Pre Audit Transition Gap Analysis QMS and EMS Company: Contact Name: Certification Number: Email: Contact Number: This document should be used in conjunction with the ISO 9001:2015 and ISO 14001:2015 standards and allows you to detail how you intend to transition your management system from the 2008 and 2004 standards to the 2015 standards. You only need to complete the common elements and the relevant sections for the individual standards required. Please complete this form in good time prior to your assessment to allow us to review the contents ahead of your next planned visit. Please do not provide supplementary documentation, please list or describe your processes, procedures, documents or records that support the way in which you meet the intent of the requirements. Following receipt of the completed form we will contact you to arrange a telephone interview with a trained auditor to discuss the content and to ensure that you have provided the relevant details. During your next planned visit your Lead Auditor will re-visit this document as part of the interview with top management to ensure that there have been no amendments or changes. If you have any queries, please contact our technical department at head office and our trained staff will be happy to help. *For further comments please use the additional comment box provided at the end of the document. ISOQAR alcumusgroup.com
Page 2 2015 Requirements Common Elements Clause 4 - Context of the organisation NEW CLAUSE - Underpins the 2015 Standards and establishes the context of the Management System (QMS and EMS). It gives you the opportunity to identify all internal and external issues that are relevant, and may affect, the strategic direction of the organisation and the management system. You will also need to identify interested parties that are relevant to your management system. These groups can include shareholders, customers, regulatory groups etc. Finally, you ll need to establish, implement, maintain and continually improve the management system. Clause 4.1 - Understanding the organisation and its context - NEW REQUIREMENT Summary: You will need to be able to demonstrate that you have identified external and internal issues, which you monitor and review. Please provide information: about the internal and external issues relevant to your organisation the process of monitoring the internal and external issues and how you have considered the impact of any changes to the issues Clause 4.2 - Understanding the needs and expectations of interested parties - NEW REQUIREMENT Summary: You will need to be able to demonstrate that you have identified, monitored and reviewed all interested parties that are relevant to the management system and its requirements. Please provide: Information about interested parties who affect or could affect your system Information about their needs and expectations The process of monitoring and reviewing interested parties and their needs
Page 3 Clause 4.3 - Determining the scope of the management system Summary: The new standard requires you to consider the context of the organisation (Clause 4.1) and interested parties (Clause 4.2). You will need to identify any boundaries to your scope and applicability of the system. This could include the whole organisation or specific functions. Please provide information on: The boundary and applicability information of the scope The products and / or services included in your quality management system Has the scope changed and if so how? Clause 4.4 - Management system and its processes Summary: To comply with this clause, you will need to establish, implement, maintain and continually improve your management system. This now requires the adoption of a process approach. Although every organisation will be different, documented information such as process diagrams or written procedures could support this. Please provide information on the process-based system including: List of processes, process sequences and interactions, methods to manage the processes, resources to support processes, process responsibilities and authorities, risks and opportunities of each process and how you ensure the system improves the processes and the quality management system. Clause 5 Leadership NEW CLAUSE. Top management are now required to have greater involvement in the operation of the management system and must ensure that the requirements are integrated into the organisation s processes and that the policy and objectives are compatible with the strategic direction of the organisation. There is also greater focus on top management to enhance customer satisfaction and they need to understand the organisations internal strengthens and weaknesses and how these can impact the delivery of products or services. Finally, the clause places requirements on top management to assign relevant responsibilities and authorities, but must remain accountable for the effectiveness of the management system.
Page 4 Clause 5.1 - Leadership and commitment - NEW REQUIREMENT Summary: The requirements within this clause are generally self- explanatory. You will need to provide information on how top management ensure the management system is compatible with the strategic direction as well as taking responsibility and promoting risk based thinking, customer focus and improvement. Please provide information on how top management ensures the management system achieves the intended results. Clause 5.2 - Policy Summary: Top management need to establish, implement and maintain a quality policy and ensure it is communicated both within the organisation but also to relevant interested parties as appropriate. Additional guidance is provided within the clause. Please provide information on when your policy was last reviewed/amended and details of any changes that were required. Clause 5.3 - Organisational roles, responsibilities, and authorities Summary: Top management need to ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood throughout the organisation. However, there is no fundamental change in approach when taking into account the guidance provided with the clause. Annex 8 also provides information on additional standards which may help. Please provide information on how top management have established and communicated responsibilities and authorities for the effective operation of the management system.
