Ferriby Group of Companies Quality Management Systems ISO 9001:2015 Auditor Transition Training Course QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies INTRODUCTIONS QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies COURSE OBJECTIVES Gain an understanding of the High Level Structure See how the HLS can be used with other Management System Standards QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies Learning Objectives Explain the purpose and use by standard writers of Annex SL Describe in outline the framework for a generic management system Explain the terms and definitions Understand the changes to ISO 9001:2015 QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies BS ISO 9001/2/ ISO ISO ISO ISO QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies Annex SL Annex SL is a guide to help standards developers write management systems standards. It forms part of the ISO Directives, which is currently its 4 th edition. ISO has adopted the high level structure, identical core text and common terms and core definitions of Annex SL The major clause numbers and titles of all management system standards will be identical QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies High Level Structure The High Level Structure (major clause numbers and titles) cannot be changed. However, sub-clauses and discipline specific text can be added. For example: New bullets Discipline specific notes or examples Discipline specific new paragraphs to sub-clauses Adding text that enhances (but does not modify) the existing requirements. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies Benefits Eliminating conflicts in Management System platforms Faster development of standards Less duplication of concepts, terms and potentially shared text Less low value revisions to common or shared areas Integrated high level, common business management goals, issues and needs QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies PLAN 1.Scope 2.Normative reference 3.Terms & Definitions 4.Context on the organization 5.Leadership 6.Planning DO 7.Support CHECK 8.Operations ACT 9.Performance evaluation 10.Improvement QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 3.Terms & Definitions  Interested party  Information  Effectiveness  Documented information  Risk  Information system  Risk-based thinking  Verification  Competence  Validation  Provider  Corrective Action  Output QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies ACTIVITY 1 New and revised Terms and Definitions 10 minutes work Directions: Individually review the terms and definitions and determine which definition belongs to which term. Enter the correct letter of the definition next to the appropriate term in the table on the activity sheet. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 4 Context of the organization 4.1 Understanding the organization & its context 4.2 Understanding the needs & expectations of interested parties 4.3 Determining the scope of the QMS 4.4 QMS & its processes QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 4.1Understanding the organization and its context The organization will need to determine the external and internal issues that are relevant to its purpose, i.e. what are the relevant issues, both inside and out, that have an impact on what the organization does, that would affect its ability to achieve the intended outcome(s) of its management system. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies ACTIVITY 2 Internal & External Issues 20 minutes work Directions: As a group list what internal and external issues you might expect to see in your own company. Write down a column for each. Discuss with the class. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies PESTEL PoliticalEconomicalSocialTechnologicalEnvironmentLegal QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 4.2Understanding the Needs & Expectations of Interested Parties An interested party is a person or organization that can affect, be affected by, or perceive themselves to be affected by a decision or activity that’s within the scope of the management system QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies ACTIVITY 3 Interested Parties 20 minutes work Directions: As a group list who you think interested parties are. Discuss with the class. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 4.3Identifying the Scope of the management system The scope of the company will be determined by the boundaries and applicability of the management system. When determining the scope, the organization should consider: A)The external and internal issues B)The requirements of relevant interested parties C)The products and services of the organization References to exclusions has now been removed in this Standard. The scope will state the types of products and services covered and provide justification for any requirements the organization determines is not applicable to the scope. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 4.4Quality Management system and its processes This is an elevated focus on processes. Adoption of the process approach is now mandatory and will be audited accordingly. The organization needs to determine required process inputs and expected outputs, assign responsibilities and authorities for processes and identify risks and opportunities for processes and pan to address these. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5 Leadership 5.1 Leadership & Commitment 5.2 Quality Policy 5.3 organization roles, responsibilities & authorities QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5.Leadership 5.1Leadership and commitment 5.1.1General There is now a requirement for top management to demonstrate leadership and commitment with respect to the QMS, e.g., ensuring the policy and objectives are compatible with strategic direction, the policy is understood and followed, the QMS is integrated into the organization’s business processes, etc. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5.Leadership 5.1.2Customer Focus Management must ensure that customers and applicable statutory and regulatory requirements are identified, understood and consistently met. They must consider and address any risks that threaten the ability of the company to provide conforming products/services, or which may negatively impact customer satisfaction. