Presented by Understanding the Key Changes to: ISO 9001 ... · Having ISO 9001 as the baseline to AS9100 helps maintain QMS continuity across the Aviation, ... • Management Representative

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Paul DionneABS Quality Evaluations

Understanding the Key Changes to: ISO 9001:2015, AS9100D, andAS9101E – Auditing Standard

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Presentation Notes

Hello and thank you for joining me today. My name is Paul Dionne and I am the ABS Quality Evaluations Global Aerospace Program Manager. ABS Quality Evaluations conducts third party auditing services for ISO9001, AS9100 and AS9120. Can I please see a show of hands of how many organizations in attendance are actually third party certified to one of the standards I just mentioned? Can I please see a show of hands of how many organizations in attendance will be possibly obtaining certification to one of the standards noted? Today I will present a high level presentation that will cover the key changes between the International Aerospace Quality Group’s (IAQG) planned revision to the AS9100 standard (9100D) and the AS9101E third party aerospace audit standard

ABS Group Organizational Overview

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First I would like to present a brief overview of our company, the American Bureau of Shipping Company. Headquartered in Houston, ABS Group of Companies, Inc., is a wholly-owned affiliate of ABS. ABS Group of Companies offers its clients a portfolio of professional services, primarily in the safety, risk and integrity management sector through its various operating subsidiaries.

ABS Group Overview

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ABS Group is strategically located in key global locations to support all product lifecycle phases from concept to operations. With more than 2,000 employees worldwide, ABS Group serves an increasingly diverse range of market sectors and industries including: Offshore & Onshore Oil and Gas, Chemical, Maritime, Government, Manufacturing, Power, Pharmaceuticals, Manufacturing, and auditing services. We provide a range of technical solutions to support safe, reliable and high-performance assets and operations.

ISO 9001:2015 and AS9100:2016

An Overview Of The Key Changes

Topics for Overview

• ISO 9001:2015 & AS9100D:2016 - ISO9001Background- ISO 9001 Revision Activities – Why Change?- ISO 9001 and AS9100 Relationship- Transition Timelines- AS9100D Revision Activities – Why Change?- Summary

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The topics that I will discuss today concerning the two noted standards will include these 5 bullet points at a high level.

ISO 9001 needs to change, to:

• Adapt to a changing world • Enhance an organization's ability to satisfy its customers• Provide a consistent foundation for the future • Reflect the increasingly complex environments in which organizations

operate • Ensure the new standard reflects the needs of all interested parties • Integrate with other management systems

Why revise ISO 9001?

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Addresses organizations that establish their QMS for more that one standard. 5 topics with greater emphasis than with the current ISO9001:2008 standard.

Key Changes

• High level structure (HLS) and terms/definitions• More efficient to address multiple management system requirements• Standardized core definitions• There is now greater emphasis on:

- The customer- Risk-based thinking- Greater flexibility with documentation - The term documented

information replaces the terms document and record- Preventive action is throughout the standard as risk

identification and mitigation- Control of externally provided products and services replaces

purchasing/outsourcing

ISO 9001:2015 Revision Activities

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Presentation Notes

Addresses organizations that establish their QMS for more that one standard. 5 topics with greater emphasis than with the current ISO9001:2008 standard.

ISO 9001:2015 Revision ActivitiesDo Check ActPlan

4 Context of organization 5 Leadership 6 Planning 7 Support 8 Operation 9 Performance and

Evaluation 10 Improvement

4.1 Understanding context

4.2 Interested parties

4.3 Scope

4.4 QMS

5.1.1 Leadership and commitment

6.1 Actions to address risk and opportunity

6.2 Objectives and planning

7.1 Resources9.1 Monitoring, measurement, analysis and evaluation

10.1 Nonconformity and corrective action

10.2 Continual improvement

5.2 Policy

5.3 Roles, responsibilities and authorities

7.3 Awareness

7.4 Communication

7.5 Documented information

7.2 Competence9.2 Internal audit

9.3 Management review

8.1 Operational planning and control

5.1.2 Customer Focus

6.2 Planning of Changes

Next Slide

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This slide shows the new alignment of the standard within the Plan, Do, Check, Act model PDCA . You will notice that the 2015 revision has 10 sections instead of 8. Product Realization formerly section 7 is now identified as Operation within section 8. The next slide identifies the sub-clauses within the Operation section.

