ISO 9001 vs API Spec Q1.

API Spec Q1 9th Edition Adds Risk Management

The most important change to API Spec Q1 you need to know is that the API added risk
assessment and risk management to the standard. In the ISO 9001 series there is less
emphasis on formally documenting risk; API Spec Q1 integrates risk assessment and risk
management throughout the standard. For your company, this change may not pose many
problems if you have already included risk assessments in your quality management
processes. For companies that have focused less on risk management, API Spec Q1 9th
Edition is a note-worthy shift away from the old ways of ISO 9001.
In total, the new version of API Spec Q1 includes five new sections and more than 85 new
clauses. A good example of the types of changes you can expect is in section five of API
Spec Q1 that adds formal (emphasis added) contingency planning to the quality management
puzzle. Certainly, your company already has such contingency procedures, but the difference
is that API Spec Q1 mandates including these procedures to gain certification. Finding
common ground between QMS and risk assessment
- See more at: http://www.iqs.com/iqs-blog/iso-9001-vs-api-spec-q1/#sthash.dCcvDULJ.dpuf

7 Key Differences between ISO 9001 and API Spec Q1 9th Edition
Risk is absolutely the most business-critical element added to the latest version of API Spec
Q1. However, you should pay close attention to other key differences, too. ISO 9001 is the
basis for most (if not all) of the industry-specific quality management standards. Structurally,
API Spec Q1 deviates from the classic ISO 9001 series, but the end results of a compliant
quality management system are still the same.
Some of the key differences you should know between API Spec Q1 9th Edition and ISO
9001 are:

formalizing employee competency and training of personnel

reinforcing risk assessment and risk management throughout the standard
contingency planning
controlling the supply chain
preventative maintenance
validation of designs
management of change

As you can see, the latest version of API Spec Q1 does in fact deviate from the ISO 9001
approach to quality management. The ISO 9001 series takes a process-focused approach, but
API Spec Q1 9th Edition takes a process-and-risk-management approach in one manner of
speaking. To state the bottom line bluntly, without formalized risk assessments in your
quality planning, your company will not meet the minimum standards to gain API
certification. Software for managing your QMS
ISO 9001 touches upon all of the aspects listed above, but the difference is the formal
inclusion of these facets to meet the APIs new standards. Developing an API-compliant

quality management system may take a top-down, wholesale refresh of how your company
approaches quality management. To meet the APIs new requirements, you cannot simply
rearrange the wording of your ISO 9001-compliant quality manual and expect success.
Your task as a quality management professional becomes more difficult as quality standards
change over the years. Updates to the APIs hallmark quality management standard API Spec
Q1 9th Edition represent a fundamental shift away from the process-based approach to
quality to a more risk-management-based method of managing quality in the oil and natural
gas industry. QMS in the Oil and Gas Industry
- See more at: http://www.iqs.com/iqs-blog/iso-9001-vs-api-spec-q1/#sthash.dCcvDULJ.dpuf