2 Standards, definitions and books T 21
2.1 Standards
Quality standards and references
The ISO 9000 family of standards contains three core booklets (and one guideline):
- ISO 9000 (2015): Quality management systems. Fundamentals and vocabulary
- ISO 9001 (2015): Quality management systems. Requirements
- ISO/TS 9002 (2016): Quality management systems - Guidelines for the application of ISO 9001: 2015
- ISO 9004 (2018): Quality management - Quality of an organization - Guidance to achieve sustained success
The AS9100 family mainly includes the following standards:
- AS9102B (2014): Aerospace Series - Quality Systems – Aerospace First Article Inspection Requirement
- AS9103A (2012): Aerospace series - Quality Management System – Variation Management of Key Characteristics
- AS9110C (2016): Quality Management Systems - Requirements for Aviation Maintenance Organizations
- AS9120B (2016): Quality Management Systems - Requirements for Aviation, Space and Defense Distributors
- XP PR EN 9130 (2001): Aerospace Series - Quality System - Document Archiving
- AS9131C (2017): Aerospace Series - Quality Management Systems – Nonconformance Data Definition and Documentation
- AS9132B (2015): Aerospace series - Quality Management Systems - Data Matrix Quality Requirements for Parts Marking
- AS9133A (2016): Aerospace Series - Quality Management Systems - Qualification Procedure for Aerospace Standard Products
- ARP9134A (2014): Aerospace Series - Quality Systems – Supply Chain Risk Management Guideline
- AS9145 (2016): Aerospace Series – Requirements for Advanced Product Quality Planning and Production Part Approval Process
Note: XP PR is for experimental standard unlike all the others which are approved standards.
ISO 31000 (2018): Risk Management - Guidelines proposes a generic approach to making risk management effective.
ISO 31010 (2019): Risk Management - Risk Assessment Techniques provides recommendations (guidelines) for selecting and applying systematic risk assessment techniques.
ISO 10007 (2017): Quality Management Systems - Guidelines for configuration management is recommended as a guide for configuration management (see AS9100D sub-clause 8.1.2).
All of these standards and many more can be ordered in electronic or paper form on the ISO site.
More than 28,000 standards (in English and other languages) are available for free on the Public.Resource.Org site.
As recalled in clause 1 of the AS9100D standard in case of conflict, statutory and regulatory requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) always prevail over those of the standard. For your company check the EU Regulation EC 216/2008 on Civil Aviation Rules and the European Aviation Safety Agency and EC 1702/2003, which lay down rules implemented for the Airworthiness and environmental certification of aircraft and associated productsany outcome of a process or activity (see also ISO 9000, 3.7.6), parts and equipment, as well as certification of design and production organizationsa structure that satisfies a need (see also ISO 9000, 3.2.1) .
The AS9100D standard fully incorporates the 10 clauses of ISO 9001: 2015 (normal characters) and adds specific requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4) for the aviation, space and defense industry (in bold italic type).
Some of these requirementsexplicit or implicit need or expectation (see also ISO 9000, 3.6.4):
- special requirements
- critical items
- key characteristics
- project management
- risk management
- control of transfer of work
- recall of equipment
- product safety
- counterfeit parts
- customer notification of changes
- approval of external providers
- evaluation of test reports
- first article inspection
- configuration management
The Oxebridge Q001 is a user-friendly, open source remix of ISO 9001:2015.
2.2 Definitions
Terms and definitions related to quality
The beginning of wisdom is the definition of terms. Socrates
Some definitions:
AQMS: aerospace quality management system
Competence: personal skills, knowledge and experiences
Conformity: fulfillment of a specified requirement
Corrective action: action to eliminate the causes of nonconformity or any other undesirable event and to prevent their recurrence
Counterfeit part: unauthorized copy, imitation, replacement part or modified part, deliberately presented as an authentic part
Critical item: item which can require specific action to control its effect
Customer: anyone who receives a product
Customer satisfaction: top priority objective of every quality management system related to the satisfaction of customer requirements
Documented information: any support allowing the treatment of information
Effectiveness: capacity to realize planned activities with minimum effort
Efficiency: financial relationship between achieved results and used resources
Competence: personal skills, knowledge
FMEA: failure mode and effects analysis
Indicator: value of a parameter, associated with an objective, allowing the objective measure of its effectiveness
Interested party: person, group or company affected by the impacts of an organization
Key characteristics: attribute which can require specific actions to manage its variation
Management system: set of processes allowing objectives to be achieved
Nonconformity: fnon-fulfillment of a specified requirement
Organization (company): a structure that satisfies a need
Process: activities that transform inputs into outputs
Product (or service): every result of a process or activity
Product safety: the state in which a product is capable of achieving its purpose without causing an unacceptable risk of harm tp persons or property
Quality: aptitude to fulfill requirements
Quality management: activities allowing the control of an organization with regard to quality
Quality management system: set of activities allowing the achievement of the quality objectives
Quality manual: document specifying the general measures taken by an organization to obtain conforming products and services
Quality objective: related to quality, measurable goal that must be achieved
