iso 9001:2015 transition training - platinum...

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ISO 9001:2015 Transition Training

Auditor Training Program


Overview• Background of Changes

• Timeline

• Client Guidelines for Transition

• Transition Plan

• Competency Requirements

• Certified Auditor Competency Requirements

• Platinum Sponsored Training

Background of Changes

Annex SLIn April 2012, the International Organization for Standardization (ISO) published Annex SL. Thisdocument was developed to provides identical structure, text and common terms and definitionsfor management system standards to follow for future revisions. This approach was developed toreduce confusion and ease implementation of multiple management system standards withinorganizations.

Three management system standards have already been published using the Annex SL formatwith another seven on the way. ISO 9001:2015 follows this new structure as does ISO14001:2015. There are 10 section in Annex SL – and these sections are also in harmonizedstandards.

• Annex SL sections rather than the 8 sections in 9001:2008:


1.Scope

3.Terms andDefinitions

5.Leadership

7.Support

9.PerformanceEvaluation

2.Normativereferences

4.Context of theorganization

6.Planning

8.Operations

10.Improvement

Background of Changes

Standard Modifications

As a general rule, International Standards are modified every 5 years. Historically, it hasbeen more than every 5 years. So, probably the next revision will occur after 2020.

The standards are modified based upon communications and expectations from usersand are influenced by other standards as they are modified and used.

The standard moved from draft international standard (DIS) to final draft internationalstandard (FDIS) and then to the final published version.

The final published version is available for purchase at www.asq.org or through ISO.org.All auditors are expected to have a legal copy of this document.

The ISO 9000:2015 standard has also been modified and it includes terminology anddefinitions used in ISO 9001:2015.



Historical QMS Documentation Structures

Quality ManualAn overview of the policies of the management system…provides a cross-reference to other documents within the

system. This is no longer specified in the 2015 version of 9001.

Quality ProceduresHigh level documents that describe the process.

Quality InstructionsDetailed documents that describe the exact methods for the process

Quality FormsDetailed documents that tell someone what to record

Quality RecordsOutputs of the performance of a process. Evidence the process was performed.


2015 Management System DocumentationStructure – Annex SL

Documented Information – Maintained(Instructions)

Documented Information – Retained (Evidence)

9001:2008 vs 9001:2015

• A comparison document is available as part of thistraining.

• Auditors use a gap checklist that will be used todemonstrate continued conformance to 2008 duringtransition assessments.


Timeline


Activity Tentative Date Comments

FDIS Release July 9, 2015

US TAG Voting Closure August 23, 2015

Platinum Accreditation by ANAB for2015 Version

Application in processHope to have completion byAugust

FDIS Official Voting Closure September 2015

Publication of ISO 9001:2015 September 15, 2015 Auditors cannot perform 2015 audits withoutmeeting qualification criteria

Final date where initial audits can beconducted to ISO 9001:2008

1 year from date of publicationSeptember 15, 2016

Final date for transition of existingclients to ISO 9001:2015

3 years from date of publicationSeptember 15, 2018

Date where ISO 9001:2008 becomesobsolete

3 years from date of publicationSeptember 15, 2018

Platinum will push transition audits back toJune 2018 (or before) for audits falling in theJuly-September timeframe

Guidelines for Transition(These are the guidelines provided to clients)

1. Transition assessments should not be scheduled until the client is prepared fortransition (i.e., system has been upgraded and a round of internal audits and acomplete management review has been performed).

2. Transition assessments will be full system reviews and will result in the re-issuanceof new certificates with new three-year expiration dates.

3. The least costly way to transition from ISO 9001:2008 to 2015 will be at the client’snormal reassessment; however, if the client’s reassessment will occur in the lastthree months prior to ISO 9001:2008’s obsolescence (i.e., July-September 2018),Platinum is encouraging them to do an early reassessment either in their normalreassessment year or when their second surveillance would be scheduled.

4. All reassessments will require additional audit time from .5 day to 1 day dependingupon the size and complexity of the client’s system and the degree of change that ismaking going to be made to the client’s system.


Guidelines for Transition

5. Clients may not want to wait until their reassessment to transition to ISO 9001:2015.That is not a problem with Platinum! There are two additional options for clients toconsider: 1) transition at early re-assessment during an normal surveillanceassessment (additional time will need to be added), 2) transition through a specialmid-cycle assessment (additional time will be added).

6. There are very few required procedures/documents in the 2015 Standard. Clientscannot eliminate any required procedures from their management system until theyhave successfully transitioned to the 2015 Standard. This is because they mustmaintain conformance to 2008 until the transition is complete to avoid a lapse incertification. As they prepare for their transition assessment, they can changeterminology to address the new requirements as long as they are careful to maintainconformance to ISO 9001:2008.



