BSA International Certification Co. Private Limited.

Transcription

1 BSA International Certification Co. Private Limited. TRANSITION GUIDELINES FOR ISO 9001:2015 As everyone in the quality game is aware, the world now has a new version of ISO ISO Standards touch almost everything we do and they help to make the world a safer and more efficient place. This drives the need to evaluate the effectiveness of the standard and make changes to drive continual improvement within our own organizations and industry wide. The task of understanding the revised standard s effect on your organization can be over whelming. We at BSA want to ease our clients and potential clients into this new standard and have composed these simplified guidelines to address some of the most pressing questions and addressed what steps can be taken now to prepare for the tractions. Transition Strategy: BSA Provides this guideline document for Existing /Certified Organizations and also fresh enquires. This aim of this transition guideline document is facility there meeting the requirements of the new international standard for Quality Management System (QMS) ISO 9001:2015, which replace the previous version ISO 9001:2008. The Joint IAF ISO Joint Communiqué confirms the formal publication date of ISO 9001:2015. Having been made available on 23 September 2015 with a publication date of 15 September 2015 on the standard itself. IAF and ISO confirm that the formal publication date for ISO 9001:2015 is 15 th September 2015.The transition of certified organization to ISO 9001:2015 must be complete by 15 th September 2018.Thus the expiration date on any 2008 certificate issued after the publication of ISO 9001:2015 will be September 15, This Guideline also covers. a) The timeliness and terms under which transition arrangements have been presented to certified organizations. b) Arrangement for ensuring continued compliance with ISO 9001:2008 during the transition period. c) Mode of transition audits.i.e: Single or Staged Visits. d) Arrangements for dealing with clients that failed to meet the transition period. e) ISO 9001:2015 Transition Checklist for your readiness of Transition Audit. Transition strategy 1. For Existing / Certified clients of BSA. Please note that no certificate of QMS shall bear the expiry date later than 15 th September 2018 as all the ISO 9001:2008 certificates will be invalid after this particular date ie.15 th September May you still want to opt for ISO 9001:2008, transition to new standard i.e.9001:2015 will be required in between to keep the certificate valid. However BSA appreciates & encourages current users of ISO 9001:2008 to implement ISO 9001:2015 at an early stage. Page 1 of 14

2 Please note that if your organization does not have a transition audit prior to the end of the transition period / obsolescence date of ISO 9001:2008, and then you will no longer be certified as of the end if the transition period. In order to become certified to ISO 9001:2015, you will need to start over with an initial audit (Stage-1 and Stage-2).The Client name who has failed to complete the transition by 15 th Sep 2018 will be removed from BSA website and information will be passed on to JAS-ANZ. If your organization does have its transition audit but the audit package is not closed prior to the end of the transition period / obsolescence date of ISO 9001:2008.then an ISO 9001:2015 certificate will be issued as soon as the package can be closed. This means that there will be a lapse in your certification status. BSA s Certification Support officers will work with you to ensure the timely scheduling of any transition audits that occur later in the transition period to avoid any unfortunate situation. Based on the agreement with you, BSA is in a potential to conduct transition activities during a routine surveillance, recertification audit or a special audit. If you plan on transitioning on normal surveillance or recertification audit, extra time will be added to your audit. Guidance published by the International Accreditation Forum clearly states the following where transition audits are carried out in conjunction with scheduled surveillance or Recertification (i.e. Progressive or staged approach ), additional time is likely to be required to ensure that all activities are covered for the existing and new standards. BSA Transition processes for Certified Organization covers any one of the following options. Special one-off transition visit. or One off Transition visit +Surveillance Visit Or One off Transition Visit + Recertification Visit. te :Around 1/3 of certification audit man days for transition visit (Subject to confirmation with BSA) BSA has completed an analysis of the new requirements and our technical experts have analyzed the time it would take to effectively audit these requirements in different companies. Please note that the new standard was published on September 15, This means that the ISO 9001:2008 standard will become obsolete on September 15, 2018, As a Result, All ISO 9001:2008 certifications issued in late 2015 and beyond will have to bear an expiry date September 15, BSA will accept a client undergoing surveillance with ISO 9001:2008 version only till May 15 th We are sending out this communiqué 4 months in advance so that you may prepare well. However if a client on special request puts up a request not to be able to entertain ISO 9001:2015 Version in the year 2016,we may consider the client in Page 2 of 14

