o BENEFITS o ELEMENTS o STEPS FOR REGISTRATIC SUSU ANC PNAC Rene UU TUBS Ser NeO OU svscu HEATWHAT IS ISO 9000? + 1809000 TU TSUENOIENE MUM ese eA HE AME Mt connec SI ee COTO Tecra tol Rec TeZ TOOT ENEMIES OMA ABUT TON TENSE 1SO 9000 helps a company to RON SIs COLEssc BENEFITS ISO certification helps in gaining customer trust. The series of standards encourages preventive thinking, which enables businesses to address iss EUR ueen ues Itminimizes the errors in recurring processes. The standards help businesses save time through the efficient management of resources, The cumulative effects of implementing these standards can result in increased market share and profit potential. The set standards reduce manual work through process automation and process integration. Employees have a clear idea regarding their roles and responsibilities. This improves job satisfaction. It recognizes the weaknesses of an organization and recommends corrective measures. Itsets the basic framework for developing an optimal process and total quality management (TQM) NO HEATHSCENEEWU Product identification and tracking Design control Corrective and Preventive Actions (CAPAs) ~ Management responsibility rennet SCs STE ce RCOL UE Secu iUEInspection and Testing Management Responsibility ASTUTE AY All incoming parts and materials must be inspected prior to use. In-process and final inspections should also occur before the finished product is shipped. Records of all inspections should be maintained. An organization’s management team should develop a quality policy and manual. The quality policy outlines the organization’s strategic goals and mission, whereas the quality manual documents the scope of the QMS. Product teams should develop a comprehensive plan for designing and developing the product. Design changes should be thoroughly documented and reviewed by key stakeholders throughout the new product development process. Additionally, verification and validation testing are necessary to ensure that the finished product meets user requirements and performs as intended.UTTER Training Management San Organizations should perform routine internal audits to ensure that their QMS meets the requirements of applicable regulations and standards. Results of the audit are subsequently communicated to the management team, and any deficiencies are addressed. Organizations must develop, maintain, and track training records to ensure that employees remain proficient on all current company policies, processes, and procedures Servicing of products should follow formal written procedures and meet customer expectations.(ere ea Cuca dere OIL aie Product and service contracts should be reviewed to ensure that they align with customer needs and expectations. The development of procedures such as work instructions and assembly instructions is necessary to ensure that products are produced consistently, efficiently, and with fewer errors. Procurement teams should document and implement procedures for evaluating vendors and suppliers and establish guidelines for sourcing parts and materials.PCa TEC Product Identification and artis LO reat Maracas Actions (CAPAs) Arobust system must be in place to ensure that all product documentation is created, distributed, reviewed, revised, stored, and disposed of in a controlled manner. Proper labeling is necessary to ensure that products are easily identifiable and traceable throughout the lifecycle. Teams must conduct investigations to identify the root cause of product nonconformities. In turn, countermeasures should be put in place to correct and prevent issues from reoccurring.Quality system Control of Non-confirming PRIUS ETN RCO TCC = This system comprises of quality manual in which Supporting procedures are created and maintained. ® Materials or products that do not comply with the specifications are rejected and separated from normal production. The concerned authorities can decide whether the rejected materials will be used, reworked or returned to the supplier. Control graphs, graphs and other analysis methods determine the working a process and facilitate its continuous improvement.TEPS FOR ISO CERTIFICATION Pre-Requiste to ISO Certification process Choosing the type of ISO Certification: Various types of ISO certification available such as 1. 180 9001 2008- Quality Management 2, 180 14001 Environmental Management 3, 18027001 ~ Information security Management 4, 15022008 Food Safety Management and so on, Choosing an ISO Certification Body: It is very important to choose recognized and credible certification body. When choosing the ISO registrar, should follow following points 1. Evaluate several ISO certification service providers. 