ISO 9001:2015 Revision Activities

8.1 Operational planning and control

8.3.6 Design and development changes

8.5.3 Property belonging to customers or external providers

8.5 Production and service provision

8.5.1 Control of production and service provision

8.5.2 Identification and traceability

8.5.6 Control of changes

8.7 Control of nonconforming process outputs, products and services

8.5.4 Preservation

8.5.5 Post-delivery activities

8.6 Release of products and services

8.2 Determination of requirements for products and services

8.2.1 Customer communication

8.2.2 Determination of requirements related to products and services

8.2.3 Review of requirements related to products and services

8.3 Design and development of products and services

8.4 Control of externally provided products and services

8.4.1 General

8.4.2 Type and extent of control of external provision

8.4.3 Information for external providers

8.3.1 General

8.3.2 Design and development planning

8.3.3 Design and development Inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

4 Context of

organization

5 Leadership

6 Planning

7 Support

8 Operation

9 Performance and

Evaluation

10 Improvement

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Presentation Notes

Operations section 8 includes 25 sub-clauses to define the following key activities: Planning, Contract Review, Communications with Customers, Design, Control of Outsourced processes, Purchasing, Production / Service controls, Post Delivery activities, and Nonconforming Material controls.

ISO 9001:2015 Revision TimelineISO 9001:2015 Timeline

June 2013 CD(Committee Draft)

May 2014 DIS (Draft International Standard)

July 2015 FDIS (Final Draft International Standard)

September 2015 Published International Standard

201520142013

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Activities / timeline for the upcoming release of the ISO9001:2015 standard. Expectations are that the standard will be released in September 2015. There will be a 3 year period for organizations to make the necessary changes to upgrade their QMS to align with the new revision. Next slide further defines the certification bodies responsibilities for this revision.

ISO 9001:2015 Transition Timeline

September 2015 start of 3 years transition period to September 2018• Certifications to ISO 9001:2008 will no longer be valid

after September 2018

2018201720162015

September 2015 Published International Standard

ISO 9001:2015 Timeline

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Third party certifications to ISO9001:2008 will be considered as expired as of September 2018. Certification Bodies such as ABS Quality Evaluations will implement transitions during the organizations annual surveillance or renewal audits.

AS9100D:2016 Transition Timeline

Follows the ISO9001:2015 transition timeline once released - mandatory transition date is September 2018

2018201720162015

AS9100D Transition Timeline

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Partnership between ISO 9001 and AS9100?

• Goal is for 90% of the tier 1 aerospace supply chain to be AS9100 certified

• It is recognized that lower tier suppliers do not always need the rigor of AS9100 based on their complexity of work

• Certification to AS9100 can be as a dual certification with ISO 9001• Having ISO 9001 as the baseline to AS9100 helps maintain QMS

continuity across the Aviation, Space & Defense (ASD) supply chain• ASD Industry can and will add additional Industry requirements as

needed in addition to ISO9001 when needed.

ISO 9001 versus AS9100 Relationship

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ISO9001 provides the foundation for the organizations’ QMS and AS9100 includes the additional requirements that are necessary to provide the additional ASD Industry requirements. The additional ASD requirements are identified in the AS9100 standard using bold italic font to provide easy identification of what the ASD industry identifies as the “adders”.

Why Revise AS9100?

AS9100 needs to change, to:

• Incorporate changes made by ISO TC176 to the embedded ISO 9001 standard

• Consider Aviation, Space and Defense stakeholders’ needs identified since the last revision

• Consider clarifications to 9100 series requests issued by IAQG since the last revision (Resolutions / Frequently Asked Questions)

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AS9100D:2016 – Key Changes

Key Changes

• Product Safety added in carefully selected areas.• Human Factors added as a consideration in Nonconformity /

Corrective Action• Risk merged current 9100 requirements with the new ISO

requirements and emphasis on Risks in Operations • Preventive Action current clause requirements absorbed into Risk &

Opportunities and Nonconformance & corrective action clauses, 9100 additions reinforce prevention

• Counterfeit Products enhanced in carefully select areas and limited new requirements

• Configuration Management clarified and improved considerably to address stakeholder needs

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Presentation Notes

You see the list of new or revised sections within the AS9100D standard.

AS9100D:2016 – Key Changes

Key Changes

• Product Realization & Planning clarified and enhanced planning throughout the standard

• Post Delivery Support merged current 9100 requirements with the new ISO requirements

• Project Management & Work Transfer combined with Operation Planning clause to address user interpretation issues

• Design Development and Supplier Management gap analysis -ISO text has been added back in a few places to meet the IAQG needs

• Quality Manual note added pointing to the requirements that make up a Quality Manual or the equivalent

• Management Representative requirement added back in for QMS oversight

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Presentation Notes

You see the list of new or revised sections within the AS9100D standard.

Organizations are recommended to take the following actions:

• identify organizational gaps which need to be addressed to meet new requirements,

• develop an implementation plan,• provide appropriate training and awareness for all parties that have

an impact on the effectiveness of the organization,• update existing quality management system (QMS) to meet the

revised requirements and provide verification of effectiveness,• where applicable, liaise with your certification body for transition

arrangements.

