ISO 9001:2015 Transition Training

Transcription

1 ISO 9001:2015 Transition Training Auditor Training Program

2 Overview Background of Changes Timeline Client Guidelines for Transition Transition Plan Competency Requirements Certified Auditor Competency Requirements Platinum Sponsored Training

3 Background of Changes Annex SL In April 2012, the International Organization for Standardization (ISO) published Annex SL. This document was developed to provides identical structure, text and common terms and definitions for management system standards to follow for future revisions. This approach was developed to reduce confusion and ease implementation of multiple management system standards within organizations. Three management system standards have already been published using the Annex SL format with another seven on the way. ISO 9001:2015 follows this new structure as does ISO 14001:2015. There are 10 section in Annex SL and these sections are also in harmonized standards. Annex SL sections rather than the 8 sections in 9001:2008: 1. Scope 3. Terms and Definitions 5. Leadership 7. Support 9. Performance Evaluation 2. Normative references 4. Context of the organization 6. Planning 8. Operations 10. Improvement

4 Background of Changes Standard Modifications As a general rule, International Standards are modified every 5 years. Historically, it has been more than every 5 years. So, probably the next revision will occur after The standards are modified based upon communications and expectations from users and are influenced by other standards as they are modified and used. The standard moved from draft international standard (DIS) to final draft international standard (FDIS) and then to the final published version. The final published version is available for purchase at 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 and definitions used in ISO 9001:2015.

5 Historical QMS Documentation Structures Quality Manual An 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 Quality Procedures High level documents that describe the process. Quality Instructions Detailed documents that describe the exact methods for the process Quality Forms Detailed documents that tell someone what to record Quality Records Outputs of the performance of a process. Evidence the process was performed.

6 2015 Management System Documentation Structure Annex SL Documented Information Maintained (Instructions) Documented Information Retained (Evidence)

7 9001:2008 vs 9001:2015 A comparison document is available as part of this training. Auditors use a gap checklist that will be used to demonstrate continued conformance to 2008 during transition assessments.

8 Timeline Activity Tentative Date Comments FDIS Release July 9, 2015 US TAG Voting Closure August 23, 2015 Platinum Accreditation by ANAB for 2015 Version Application in process Hope to have completion by August FDIS Official Voting Closure September 2015 Publication of ISO 9001:2015 September 15, 2015 Auditors cannot perform 2015 audits without meeting qualification criteria Final date where initial audits can be conducted to ISO 9001: year from date of publication September 15, 2016 Final date for transition of existing clients to ISO 9001: years from date of publication September 15, 2018 Date where ISO 9001:2008 becomes obsolete 3 years from date of publication September 15, 2018 Platinum will push transition audits back to June 2018 (or before) for audits falling in the July-September timeframe

9 Guidelines for Transition (These are the guidelines provided to clients) 1. Transition assessments should not be scheduled until the client is prepared for transition (i.e., system has been upgraded and a round of internal audits and a complete management review has been performed). 2. Transition assessments will be full system reviews and will result in the re-issuance of 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 s normal reassessment; however, if the client s reassessment will occur in the last three 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 normal reassessment year or when their second surveillance would be scheduled. 4. All reassessments will require additional audit time from.5 day to 1 day depending upon the size and complexity of the client s system and the degree of change that is making going to be made to the client s system.

10 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 to consider: 1) transition at early re-assessment during an normal surveillance assessment (additional time will need to be added), 2) transition through a special mid-cycle assessment (additional time will be added). 6. There are very few required procedures/documents in the 2015 Standard. Clients cannot eliminate any required procedures from their management system until they have successfully transitioned to the 2015 Standard. This is because they must maintain conformance to 2008 until the transition is complete to avoid a lapse in certification. As they prepare for their transition assessment, they can change terminology to address the new requirements as long as they are careful to maintain conformance to ISO 9001:2008.

11 Guidelines for Transition 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 should be cautioned that there are risks involved in this approach. Auditors will have to rely on interviews and records reviews to demonstrate that a repeatable process exists and to confirm conformance to requirements. Conformance to undocumented processes may be demonstrated in this manner when the processes are stable and the client s personnel is well trained, or, of course when tools are in place to control the processes. Not documenting processes also opens the organization up to risk if key personnel leave. Checking with interested parties before eliminating quality manuals and procedures can help to assure that their needs are satisfied as the client modifies their management system.

12 Guidelines for Transition 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 their approach. 9. Transition assessments occurring after July 2018 will be subject to an expedite fee equivalent to one assessment day, transition assessments occurring after August 2018 will be subject to an expedite fee equivalent to two assessment days and transition assessments occurring in September 2018 will be subject to an expedite fee equivalent to three assessment days. This is being instituted to persuade clients from waiting until the last minute to transition. 10. Failure to transition (meaning audit is complete, corrective actions have been received, reviewed and approved AND the file has been reviewer with certification granted) prior to September 15, 2018 will result in the withdrawal of certification. If this occurs, then the client will need to start again with an initial assessment to have certification reinstated.

13 Transition Plan Platinum will transition all 9001:2008 clients by September 15, The office will be contacting all clients with a Transition Guidance, Expectations and Application document to determine their approach and desired timeline for transition. This timeframe will be recorded in the audit database and the transition audit will be identified as such in the database assessment opening meeting checklists for 9001:2008 assessments will prompt the 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 each assessment, 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 the audit 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 the schedule.