Page 5 Clause 7 Support Clause 7 ensures that you have the right resources, people and infrastructure required to meet your organisational goals. Organisational knowledge is a new requirement for competence, awareness and communication of the QMS, a key requirement is to ensure that knowledge is held to ensure conformity of the products or service. Finally, there are the requirements for documented information which replaces documents and records in the 2008 version. Clause 7.1 - Resources Summary: You need to consider internal and external providers and meet customer and applicable statutory and regulatory requirements. Monitoring and measuring equipment has been changed to resource; this could be visual inspection. You need to identify what information you need and how knowledge can be updated and maintained within the organisation, for example by addressing succession planning. Additional guidance is included within the clause and Annex A7. Please provide information on how internal and external resource requirements are considered for the establishment, implementation and improvement of the management system. Also demonstrate how knowledge required has been determined for the operation of its processes and achievement of conformity of products and services. Clause 7.2 - Competence Summary: You need to determine the competency of people and ensure that these are met and maintained. This applies to any person affecting the organisations quality performance including contractors. Within this clause you are required to retain documented information as evidence of competence. Please provide information on those persons who can affect the performance of the QMS and are competent on the basis of appropriate education, training, or experience, and how the information required for the effective implementation and operation of the QMS has been determined.
Page 6 Clause 7.3 - Awareness Summary: This clause covers awareness of the quality policy, objectives and the implications of not conforming to the requirements. However, there is no fundamental change in approach when taking into account the guidance provided within the clause. Please provide information on how you have raised awareness of the policy and the QMS requirements. Clause 7.4 - Communication Summary: This clause has now been expanded to include both internal and external communications relevant to the quality management system. You will need to think about what you need to communicate, when, to whom and how. Please provide information on how this is achieved. Clause 7.5 - Documented information Summary: Clause 7 replaces documented procedures and records from the 2008 version with documented information. Additional requirements now include the activity to control distribution of necessary documented information, especially with regards to permission to view and authority to change. However, there is no fundamental change in approach when taking into account the guidance provided within the clause contents of 7.5.3. Please provide information on how you control the distribution of necessary documentation.
Page 7 Clause 9 - Performance evaluation Summary: Performance evaluation covers many of the areas previously featured in Clause 8 of the 2008 version. Requirements for monitoring, measurement, analysis and evaluation are covered and you ll need to consider what needs to be measured, methods employed, when data should be analysed and reported on. Documented information that provides evidence of this must now be retained. Describe how you meet these requirements. Clause 9.1 - Monitoring, measurement, analysis and evaluation Summary: You will need to determine when monitoring and measurement shall be performed and when the results will be analysed and evaluated. However, there is no fundamental change in the approach when taking into account the guidance provided within the clause contents and the Quality Management Principles. Describe how you meet these requirements: Clause 9.2 - Internal Audit Summary: Additional requirements are now specified relating to defining the `audit criteria and ensuring that the results of the audits are reported to relevant management, however there is no fundamental change in approach when taking into account the guidance provided within the clause contents. Please provide information on how your organisation addresses internal audit requirements and details of any changes that have had to be made to the existing provision if required.
Page 8 Clause 9.3 - Management Review Summary: There are now additional requirements including the consideration of changes in external and internal issues that are relevant to the QMS; however, there is no fundamental change in approach when taking into account the guidance provided within the clause contents. Please provide information on how your organisation addresses these changes. Clause 10 Improvement Summary: This clause starts with a new section that organisations should determine and identify opportunities for improvement such as improved processes to enhance customer satisfaction. There is also a need to actively look for opportunities to improve processes, products and services, and the QMS especially with future customer requirements in mind. Clause 10.1 General OTHER CHANGES Summary: This clause covers the general need for improvement, whether to meet existing and future customer requirements, correcting or reducing undesired effects or improving the performance or effectiveness of the system. Please provide information on how your organisation has addressed these changes.
Page 9 2015 Requirements ISO 9001 Only Clause 6 Planning There is an increased focus on ensuring that planning is considered within the context of the organisation and interested parties. Now there is a requirement to identify risks and opportunities, and the impact these may have on the conformity of products and services and how you plan to address these. Finally, you will need to consider planning for changes in a systematic manner. Clause 6.1 - Actions to address risks and opportunities Summary: This clause requires you to identify the risks and opportunities that need to be managed. You need to consider the outputs from understanding the context of the organisation (Clause 4.1) and interested parties (Clause 4.2). The requirements in relation to contingency planning and preventive action are now addressed within this clause. This is not a risk assessment although a formal risk assessment is one way of demonstrating you have considered and addressed risk; it is risk- based thinking. Annex A4 provides more guidance. Please provide information on how the risks and opportunities have been identified and how actions to address these have been managed. Clause 6.2 - Quality objectives and planning to achieve them Quality objectives need to be consistent with the quality policy, relevant to the conformity of products and services as well as enhancing customer satisfaction. Once defined, the objectives need to be monitored, communicated and updated as appropriate. Whilst this clause is more specific than previous, there is no fundamental change in the approach. Guidance is contained within the clause contents. Please provide information on how the organisation ensures objectives are relevant to the organisations policy, how they are communicated and monitored.