2, Check ifthey are following the CASCO standards (CASCO is the ISO committee) 3, Check weather it is accredited or not,STEPS FOR ISO CERTIFICATION Create an application/ contract: The applicant and the registrar should agree on a contract. This contract usually defines rights and obligations ofboth parties and includes liability issues, confidentiality, and access rights. Quality Documents Review: The ISO auditor will view all the quality manuals and documents related to various policies and procedures being followed in the organization. ISO auaitor to identify the possible gaps against the requirements stipulated in the ISO standards. Make an action Plan: After the ISO auditor communicates the existing gaps in the organization, then the organization should prepare an action plan to eliminate these gaps.STEPS FOR ISO CERTIFICATION Initial Certification Audit: The initial certification audit is divided in to Two categories Stage-1: The ISO auditor will audit the changes made by the organization. Then they will ry to identify the possible non-conformities in the systems and procedures to the desired quality management system. Stage 2 Afterall the required changes are done in the organization, the ISO auditor does the final auditing. The auditor will check whether all the non-conformities have been eliminated or not as per ISO quality standards, ifthe ISO auditor is satisfied, they will prepare the final ISO audit report and forward it to registrar, Completing the ISO Certification: Afterall non-conformities are addressed and all the findings are put inthe ISO audit report, the registrar will grant you the ISO certification. Surveillance Audits: Surveillance audit is basically conducted to ensure that [SO quality standards are being maintained by the organization It is conducted from time to time. S15 COLEGEOF PARA ANO HEALTH SCENES COMWHAT IS ISO 14000? NORE USER omoasen tare tn To COE NUTR UR ON CRU ISTE TAC TuE on the environment, It’s a framework for improved and more environmentally-conscious quality Bene Tan a yy organizations large and small. ISO 14000 is meant to be a step-by-step guide for establi ishing and then achieving environmentally-friendly objectives for business practices and Pelee ay Wr eg oH T OSeeECON a OOH ET CABUIE UE Tom Cuan CCC NANYINI minimizing environmental effects.BENEFITS Companies and customers may also pay more for products that are considered environmentally friendly. On the cost side, meeting the ISO 14000 standards can help reduce costs, as it stresses the efficient use of resources, limiting waste, recycling, and even finding new uses for previously disposed of byproduc EORTC RMA OOM ATE NE RTT CmeaccOn ge cd Italso help companies meet certain environmental regulations. To sell products to companies that use ISO 14000- certified suppliers. RSNTESN CO MUNLUULE Improve industry- government relationsISO 14000 STANDARDS The ISO 14000 family of standards is developed by ISO Technical Committee ISO/TC207 and its various subcommittees, ISO 14000: standards and practices can be applied to any organization, regardless of size or industry. ONE noe once cena Tra ea ahs ISO 14004; 2016 Environmental management systems - General guidelines on implementation. OC MOO Een MON cn Mac mM i i ODES cna RUToLe RUE UNE oR OeU Ite uu ON ECSeRTU NamTaieItCOIm i i TSO 14015: 2001 Environmental management - Environmental assessment of sites and organizations (EASO)SO 14000 STANDARDS * ISO 14020:2000 to 14025: 2000 Environmental labels and declarations- General Principles + ISO/NP 14030: Green bonds -- Environmental performance of nominated projects and assets; discusses post- POCO ceo + ISO 14031: 2013: Environmental management - Environmental performance evaluation ~ Guidelines + ISO 14040: 2006 to 14049: 2006; Environmental management - Life cycle assessment discusses pre-productive PETITE RCM SST + ISO 14050; 2009: Environmental management - Vocabulary; terms and definitions + ISO/TR 14062: Environmental management - Integrating environmental aspects into product design and Coryuntaie SCO cm ane eer oe eM Cee Tn eoc sy + 180 14064: 2006:Greenhouse gases; measuring, quantifying, and reducing green house gas emissions. + ISO 14090: 2019: Adaptation to climate change — Principles, requirements and guidelinesELEMENTS OF ISO 14000 Environmental policy: Develop a statement of organization's commitment tothe environment. Use ths policy as a fiamework for planning and action Environmental aspects: Identify environmental attributes of the products, activities and services. Legal and other requirements: Identify and ensure access to relevant laws and regulations, Objectives and Targets: Establish environmental goals for the organization, in line with the poliey, environmental impacts, views of interested parties and other factors, Envi Structure and responsi mnmental management program: Plan actions to achieve objectives and targets + Establish roles and responsibilities and provide resource. Training, awareness and competence: Ensure thatthe employees of the organization are trained and capable of carrying out their environmental responsibilities. Communication: Establish processes for internal and external communications on environmental management issues. EMS documentation: Maintain information on your EMS and related documents. Document control: Ensure effective management to procedures and other systemREGISTRATION AND THE AUDIT PROCESS ‘Two levels of certification Self Declaration 2 Certification / Registration Eight steps of registration process Decision Intemal preparation Intemal Determination Accredited ISO 14000 Registrar Preliminary assessment Document review Formal