14 Transition Plan 2015 assessment checklists and reporting tools will only be available for transition assessments in the database to reduce the chance of errors. A Transition Checklist will be available on the server for auditing the delta between 2008 and This checklist will be used for each transition assessment along with the 2015 checklist. All transition assessments will be a full system review using the same methodology as for 9001:2008. We will use a Process Analysis Tool to evaluate client processes when auditing to ISO 9001:2015, particularly where there are no documented procedures. This data will be captured by our database for use in future audits of the client's systems. All issues that require client action for conformance with the new requirements will be clearly identified and raised as documented nonconformances in the same manner as for 9001:2008, using the same tools. All nonconformances must be corrected and, where appropriate, be resolved with corrective action. Evidence of corrective action and verification activities must be provided and accepted prior to being recommended for certification.

15 Transition Plan Where nonconformances are identified, they will be written against ISO 9001:2015 unless the nonconformance is only related to a requirement that is only in ISO 9001:2008. In addition, a cross-reference matrix has also been developed as a tool to guide clients through the transition from ISO 9001:2008 to ISO 9001:2015. This will also be available on the Platinum website. Note: The Process Analysis Tool that we will use will to evaluate clients processes will also be available to clients on our website along with a summary of changes between 9001:2008 and 9001:2015. You can point the clients to the website for these documents!

16 Short-Term Competency Requirements Everyone who audits and supports the audit process will have to demonstrate that they are competent to perform their respective jobs. In the short term: Knowledge of the Transition Process Auditors, Reviewers, Sales Personnel, Project Managers/Assessment Coordinators and Management will need to understand the transition process and the Transition Procedure. Knowledge will be determined 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 and the Differences Between 9001:2008 to 9001:2015. Knowledge will be determined within the Standards quiz.

17 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 auditing approaches are understood. This transition training will address auditing approaches for new issues introduced with the formati of 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. After one on one training, Management will sign off competency records for quoting to 9001:2015 once it is clear that the individual being trained understands how to quote transition assessments.

18 Long-Term Competency Requirements In order to maintain certification, auditors will be required to provide evidence of ISO 9001:2015 competency (two day transition) training for IRCA by September 1, In order to maintain certification, auditors will be required to provide evidence of ISO 9001:2015 competency test for Exemplar Global by December 31, 2015 and then you have three years to audit to the Standard.

19 Platinum-Sponsored Transition Training for Auditors Platinum will sponsor an IRCA-accredited two day transition training course. It will be held at the Doubletree on Quebec at Stapleton. Participants need to be present from 7:45 am 5:00 pm. The course will begin promptly at 8:00 am. All personnel and contractors will be welcome to attend. Lunch will be provided. Attendees must read the standard and sit our internal exams in advance of this class. We would like everyone through the internal course and exams by the 7 th of November.

20 Requirements Awareness and Platinum Auditing Policies

21 Requirements Awareness and Platinum Auditing Policies Scope - describes the boundary of the system and what is being certified during 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 the management system are not certified, for example. If the company does more than is being certified, the manual must clearly identify the boundary of the certification. Auditors cannot add to the scope without assuring that the office is aware of the change 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.)

22 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 as such. These will be identified on the certificate. Site exclusions are identified on multi-sites so that users of the certificate and reviewers clearly understand the activities of the various locations associated with the certificate. For 2008, the overall certificate scope identified on page 1 of the certificate can only include exclusions 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 certificate only by location for multi-sites.

23 Stage 1 Assessments During Transition Stage 1 assessments may not be required if the Application provided by the client demonstrates that the changes being made to the organization are not significant. Stage 1 assessments will be performed if there is a concern that the client may have issues passing the transition assessment.

24 Systems without Procedures & Work Instructions 9001:2015 does not specifically require documented procedures. Systems without documented procedures must be assessed by asking about the business process and then confirming that the process is followed in a systemlike manner through interviews and reviewing documented information retained as evidence. The Process Analysis Tool will facilitate getting prepared for such audits. Auditors must be able to confirm that a process exists and that the system is not being performed haphazardly. Consistent interviews and documented evidence will be imperative. IMPORTANT!!!! If a defined process cannot be demonstrated, the effectiveness of the process cannot be demonstrated either.

25 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 this group of individuals must be able to demonstrate leadership and commitment requirements defined by the standard. If all of top management is not available, the audit team can be flexible and speak with some of top management, but this cannot be the case over the all of the audits in the certification cycle. Failure of top management to be available could result in a significant nonconformance and/or a follow-up assessment.

26 A New Approach to Stage 1 Assessments Stage 1 assessments will focus on the implementation and the readiness of the system and less on the requirements being translated into documented information. We will continue to use the stage 1 checklist, supplemented with the Process Analysis Tool, reviewing implementation and documented information retained, where possible. Stage 1 assessments may not be required for existing customers, unless their transition approach has caused significant changes to their management system.

27 Summary We have contacted our clients and we are not getting any message for an urgent need to transition prior to Clients will be communicated to regarding expectations and the transition process and application. We will continue to monitor the clients requested schedules for transition until they are though the process. Auditors should continue to train and provide feedback on the tools and approach. Please remember to take the exam and send the certificate to the office! (Print the certificate in landscape.)