The document provides a gap analysis between the requirements of ISO 9001:2015 and API Q1 9th Edition. It identifies 62 potential gaps in requirements between the two standards. The gaps are classified as unclear, clear but low impact, or clear but high impact. There are 9 unclear requirements, 31 low impact requirements, and 22 high impact requirements identified. The analysis indicates that while ISO 9001:2015 and API Q1 9th Edition specify similar quality management systems, there are some notable differences in specific requirements between the two standards.

1. EFFECT OF ISO 9001:2015
ON API Q1-9TH
AND THE OIL & GAS INDUSTRY
Raouf Naguib
3/17/2016
ANY and ALL Trade Marks mentioned or referenced in this presentation are registered property and belong
wholly to ISO or API. They are used here for illustration purposes only.
ISO and/or API are not responsible for any of the content of this presentation.

2. Bio
• 14+ years of experience with lean manufacturing, QA/QC, Quality Management
Systems, and supply chain, with the past 9 years in the Oil & Gas industry.
• BS in Mechanical Engineering from Cairo University.
• MS in Material Science from Cullen college of Engineering, UH.
• MBA from Bauer College of Business, UH.
• Certified Lean Six Sigma Green Belt.
• Certified Manager of Quality.
• Served as chair/member of several API standards-writing committees.
• Extensive experience with ISO 9001 and Q1, Q2, 6A, 16A, 20C, 18LCM.
• Served as VP of the Association of Well Head Equipment Manufacturers .
PUBLICATIONS
• Talk: "Densification of Fe-sheathed MgB2 wires", 106th Annual Meeting &
Exposition of the American Ceramic Society, April 2004, Indianapolis, IN.
• Paper: "Development of cube textured Ni-W tapes for HTS coated conductors”.
Superconductor Science and Technology, 17 (2004) Page 947.
• Paper: "Development of metallic textured substrates for coated conductors using
powder metallurgy". Proceeding of International Workshop on Coated
Conductors Applications, CCA2005.

3. History

4. Spec Q1 9th Ed

5. ISO 9001:2015

6. Next Step
ANY and ALL Trade Marks mentioned or referenced in this presentation are registered property and belong wholly to ISO or API. They are used here for illustration purposes only.
ISO and/or API are not responsible for any of the content of this presentation.

7. History – Q1
• API started the Monogram Program in Oct 1924.
“To facilitate the availability of safe, interchangeable, off-the-shelf equipment
and materials for general use in the petroleum drilling and production industry”.
• Early 80’s, API changed the monogram program
from a "self certification" to a “On-site
Verification” by a third party.
• API Established SC18 on Quality
• Began drafting 1st ed Spec Q1 early 1983.
• Published January 1, 1985

8. • ISO published its first Quality Management standard
in 1987.
• Originally there were subsets with exclusions:
ISO 9001, ISO 9002, ISO 9003
– AS 9001: for Air Space
– TL 9001: for Telecommunications
– ISO 16949: for Automotive
• Updated versions in 1994 , 2000 , 2008 , 2015
History – ISO 9001

9. History – ISO/TS 29001
• With Q1-5th Ed, API Joined hands with ISO to create
ISO/TS 29001
• ISO/TS 29001 defines the quality management system for
product and service supply organizations for the petroleum,
Oil & Gas industries.
• Boxed text = Original ISO 9001 text unaltered
• Supplemental Requirements = industry-specific
requirements, outside the boxes

10. History – New Era
• In 2011, API decided to separate from ISO
• The charge to the TG2 was write Q1-9th Ed, and to
Meet / Exceed ISO 9001:2008 requirements
• API published Q1-9th Ed June 2013 with Effective
date of June 2014.
• No more Boxed text , No more supplemental
requirements, no more similar structure.

11. SPEC Q1 9TH ED

12. Q1 9th Ed
• Modeled on Q2, Structurally deviates from ISO
• End results of a compliant QMS are still the same.
• Key differences areas :
– Formal personnel competency and training
– Reinforced risk assessment / risk management
– Introduction of Contingency planning
– Controlled supply chain (Outsourcing / Critical Suppliers)
– Preventative maintenance
– Validation of designs
– Management of Change

