What is Acceptable Quality Level (AQL) and why it matters?

AQL is an industry standard that is a statistical sampling process for evaluating quality. According to the International Standards Organization (ISO) (2859-1: 1999)1, AQL is “the worst tolerable process average when a continuing series of lots is submitted for acceptance sampling”. AQL measures quality by determining the highest number of defects accepted in a random selection of a glove product batch. The lower the AQL, the better the quality and less likelihood of defects.

AQL is a pass/fail where a predetermined sample size of a manufactured lot is assessed following the sampling plan and protocols established by the various international standards. More stringent standards can also be set by manufacturers to ensure stricter and higher quality is delivered to the customer. The sampling plan is an inspection procedure of a sample size (which are gloves that are randomly selected from a batch of gloves) that is used to determine acceptance or rejection criteria from an inspection batch or lot. The sample size to be tested is set by:

The lot or batch size
The inspection level - determined by region as reflected in Table 1 and Table 2
AQL level specified in standards for the market or determined by individual manufacturers

Surgical Gloves Standards	Inspection Level	AQL
AS/NZS 4179:2014²Applicable to Australia/New Zealand	G1	1.0
ASTM D3577:19⁴Applicable to US & Canada	G1	1.5
EN 455-1:2020⁸Applicable to the European Union	G1	0.65
ISO 10282:2023⁹Adopted by the rest of the World	G1	1.5
JIS T9107:2018¹¹Applicable to Japan	G1	1.5

^{Table 1: Surgical Gloves Standards}

Examination Gloves Standards	Inspection Level	AQL
AS/NZS 4011:2014³Applicable to Australia/New Zealand	G1	1.5
ASTM D3578:19⁵ ASTM D6319-19⁶ ASTM D6977-19⁷ Applicable to US & Canada	G1	2.5
EN 455-1:2020⁸ Applicable to the European Union	G1	1.5
ISO 11193-1:2020¹⁰Adopted by the rest of the World	G1	2.5
JIS T9115:2008¹²Applicable to Japan	G1	2.5

^{Table 2: Examination Gloves Standards}

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^{Sources:

1. International Standards Organization, ISO 2859-1:1999 Sampling procedures for inspection by attributes — Part 1: Sampling schemes indexed by acceptance quality limit (AQL) for lot-by-lot inspection
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=1141 Accessed 26/11/2015

2. Standard New Zealand Te Mana Tautikanga O Aotearoa, AS/NZS 4179:2014 Single-use sterile rubber surgical gloves
http://infostore.saiglobal.com/store/Details.aspx?ProductID=1742680 Accessed 4-12-15

3. Standard New Zealand Te Mana Tautikanga O Aotearoa, AS/NZS 4011.1:2014 Single-use medical examination gloves
http://infostore.saiglobal.com/store/Details.aspx?ProductID=1742678 Accessed 4-12-15

4. American Society for Testing and Materials, ASTM D3577-19 Standard Specification for Rubber Surgical Gloves
http://www.astm.org/Standards/D3577.html Accessed 4-12-15

5. American Society for Testing and Materials, ASTM D3578-19 Standard Specification for Rubber Examination Gloves
http://www.astm.org/Standards/D3578.html Accessed 08-03-22

6. American Society for Testing and Materials, ASTM D6319-19 Standard Specification for Nitrile Examination Gloves for Medical Application
http://www.astm.org/Standards/D6319.html Accessed 08-03-22

7. American Society for Testing and Materials, ASTM D6977-19 Standard Specification for Polychloroprene Examination Gloves for Medical Application
http://www.astm.org/Standards/D6977.html Accessed 08-03-22

8. European norm, EN 455 Part 1: 2020 Medical Gloves for single use
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/medical-devices/index_en.html Accessed 08-03-22

9. International Standardization Organization, ISO 10282:2023 Single-use sterile rubber surgical gloves https://www.iso.org/standard/80474.html Accessed 20th October 2023

10. International Standardization Organization, ISO 11193-1:2020 Single-use medical examination gloves https://www.iso.org/standard/75379.html Accessed 08-03-22

11. Japanese Industrial Standard, JIS T 9107:2018 Single-use Sterile Surgical Rubber Gloves http://infostore.saiglobal.com/store/Details.aspx?ProductID=800132 Accessed 4-12-15

12. Japanese Industrial Standard, JIS T 9115:2018 Single-use Rubber Examination Gloves https://global.ihs.com/doc_detail.cfm?document_name=JIS%20T%209115&item_s_key=00394418 Accessed 08-03-22}

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What is Acceptable Quality Level (AQL) and why it matters?

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