News on the standard AS9100D version 2016: Quality management systems - Requirements for Aviation, Space, and Defence Organizations

13/10/2023

The AS9100D standard - Quality Management Systems - Requirements for Aviation, Space and Defense Organizations was published on 20 September 2016 by SAE at Price of $ 74.00 (about 60 euros).

This standard was prepared by the IAQG (International Aerospace Quality Group). The EN 9100 version 2009 certification will be valid until September 14, 2018.

The AS9100D standard incorporates the full text of ISO 9001 version 2015 and adds specific aerospace requirements.

News from ISO 9001 version 2015

Requirements of  ISO 9001 version 2015

Requirements of AS9100D version 2016

See also the quiz "AS9100D version 2016 requirements"

The course T 21v16 AS9100D version 2016 readiness and its free demo without registration

The course T 41v16 AS9100D version 2016 internal audit and its free demo without registration

The training package T 71v16 AS9100D version 2016 readiness and internal audit

Specifics of aeronautics, space and defense:

• products with high risk and costs
• mandatory statutory, regulatory and customer requirements
• safety is essential
• failure is not an option

1. The clauses are 11 (10 ACCORDING TO THE high LEVEL STRUCTURE)

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization (P)
5. Leadership (P, D, C, A)
6. Planning (P)
7. Support (D)
8. Operation (D)
9. Performance evaluation (C)
10. Improvement (A)
11. Notes

Many notes and examples for clarity

2. Some new requirements

• more documented information on the quality management system (QMS) to maintain (possibility to use a quality manual)
• measurement of on-time delivery performance, including for external providers
• the term management representative is retained
• monitoring and measurement equipment recall process
• enhanced planning (including risks and opportunities)
• awareness of the individual contribution is reinforced
• planning of product and service provision
• transfer of work process
• the risk-based approach concerns the whole system and particularly the operational activities (clause added)
• configuration management is simplified and clarified and includes the product lifecycle
• product safety process (definition and sub-clause added) is taken into account throughout the product lifecycle
• process for the prevention of counterfeit parts (definition and sub-clause added) or suspected as such is introduced
• coordination of review of product and service requirements
• negotiation with the customer in case of non-conformity
• verification and validation tests of design and development
• responsibilities, monitoring, verification, validation, information and risks related to external providers
• enhanced management of controlled conditions including software
• appropriate actions when detecting problems after delivery
• documented information to maintain on nonconforming product control process
• human error is taken into account during the determination of the root causes
• documented information to maintain on the process of controlling nonconformities and corrective actions

3. Risk-based thinking is the big novelty

The term risk appears 54 times in clauses 1 to 10 alone or in combination with the word opportunity

4.The quality manual and procedures are not any more mandatory but however there are requirements:

• maintain documented information (procedures) - 7 cases
  • scope (§ 4.3)
  • description of the QMS or quality manual (§ 4.4.2) 
  • quality policy (§ 5.2.2 a)
  • quality objectives (§ 6.2.1)
  • operational control (§ 8.1)
  • nonconforming output (§ 8.7.1)
  • corrective action (§ 10.2.1)
• retain documented information (records) - 26 cases 
  
  • processes (§ 4.4.2 b)
  • adequacy of inspection resources (§ 7.1.5.1)
  • calibration (§ 7.1.5.2)
  • competence of staff (§ 7.2)
  • external origin (§ 7.5.3)
  • product and service conformity (§ 8.1)
  • results of review of the requirements for products and services (§ 8.2.3.2)
  • inputs of design and development (§ 8.3.3)
  • results to be achieved, reviews, verifications and validations of design and development (§ 8.3.4)
  • outputs of design and development (§ 8.3.5)
  • design and development changes (§ 8.3.6)
  • activities and action of evaluating external providers (§ 8.4.1)
  • retention periods and disposition requirements (§ 8.4.3 k)
  • characteristics of products and services, related activities and results to be achieved (§ 8.5.1)
  • monitoring and measurement activity (§ 8.5.1 c)
  • validation and control of special processes (§ 8.5.1.2 f)
  • results of production process verification (§ 8.5.1)
  • product and service traceability (§ 8.5.2)
  • status of customer property (§ 8.5.3)
  • results of change review (§ 8.5.6)
  • release of products and services (§ 8.6)
  • product qualification (§ 8.6)
  • treatment of nonconforming products and services (§ 8.7.2)
  • inspection results (§ 9.1.1)
  • audit programme and audit results (§ 9.2.2)
  • management review outputs (§ 9.3.3)
  • nonconformities, actions and results (§ 10.2.2)

5. The verb SHALL is present 460 times in the clauses 4 to 10

In the version 2009 it was 464 times

6. New sub-clauses

• 8.1.1 Operational risk management
• 8.1.3 Product safety
• 8.1.4 Prevention of counterfeit parts
• 8.5.1.1 Control of equipment, tools and software programmes
• 8.5.1.2 Validation and control of special processes
• 8.5.1.3 Production process verification

