Track requirements and evaluation schedules
