ISO 9001 2015 Standard Training What is a

ISO 9001: 2015 Standard Training What is a nonconformity? Version: 10/17/18

Agenda ü ISO Overview ü Nonconformity Actions ü Questions Version: 10/17/18

ISO Overview Version: 10/17/18

What is ISO? ISO is an international quality management standard and framework for business-to-business dealings, focusing on: § meeting customer quality and applicable regulatory requirements, § enhancing customer satisfaction, and § continually improving business performance from the initial proposal/contracting stage through the delivery of service. Version: 10/17/18

ISO Timeline § IPRO has held ISO certification since 2003. § IPRO is currently certified to ISO 9001: 2015. § Independent certification audit was in June 2018; recertification audits in June 2019 and June 2020. Version: 10/17/18

ISO 9001: 2015 Basics § Role of management to demonstrate leadership and commitment to the Quality Management System (QMS). § Quality and customer service are a part of everyone’s job! § Requires an emphasis on risk based thinking (good and bad risks). § Continuous improvement - Just conforming to the ISO requirements is not improvement. Version: 10/17/18

ISO 9001: 2015 Structure PLAN 4. Context of the Organization Understanding of the organization & its context 5. Leadership & commitment Expectations of interested parties Scope of management system QMS and its processes Policy Roles, responsibilities & authorities 6. Planning Actions to address risk & opportunity 7. Support Resources DO CHECK 8. Operation 9. Performance Evaluation 10. Improvement Operations planning & control Monitoring, measurement, analysis & evaluation Requirements for products & services Internal audit Non-conformity & corrective action Management review Continual improvement Quality objectives Competence Planning of changes Awareness Design & development Documented information Production & service provision Control of externally provided processes, products & services Release of products & services Control of nonconforming outputs Version: 10/17/18 ACT General

Nonconformity Version: 10/17/18

What is a nonconformity? A nonconformity is a non-fulfillment of a requirement. Version: 10/17/18

What is a nonconformity? A nonconformity is when what is required by the ISO standard is NOT done. This includes through: § internal work processes (instructions, policies, procedures), § external factors (e. g. , equipment failure, supplier defects), § regulations, § contract provisions, § QMS documented information, or § external parties (e. g. , subcontractor, vendor, consultant). Version: 10/17/18

What is NOT a nonconformity? • Compliance issues such as Privacy, Conflict of Interest, Ethics, Discrimination, Workplace Safety or any other type of compliance issues. • To report actual or potential Privacy, Conflict of Interest, Ethics, Discrimination, Workplace Safety or any other type of compliance issues, please notify your supervisor, manager or call IPRO's Compliance Manager at 516. 209. 5671. You may also call the Anonymous Compliance Hotline at 1. 800. 331. 5118 or file an online report at https: //iprocomplianceprogram. wufoo. com/forms/anonymouscompliance-reporting-system/ Version: 10/17/18

What is NOT a nonconformity? • Personnel issues should be referred to Human Resources (see the HR Manual on IPROconnect). • Ideas for improving work processes, etc. should be submitted through Th. In. C - the IPRO Innovation Center at labs. ipro. org Version: 10/17/18

How can nonconformties be a good thing? § Enable companies to identify oversights, errors, and mistakes in a timely manner and deal with them effectively. § Nonconformities can be identified by anyone at any time. During every day operations, in the monitoring process, during internal audits, after service delivery, etc. Version: 10/17/18

Nonconformity Examples • Work process/procedure requires a specific form for capturing review results but staff use another outdated form. • Reports are late going to the customer and the contract requires reports within specified time frames. • Customer reports have typographical or data errors. • The work process requires computer system backup once a day, but the backup was performed only four times in the month. • Training records are missing and/or all employees are not trained as they should be. Version: 10/17/18

Nonconformity Examples • The building’s air conditioning system goes down on a weekend appropriate IPRO staff members are notified per procedure (external factor). • A medical record review vendor doesn’t have enough staff to complete a subcontracted review on time (external party). • Vendor outage on Internet Server Provider (ISP) lines - Albany users could not reach data servers in Lake Success users could not reach data servers in Albany (external factor). Version: 10/17/18

Nonconformities Cost Version: 10/17/18

Nonconformity Actions: Correction Corrective Action Preventive Action Version: 10/17/18

Nonconformity Actions § IPRO must react to a nonconformity by taking actions to control it and deal with the consequences. § Once identified, a nonconformity should trigger a corrective action in order to remove the cause of the nonconformity and prevent its recurrence. § The effectiveness of actions taken must be evaluated and documented, along with the originally reported information about the nonconformity and the results achieved. Version: 10/17/18

Nonconformity Actions Nonconformities must be reported either • through the QMS Process Improvement Form at https: //iprocomplianceprogram. wufoo. com/forms/z 5 ittcl 1 xsbhpr/ • Or, by email to jcashman@ipro. org Version: 10/17/18

Correction § A correction is an action to eliminate a nonconformity. § Correction is like first-aid, its the instant action that is taken to correct the nonconformity or to reduce the impact. § Requirements = take without undue delay and remove consequences/deal with nonconforming process outputs, products and/or services. Version: 10/17/18

Corrective Action § A corrective action is an action to eliminate the cause of a nonconformity and prevent recurrence. § Take corrective action without undue delay. § Must be based on the nature of the nonconformity and its impact on the conformity of products and services. Version: 10/17/18

Corrective Action What is required when a nonconformity occurs? § Action to eliminate the root cause of the nonconformity by § reviewing the nonconformity; § determining the causes of the nonconformity; and § determining if similar nonconformities exist, or could potentially occur. § Implement needed corrective actions. § Review the effectiveness of any corrective action taken. § Make changes, if necessary. Version: 10/17/18

Preventive Action Ideally - improve processes to prevent nonconformities Identify risks and mitigate them. Version: 10/17/18

Questions about potential nonconformities - send an email to Judy Cashman at jcashman@ipro. org Version: 10/17/18

Thank You Judy Cashman Quality Management Ambassador jcashman@ipro. org Version: 10/17/18