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5.Leadership 5.2Policy Top management must establish the policy that is appropriate to the purpose and context of the organization and crucially, it must support its strategic direction. It must additionally provide a framework for the setting and review of quality objectives, and include commitments to satisfy any applicable requirements and to continually improve their QMS. Top management must implement and maintain the policy. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5.Leadership 5.3Organizational Roles, responsibilities and authorities Top management needs to ensure assignment of the necessary responsibility and authorities to the organizational roles.  The requirements set out in the standard are met.  QMS process are delivering their intended outputs  Reporting on the operation of the QMS and identifying any opportunities for improvement is taking place QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 5.Leadership 5.3Organizational Roles, responsibilities and authorities (cont.)  The requirements set out in the standard are met.  QMS process are delivering their intended outputs  Reporting on the operation of the QMS and identifying any opportunities for improvement is taking place  A customer focus is promoted throughout the organization  Whenever changes to the QMS are planned and implemented, the integrity of the system is maintained. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies ACTIVITY 4 How can Top Management show Leadership 15 minutes work Directions: As a group discuss examples of how Management can show leadership. Write the answers down on the flip chart. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 6 Planning for the QMS 6.1 Actions to address risks & opportunities 6.2 Quality objectives & planning to achieve them 6.3 Planning of changes QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 6.Planning of the QMS 6.1Actions to address risks and opportunities The company must consider their internal and external issues they face and the relevant requirements of their relevant interested parties and how these impact on their QMS. The organization must determine the risks and opportunities that need to be addressed for its given context. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 6.Planning of the QMS 6.2Quality Objectives & Planning to Achieve Them Objectives must be set for relevant functions, levels and processes within its QMS. Objectives must be consistent with the organizations policy and be relevant to the conformity of products and services and the enhancement of customer satisfaction. Objectives must be measurable, taking into account applicable requirements and be monitored to determine whether they are being met. They must also be monitored and communicated across the organization. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 6.Planning of the QMS 6.3Planning of Changes Changes need to be planned first and then methodically enacted. The organization needs to be clear as to what is attempting to achieve by implementing the proposed change and what the consequences (both positive and negative) of proceeding may be. The organization must also consider whether there are sufficient resources available to effect the change and whether any changes in responsibilities or authority levels are necessary to drive the changes through. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies Risk Based Thinking There is a demand to consider risk and opportunities throughout: For an organization to understand its context (4.1) To determine risks as a basis for planning (6.1) In implementing processes (4.4) QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies Risk Based Thinking Ensures: Ensures risk is considered throughout the process approach Makes prevention of error integral to the management system Can help to identify opportunities QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.1Resources The organization must determine and then provide the resources necessary to establish, implement, maintain and continually improve its management system. Resources include: People; Infrastructure; The environment for the operation of processes; Monitoring and measuring resources; and Organizational knowledge QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.2Competence The organization must determine the competency requirements for those people performing work under its control, including external people. If there is a competency deficiency, action must be taken to achieve competence or to gain the necessary competencies from other sources, for example, recruitment or use of external people. An assessment needs to be subsequently undertaken to determine whether this has been successful in raising competence to the required level. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.3Awareness People doing work under the organization’s control need to be aware of the organization’s policy, any objectives that are relevant to them, how they are contributing to the effectiveness of the management system and what the implications are of them not conforming to the management system requirements. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.4Communication Communication is internal and external communication relating to an organization’s management system. The company must determine those management system related matters on which it wishes to communicate. Consideration must then be given as to the timing of such communications, their target audience and their method of delivery. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.5Documented Information There is no requirement for a Manual. However, if the organization finds it useful, there is no reason to delete it. Documented information can differ between organizations due to their size, complexity, the products and services as well as the competency of their people. When documented information is created or updated, the organization must ensure that it is appropriately identified and described (e.g.. Title, date, author, reference number). QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 7.SUPPORT 7.5Documented Information (cont.) Documented information must be reviewed and approved for suitability and adequacy. Documented information must be controlled in order to ensure that it is available where and when needed. It must also be protected against improper use, loss of integrity and loss of confidentiality. The organization must determine how it will distribute, access, retrieve and use documented information. This includes control changes, retention and disposal. