Q: How much of ISO 9001:2015 will we be able to adopt into Q1?
A: API Spec. Q1 has mandatory requirements for documented procedures, whereas ISO 9001:2015 discusses the term “documented information.”
“information (3.8.2) required to be controlled and maintained by an organization(3.2.1) and the medium on which it is contained.
Note 1 to entry: Documented information can be in any format and media and from any source.
Note 2 to entry: Documented information can refer to:
– the management system (3.5.3), including related processes (3.4.1);
– information created in order for the organization to operate (documentation);
– evidence of results achieved (records [3.8.10])”
* Excerpt from ISO 9000:2014, Quality Management Systems-Fundamentals & Vocabulary
The term “documented information” refers to documentation, the quality manual, documented procedures and records.
The philosophy of the new ISO 9001 focuses on the level of applicable documented information that best suits the organization implementing the 2015 requirements.
The determination of the level of documented information that is necessary is more or less left up to the company implementing the ISO 9001:2015.
However, conversely, API Spec. Q1 clearly specifies the level of documented procedures needed. See Table 1, which shows the decline of the requirement for documented procedures in ISO 9001 since its inception in 1994 through the 2008 Edition.
Further guidance on the level of ISO 9001:2015 requirements that will be addressed in a future revision to Q1, 9th Edition, will be forthcoming. During the 2015 API Summer Standardization Conference in San Francisco, API’s Committee on Quality, SC18, assigned a work group to perform a gap analysis of the Final Draft Standard ISO 9001:2105 as it applies to Spec. Q1, 9th Edition.
The publication of this information will provide a roadmap as to which ISO 9001:2015 requirements will be integrated with API Spec. Q1, 9th Edition.
— Bud Weightman
President, Qualified Specialists, International
Who We Are
Qualified Specialists, International (QSI) is a professional consulting, training, and management systems technology firm headquartered in Houston, TX. Founded by R.T. (Bud) Weightman in 1989, QSI has a global presence and has implemented and assessed management systems in over 28 countries world-wide – with certifications ranging from ISO 9001, ISO 14001, OHSAS 18001, API Spec. Q1 / Q2, and more.
Our specialty spans quality, health and safety, and environmental (QHSE), and our products and services have been applied in engineering, manufacturing, fabrication, distribution, service, projects, and operations.
We excel in helping our clients to achieve regulatory compliance, certification, and industry licensing through our superior software solutions, consulting services, and industry-leading training.
Bud Weightman, President of QSI, is an international management systems expert involved with management and technical systems for over 40 years. As President of QSI, Bud is involved with the industry committees responsible for emerging requirements, including: revision of API specifications, leading various API Task Groups, and lead auditor for the accreditation of SEMS Audit Providers through the Center for Offshore Safety. Bud’s experience includes working with ISO 9001, ISO 14000, and OHSAS 18000 management systems, as well as industry-specific certification schemes such as API Q1 and Q2, AS9100, ASME systems, and numerous other standards.
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