3 Please note that 1 st January 2016 onwards BSA shall be ready to take up any client which requests its surveillance against ISO 9001:2015.Clients are welcome to state that they want the Surveillance assessment to be transition BSA shall perform it against ISO 9001:2015.However we are not imposing the same upon the client. If the audit is based on ISO 9001:2008, any findings related to the new standard will be raised observations for the client information.if audit is based on ISO 9001:2015,any findings will be categorized as n-conformity and dealt with NC Handling Process as Contract Terms Conditions of BSA. If you have a Recertification audit in early 2016,it will be your strategic decision that to choose the version,but there are a few key points to bear in mind. If you have had a chance to examine your quality system against the revised requirements and feel that you are ready, you can certainly request that a transition audit to ISO 9001:2015 be performed. Timing the transition to its regular recertification audit is ideal, but not in any way mandatory. You may certainly perform 2016 Recertification Audit to ISO 9001:2008, and then complete a Transition audit to ISO 9001:2015 in Actions required from existing customers: The International Accreditation Forum (IAF) has published an informative Document (ID 9)which recommends the following steps be taken in a the transition to ISO 9001: A Full review of the ISO 9001:2015 standards should be performed by Top Management identifies the gaps that need to be addressed.(in this case you may use below ISO 9001:2015 Transition checklist ) 2. A Plan of implementation should be developed with assigned responsibilities. 3. All Quality management system documents (including the quality and procedure manual (If Applicable) should be updated to reflect any new or revised processes. 4. All necessary awareness and transition training should be completed. 5. A Full system internal audit followed by a management Review should be Complete. 6. Corrective Actions for all internal audit findings should be in process or complete. 7. Coordinate with BSA for Planning of transition arrangements. Page 3 of 14

4 2. For Fresh Enquires If an organization is not yet certified & has been working at implementing ISO 9001:2008 for a while, BSA appreciates that a lot of work may have gone into preparing for certification to ISO 9001:2008.BSA will allow initial audits to the 2008 version of the standard However keeping in mind that ISO 9001:2008 will be Obsolete on September 15,2018. Since for new applicants, BSA needs to decide about the cut off date beyond which old standard s application shall not be accepted, BSA had kept the cut off as September 15, The expiration date on any 2008 certificate issued after the publication of ISO 9001:2015 will be September 15,2018.Thus,it may appear that you are not being granted a full, three-years certificate. However, after successful transition to ISO 9001:2015, the expiry date of your certificate will be amended to reflect a full three-year certification. In any of the cases, it is important to avoid waiting until the last minute Please support BSA to ensure the following during Transition activities: 1. All issues that require your action for compliance with the new requirements be clearly identified and raised as documented findings. 2. Only when all identified outstanding issues have been appropriately addressed and the effectiveness of the management system demonstrated, the auditors recommend certification to the published ISO 9001:2015 standard for your organization. 3. Your Quality Management System s records are verified to demonstrate that all prior traction audit findings have been evaluated for corrective action and compliance before any recommendation for approval to ISO 9001:2015 be made. 4. BSA ensures that the evaluation of your conformance to the new requirements during the transition phase does not interfere with your ongoing conformance to ISO 9001:2008. Page 4 of 14

