Clauses 8.5 through 8.7 of ISO 9001:2015 cover the operational heart of the quality management system: controlled conditions for production and service provision, identification and traceability, customer and external provider property, preservation, post-delivery activities, control of changes, release of products and services, and control of nonconforming outputs.
8.5.1: Control of Production and Service Provision
Implement production and service provision under controlled conditions including the availability of documented information defining product/service characteristics and activities, the availability and use of suitable monitoring and measuring resources, implementation of monitoring and measurement at appropriate stages, use of suitable infrastructure and environment, appointment of competent persons, validation and revalidation of processes that cannot be verified by subsequent monitoring, and implementation of actions to prevent human error.
8.5.2: Identification and Traceability
Use suitable means to identify outputs when necessary to ensure conformity. Identify the status of outputs with respect to monitoring and measurement requirements. Control the unique identification of outputs when traceability is a requirement, and retain documented information needed to enable traceability.
8.5.3: Property of Customers or External Providers
Exercise care with property belonging to customers or external providers while it is under the organization’s control or being used. Identify, verify, protect, and safeguard this property. If any property is lost, damaged, or found unsuitable, report this to the owner and retain documented information.
8.5.4-8.5.6: Preservation, Post-Delivery, and Control of Changes
Preserve outputs during production and service delivery to the extent necessary (identification, handling, contamination control, packaging, storage, transmission, transportation, protection). Determine and meet post-delivery requirements (warranty, maintenance, recycling, disposal). Review and control changes for production or service provision to ensure continuing conformity.
8.6: Release of Products and Services
Implement planned arrangements to verify product and service requirements have been met. Release shall not proceed until planned arrangements are satisfactorily completed, unless approved by a relevant authority and by the customer. Retain documented information including evidence of conformity and traceability to authorizing persons.
8.7: Control of Nonconforming Outputs
Ensure that outputs not conforming to requirements are identified and controlled to prevent unintended use or delivery. Take appropriate action: correction, segregation, containment, return, suspension, informing the customer, or obtaining authorization for acceptance under concession.
Best Practices
- Implement process controls at critical quality points, not just final inspection
- Use traceability systems (lot numbers, serial numbers, batch codes) proportionate to risk
- Establish clear procedures for identifying, segregating, and dispositioning nonconforming product
- Validate special processes (welding, sterilization, heat treatment) that cannot be verified by inspection
- Retain release records showing what was checked, the results, and who authorized release
Common Pitfalls
- Not validating special processes where output cannot be verified after the fact
- Inadequate identification and segregation of nonconforming product
- Releasing product before all planned verification activities are complete
- Not managing changes to production processes through a controlled process
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
