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

Acceptable Quality Level (AQL) is an international industry standard sampling process for evaluating the quality of a finished glove product. 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
AQL level specified in standards for the market or determined by individual manufacturers

Surgical Gloves Standards	Inspection Level	AQL
AS/NZS 4179:2014¹Applicable to Australia/New Zealand	G1	1.0
ASTM 3577:2009²Applicable to US & Canada	G1	1.5
EN 455 Part 1:2000³Applicable to the European Union	G1	1.5
ISO 10282:2014⁴Adopted by the rest of the World	G1	1.5
JIS T9107:2005⁵Applicable to Japan	G1	1.5

^{Table 1: Surgical Gloves Standards}

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^{1. AS/NZS 4179:2014 Single-use sterile rubber surgical gloves
http://infostore.saiglobal.com/store/Details.aspx?ProductID=1742680 Accessed 4-12-15}
^{2. ASTM 3577:2009 Standard Specification for Rubber Surgical Gloves
http://www.astm.org/Standards/D3577.htm Accessed 4-12-15}
^{3. EN 455 Part 1: 2000 Medical Gloves for single use
http://ec.europa.eu/growth/single-market/european-standards/harmonised-standards/me dical-devices/index_en.htm Accessed 4-12-15}
^{4. ISO 10282:2014 Single-use sterile rubber surgical gloves
http://www.iso.org/iso/home/store/catalogue_tc/catalogue_detail.htm?csnumber=63706

Accessed 4-12-15} ^{5. JIS T 9107:2005 Single-use Sterile Surgical Rubber Gloves
http://infostore.saiglobal.com/store/Details.aspx?ProductID=800132 Accessed 4-12-15}

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

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