Is ISO 9001 Suitable for Non-Corporate Organizations Like Charities and Governments?

Although ISO 9001 is a comprehensive standard for application across diverse use cases, there are some industries with particularly sensitive safety and quality requirements for which a more specialized quality management system standard may be more appropriate. Such industries include aerospace, automotive, and energy. In all three cases, trade organizations for these sectors have created their own quality management system standards, which have been designed to work in tandem with ISO 9001. For example, the oil and gas industry uses the American Petroleum Institute’s API Q1 standard, which has been aligned with ISO 9001 and is periodically updated to remain in conformance with ISO 9001’s own updates. Moreover, the organizations that issue these industry-specific standards often suggest or enable companies which adopt their standard to also adopt ISO 9001 and thereby maintain compliance with both. Returning to the API Q1 standard, the American Petroleum Institute has gone so far as to enable API Q1 users to become registered for ISO 9001 at no additional charge, since API Q1 so fully overlaps with ISO 9001 as to ensure that compliance with the former also establishes compliance with the later.

Besides the aforementioned API Q1, the other major non-ISO industry-specific standards are AS9001 Revision D for the aerospace industry, and IATF 16949:2016 for the automotive industry. Both are aligned with ISO 9001, but the level of cooperation between the issuing organizations and the ISO varies.

AS9001 Revision D, which is jointly issued by the International Aerospace Quality Group (IAQG) and its publishing partner SAE International, is built for full overlapping compliance with ISO 9001. This specialty standard is quite literally derived from ISO 9001, with the chief differentiators being additional stringent requirements for risk mitigation and safety that are specific to aerospace. This is accomplished by AS9001 Revision D adding further language in their standard to contextualize and define the concept of “risk,” and to outline how it must be addressed. Because AS9001 Revision D matches ISO 9001 in all areas and surpasses its requirements for crucial focal points, fulfillment of AS 9001 Revision D ensures that ISO 9001 compliance can also be achieved, should a company wish to also become certified for ISO 9001.

For IATF 16949:2016, the overlap with ISO 9001 is still very obvious. However, the cooperation between the ISO and IATF 16949:2016’s issuing organization, the International Automotive Task Force (IATF), is much less clear. Fundamentally, this is due to a political situation, rather than an

issue with the standards themselves. Although the IATF based their standard upon ISO 9001, they were unable to reach a licensing agreement with the ISO to issue the standard as a supplementary or derivative document. As a result, the IATF has not been able to provide a discounted or free copy of ISO 9001 to companies that wish to adopt IATF 16949:2016, and thus requires them to purchase both standards in order to ensure full compliance, should compliance with both be desired. This means that users of the IATF standard must follow a ‘two manuals’ system, referring to both IATF 16949:2016 and ISO 9001 throughout the process of implementing and maintaining their quality management system. However, aside from this inconvenience, the two standards otherwise overlap and complement one another, allowing for an automotive company which chooses the IATF standard to also seek and receive certification for ISO 9001.

Industry-Specific Standards and Their Relationship to ISO 9001

Standard Name	Regulating Organization(s)	Target Focus of Standard	Relationship to ISO 9001
AS9001 Rev D	International Aerospace Quality Group (IAQG), SAE	QMS Guidance for the Aerospace Industry	Derived from ISO 9001 with Full Overlapping Compliance
API Q1	American Petroleum Institute (API)	QMS Guidance for the Petroleum Industry	Aligned with ISO 9001 with Full Overlapping Compliance; Companies with API Q1 Certification Can Register for ISO 9001 at No Additional Charge
IATF 16949:2016	Automotive Industry Action Group (AIAG)	QMS Guidance for the Automotive Industry	Aligned with ISO 9001 but Requires Both Standards to be Followed for Compliance

Is ISO 9001 Compatible with Other Industry-Specific QMS Standards?

As noted above, the ISO has modified and adapted ISO 9001 to match changes in quality and safety requirements, to learn from problems with past applications of the standard, and to acknowledge requests from industry and trade organizations. Over the decades since ISO 9001 was first introduced, it has been updated numerous times to reflect the changing needs of the world’s companies, organizations, and customers. For example, the version of the standard issued in 1994 placed a great deal of importance on how a user’s Quality Manual was written, while the next update to the standard in the year 2000 instead placed greater emphasis on creating a customer satisfaction feedback system; this was due to feedback the ISO received stemming from the Firestone case, from defense contractors who felt that subcontractor quality was too frequently substandard, and from the needs of non-company organizations which sought greater applicability of the standard for their needs. So substantial were the changes from the 1994 to 2000-era versions that even the name of the ISO 9001 document was changed: from a standard for “Quality Assurance” to a standard for “Quality Management.”As another example, the 2008 iteration of the standard placed relatively little emphasis on the concept of ‘risk,’ with the word only infrequently mentioned. Due to feedback from risk-conscious industries such as aerospace, the now-current 2015 version places a much larger degree of focus on the ‘risk’ concept, with a complete section devoted to it in the informational clauses and annex. Changes such as these, whether of great consequence like the examples mentioned, or of the smaller yet still important category such as the February 2024 amendment to consider climate change actions, have continued to keep ISO 9001 accurate, responsive, and relevant for the needs of today and tomorrow.

History of ISO 9001 Version Updates

Update Name (with Publication Year)	Significant Changes
ISO 9001:1987	Introduced System (Based on BS 5750) with Three Models for Different Use Cases (Eventually Consolidated into the Single ISO 9001 Standard in the Year 2000)
ISO 9001:1994	Minor Update: Added the Concept of Preventative Action; Significant Focus on Generation of Procedure Conformance Documentation
ISO 9001:2000	Major Update: Consolidated Three Use Case Model Version into the Single ISO 9001 Standard; Added the Concepts of Processes and Systems, Management of Integrated Processes, and Continuous Improvement; Required the Participation of Senior Management and the Use of Performance-Tracking Metrics; Emphasized Customer Satisfaction; Reduced Emphasis on Documenting Quality Manual Procedure Conformance and Other Paperwork; Changed Standard Focus from ‘Quality Assurance’ to ‘Quality Management’
ISO 9001:2008	Minor Update: Revised Wording and Clarification to Match Changing Times, but No Significant Changes from the 2000 Version
ISO 9001:2015	Major Update: Introduced the Concept of Risk-Based Thinking; Added the ‘Plan, Do, Check, Act’ (PDCA) to the List of Clauses for Required Actions; Conformed to Match the ISO’s High-Level Structure (Annex SL) Guidelines; Emphasized Process Based Approach and Input-Output Focus