Quality plan: document specifying the methods, means, responsibilities and stages of activities related to quality, applied specifically to a product, project or process
Quality policy: statement by top management allowing the establishment of quality objectives
Requirement: explicit or implicit need or expectation
Risk: likelihood of occurrence of a threat or an opportunity
Special requirement: requirement at the limit of its technical capability
System: set of interacting processes
Top management: group or persons in charge of the company's control at the highest level
In the terminology of quality management systemsset of processes allowing the achievement of the quality objectives (see also ISO 9000, 3.5.4), do not confuse:
- accident and incident
- an accident is an unexpected serious event
- an incident is an event that can lead to an accident
- anomaly, defect, dysfunction, failure, nonconformity, reject and waste:
- anomaly is a deviation from what is expected
- defect is the non-fulfillment of a requirement related to an intended use
- dysfunction is a degraded function that can lead to a failure
- failure is when a function has become unfit
- nonconformity is the non-fulfillment of a requirement in production
- reject is a nonconforming product that will be destroyed
- waste is when there are added costs but no value
- audit program and plan
- an audit program is the annual planning of the audits
- an audit plan is the description of the audit activities
- audit, inspection, auditee and auditor
- an audit is the process of obtaining audit evidence
- an inspection is the conformity verification of a process and product
- an auditee is the one who is audited
- an auditor is the one who conducts the audit
- control and optimize
- control is meeting the objectives
- optimize is searching for the best possible results
- customer, external provider and subcontractor
- a customer receives a product
- an external provider provides a service or a product
- a subcontractor provides a product or service on which specific work is done
- effectiveness and efficiency
- effectiveness is the level of achievement of planned results
- efficiency is the ratio between results and resources
- follow-up and review
- follow-up is the verification of the obtained results of an action
- review is the analysis of the effectiveness in achieving objectives
- inform and communicate
- to inform is to give someone meaningful data
- to communicate is to pass on a message, to listen to the reaction and discuss
- objective and indicator
- an objective is a sought after commitment
- an indicator is the information on the difference between the pre-set objective and the achieved result
- organization and enterprise, society, company
- organization is the term used by the ISO 9001 standard as the entity between the supplier and the customer
- an enterprise, society and company are examples of organizations
- process, procedure, product, activity and task
- a process is how we satisfy the customer using people to achieve the objectives
- a procedure is the description of how we should conform to the rules
- a product is the result of a process
- an activity is a set of tasks
- a task is a sequence of simple operations
Remark 1: the use of ISO 9000 and AS9100D definitions is recommended. The most important thing is to determinate a common and unequivocal vocabulary for everyone in the company.
Remark 2: the customer can also be the user, the beneficiary, the trigger, the ordering party or the consumer.
Remark 3: documented information is any information that we must maintain (procedure ) or retain (record )
For other definitions, comments, explanations and interpretations that you don’t find in this module and annex 06, you can consult:
- ISO Online Browsing platform (OBP)
- IEC Electropedia
- ISO 9000: 2015 - Quality management systems. Fundamentals and vocabulary
2.3 Books
Books related to quality
Books for further reading on qualityaptitude to fulfill requirements (see also ISO 9000, 3.6.2):
- Philip Crosby, Quality is free; the Art of Making Quality Certain, McGraw-Hill, 1979
- Joseph Juran, Management of quality, mcGraw-Hill, 1981
- Kaoru Ishikawa, What is Total Quality Control, The Japanese Way, Prentice-Hall, 1981
- Edwards Deming, Out of the Crisis, MIT Press, 1982
- Eliyahu Goldratt, Jeff Cox, The Goal, A Process of Ongoing Improvement, North River Press, 1984
- Masaaki Imai, KAIZEN, The Key to Japan’s Competitive Success, McGraw-Hill, 1986
- James Harrington, Poor-Quality Cost, Dekker, 1987
- Larry Webber, Michael Wallace, Quality Control for Dummies, Wiley, 2007
- Erik Myhrberg, Dawn Crabtree, A Practical Field Guide for AS9100, ASQ Quality Press, 2010
- Denise Robitaille, The (Almost) Painless ISO 9001:2015 Transition, Paton Professional, 2015
- Jan Gillet, Implementing Iso 9001:2015: Thrill your customers and transform your cost base with the new gold standard for business management, Infinite Ideas, 2015
- Charles Cianfrani, John West, ISO 9001:2015 Explained, ASQ Quality Press, 2015
- Craig Cochran, ISO 9001:2015 in Plain English, Paton Professional, 2015
- Denise Robitaille, ISO 9001:2015 Handbook for Small and Medium-Sized Businesses, Quality Press, 2016
- Alka Jarvis, Paul Palmes, ISO 9001: 2015: Understand, Implement, Succeed!, Prentice hall, 2016
- Ray Tricker, ISO 9001:2015 for Small Businesses, Routledge, 2016
- K Thomas, Implement AS 9100 Rev D for Business Excellence: Quality Management System Requirements for Aviation, Space and Defence Organisations, includes ISO 9001:2015, Thomas Orchard Publishers, 2017
- Edward Link, An Audit of the System, not of the People - An AS9100D Pocket Guide for Every Employee, Quality Pursuit, 2017
- Christopher Paris, Mark Stevens, Surviving AS9100 Rev. D: Implementing the Aerospace Quality Management System Standard Without Crashing Into Anything, Oxebridge Quality Press, 2019
Minute of relaxation. Game: Procedure
When I think of all the books still left for me to read, I am certain of further happiness. Jules Renard