7. They may elect to delete the documents once they have successfully transitioned,provided they are not required by the ISO 9001:2015 Standard; however, they shouldbe cautioned that there are risks involved in this approach. Auditors will have to relyon interviews and records reviews to demonstrate that a repeatable process existsand to confirm conformance to requirements. Conformance to undocumentedprocesses may be demonstrated in this manner when the processes are stable andthe client’s personnel is well trained, or, of course when tools are in place to controlthe processes. Not documenting processes also opens the organization up to risk ifkey personnel leave. Checking with interested parties before eliminating qualitymanuals and procedures can help to assure that their needs are satisfied as theclient modifies their management system.



8. The management system and Internal Audits will be expected to be process-based.If a client’s audits are strictly standards-based – then they should revisit theirapproach.

9. Transition assessments occurring after July 2018 will be subject to an expedite feeequivalent to one assessment day, transition assessments occurring after August2018 will be subject to an expedite fee equivalent to two assessment days andtransition assessments occurring in September 2018 will be subject to an expeditefee equivalent to three assessment days. This is being instituted to persuade clientsfrom waiting until the last minute to transition.

10. Failure to transition (meaning audit is complete, corrective actions have beenreceived, reviewed and approved AND the file has been reviewer with certificationgranted) prior to September 15, 2018 will result in the withdrawal of certification. Ifthis occurs, then the client will need to start again with an initial assessment to havecertification reinstated.


Transition Plan

• Platinum will transition all 9001:2008 clients by September 15, 2018.

• The office will be contacting all clients with a Transition Guidance, Expectations andApplication document to determine their approach and desired timeline for transition.This timeframe will be recorded in the audit database and the transition audit will beidentified as such in the database.

• 2008 assessment opening meeting checklists for 9001:2008 assessments will promptthe auditor to discuss the upcoming transition years and methods.

• Making sure that we know the criteria to audit to is critical. 90 days prior to eachassessment, the database is programmed to send a confirmation letter to the client.30 days before the audit (or as soon as is practicable, the Lead Auditor will send theaudit schedule to the client. One week before the audit (or before purchasing airfare)the Lead Auditor will contact the client to confirm details of the audit and receipt of theschedule.


Transition Plan

• 2015 assessment checklists and reporting tools will only be available for transitionassessments in the database to reduce the chance of errors. A Transition Checklistwill be available on the server for auditing the delta between 2008 and 2015. Thischecklist will be used for each transition assessment along with the 2015 checklist.

• All transition assessments will be a full system review using the same methodologyas for 9001:2008. We will use a Process Analysis Tool to evaluate client processeswhen auditing to ISO 9001:2015, particularly where there are no documentedprocedures. This data will be captured by our database for use in future audits of theclient's systems.

• All issues that require client action for conformance with the new requirements will beclearly identified and raised as documented nonconformances in the same manner asfor 9001:2008, using the same tools. All nonconformances must be corrected and,where appropriate, be resolved with corrective action. Evidence of corrective actionand verification activities must be provided and accepted prior to being recommendedfor certification.


Transition Plan

• Where nonconformances are identified, they will be written against ISO 9001:2015unless the nonconformance is only related to a requirement that is only in ISO9001:2008.

• In addition, a cross-reference matrix has also been developed as a tool to guideclients through the transition from ISO 9001:2008 to ISO 9001:2015. This will also beavailable on the Platinum website.

• Note: The Process Analysis Tool that we will use will to evaluate clients processeswill also be available to clients on our website along with a summary of changesbetween 9001:2008 and 9001:2015. You can point the clients to the website forthese documents!


Short-Term Competency Requirements

• Everyone who audits and supports the audit process will have todemonstrate that they are competent to perform their respectivejobs.

• In the short term:– Knowledge of the Transition Process

• Auditors, Reviewers, Sales Personnel, Project Managers/Assessment Coordinators and Managementwill need to understand the transition process and the Transition Procedure. Knowledge will bedetermined though a quiz.

– Knowledge of the Standard• Auditors, Reviewers, Sales Personnel, Project Managers/Assessment Coordinators and Management

must be familiar with the requirements of ISO 9001:2015. Knowledge will be determined though a quiz.

– Knowledge of Key Differences• Auditors, Reviewers and Sales Personnel must understand the key changes between the 2008 and

2015 standards. These are discussed here in this presentation as well as the Transition Checklist andthe Differences Between 9001:2008 to 9001:2015. Knowledge will be determined within theStandards quiz.


Short-Term Competency Requirements

– Auditing skills• Auditors and Reviewers must have skills to perform ISO 9001:2015 audits The skills in auditing

9001:2008 transfer to the new standard, as long as key differences in the standard and auditingapproaches are understood.

• This transition training will address auditing approaches for new issues introduced with the formati of2015.