EMS audit Certification assessment Elimination of Noneonformance istration - AwardedTEPS FOR REGISTRA Ss cOUE Step 1: Seeure Commitment From the Top 1 Theneed for resources (money, employee, time) that only top management can authorize. Inevitably there willbe individual who prefer the status. When they hold senior positon in the organization it takes intervention by top ‘management to overcome their resistance. © The most importance aspect of leader is setting a positive example for employees to follow. Step 2: Decision to Proceed Develop a rough draft of the costs fr external servies and time for internal asks. = Anestimate of risk shouldbe included inthe decision-making proces * Management should publicizing the ISO 14000 effort to all level of employees. Step 3 Form a Steering Committee «The steering committee provides leadership in establishing and implementing the EMS and in monitoring its performances, + The tering commites oles to determine whats needed, secur the resouresto satis those needs, and manage the activities of those given assignments,STEPS FOR REGISTRATION ss cOUE ‘Step 4 Steering Committee Training 1 The-steering committe members also must understand the rationale for undertaking the project, that the work does not end with registration, and that ISO 14000 wil be anormal part of doing business forever. + A team-building seminar shouldbe included inthe Steering Committees raining since members wil have to workefetively as team. Step 5 Train Internal Auditors * The mumber of intemal auditors needed will depend onthe siz and complexity ofthe organization. * Toensure effectiveness, the intemal auditors should compete an environmental course ‘Step 6 Asses Current Conformance © Usually observe by internal auditors (steering committee) © The goa i to determine what needs to be done to satisfy the requirement of IO 14000 and applicable laws and regulations, Step 7 Plan Preparation Project * Using the rests ofthe inital assessment, develop alist of ask that must be performed to bring the organization into conformance * Thetimeline and timeline chart also necessary forthe steering committee to done some tsk or plana schedule fr the registrationSTEPS FOR REGISTRATION Step 8 Select Project Teams * Once the plan has been develop, the tering commit then determines the composition of the team that wl be assigned specific tasks. Ensure thatthe team is crss-unctional It wil need someone with unbiased views (an outsider) Step 9 Train Project Teams © Once the members of project teams has been selected, they will be trained in some essential subjects. + Thetainer sully the trains internal auditors and senior manager. Step 10 Activated Project Teams Project team activation shouldbe a forma, structured and interactive process. * Theteam activation given overview ofthe project ~set the schedule of meeting = proposed schedule for individual tsk and overall project Step 11 Project Feedback and Monitoring + The tering commit wil receive feedback from all eans. The steering committee use this information to monitor progress andtoprovidenew instrution forthe team as appropriate. 0 HELTHSCENESCOMBATORESTEPS FOR REGISTRATION Step 12 Selecta Registrar * Companies typically select ther registra 6 to 18 months prior tothe target dat forthe epsration aut Aspect of registrar ~ background information on potential registrar solicit references on registra from other companies question potential registrar directly - make sure the potential registrar can accommodate your schedule for registration Step 13 Preliminary Assessment Audit and Document Review The preliminary assessment audit is conducied to ISO 14000, The review usually conducted at the registrar ect ‘Step 14 Final Pre-audit Touch-Up * Before registration aut the final preauit touch-up must be fre from any major or minor conformance, ‘Step 15 Registration Audit * Tfno major non-conformance are found and the auditors are satisfied that the implementation of the EMS is sound, the lead auditor will recommend the registrar grant registration.ISO 9000 Standards ISO 14000 Stand: i 130 9000 is devoted to quality management. Itis designed to help companies and other organizations ensure thatthe products and services they create andthe processes they use to create them meet a high standard of quality and integrity. 180 9001:2015: Quality Management Systems - Requirements 180 9000:2015: Quality Management Systems - Fundamentals and Vocabulary (definitions) 130 9004:2018: Quality Management - Quality of an Organization ~ Guidance to Achieve Sustained Success (continuous improvement) ISO 19011:2018: Guidelines for Auditing Management Systems ISO 14000 is a set of standards for companies and other organizations that want the processes they use andthe products they create to have a minimal adverse impact on the environment. 180 14001 and ISO 14002: Specification of Environmental Management Systems TSO 14004: Guideline Standard ISO 14015, ISO 14016, and ISO 14017: Environmental Auditing and Related Activities ISO 14020, ISO 14021, and ISO 14024: Eco labelling ISO 14030 and ISO 14031: Environmental Performance Evaluation 1SO 14040 - ISO 14043: Life Cycle AssessmentTHANK YOU!!!