16. ISO9001:2015

18. ISO 9001:2015 Structure
4 Context of
organization
5 Leadership 6 Planning 7 Support 8 Operation
9 Performance
Evaluation
10 Improvement
4.1
Understand
context
4.2
Interested
parties
4.3
Scope
4.4
QMS
6.1
Risks and
opportunities
6.2
Planning
7.1
Resources
7.3
Awareness
7.4
Communication
7.5
Documented
information
7.2
Competence
9.1 Monitoring,
measurement,
analysis and
evaluation
9.2
Internal audit
9.3
Management
review
8.1
Operational
planning and
control
10.1
General
10.3
Continual
improvement
10.2
Nonconformity
and corrective
action
5.1
Leadership
and
commitment
5.2
Policy
5.3
Organizational
roles,
responsibilities
and authorities

19. ISO/DIS 9001:2015
1. Scope
2. Nominative References
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement
ISO 9001:2008
Scope
Nominative References
Terms and definitions
Quality Management System
Management responsibility
Resource management
Product realization
Measurement, analysis, and improvement

20. Key-Feature Changes
• 10-clause structure and core text for all MSS Standards
• More compatible with services and non-manufacturing users.
• Require clearer understanding of the organization’s context.
• More explicit Process approach.
• Preventive action addressed throughout the standard by risk
identification and mitigation.
• Documented information replaces document and record.
• Control of externally provided products and services replaces
purchasing/outsourcing.
• Emphasis on seeking improvement opportunities.

21. Different ISO Auditing ?
(1) Context of the Organization
Prove understanding the needs and expectations of "relevant parties" (think shareholders,
employees, customers, suppliers and even trade associations and regulatory bodies).
(2) Leadership
How will management take responsibility and promote risk-based thinking, customer
focus and improvement throughout the organization?
(6) Planning
How will you identify risks within your organization? What is its impact on the conformity
of products, services and customer satisfaction?
(8) Operations
Auditors may actually test how risk-management actions have been implemented and
controlled, by following these throughout your organization. Will you be ready?
(9) Performance evaluation
You’ll need to consider what needs to be measured, the methods employed, when data
should be analyzed and when it should be reported.
(10) Improvement
The main change is the requirement for corrective action is more explicit. It breaks down
the various stages of action i.e. correction, investigation and corrective action.

22. GAP ANALYSIS

23. • One direction analysis between ISO 9001:2015 and API Q1
9th Ed.
• All the individual requirements (Shall Statements) from ISO
9001:2015 are listed
• Matched each requirement with the equivalent
requirement(s) from API Q1, 9th Ed
• Possible gaps are identified.
Gap Analysis

25. • Classified Possible Gaps based on clarity and impact:
– Unclear requirement.
– Clear / Low Impact requirement.
– Clear / High Impact requirement.
• A total of 62 gaps:
– 9 Unclear requirements.
– 31 Low Impact Requirements.
– 22 High Impact Requirements.
Gap Analysis Results

26. ISO
9001
Requirement Description
Q1
9th Ed
Impact
4.1 - Determine External and internal issues Unclear
4.1 - Monitor and review information about issues Unclear
4.2.a - Determine Interested parties Clear / High Impact
4.2.b - Determine requirements of interested parties Clear / High Impact
4.3 Org shall determine boundaries and applicability of QMS 4.4.1.a
4.3 Org shall Determine Scope 4.4.1.b.1
4.3.a - Consider External and internal issues 4.4.1
4.3.b - Consider requirements of interested parties 5.4.2, 5.1.2, 5.1.3
4.3.c - Products and services offered 4.4.1
4.3 Org Shall Apply all applicable requirements of ISO9001 4.4.1.b
4.3 Scope shall be available 4.4.1.b.1
4.3 Scope shall be maintained 4.4.1.b.2
4.3 Scope shall state types of products and services covered Clear / High Impact
4.3 Scope shall justify exclusion of requirements 4.4.1.b.1
4.4.1 - Organization Establish, implement, maintain, and continually improve QMS 4.1.1 , 6.1
4.4.1 - Organization Determine processes needed for QMS and their application 4.1.4.a , 4.1.4.b
4.4.1.a - Organization Determine Inputs and outputs 5.4.2, 5.1.2, 5.1.3
4.4.1.b - Organization Determine Sequence and interaction of processes 4.4.1.b.2
4.4.1.c - Organization Determine Criteria and methods 4.1.4.a, 4.1.4.b
4.4.1.d - Organization Determine resources and ensure their availability 4.2.1
4.4.1.e - Organization assigns responsibilities and authorities for processes 4.2.2
4.4.1.f - Organization address risks and opportunities 5.2.d, 5.3 Clear / Low Impact
4.4.1.g - Organization evaluates processes and implement needed changes 6.2.3, 6.3.d
4.4.1.h - Organization improve processes and QMS 4.1.1, 6.1 , 6.5
4.4.2.a - Organization maintain documented information 4.4.1.c
4.4.2.b - Organization retain documented information 4.4.1.d , 4.4.3, 4.5

