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.

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.

History

Spec Q1 9th Ed

ISO 9001:2015

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.

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

• 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

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

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.

SPEC Q1 9TH ED

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

ISO9001:2015

ISO 9001:2015 Structure

4 Context of

organization5 Leadership 6 Planning 7 Support 8 Operation

9 Performance

Evaluation10 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

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

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.

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.

GAP ANALYSIS

• 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

• 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

ISO

9001Requirement Description

Q1

9th EdImpact

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

ISO

9001Requirements Description

Q1

9th EdImpact

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 opportunities6.4.2.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

ISO

9001Gap 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

7.1.6Determine the knowledge necessary for the operation of its processes and to achieve conformity

of products and services.Clear / High Impact

7.1.6 knowledge shall be maintained and be made available to the extent necessary. Clear / High Impact

7.1.6shall consider its current knowledge and determine how to acquire or access any necessary

additional knowledge and required updatesClear / 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

ISO 9000, 2005 => 2015Concession

permission to use or release a product or service that does not conform to

specified requirements

Customerperson or organization that could or does receive a product or a service that is

intended for or required by this person or organization

Customer Satisfactioncustomer’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

Capabilityability of an [organization, system or process] object to realize an output that will

fulfil the requirements for that [product] output

Quality Management Systempart of a management system [to direct and control an organization ]with regard

to quality

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.

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

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

• ASQ Standards Channel 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.

QUESTIONS?