20200126-ISO 9001:2015-Eng.Dima Ayesh

Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • new clause • must take accountability for the QMS’ effectiveness • ensure Quality Policy and quality objectives are established • ensure QMS is integrated into business processes • ensure resources are available; 2008 – Clause 5

Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General…cont 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • communicate importance of effective QMS and conformance • ensure QMS achieves intended results • promote improvement • support other management to demonstrate leadership. 2008 – Clause 5

Section 5 - Leadership 5.1 Leadership and commitment 5.1.1 General 5.5.1 Customer focus 5.2 Policy 5.3 Organisational roles, responsibilities and authorises • top management must ensure: • customer and regulatory requirements are met • risks and opportunities are determined and addressed • focused on enhancing customer satisfaction. 2008 – Clause 5

Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities • now split into two sub-clauses to save the confusion in the previous version of what must be in the policy and what must be done with the policy • must be documented • must be available internally and to interested parties. 2008 – Clause 5.3

Section 5 – Leadership 5.1 Leadership and commitment 5.2 Policy 5.3 Organisational roles, responsibilities and authorities • ensures responsibilities and authorities for relevant roles are assigned, communicated and understood • no formal requirement for specific management representative • specific mention of changes to QMS. 2008 – Clause 5.5

Section 6 – Planning 2008 – Clause 5.4.2

Section 6 – Planning 6.1 Actions to address risks • introduces risk based and opportunities approach to planning 6.2 Quality objectives and • addresses risks, planning to achieve opportunities and quality them objectives 6.3 Planning of changes How quality planning is achieved. 2008 – Clause 5.4.2

Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • when planning, must consider external/internal issues and interested parties • determine risks to ensure QMS achieves results, enhance desirable effect and achieve improvement • must evaluate effectiveness of actions • must be risk based. 2008 – Clauses 5.4.2 & 8.5.3 3

Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • quality objectives need to be established at relevant functions, levels and processes • these objectives should be: ─ consistent with the Quality Policy, measurable and take into account applicable requirements ─ relevant to conformity of products and services, and the enhancement of customer satisfaction ─ monitored, communicated and updated as appropriate • must determine what, how, who, when, etc • quality objectives must be documented. 2008 – Clause 5.4.1

Section 6 – Planning 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them 6.3 Planning of changes • where change is needed, it needs to be carried out in a planned and systemic manner • must ensure integrity of QMS. 2008 – Clause 5.4.2

Section 7 - Support 2008 – Clause 6

Section 7 - Support 7.1 Resources • newly constructed clause 7.2 Competence • much of what was in 2008 7.3 Awareness 7.4 Communication Version Clauses 4,5 & 6 7.5 Documented information The support required to meet the organisation’s goals. 2008 – Clause 6

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • must provide resources for the implementation and maintenance of the QMS • must consider constraints of existing resources and what may be provided from external providers. 2008 – Clause 6.1

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • new clause • must determine and provide people necessary for effective information of QMS and operations/control of processes. 2008 – Clause 6.1

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • same as for previous Clause 6.3. 2008 – Clause 6.3

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • same as for previous Clause 6.4 • note definition of work environment. 2008 –Clause 6.4

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • previous Clause 7.6 split into two clauses • determine resources needed to ensure valid and reliable monitoring and measuring results • resources must be suitable for the activity and maintained as fit for purpose • evidence of fit for purpose must be retained • other requirements for measuring equipment unchanged. 2008 –Clause 7.6

Section 7 - Support 7.1 Resources 7.1.1 General 7.1.2 People 7.1.3 Infrastructure 7.1.4 Environment for the operation of processes 7.1.5 Monitoring and measuring resources 7.1.6 Organisational knowledge • new clause required to determine, maintain and make available the knowledge necessary for the operation of its processes and to achieve conformity of products and services • particular care required for changing need and trends. 2008 – No equivalent clause

7.1.6 Organisational Knowledge Note: • organisational knowledge can include information such as intellectual property and lessons learned • may consider: ─ internal sources (eg learning from failures and successful projects, capturing undocumented knowledge and expert experience) ─ external sources (eg standards, training, conferences, knowledge from customers or providers). 2008 – No equivalent clause

Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information • very similar to previous Clause 6.2.2 • removal of providing ‘training’ to ‘competence’ • documented information (record) must be obtained of competence. 2008 – Clause 6.2.2

Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information • specific clause for awareness • must be aware of Quality Policy, quality objectives, contribution to effective QMS and implication of not conforming with QMS. 2008 – Clause 6.2.2

Section 7 - Support 7.1 Resources 7.2 Competence 7.3 Awareness 7.4 Communication 7.5 Documented information • much expanded clause for communication • must now determine what will be communicated internally and externally about the QMS, when, to whom, how and by whom. 2008 – Clause 5.5.3

Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • QMS needs documented information required by the Standard and as determined by the organisation Note: the extent of documented information can differ from one organisation to another due to its size, activities, processes, products and services, complexity of processes and their interactions, and the competence of people. 2008 – Clause 4.2.1

Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • documented information requires: ▫ identification and description ▫ format and media ▫ review and approval. 2008 – Clause 4.2.3

Section 7 - Support 7.5 Documented information 7.5.1 General 7.5.2 Creating and updating 7.5.3 Control of documented information • combines previous Clauses 4.2.3 (documentation) and 4.2.4 (records). 2008 – Clauses 4.2.3 & 4.2.4