27. ISO
9001
Requirements Description
Q1
9th Ed
Impact
9.1.1.a) Org determine what needs to be monitored and measured Clear / Low Impact
9.1.1.b) Org determine methods 6.1
9.1.1.c) Org determine when Clear / Low Impact
9.1.1.d) Org determine when to analyze and evaluate Clear / Low Impact
9.1.1 Org evaluate performance and effectiveness of QMS 6.1
9.1.1 Org retain documented information as evidence of the results Throughout 6
9.1.2 Org Monitor customer perceptions of meeting expectations 6.2.1
9.1.2 Org determine methods of obtaining, monitoring, reviewing 6.2.1
9.1.3 Org analyze and evaluate data from monitoring and measuring 6.3
9.1.3.a) Results evaluate: - Product Conformity 6.3.b
9.1.3.b) - Customer satisfaction 6.3.a
9.1.3.c) - Performance and effectiveness of QMS 6.3
9.1.3.d) - Effectiveness of planning 6.2.3 Possible Gap
9.1.3.e) - effectiveness of actions taken to address risks and opportunities
6.4.2.f + 6.4.3.a +
6.4.3.e + 6.5.2.f
9.1.3.f) - Performance of External Providers 6.3.e + 6.5.h
9.1.3.g) - Needs for QMS improvements 6.3 + 6.5.2.j
9.2.1 Org Conducts Internal Audit 6.2.2.1
9.2.a) 1 - QMS conforms to Org Requirements for QMS 6.2.2.1
9.2.a) 2 - ISO requirements Clear / High Impact
9.2.b) QMS implemented and maintained 6.2.2.1

28. ISO
9001
Gap Requirements Impact
4.1 - Determine External and internal issues Unclear
4.1 - Monitor and review information about issues Unclear
4.2.a - Determine Interested parties (Stakeholders: Affecting / Affected by Organization) Clear / High Impact
4.2.b - Determine requirements of interested parties Clear / High Impact
4.3 Scope shall state types of products and services covered Clear / High Impact
4.4.1.f - Organization address risks and opportunities Clear / Low Impact
5.1.1.c - Top Management Ensure integration of QMS requirements into Bus. Process Unclear
5.1.1.d - Top Management promotes use of Process approach and Risk management Unclear
5.1.1.f - Top Management communicate importance of QMS Clear / Low Impact
5.1.1.h - Top Management engage direct and support contributions to QMS Clear / Low Impact
5.1.1.i - Top Management promotes improvement Clear / Low Impact
5.1.1.j - Top Management promotes other roles to demonstrate leadership Clear / Low Impact
5.1.2.c - Maintain focus on enhanced customer satisfaction Clear / Low Impact
5.2.1.a - Quality Policy appropriate for the purpose / context of the Org / supports direction Clear / Low Impact
5.2.2.c - Quality Policy available to interested Parties Clear / Low Impact
5.3.a - QMS conforms to requirements of ISO Clear / Low Impact
5.3.b - Processes are delivering their intended outputs Clear / High Impact
6.1.1.a - Assurance that QMS CAN achieve intended results. Unclear
6.1.1.b - Enhance desirable effects Unclear
6.1.1.d - Achieve Improvements Unclear
6.2.1.f - Quality Objectives: communicated Clear / Low Impact
6.2.1.g - Quality Objectives: updated as appropriate Clear / Low Impact
6.2.1 - Organization shall maintain documented Information on Q. Objectives Clear / Low Impact
6.2.2.a - What will be done Clear / High Impact
6.2.2.b - Resources Required Clear / High Impact
6.2.2.c - Responsibility Clear / High Impact
6.2.2.d - Completion time Clear / High Impact
6.3.c - Organization Consider availability of resources Clear / High Impact
6.3.d - Organization Consider Allocation / reallocation of roles and responsibilities Clear / High Impact
7.1.1.b Consider what needs to be obtained from external providers Clear / Low Impact
7.1.6
Determine the knowledge necessary for the operation of its processes and to achieve conformity
of products and services.
Clear / High Impact