• Additional techniques will be addressed during the 2 day transition training course in December

• Ongoing witness audits and reviews will confirm auditor skills in practice.

– Quoting Knowledge• Sales Personnel, Project Managers and Management must be familiar with the quoting process and

the calculation of audit days for transition assessments per the Transition and Sales Procedures. Afterone on one training, Management will sign off competency records for quoting to 9001:2015 once it isclear that the individual being trained understands how to quote transition assessments.


Long-Term Competency Requirements

• In order to maintain certification, auditors will be required to provideevidence of ISO 9001:2015 competency (two day transition) trainingfor IRCA by September 1, 2018.

•

• In order to maintain certification, auditors will be required to provideevidence of ISO 9001:2015 competency test for Exemplar Global byDecember 31, 2015 and then you have three years to audit tothe Standard.


Platinum-Sponsored Transition Training for Auditors

• Platinum will sponsor an IRCA-accredited two day transition trainingcourse. It will be held at the Doubletree on Quebec at Stapleton.Participants need to be present from 7:45 am – 5:00 pm. Thecourse will begin promptly at 8:00 am. All personnel and contractorswill be welcome to attend.

• Lunch will be provided.

• Attendees must read the standard and sit our internal exams inadvance of this class. We would like everyone through the internalcourse and exams by the 7th of November.



Requirements Awareness and Platinum Auditing Policies


Requirements Awareness and Platinum Auditing Policies

Scope - describes the boundary of the system and what is being certifiedduring the audit.

– The scope in the Quality Manual should “match” the Company Information Sheet,Authorization to Proceed. The scope need not “match” when parts of themanagement system are not certified, for example.

– If the company does more than is being certified, the manual must clearly identifythe boundary of the certification.

– Auditors cannot add to the scope without assuring that the office is aware of thechange and that the audit checklist supports the scope statement.

– Scopes must be identified for each location when multiple sites are in scope.(This is new in 2015, but we will do this for 2008 audits as well.)


Applicability of Exclusions

Exclusions vs Requirements Not Applicable– In 2008, these can only be included where the client does not perform the activities identified

in section 7 of the Standard.

– In 2015 – any requirement that the company determines is not applicable can be identified assuch. These will be identified on the certificate.

Site exclusions are identified on multi-sites so that users of the certificateand reviewers clearly understand the activities of the various locationsassociated with the certificate.

– For 2008, the overall certificate scope identified on page 1 of the certificate can only includeexclusions in section 7. Site exclusions can identify other areas of the Standard as well.

– For 2015 – requirements that are deemed to be not applicable will be listed on the certificateonly by location for multi-sites.

Stage 1 Assessments During Transition

Stage 1 assessments may not be required if the Application provided by theclient demonstrates that the changes being made to the organization are notsignificant.

Stage 1 assessments will be performed if there is a concern that the client mayhave issues passing the transition assessment.


Systems without Procedures & Work Instructions

9001:2015 does not specifically require documented procedures. Systemswithout documented procedures must be assessed by asking about thebusiness process and then confirming that the process is followed in a system-like manner through interviews and reviewing documented information retainedas evidence. The Process Analysis Tool will facilitate getting prepared for suchaudits.

Auditors must be able to confirm that a process exists and that the system isnot being performed haphazardly.

Consistent interviews and documented evidence will be imperative.

IMPORTANT!!!!

If a defined process cannot be demonstrated, the effectiveness of the processcannot be demonstrated either.


Top Management Responsibility

9001:2015 eliminates the requirement for a management representative.Instead it calls for top management’s leadership and commitment.

This means that the audit team must interview top management and that thisgroup of individuals must be able to demonstrate leadership and commitmentrequirements defined by the standard. If all of top management is notavailable, the audit team can be flexible and speak with some of topmanagement, but this cannot be the case over the all of the audits in thecertification cycle.

Failure of top management to be available could result in a significantnonconformance and/or a follow-up assessment.


A New Approach to Stage 1 Assessments

Stage 1 assessments will focus on the implementation and the readiness of thesystem and less on the requirements being translated into documentedinformation.

We will continue to use the stage 1 checklist, supplemented with the ProcessAnalysis Tool, reviewing implementation and documented information retained,where possible.

Stage 1 assessments may not be required for existing customers, unless theirtransition approach has caused significant changes to their managementsystem.



Summary

• We have contacted our clients and we are not gettingany message for an urgent need to transition prior to2016.

• Clients will be communicated to regarding expectationsand the transition process and application. We willcontinue to monitor the clients’ requested schedules fortransition until they are though the process.

• Auditors should continue to train and provide feedbackon the tools and approach.

• Please remember to take the exam and send thecertificate to the office! (Print the certificate inlandscape.)

iso 9001:2015 transition training - platinum...

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