Recommended Steps For ISO and or AS transition

NOTE: users should be aware that at Draft International Standard (DIS) stage technical changes may still occur, therefore it is recommended that, while preparation can be carried out at DIS, significant changes should not be implemented until the Final Draft International Standard (FDIS) is issued and the technical content is finalized.

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Key steps that Organizations should take to upgrade their QMS to the latest revisions of the standards.

Implementation Benefits• When implemented and managed well:• Organization will produce and continually improve safe and reliable

products• Meet or exceed customer and regulatory requirements to ensure

satisfaction• Processes necessary to conduct day-to-day business are defined and

managed• Documentation accurately reflects the work to be performed and

actions to be taken• Focus on the complete supply chain and stakeholders• Fewer customer unique documents• Recognized by Regulatory Authorities

ISO9001:2015 / AS9100D:2016 Benefits Summary

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… Across Aviation, Space and Defense Industries

AS9101EAuditing Standard

Changes Overview

AS 9101E (2013) Revision – Revision Overview• Team Membership• Why is 9101 important? Why do we care?• 9101E Key Change Summary – What is different?

- Changes to the methods for recording objective evidence- Changes to the NCR, PEAR and Process Evaluation Matrix

forms- Definitions

AS9101E Revision Overview

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Previous version of AS9101D required auditors to records objective evidences on the Objective Evidence Checklist which did not promote process auditing. I will review today the: Changes regarding 9101E as it relates to (Process Effectiveness Assessment Reports) PEAR’s, Use of new PEM (Process Evaluation Matrix) Collecting objective evidence Key Definitions

IAQG 9101 Writing Team Member Companies

CB Representation

• ABS Quality Evaluations• Bureau Veritas Certification• Det Norske Veritas• Japan Quality Assurance• Lloyd’s Register Quality

Assurance

Industry Representation

• Rolls Royce• PFW• GKN Aerospace• Safran• Zodiac• Lockheed Martin• United Technologies• Mitsubishi Heavy

Industries

IAQG 9101 is a document of international consensus

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Presently 8 major Aerospace Industry Companies and 4 Certification Bodies are included on the AS9101E writing team. JQA has recently left the team.

• Better alignment with ISO 17021 and the IAQG’s AS 9104-1 rule standard. ASD Industry learned valuable lessons:- Previous AS9101 version changed the focus from

conformance to effectiveness; AS9101E attempts to create a balance

- The Industry was looking for a more efficient way to record objective evidence

- There was a need to remove “hidden” requirements fromAS9101forms instructions

Why Change The Audit Process?

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Key point is that auditors will now evaluate organizations QMS processes for their effectiveness.

• Defined processes and sequencing offers better repeatability and predictability

• Processes measurements can be used to:- Determine health of QMS processes- Identify waste and improvement opportunities- Manage consumer and producer risks

• AS9101E defines how these processes will be assessed by third party auditors in a standardized manner

• This is how we will all be measured by our auditors and customersIt is good to be knowledgeable of the auditing requirements to support the conduct of the audit

• Understanding the requirements can help organizations understand what their certification body auditors are looking for

Why Are Audits Important To Your organization?

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Presentation Notes

Having a QMS isn’t about creating a gold plated system with lots of procedures and measurements that add no value It isn’t about what things we can do to check the box or “pass the audit” It is about creating a framework to standardize the way processes are carried out and measured- the value to the business and to the customer will be apparent .

• Specific call out of ISO/IEC17021 requirements by clause number e.g.

• 4.2.2.4 Audit Conduct - “The requirements of ISO17021 clauses 9.1.9.3 thru 9.1.9.5 apply. In addition, the audit shall be conducted …….....”

• Incorporation of AS9104/1 requirements including the new certification structures (single site, multiple site, several sites, campus, and complex)

• Defined audit approaches

• General improvements to Audit Reports

AS9101E Key Changes

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Presentation Notes

Important comments: Certification Structures are now addressed in the audit reporting forms. Mandatory audit approaches Shifting the locations to document objective evidence during the course of the audit (elimination of the OER now requires the auditors to record the OE on the QMS Process Matrix and PEAR report).

