IATF 16949 Quality Management System Operations
- Plan, implement and control processes need to meet requirements for products and services
- Ensure requirements for products and services are defined and claims for products and services offered are met
- Establish, implement and maintain an appropriate design and development process
- Ensure externally provided processes, products and services conform to requirements
- Production and service provision must be under controlled conditions (identification, verification and validation)
- Products and services are not to be released until planned arrangements are completed
- Nonconforming outputs are to be identified and controlled
Section 8 Operation
Section 8.1: Operational planning and control
ISO 9001:2015 requires that quality planning is used in ongoing organizational management. IATF 16949 provides supplemental requirements to meet the automotive QMS.
This section on operational management is one of the longest of ISO 9001 in the standard and requires:
- Documentation of requirements for all products or services
- An equally specific benchmark for measuring all operational processes and resulting product/service suitability or “acceptance”
- An assessment of required resources to achieve the above
- Meeting product/service prerequisites through all actions
- Verification of resulting product/service consistency
- The result of any quality management process be applicable to all organization’s actions.
Additionally, IATF 16949 has additional operational planning and control requirements. When planning for production realization, organizations must include:
- customer product requirements and technical specifications
- logistics requirements;
- manufacturing feasibility
- project planning
- acceptance criteria
Section 8.2: Requirements for Products and Services
IATF 16949 expands greatly upon, ISO 9001 requirements which expand on the need for specification of product/service needs.
Additional to ISO 9001 requirements for products and services IATF 16949 has introduced many supplemental information including:
- 8.2.1.1 Customer Communication
- 8.2.2.1 Determining the requirements for products and services
- 8.2.3.1.1 Review of the requirements for products and services
- 8.2.3.1.2 Customer-designated special characteristics
- 8.2.3.1.3 Organization manufacturing feasibility
Section 8.3: Design and Development of Products and Services
If your organization is designing and developing its own products and services, then this process is likely going to be the most complex. Section 8.3, is one of the longest for both ISO 9001 and IATF 16949 supplementary sub-clauses. Therefore, it is highly recommend to document this process in a procedure to close any gaps that may put your certification at risk. In this section we are going to focus on the subclauses specifically for IATF 16949 including:
- 8.3.1.1 Design and Development of products and services
- 8.3.2.1 Design and Development Planning
- 8.3.2.2 Product Design Skills
- 8.3.2.3 Development of products with embedded software
- 8.3.3.1 Product Design Input
- 8.3.3.2 Manufacturing Process Design Input
- 8.3.3.3 Special Characterictics
- 8.3.4.1 Monitoring
- 8.3.4.2 Design and development Validation
- 8.3.4.3 Prototype programme
- 8.3.4.4 Product Approval Process
- 8.3.5.1 Design and Development Outputs
- 8.3.5.2 Manufacturing Process Design Output
- 8.3.6.1 Design and Development Changes
Section 8.4: Control of Externally-Provided Processes, Products and Services
ISO 9001 and IATF 16949 requires that organizations have the same oversight for products, services and any supporting methodologies that are acquired outside of the organization, this includes:
- Externally purchased products/services must come under QMS control:
- When they are incorporated (in part or in full) into the organization’s own products/services
- When they are delivered directly to the organization’s customers
- There must be a process, determined by the organization, for assessing, choosing, reviewing, improving and replacing these external suppliers against stated expectations.
- These review/adjustment processes must also be documented properly
The supplementary requirements for IATF 16949 certification state that organizations must include all products and services that affect customer requirements this includes: subassembly, sequencing, sorting reworking and calibration services in the scope of their definition. In addition to ISO 9001 sub-clauses for Section 8.4 IATF expands with these additional clauses:
- 8.4.1.2 Supplier selection process
- 8.4.1.3 Customer- directed sources
- 8.4.2.1 Type and extent of control
- 8.4.2.2 Statuory and regulatory requirements
- 8.4.2.3 Supplier Quality management system development
- 8.4.2.3.1 Automotive product-related software or automotive products with embedded software
- 8.4.2.4 Supplier monitoring
- 8.4.2.4.1 Second-Party audits
- 8.4.3.1 Information for external providers
Section 8.5: Production and Service Provision
Section 8.5 addresses the requirement of management and accountability in how a service and/or product is produced. This requirement emphasizes on key performance criteria determination and tracking, this standard requires a method for determining, tracking, tracing and controlling key performance criteria associated with service/product provision.
In addition to ISO 9001 requirements, IATF has many supplementary requirements to meet certification including:
- 8.5.1.1 Control Plan
- 8.5.1.2 Standardized work- operator instructions and visual standards
- 8.5.1.3 Verification of job set-ups
- 8.5.1.4 Verification after shutdown
- 8.5.1.5 Total productive maintenance
- 8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment
- 8.5.1.7 Production Scheduling
- 8.5.2.1 Identification and traceability
- 8.5.4.1 Preservation
- 8.5.5.1 Feedback of information from service
- 8.5.5.2 Service agreement with customer
- 8.5.6.1 Control of changes
- 8.5.6.1.1 Temporary change of process controls
Section 8.6: Release of Products and Services
Prior to releasing a product or service, it is imperative that there is a process to ensure that customer expectations have been met at each stage or production, this includes documentation of formal customer approval. Section 8.6 has additional requirements to meet IATF 16949 certification beyond ISO 9001 these subclauses are:
- 8.6.1 Release of products and services (additional to 8.6)
- 8.6.2 Layout Inspection and functional testing
- 8.6.3 Appearance items
- 8.6.4 Verification and acceptance of conformity of externally provided products
- 8.6.5 Statutory and regulatory conformity
- 8.6.6 Acceptance Criteria
Section 8.7: Control of Nonconforming Outputs
This is the requirement to detect and correct any non-compliant services/products before their delivery or use. This means the problem needs to be corrected, separate and return the offending product/service, communicate the issue to customers, and also gaining authorization to verify and address the non-conformity. Any non-conformance documentation must include a full description of the problem, the corrective actions, and any agreed upon compromises or adjustments reached with the customer, and also who authorized the remedies. In addition IATF 16949 expanded upon 8.7 with these additional requirements:
- 8.7.1.1 Customer authorization for concession
- 8.7.1.2 Control of nonconforming product
- 8.7.1.3 Control of suspect product
- 8.7.1.4 Control of reworked product
- 8.7.1.5 Control of repaired product
- 8.7.1.6 Customer Notification
- 8.7.1.7 Nonconforming product disposition
Please note that certain text from the ISO 9001 standard is only used for instructional purposes. Standard Stores recognizes and respects the International Organization for Standardization (ISO) copyright and intellectual property guidelines.
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