Home » ISO/TS 16949 Requirements & Eligibility
ISO/TS16949 Requirements & Eligibility
TS16949 includes 100% of the ISO 9001 requirements plus some additional requirements specific to the Automotive industry. , including a working knowledge of the AIAG Core Tools.
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TS 16949 challenges your company to meet your objectives as well as customer requirements on delivery, design and competitive cost. It also requires you to link your organizations' business plan to the QMS (quality policy, quality objectives and measures).
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Use of Core Tools to drive improvement
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Top management involvement
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Link the business plan to clearly defined measurable quality objectives.
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Customer specific requirements added to TS 16949 certification scope
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Focus on HR function and the personnel in your organization:
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Process for defining competency requirements
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Providing training
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Verifying the effectiveness of actions taken.
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Processes to motivate employees to reach quality objectives,
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Attain continual improvement
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Foster innovation
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Measure personnel involvement in attaining quality objectives.
- Product and process design
- Supplier conformance to TS 16949
- Control of laboratories.
- Measure customer satisfaction through auditing of Processes
Exclusions?
To effectively control the processes of the quality management system, additional procedures may be necessary. the product design aspect of clause 7.3, design and development, is the only exclusion permitted and only if
they are not “design responsible.†Organizations with the authority to establish a new, or change an existing, product must comply.
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3 Terms and definitions
Terms and definitions for the automotive industry
- Control Plan
- Design Responsible Organization
- Error Proofing
- Laboratory
- Laboratory Scope
- Manufacturing
- Predictive Maintenance
- Preventive Maintenance
- Premium Freight
- Remote Location
- Site
- Special Characteristic
4 Quality management system
General requirements & Supplemental
Engineering specifications
Control of records & retention
5 Management responsibility
Management Responsibility & Review
Process efficiency
Quality objectives - Supplemental
Responsibility for quality
Customer representative
Quality management system performance
Review input - Supplemental
6 Resource management
HR/Training/Infrastructure
Product design skills
Training on the job
Employee motivation and empowerment
Plant, facility and equipment planning
Contingency plans
Personnel safety to achieve conformity to product requirements
Cleanliness of premises
7 Product realization
Planning of product realization - Supplemental
Acceptance criteria
Confidentiality
Change control
Customer-related processes
Determination of requirements related to the product
Customer-designated special characteristics
Review of requirements related to the product - Supplemental
Organization manufacturing feasibility
Customer communication - Supplemental
Design and development
Planning with a Multidisciplinary approach (APQP - Core Tool)
Product design input
Manufacturing process design input
Special characteristics
Product design outputs - Supplemental
Manufacturing process design output
Design and development review, Monitoring, Verification & Validation
Prototype program
Product approval process (PPAP-Core Tool)
Statutory and regulatory conformity
Supplier QMS development
Customer-approved sources
Incoming product conformity to requirements
Supplier monitoring
Control plan
Work instructions
Verification of job set-ups
Preventive and predictive maintenance
Management of production tooling
Production scheduling
Feedback of information from service
Service agreement with customer
Validation of processes for production and service provision - Supplemental
Identification and traceability - Supplemental
Customer-owned production tooling
Storage and inventory
Measurement system analysis (MSA - Core Tool)
Calibration/verification records
Laboratory requirements
8 Measurement, analysis and improvement
Identification & Knowledge of basic statistical concepts (SPC - Core Tool)
Customer satisfaction - Supplemental
QMS audit
Manufacturing process audit
Product audit
Internal audit plans
Internal auditor qualification
Monitoring and measurement of manufacturing processes
Control of nonconforming product - Supplemental
Control of reworked product
Customer information
Analysis and use of data
Continual improvement of the organization
Manufacturing process improvement
Problem solving
Error-proofing
Corrective action impact
Rejected product test/analysis (FMEA - Core Tool)
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Required Documentation
The Standard requires that you document the following:
- Quality Manual
- Quality Policy
- Quality Objectives
- Quality Records
- Seven Procedures
- Control of Documents (4.2.3)
- Control of Records (4.2.4)
- Training (6.2.2.2)
- Internal Audit (8.2.2)
- Control of Nonconforming Product (8.3)
- Corrective Action (8.5.2)
- Preventive Action (8.5.3)
ISO/TS 16949 requires 7 mandatory documented procedures, but we recommend additional procedures to cover the key manufacturing processes.
Implementing the minimum in order to meet the requirements of the standard defeats the purpose.
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