Section 8 - Operation 2008 – Clause 7

Section 8 - Operation 8.1 Operational planning and control • covers many of the Product Realisation 8.2 Requirements for products and requirements services contained in Clause 7 of the 2008 version 8.3 Design and development of products and services The heart of the management system 8.4 Control of externally provided processes, products and services (the business). 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs 2008 – Clause 7

Section 8 - Operation 8.1 Operational planning and control • similar to previous Clause 7.1 • must plan, implement and control processes needed to meet requirements for the provision of products and services • must control planned changes and review unintended changes • any outsourced processes must be controlled. 2008 – Clause 7.1

Section 8 - Operation 8.2 Requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services • same as previous Clause 7.2.3 • includes communicating with customers about handling and controlling their property, establishing contingency requirements, when relevant. 2008 – Clause 7.2.3

Section 8 - Operation 8.2 Determination of requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services • same as previous Clause 7.2.1 • plus the organisation must meet the claims of products or services it offers. 2008 – Clause 7.2.1

Section 8 - Operation 8.2 Determination of requirements for products and services 8.2.1 Customer communication 8.2.2 Determining the requirements for products and services 8.2.3 Review of requirements for products and services 8.2.4 Changes to requirements for products and services • combines previous Clauses 7.2.1 and 7.2.2 • documented information required on results of the review and any new requirements. 2008 – Clause 7.2.2

Section 8 - Operation 8.3 Design and development 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, such that they are adequate for subsequent production or service provision, the organisation shall establish, implement and maintain a design and development process; 2008 – Clauses 7.3

Section 8 - Operation 8.3 Design and development of products and services…cont • changes are mainly terminology and simplified wording • there is, however, a significantly increased focus on the role the customer has in all stages of the design process • the need for documented information to confirm appropriateness of all stages is also clearly stated • any changes made to design inputs and design outputs during the design and development must be clearly identified. 2008 – Clause 7.3

Section 8 - Operation 8.4 Control of externally provided processes, products and services 8.4.1 General 8.4.2 Type and extent of control 8.4.3 Information for external providers • changes are mainly terminology and revised wording (ie suppliers become ‘external providers!’) • much as before, each stage of the purchasing process, including evaluation, selection, performance monitoring and re-evaluation remains a key requirement • there is a significant increase in the steps needed to control external provision. 2008 – Clauses 7.4

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • changes are mainly terminology and revised wording • the most significant change is the move of monitoring and measuring equipment to Section 7 •200re8 f–eCrlaeunsecse7.t5o ‘changes and post delivery activities’ have been strengthened.

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • previous Clauses 7.5.1 and 7.5.2 combined. 2008 – Clauses 7.5.1 & 7.5.2

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • no change. 2008 – Clause 7.5.3

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • no change. 2008 – Clauses 7.5.4

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • no change. 2008 – Clauses 7.5.5

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • new clause for post-delivery activities • a number of considerations are required. 2008 – Clauses 7.5.1

Section 8 - Operation 8.5 Production and service provision 8.5.1 Control of production and service provision 8.5.2 Identification and traceability 8.5.3 Property belonging to customers or external providers 8.5.4 Preservation 8.5.5 Post-delivery activities 8.5.6 Control of changes • specific clause for control of changes to ensure continuing conformity • documented information must be retained describing the review of changes and any action arising. 2008 – Clauses 7.3.7

Section 8 - Operation 8.6 Release of products and services • must verify that product and service requirements have been meet and evidence of conformity retained • release to customer does not proceed until the planned verification of conformity has been satisfactorily completed, unless otherwise approved by a relevant authority and by the customer • documented information to provide traceability to the person(s) authorising release for delivery to the customer. 2008 – Clause 8.2.4

Section 8 - Operation 8.7 Control of nonconforming outputs • similar to previous Clause 8.3 • documented information required describing nonconformity, actions taken, any concessions and authority for taking action. 2008 – Clause 8.3

Section 9 – Performance Evaluation 2008 – Clause 8

Section 9 – Performance Evaluation 9.1 Monitoring, Determining what is to be measurement, analysis and evaluation monitored, measured, analysed 9.2 Internal audit and evaluated will enable the organisation to determine ‘if the 9.3 Management review management system suitable, adequate and effective ?’ How performance of the QMS is evaluated. 2008 – Clause 8

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • must determine what needs to be monitored and measured, the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid results • additionally, when the monitoring and measuring is to be performed and when the results from monitoring and measurement is to be analysed and evaluated • retain appropriate documented information as evidence of the results. 2008 – Clause 8.2.3

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • same as previous Clause 8.2.1. 2008 – Clause 8.2.1

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.1.1 General 9.1.2 Customer satisfaction 9.1.3 Analysis and evaluation • information resulting from monitoring and measuring appropriate data should be analysed and evaluated • the results of analysis is to be used to evaluate seven specific criteria described. 2008 – Clause 8.4

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review • same as previous Clause 8.2.2 • split into two sub-clauses • still at planned intervals • evidence of internal audits and results must be documented. 2008 – Clause 8.2.2

Section 9 – Performance Evaluation 9.1 Monitoring, measurement, analysis and evaluation 9.2 Internal audit 9.3 Management review • similar to previous Clause 5.6 • still at planned intervals • clearer agenda items (inputs) • evidence of management review results must be documented. 2008 – Clause 5.6