• Updated the methods for recording of objective evidence:

- Objective Evidence Report (OER) no longer required - Objective Evidence is recorded on PEAR reports for QMS

processes that are directly related with Product Realization- Objective Evidence is recorded on QMS Matrix for QMS processes

audited that are not directly related with Product Realization- Completed audit forms will be posted on OASIS – can be

implemented by all organizations (not just a third party auditprocess)

AS9101E Key Changes

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Presentation Notes

Why did we change? There was a call by most within the auditing community to eliminate the OER The OER is really a checklist organized by each of the AS9100 series of standards and the sub-clauses There are over 400 lines in the checklist and some believed the OER added little value and did not promote process approach auditing techniques Often when a checklist is used, the auditors focus is narrowed to the items on the list, more effective methods of process auditing are lost As a concession and to ensure that necessary audit reporting is maintained, the IAQG still requires the need to record objective evidence that was previously recorded on the OER. The IAQG and Aerospace community do require that the Audit Reports, NCRs, PEAR reports, and QMS Process Matrix be uploaded into the OASIS database. So future AS9101E audit reporting will include objective evidences to be recorded on the QMS Process Matrix and PEAR forms. The OER has never been uploaded into OASIS due to its size of the file There was a need to add clarification of reporting for the new structures defined in AS9104/1 Alignment to 17021 was important to harmonize the approach and remove duplicate requirements

• Now structured into (4) Sections

• Section 1 - Process Details: Inputs, Activities, Outputs and Interactions

• Section 2 – Process Results includes the identification of performance measures and KPIs.

• Section 3 - Process Realization summarizes audit trails and sources of evidence (formerly recorded on the OER).

• Section 4 – Process Effectiveness includes an evaluation matrix (to be used after a process has been assessed).

AS9101E Key Changes: PEARs

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Presentation Notes

Aligned the Process Effectiveness Assessment Report (PEAR) to ISO 9000 definition of “Effectiveness” Effectiveness: extent to which planned activities are realized and planned results achieved Physical changes to Form 3 (PEAR) Section 1: Process inputs, activities, outputs, interactions Section 2: Performance towards planned results Section 3: Objective evidences formerly recorded on the OER Section 4: Process Evaluation Matrix (PEM) used after a process has � been assessed to ‘rate’ its effectiveness Signature line removed from the form

- Extent to which planned activities are realized and planned resultsachieved

Source: ISO 9000-2005

AS9101E Key Definitions

• Effectiveness?

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Presentation Notes

This is the ISO 9000 definition. Discuss meaning of effectiveness and give some examples. Contrast with efficiency and give some examples Brian – I like the example that you used during the auditor workshop about the drawing requirement versus complete part results better. Tent stake example Splitting wood- splitting maul VS hydraulic splitter

- The means, methods and internal requirements by which an organization intends to achieve planned results of a given process to meet customer requirements

Planned activities include conformity to process requirements and procedures.

• Planned Results?- The intended performance of a process, as defined and measured by

the organization

Planned results include product conformity (Quality) and On-time delivery (OTD) to meet customer requirements, and may include other elements as defined by the organization.

AS9101E Key Definitions• Planned Activities?

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Presentation Notes

Animated slide: Planned activities is only shown. Ask participants what are their thoughts of what the definition is . Click spacebar to reveal definition. We could think of planned activities as the conformance side of the equation.

• Designed to aid the auditor in determining process effectiveness level.

• Understanding if appropriate action is being taken is key.

Process Evaluation Matrix (PEM)CO

NFO

RMAN

CE

PERFORMANCE

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Process Evaluation Matrix Animated slide: click once to enlarge the PEM Discuss the easy stuff- level one and level 4 then talk about each of the others click twice to activate Y axis Conformance Arrow HIGHLIGHT the fact the top paragraph is the same in each cell of a row then talk about each of the rows with respect to Conformance / process realization Click thrice to activate the X axis Performance “Planned results” arrow Discuss the easy stuff- level one and level 4 then talk about each of the others. HIGHLIGHT the fact the bottom paragraph is the same in each cell of a column Fourth click activates the Effectiveness diagonal arrow However leads in negative factor but with positive results.

• The OER is no longer a mandatory form to be completed by the auditor: Objective Evidence will be recorded on the PEAR and the QMS Process Matrix

• The definitions of planned activities and planned results are added to support the definition of effectiveness

• PEM added to standardize and add clarity to effectiveness levels• Forms will no longer be part of the standard and will appear online

Summary

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The 9101 standard is not a standard for the organization to be conformant with. This standard in addition to ISO 17021 is for the conduct of the audit against the 9100 series standards

Please stop by our booth for additional literature or if you have additional questions from today’s presentation

Thank you all very much for attending this presentation!

Questions?

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Presentation Notes

The 9101 standard is not a standard for the organization to be conformant with. This standard in addition to ISO 17021 is for the conduct of the audit against the 9100 series standards

Paul Dionne, Manager, Global Aerospace Programs

ABS Quality Evaluations

[email protected]

Understanding the Key Changes to: ISO 9001:2015, AS9100D, andAS9101E – Auditing Standard

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Documents

Presented by Understanding the Key Changes to: ISO 9001 ... · Having ISO 9001 as the baseline to AS9100 helps maintain QMS continuity across the Aviation, ... • Management Representative