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AS9100D Objective Evidence Requirements (Documentation & Records)
AS 9100D is an incredibly poorly written QMS standard littered with ambiguous / vague requirements that have resulted in subjective interpretations and inconsistent implementation.
This article discusses the minimum “Objective Evidence” actually by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) is based purely on subjective opinion.
AS 9100:2016 (Rev. D) Annex states:
A.6 Documented Information
Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”, “quality manual” or “quality plan”, ISO 9001:2015 defines requirements to maintain documented information.
Where ISO 9001:2008 used the term “records” to denote documents needed to provide evidence of conformity to requirements, this is now expressed as a requirement to retain documented information.
| # | “Maintain” as Documented Information (Documents) | Sec. |
|---|---|---|
| 1 | To the extent necessary, the organization shall: a. maintain documented information to support the operation of its processes; [SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)… NOT the auditor.] | 4.4.2 |
| 2 | a general description of relevant interested parties (see 4.2 a); | 4.4.2 |
| 3 | the scope of the quality management system, including boundaries and applicability (see 4.3); | 4.3 & 4.4.2 |
| 4 | a description of the processes needed for the quality management system and their application throughout the organization; | 4.4.2. |
| 5 | the sequence and interaction of these processes; | 4.4.2 |
| 6 | assignment of the responsibilities and authorities for these processes. | 4.4.2 |
| 7 | Quality policy | 5.2.2.a |
| 8 | Quality objectives | 6.2.1 |
| 9 | a register of the monitoring and measuring equipment (that includes: the equipment type, unique identification, location, and the calibration or verification method, frequency, and acceptance criteria). | 7.1.5.2 |
| 10 | The organization shall “determine” and “maintain” documented information “to the extent necessary:” 1. to have confidence that the processes have been carried out as planned; 2. to demonstrate the conformity of products and services to their requirements; [SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)… NOT the auditor.] | 8.1.e |
| 11 | Controlled conditions shall include, as applicable: a. the availability of documented information that defines: 1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed; 2. the results to be achieved; [This documented information may be provided by the customer] | 8.5.1.a |
| 12 |
* criteria for acceptance and rejection;
- where in the sequence verification operations are to be performed;
- measurement results to be retained (at a minimum an indication of acceptance or rejection);
- any specific monitoring and measurement equipment required and instructions associated with their use; | 8.5.1.c1 |