29. 7.1.6 knowledge shall be maintained and be made available to the extent necessary. Clear / High Impact
7.1.6
shall consider its current knowledge and determine how to acquire or access any necessary
additional knowledge and required updates
Clear / High Impact
7.3.d implications of not conforming with the quality management system requirements Clear / Low Impact
7.4.b when to communicate Clear / High Impact
7.4.c with whom to communicate Clear / High Impact
7.4.d how to communicate Clear / High Impact
7.4.e who communicates Clear / High Impact
7.5.2.b ensure appropriate format Clear / Low Impact
8.1 Org review the consequences of unintended changes Clear / High Impact
8.3.2a a) the nature, duration and complexity of the design and development activities Clear / Low Impact
8.3.2h h) requirements for subsequent provision of products and services; Unclear
8.3.2i i) level of control expected for design and development process by relevant interested parties Clear / Low Impact
8.4.3d d) the external providers’ interactions with the organization; Clear / Low Impact
8.5.1.g) g) Implementation of actions to prevent human errors. Clear / High Impact
8.5.3 Property belonging to customers or external providers Clear / Low Impact
8.5.5.a) a) statutory and regulatory requirements Clear / Low Impact
8.5.5.b) b) the potential undesired consequences associated with its products and services Unclear
8.5.5.c) c) the nature, use and intended lifetime of its products and services Clear / Low Impact
8.5.5.d) d) customer requirements Clear / Low Impact
8.5.5.e) e) customer feedback. Clear / Low Impact
8.7.2 - d) Identification of the authority deciding the actions taken. Clear / Low Impact
9.1.1.a) Organization determine what needs to be monitored and measured Clear / Low Impact
9.1.1.c) Organization determine when Clear / Low Impact
9.1.1.d) Organization determine when to analyze and evaluate Clear / Low Impact
9.2.a) 2 - ISO requirements Clear / High Impact
9.3.2.c) 1 + Customer satisfaction / feed back Clear / Low Impact
9.3.2.c) 2 + Meeting Quality Objectives Clear / Low Impact
9.3.2.d) - Adequacy of Resources Clear / Low Impact
9.3.3.a) - Opportunities for improvements Clear / Low Impact
10.1 - Organization implement actions to meet customer requirements / improve customer satisfaction Clear / Low Impact
10.1.a) - Improving Products Clear / High Impact
10.2.1.b) 3 - Detect other / potential nonconformities Clear / High Impact

30. ISO 9000, 2005 => 2015
Concession
permission to use or release a product or service that does not conform to
specified requirements
Customer
person or organization that could or does receive a product or a service that is
intended for or required by this person or organization
Customer Satisfaction
customer’s perception of the degree to which the customer’s [requirements]
expectations have been fulfilled
Competence
[demonstrated] ability to apply knowledge and skills to achieve intended results
Capability
ability of an [organization, system or process] object to realize an output that will
fulfil the requirements for that [product] output
Quality Management System
part of a management system [to direct and control an organization ]with regard
to quality

31. The Way Forward
• SC18 to issue immediately ballots to correct the normative
references for ISO 9000 in Q1, 9th Ed and Q2, 1st Ed to be
edition specific.

32. The Way Forward
• SC18 to issue immediately ballots to correct the normative
references for ISO 9000 in Q1, 9th Ed and Q2, 1st Ed to be
edition specific. Addendum Issued 2/26/16 Closes 3/25/16
• SC18 to publish the work of the TG by circulating it to its
general membership. Published in the meeting minutes.
• TG2 to work on suggested wordings to close the gaps, and use
it as a segway to write API Q1, 10th Ed. New Chair Jason Kody
with Shell

33. Resources
• API SC18 on Quality, Meeting Minutes for 2016 Winter Standards Meeting,
Austin-Texas , January 2016.
http://mycommittees.api.org/standards/ecs/sc18/Meeting%20Materials/2016/January%20
2016%20-%20Austin,%20TX/SC18%20Minutes%20-%20Austin%20January%202016.pdf
• Whitepaper: Auditing Under ISO 9001:2015
http://go.pardot.com/l/73472/2016-02-02/3qnf1b
• ISO in Plain English http://www.praxiom.com/iso-definition.htm
• ISO 9001:2008 to ISO 9001:2015 Summary of Changes
http://www.iso.org/tc176/sc02/public
• Awareness and Use of ISO 9000:2015: Quality management systems — Fundamentals and
vocabulary
• ASQStandardsChannel http://videos.asq.org/asq-standards-channel
ANY and ALL Trade Marks mentioned or referenced in this presentation are registered property and belong wholly to ISO or API. They are used here for illustration purposes only.
ISO and/or API are not responsible for any of the content of this presentation.

34. QUESTIONS?