Page 10 Clause 6.3 - Planning of changes The integrity of the QMS must be maintained when planning changes. However, you now need to consider the purpose of change, why it s being made, potential consequences and the resources and (re) allocation of responsibilities. Please provide information on how the organisation manages and implements change. Clause 8 Operation This clause deals with the execution of the plans and processes that meet the requirements for the provision of products and services and is the clause that covers most QMS specific requirements. The standard acknowledges the trend towards a greater use of sub-contractors and outsourcing and these must be monitored effectively. There is also a new clause covering post-delivery activities such as maintenance programmes or work carried out under warranty. Clause 8.1 - Operational planning and control Summary: Processes needed to meet requirements of the organisation, need to be planned, implemented and controlled, as do the actions identified in 6.1. Requirements in relation to change control and outsourced processes have also been introduced. Please provide information on how this is achieved.
Page 11 Clause 8.2 - Requirements for products and services Summary: This clause requires communication with regards to contingency actions where required and also the treatment of customer property. The requirements cover communication in Clause 8.2.2 and communication to potential customers which is useful for bringing new offerings or solutions to the market place. It has the ability to meet the defined requirements and substantiate the claims for the products and services it offers. Please provide information on how this is achieved. Clause 8.3 - Design and development of products and services Summary: This clause requires the organisation to establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services. Where the detailed requirements of the organisation s products and services are not already established or not defined by the customer or by other interested parties, the organisation shall establish, implement and maintain a design and development process. Clause 8.3.3 is more explicit in terms of c) standards or codes of practice that the organisation has committed to implement; d) internal and external resource needs for the design and development of products and services; e) the potential consequences of failure due to the nature of the products and services Please provide information on how this is achieved.
Page 12 Clause 8.4 - Control of externally provided processes, products and service Summary: This clause covers the control of externally provided processes, products and services. You need to ensure personnel are competent and have the necessary qualifications, their interactions with the QMS and how you control the external provider s performance. There is the need to establish specific criteria for monitoring performance of and communication with external providers. Please provide information to address these changes. Clause 8.5 - Production and service provision Other Changes Summary: Clause 8.5.3 is enhanced to cover property belonging to customers and external providers and this must be identified, verified, protected and safeguarded and if damaged, unsuitable or lost must be reported to the customer or external provider. Otherwise no major changes. Please supply details of how this is addressed. Clause 8.6 - Release of products and services Summary: This clause now covers the arrangements for the release of products and services. You will need to verify that the products and services have met the customer requirements and retain documented information on the release.
Page 13 Clause 8.7 - Control of nonconforming output Summary: You are required to ensure that outputs that do not conform to their requirements are identified and controlled. There are no requirements for a procedure but you are required to retain documented information that describes the nonconformity, the actions taken and the concessions obtained. Describe how you meet this requirement.
Page 14 2015 Requirements ISO 14001 Only Clause 6 Planning There is now an increased focus on ensuring that planning considers with the context of the organisation and interested parties. It focuses the organisation on the development and use of a planning process to address the risks associated with environmental aspects, compliance obligations and issues identified in the context and interested party s evaluation. In addition to planning to achieve environmental objectives, there is now a specific requirement to determine how the results of actions will be evaluated using indicators for monitoring progress. Clause 6.1 - Actions to address risks and opportunities Summary: The organisation needs to determine its risks and opportunities that need to be addressed and plan actions to address them. These risks and opportunities can be related to environmental aspects, compliance obligations, other issues or other needs and expectations of interested parties. Please provide information on how the risks and opportunities have been identified and how actions to address these will be managed. Clause 6.2 - Environmental objectives and planning to achieve them Summary: Environmental objectives need to be consistent with the environmental policy, and take into account your significant environmental aspects and compliance obligations and considering the risks and opportunities. Once defined, the objectives now need to be monitored, communicated and updated as appropriate. Please provide information on how the organisation ensures objectives are relevant to the organisations policy, how they are communicated and monitored.
Page 15 Clause 8 - Operation New, more specific requirements that relate to the control or influence exercised over outsourced processes are included. There is a requirement for consistency of processes with a life-cycle perspective in mind in this part of the standard. Clause 8.1 - Operational planning and control Summary: Processes needed to meet requirements need to be planned, implemented and controlled and actions identified need to be implemented. There is a need to control planned changes and review unintended ones. In addition, there is a need to ensure that outsourced processes are controlled or influenced. Consistent with a life cycle perspective an organisation shall determine environmental requirements for the procurement of goods and services, ensure environmental requirements are considered in the design process, consider the need to provide information about significant impacts during the delivery of the goods or services during use and end of life treatment. Please provide information on how your organisation achieves this. Clause 8.2 - Emergency preparedness and response Summary: You need a process specifying how you will take action to prevent and if necessary, respond to potential environmental emergency situations. In addition, you now need to test the procedure and review, especially after an actual incident. Please provide information on your emergency preparedness and response process
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