7. Details of clauses and sub-clauses (in bold AS9100D clauses and sub-clauses)

• Rationale
• Foreword
• Intended application
• Introduction
  • 0.1 General
  • 0.2 Quality management principles
  • 0.3 Process approach
    • 0.3.1 General
    • 0.3.2 Plan-Do-Check-Act cycle
    • 0.3.3 Risk-based thinking
  • 0.4 Reliationship with other management systems standards
• 1 Scope
• 2 Normatives references
• 3 Term and définitions
• 4 Context of the organisation
  • 4.1 Understanding the organisation and its context
  • 4.2 Understanding the needs and expectations of interested parties
  • 4.3 Determining the scope of the quality management system
  • 4.4 Quality management system and its processes
• 5 Leadership
  • 5.1 Leadership and commitment
    • 5.1.1 General
    • 5.1.2 Customer focus
  • 5.2 Policy
    • 5.2.1 Establishing the quality policy
    • 5.2.2 Communicating the quality policy
  • 5.3 Organizational roles, responsibilities and authorities
• 6 Planning
  • 6.1 Actions to address risks and opportunities
  • 6.2 Quality objectives and planning to achieve them
  • 6.3 Planning of changes
• 7 Support
  • 7.1 Resources
    • 7.1.1 General
    • 7.1.2 People
    • 7.1.3 Infrastructure
    • 7.1.4 Environment for the operation of processes
    • 7.1.5 Monitoring and measuring resources
    • 7.1.6 Organizational knowledge
  • 7.2 Competence
  • 7.3 Awareness
  • 7.4 Communication
  • 7.5 Documented information
    • 7.5.1 General
    • 7.5.2 Creation and updating
    • 7.5.3 Control of documented information
• 8 Operation
  • 8.1 Operational planning and control
    • 8.1.1 Operational risk management
    • 8.1.2 Configuration management
    • 8.1.3 Product safety
    • 8.1.4 Prevention of counterfeit parts
  • 8.2 Requirements for products and services
    • 8.2.1 Customer communication
    • 8.2.2 Determining the requirements for products and services
    • 8.2.3 Review of the requirements for products and services
    • 8.2.4 Changes to requirements for products and services
  • 8.3 Design and development of products and services
    • 8.3.1 General 
    • 8.3.2 Design and development planning
    • 8.3.3 Design and development inputs 
    • 8.3.4 Design and development controls
    • 8.3.5 Design and development outputs 
    • 8.3.6 Design and development changes 
  • 8.4 Control of externally provided processes,  products and services                   
    • 8.4.1 General 
    • 8.4.2 Type and extent of control 
    • 8.4.3 Information for external providers 
  • 8.5 Production and service provision 
    • 8.5.1 Control of production and service provision
      • 8.5.1.1 Control of equipment, tools, and software programs
      • 8.5.1.2 Validation and control of special processes
      • 8.5.1.3 Production process validation
    • 8.5.2 Identification and traceability 
    • 8.5.3 Property belonging to customers or external providers 
    • 8.5.4 Preservation
    • 8.5.5 Post-delivery activities
    • 8.5.6 Control of changes
  • 8.6 Release of products and services
  • 8.7 Control of nonconforming outputs
• 9 Performance evaluation
  • 9.1 Monitoring, measurement, analysis and evaluation 
    • 9.1.1 General
    • 9.1.2 Customer satisfaction
    • 9.1.3 Analysis and evaluation 
  • 9.2 Internal audit
  • 9.3 Management review
    • 9.3.1 General
    • 9.3.2 Management review inputs
    • 9.3.3 Management review outputs
• 10 Improvement
  • 10.1 General
  • 10.2 Nonconformity and corrective action 
  • 10.3 Continual improvement
• 11 Notes
• Annex A - Clarification of new structure, terminology and concepts (informative)
• Annex B - Other international standards on quality management and quality management systems developed by ISO/TC 176 (informative)
• Annex C - Other international standards on quality management and quality management systems developed by the international aerospace quality group (informative)
• Annex D - Bibliography
• Annex E - Aviation, space, and defence bibliography

8 CORRESPONDANCES between veRSION 2016 ET 2009

9. Some cOMMENTS on the ISO 9001 version 2015 standard

• the term "conformity to requirements" is a pleonasm because the definition of conformity is "fulfilment of a requirement" and so we obtain "fulfilment of a requirement to requirements"
• no process mapping requirement
• no documented information requirement for risk (to maintain or to retain)
• no requirement on quality costs
• no requirement for staff satisfaction, perception, valuation and recognition 
• no requirement on partner management
• no requirement on listening to the market
• no requirement on innovation (cited in the introduction and in the Note to sub-clause 10.1)
• the motivation and commitment of staff are not covered but only awareness is present (sub-clause 7.3)