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.1Operational Planning & Control The organization must plan, implement and control those processes that it has previously identified (clause 4.4) as necessary in order for it to meet the requirements for product and service delivery. It must additional plan how it will address any risks and opportunities that may impact these processes (clause 6) and, therefore, its ability to achieve these requirements. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.2Requirements for Products and Services The organization must communicate effectively with its customers. This covers product and service information, enquiry, contract or order handling (including amendments), customer feedback relating to the organization's products and services (including complaints), the management of customer property and specific requirements for contingency actions when relevant. The organization is required to determine requirements for the products and services it intends to offer to customers. They must ensure that they can meet claims made for products/services offered. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.2Requirements for Products and Services (cont.) The organization must review product/service requirements for customer offerings before it commits to supply. Including, delivery and post-delivery activities and statutory or regulatory requirements. The organization must keep documented information (records) relating to requirement reviews including results. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning The organization is required to plan the design and development of its products/services. They must consider: The complexity, nature and duration of the design and development activities; The required stations (including applicable design and development reviews); The required design and development verification and validation activities; The responsibilities and authorities of those involved in the design and development process. The required resources (both internal and external); QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning (cont.) The need to control interfaces between individuals involved in the design and development process; Whether it is necessary to involve the customer and users in the design and development process; Requirements for subsequent provision of products and services; How much control customers and other relevant interested parties expect from the design and development process; The documented information that will be necessary to confirm the design and development requirements have been met. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning - Inputs Both functional and performance-related requirements; Information from previous design and development activities that are similar; Statutory or regulatory requirements; Any standards or codes of practice the organization has committed to implement; Any possible impacts of failure due to the nature of the products and services; The potential consequences of failure due to the nature of the product or service. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning - Controls The results needed from undertaking the design and development are defined; Reviews are conducted to evaluate the ability of design and development results to meet requirements; Verification activities are conducted to ensure that the design and development outputs meet the input requirements; Validation activities are conducted to ensure that the resulting products and services are fit for their specified application or intended use; Any necessary actions are taken on problems determined during the reviews, or verification and validation activities; Documented information (records) of these activities (reviews, verification, validation and actions) is kept. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning - Outputs Outputs from the design and development must meet the input requirements and are suitable for provision of products and services. Design and development must include or reference monitoring and measuring requirements and acceptance criteria, as appropriate. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.3Design and Development Planning - Changes If changes are made during or after design and development that have an adverse impact on conformity to requirements then the organization must identify, review and control those changes. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.4Control of externally provided processes, products and services The organization must implement controls to enable it to verify that externally provided processes, products or services meet these requirements. Examples when controls need to be implemented: Products and services from external providers for incorporation into the organization’s own products and services; Products and services to be provided directly to the customer by the external provider on the organization’s behalf; Outsourced processes or parts of processes from an external provider based on the organization’s decision. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.4Control of externally provided processes, products and services (cont.) The organization must determine and implement criteria that allows it to evaluate and select external providers that allow it to monitor their performance and to subsequently re-evaluate them based on their ability to provide processes, products and services that conform to requirements. The organization needs to make sure that there is no negative impact that the externally provided processes, products or services could have on its ability to supply conforming products and services to its customers. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.4Control of externally provided processes, products and services (cont.) The organization must communicate to external providers regarding: The processes, products and services to be provided; The approval of the product and service; The approval of methods, processes and equipment; the approval of the release of products and services; The competence of personnel, including any necessary qualifications; The interactions between the organization and the external provider; How the external providers performance will be monitored and controlled by the organization; Verification or validation activities that the organization (or its customer) intends to perform at the external provider’s premises. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.5Production and service provision The organization must determine and implement criteria that allows it to evaluate and select external providers that allow it to monitor their performance and to subsequently re-evaluate them based on their ability to provide processes, products and services that conform to requirements. The organization needs to make sure that there is no negative impact that the externally provided processes, products or services could have on its ability to supply conforming products and services to its customers. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.5Production and service provision (cont.) In cases where traceability is a requirement, the organization must ensure that its outputs are uniquely identifiable. Documented information (records) that enables outputs to be traced back through the management system must be retained only when traceability is a requirement. Property belonging to customers must be identified, verified, protected and safeguarded. If anything should happed to the customer property this must be reported back to the customer along with documented information. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.5Production and service provision (cont.) The organization must take appropriate measures during production to safeguard outputs in order to maintain their conformity to requirements. These include identification, handling, contamination control, packaging, storage, transmission or transportation and protection. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.5Production and service provision (cont.) When post-activities need to be carried out the organization must consider statutory or legal requirements, any possible unwanted consequences associated with the particular product or service, the nature of the product or service, how the product or service will be used and what the product or service’s intended lifetime is. The organization is required to control any changes that are necessary in order to ensure that products or services continue to meet their specified requirements. Documented information must be retained to show the results of the review of change. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.6Release of Products & Services The organization must carry out arrangements at appropriate stages of the production/service delivery in order to verify that products and services meet all requirements (including acceptance). Products or services should not be released to the customer until all the planned activities, tests and checks have been satisfactorily completed, unless a relevant authority approves their early release. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.7Control of Nonconforming Outputs The organization is required to identify any outputs that do not conform to their intended requirements and controls need to be established and implemented to ensure that these ‘nonconforming outputs’ are not delivered to the customer or their unintended use is prevented. When nonconforming outputs are identified, the organization is required to take appropriate action based on the nature of the nonconformity and its effect on the conformity of the products and services. This again is the application of risk-based thinking. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 8.OPERATION 8.7Control of Nonconforming Outputs (cont.) The documented information (records) is to be retained, including records of nonconformities and resultant actions. It must identify the authority deciding the action. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 9 Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.3 Management Review 9.2 Internal Audit QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 9.Performance Evaluation There have been very few changes to this clause. There is an additional requirement for the organization to evidence evaluation of the results of monitoring and measurement, not just their analysis. There is a new requirement to monitor the quality performance and effectiveness of the organization’s management system. Organizations are required to seek customer perception about the degree to which the organization has met customer’s needs and expectations. The terminology has changed and now refers to analysis and evaluation, rather than just analysis. A procedure for internal audits is no longer required although document information must be available to evidence the results of audits. There is an additional sub clause for management review (9.3.2) which requires information on trends in a list of items. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies 10.Improvement The organization must actively seek out and realise improvement opportunities that will better enable the organization to meet customer requirements and enhance their customer’s satisfaction. There is no longer a requirement for preventive action. As a result, it is no longer necessary to have a documented procedure for preventive action. On the occurrence a nonconformity, there is a requirement for the organization to determine whether other similar nonconformities actually do or potentially could exist. The organization will now need to demonstrate that they are using the outputs from their analysis and evaluation processes to identify areas of underperformance and opportunities for improvement. QMST v1 Jan 2016 ©Ferriby Marine Ltd

Ferriby Group of Companies EXAM GO THROUGH THE EXAM PAPER AND LIST TRUE OR FALSE NEXT TO THE STATEMENTS. IF AN ANSWER IS TRUE, THEN PUT THE CLAUSE NUMBER IT RELATES TO NEXT TO IT. YOU MAY USE YOUR DELEGATES NOTES AND ANY OTHER NOTES YOU HAVE TAKEN DURING THE COURSE. WE ASK THAT YOU WORK INDIVIDUALLY DURING THE EXAM AND PLEASE REMAIN SILENT THROUGHOUT. IF YOU HAVE ANY QUERIES, PLEASE APPROACH THE INSTRUCTOR. YOU HAVE 1 HOUR TO COMPLETE THE EXAM. QMST v1 Jan 2016 ©Ferriby Marine Ltd