5 ISO 9001 : 2015 CLIENT TRANSITION CHECKLIST It is not mandatory to use this document. It is a guide to give you an indication of your readiness for audit against ISO 9001:2015. It may be useful to use this as an indication of how close to compliance you are and to give you confidence when applying for the standard upgrade. Our auditors will not ask for this as evidence of compliance as they will be using their own audit procedures. Please be aware that this does not guarantee that you will be recommended for certification to ISO 9001:2015 and you will also need to obtain a copy of the published standard as the Clauses are not covered in their entirety by this document. ISO 9001:2015 Clause 4 Context of the organization 4.1 Understanding the organization and its context The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system. The organization shall monitor and review the information about these external and internal issues 4.2 Understanding the needs and expectations of interested parties Due to their impact or potential impact on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine: The interested parties that are relevant to the quality management system The requirements of these interested parties that are relevant to the quality management system; the organization shall monitor and review the information about these interested parties and their relevant requirements New Requirement Complies ( / ) Evidence 4.3 Determining the scope of the quality management system The organization shall determine the boundaries and applicability of the quality management system to establish its scope 4.4 Quality management system The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions Page 5 of 14

6 ISO 9001:2015 Clause 5 Leadership 5.1 Leadership and commitment New Requirement Complies ( / ) Evidence General Top management shall demonstrate leadership and commitment with respect to the quality management system by: Taking accountability of the effectiveness of the QMS Ensuring that the quality policy and objectives are established for the QMS and are compatible with the context and strategic direction of organization Ensuring the integration of the QMS requirements into the organization s business processes Promoting the use of the process approach and risk based thinking Ensuring that the resources needed for the QMS are available Communicating the importance of effective quality management and of conforming to the QMS requirements Ensuring that the QMS achieves its intended results Engaging, directing and supporting persons to contribute to the effectiveness of the QMS Promoting continual improvement Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility Customer Focus Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring: a) Customer and applicable statutory and regulatory requirements are determined, understood and consistently met b) The risks and opportunities that can effect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed c) The focus on enhancing customer satisfaction is maintained Page 6 of 14

7 ISO 9001:2015 Clause 5.2 Policy Developing the Quality Policy Top management shall establish, review and maintain a quality policy that: Is appropriate to the purpose and context of the organization. New Requirement Complies ( / ) Evidence Provides a framework for setting and reviewing quality objectives Includes a commitment to satisfy applicable requirements It should communicated and understood and be available to relevant interested parties as appropriate Communicating the Quality Policy The quality policy shall: a) Be available and be maintained as documented information b) Be communicated, understood and applied within the organisation c) Be available to relevant interested parties, as appropriate 5.3 Organizational roles, responsibilities and authorities Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization 6 Planning 6.1 Actions to address risk and opportunities When planning for the QMS the organization shall consider the issues referred to 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to: a)give assurance that the QMS can achieve the intended results b) enhance desirable effects c) prevent or reduce, undesired effects d) achieve improvement Page 7 of 14

8 ISO 9001:2015 Clause 6.1.2The organization shall plan: New Requirement Complies ( / ) Evidence a) actions to address these risks and opportunities b) how to: 1) Integrate and implement the actions into its QMS 2) Evaluate the effectiveness of these actions 6.2 Quality objectives and planning to achieve them 6.2.1The organization shall establish quality objectives at relevant functions, levels and processes needed for the QMS 6.2.2When planning actions to achieve quality objectives the organization shall determine: What will be done, what resources will be required, who will be responsible, when will it be completed, how will the results be evaluated 6.3 Planning of changes When the organisation determines the need for changes to the QMS, the changes shall be carried out in a planned manner: The purpose of the change and any potential consequences, the integrity of the QMS, the availability of resources, the allocation or reallocation of responsibilities and authorities 7 Support 7.1 Resources The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system Page 8 of 14

9 ISO 9001:2015 Clause New Requirement Complies ( / ) Evidence 7.2 Competence The organization shall: Determine the necessary competence of persons doing work under its control that affects the performance and effectiveness of the QMS Ensure that these persons are competent on the basis of appropriate education, training or experience Where applicable take actions to acquire the necessary competence and evaluate the effectiveness of the actions taken Retain appropriate documented information as evidence of competence 7. 3 Awareness Persons doing work under the organization s control shall be aware of: The quality policy and relevant quality objectives Their contribution to the effectiveness of the QMS, including the benefits of improved performance The implications of not conforming with the QMS requirements 7.4 Communication The organization shall determine internal and external communications relevant to the QMS What it will communicate? When to communicate? With whom to communicate? How to communicate? Page 9 of 14

10 ISO 9001:2015 Clause 7.5 Documented information General The organizations QMS shall include: New Requirement Complies ( / ) Evidence Documented information required by this international standard and determined by the organization as being necessary for the effectiveness of the QMS Creating and updating When creating and updating documented information the organization shall ensure appropriate: Identification and description (e.g. a title, date, author, or reference number); format (e.g. language, software version, graphics) and media (e.g. paper, electronic); review and approval for suitability and adequacy Control of documented information Documented information required by the QMS and by this International Standard shall be controlled to ensure: it is available and suitable for use, where and when it is needed it is adequately protected For control of documented information the organization shall address the following activities where applicable: Distribution, access, retrieval and use Storage and preservation Control of changes Retention and disposition Documented information of external origin shall be identified as appropriate and controlled Page 10 of 14

11 ISO 9001:2015 Clause New requirement Complies (/) 8 Operation 8.1 Operational planning and control The organization shall plan, implement and control the processes needed to meet requirements for the provision of products and services, and to implement the actions determined in 6.0 by: Evidence Determining requirements for the products and services Establishing criteria for the processes and for the acceptance of products and services Determining the resources needed to achieve conformity to product and service requirements Implementing control of the processes in accordance with the criteria Determining and keeping documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements The organization shall control planned changes and review the consequences of unintended changes taking action to mitigate any adverse effects as necessary The organization shall ensure that outsourced processes are controlled in accordance with Requirements for products and services Customer communication Communication with customers shall include: Providing information relating to products and services Handling enquiries, contracts or orders including changes Obtaining customer feedback, including customer complaints Page 11 of 14

12 The handling or controlling customer property Establishing specific requirements for contingency actions when relevant Determining requirements related to products or services Review of requirements related to products and services Changes to requirements for products and services 8.3 Design and development General The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services Design and development planning Design and development inputs Design and development controls Design and development outputs Design and development changes 8.4 Control of externally provided services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming process outputs Page 12 of 14

13 9 Performance evaluation 9.1 Monitoring, measurement, analysis and evaluation General The organization shall determine: what needs to be monitored and measured, the methods of monitoring measurement, analysis and evaluation as applicable to ensure valid results when monitoring and measuring will be performed and when results from monitoring and measurement shall be analyzed and evaluated The organization shall evaluate the quality performance and effectiveness of the QMS Customer Satisfaction Analysis and evaluation 9.2 Internal Audit The organization shall conduct internal audits at planned intervals to provide information on whether the QMS conforms to the organizations own requirements for its QMS and to this international standard and is effectively implemented and maintained 9.3 Management Review Top management shall review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness New clause but not really any new requirements New clause but not really any new requirements 10 Improvement 10.1 General 10.2 nconformity and corrective action When a nonconformity occurs, including those arising from complaints, the organization shall react to the nonconformity 10.3 Continual improvement The organization shall continually improve the suitability, adequacy and effectiveness of the QMS New clause but not really any new requirements New clause but not really any new requirements Page 13 of 14

14 MAJOR DIFFERENCES IN TERMINOLOGY You will find that some of the familiar terminology of ISO 9001:2008 has either been changed or removed. Here are the highlights, but please also refer to our document on key concepts for additional guidance: ISO 9001:2008 ISO 9001:2015 Products Products and services Supplier External provider Documentation and records Documented information Work environment Environment for the operation of processes Purchased product Externally provided products and services Exclusions Term not used Management representative Term not used Documented procedure Term not used Quality manual Term not used Preventive action Term not used Term not used Leadership Term not used Risk May you have any queries or any issues you may want to discuss with us regarding your transition, please feel free to write in / call on the following Contact Details. BSA International Certification Co. Private Limited 2nd floor, GRM complex, Denkanikotta Road, Near St. John Bosco School, HOSUR ,Tamilnadu,INDIA. Tel: , , , , Tele fax: bsacertifications@gmail.com, Web: Cell: / Page 14 of 14