Compliance Requirement


Is QMS considered as a strategic tool and aligned with business objective & Strategic direction of your organization?

Have you scanned your business environment & identified challenges including internal issues, external issues and needs - expectations of interested parties. Did you extend this exercise to identification of risks & opportunities for each of the them if not properly addressed ?

Have you identified scope for your QMS and identified requirements which can not be applied with proper justification?

Have you identified risks and opportunities from context, processes, services / products / projects and changes executed or planned in the organization? Did you consider strategic and operational factors while identification of risks & opportunities?

Are these risks & opportunities communicated to relevant employees? Do you evidence of planning to address these risks & opportunities and actual actions taken? Are they reviewed at regular interval?

To what extent the top management is involved and actively participates in the QMS implementation, maintenance and improvement process ?

Have you identified ISO representative(s) / ISO in charge and core team ? Did you formally communicate their role, responsibilities and authority ?

Is the quality policy prepared, communicated and understood by everyone in the organization. If required, have you translated it in to the local language to ensure need of the employees who do not understand English is addressed?

Are SMART (Specific, Measurable, Achievable, Realistic & Timebound) quality objectives established with achievement plan prepared and regular performance tracking done.

Are employees aware about their department / process / project specific quality objectives ?

Have you identified processes in your organization ?

Have your clearly identified / documented process input, responsibility / accountability, knowledge requirement for process execution, procedure / process description, process output, process effectiveness parameters / KPIs, risks & opportunities etc. for various critical processes in the organization? Can you demonstrate control over your process and execution of the process in a standardized manner?

Have you documented critical processes through process document / Procedure / Work Instructions / SOPs / flow charts / Operational Manual etc. and ensured their availability at the point of use and compliance to the established procedures? -

Do you have an updated organization chart defining various roles and hierarchy ?

Have you identified, documented and communicated roles, responsibility & authority for all the employees ?

Did you identify minimum / ideal competence level for various roles / designations and mapped it with existing competence level of the employees? Did you identify gaps in competence for all the employees?

Are training needs identified for employees and did it result in some kind of training calendar / schedule? Do you have evidences of training execution, attendance etc. for all the trainings which are delivered so far?

For all the completed trainings did you carry out effectiveness of the trainings ?

Are purchase orders available for all the purchases made with all the information including product / service technical details / acceptance criteria / delivery date etc.?

Are purchase orders available for all the purchases made with all the information including product / service technical details / acceptance criteria / delivery date etc.?

Have you identified evaluation criteria for all the suppliers whose product / service affect quality ? Do you have records of such evaluation for all the suppliers form whom you have purchased?

Does this result into a ready to use and accessible list of approved suppliers ?

Have you identified re-evaluation criteria for all the suppliers whose product / service affect quality ? Do you have records of such re-evaluation for all the suppliers with whom you are doing business? Is re-evaluation frequency identified and re-evaluation done as per that frequency?

Do you have records of in-coming inspection or verification of purchased products / services ? Are third party inspection certificate for purchases / supplier test report available where incoming inspection is not possible / feasible / practical?

Do you have a document describing your product/service/project at a macro level covering information like process required, resources required, acceptance criteria etc.?

Do you have operational work instructions / SOPs/guidelines for production/service/ projects execution to ensure control over the activities and a standardized output?

Do you identify resources / work environment for effective execution of the processes and service / product / project delivery? Do you consider physical, social, psychological parameters while defining work environment?

Do you prepare production plan / service delivery plan / project execution plan and report for a specific frequency (e.g. daily, weekly/fortnightly/monthly/quarterly etc.) as per your business requirements?

Are all the enquiries / business leads received formally documented & tracked?

Do you review your organization's capability to meet customer's requirements before commitment to supply product / service.

Do you identify legal / statutory / regulatory / compliance obligations or requirements if applicable during pre-sales process.

Do you document client complaints with correction, root cause, corrective actions & effective evaluation of corrective actions along with its review and analysis?

Do you measure Customer feedback / perception / satisfaction level? Do you carry out analysis of it?

Have you identified all the applicable legal, statutory & regulatory compliance requirements for your organization for the scope of QMS?

Have you identified resources (machine / equipment /devices / instruments/ hardware / software etc.) requiring calibration? Do you have calibration / verification records with availability of calibration certificate.

Do you put calibration tag on the instruments / equipment for identification and traceability?

Do you manage your assets / equipment / machines with a proper preventive maintenance plan? Do you have records of preventive maintenance an breakdown maintenance?

Do you have incoming inspection quality plan and records

Do you have in process & final inspection quality plan and records.

Do you outsource any processes / activities ? IF yes, have you identified such outsourced processes?

Do you have records to prove that outsourced partner's work is as per your requirement and is meeting product / service conformity requirements ? Are you able to demonstrate control over outsourced process?

Do you have any special processes wherein defect / non-conformity appears only after the product is delivered / is in use. Do you have a list of such processes that needs to be validation?

Do you control your documented information for creating, issuing, using, revision etc.? Do your documents have information like document name, number, revision no, effective date, issued to and records information like location, retention period, disposal mechanism, disposal authority etc. ?

Do you ensure document of the most recent version is available to the users?

Do you ensure any document change is controlled and after a document has been revised, old version is recalled and marked suitably to prevent its unintended use?

Do you control documents of external origin

Have you identified Internal audit schedule to ensure various processes / departments / sites are audited regularly?

Is there an internal audit plan for specific audit to be carried out like date, time, location, auditor, auditee etc.?

Do you generate an internal audit summary report for each audit conducted?

For deviations identified during the internal audit, do you generate non conformity report and address it with correction, root cause analysis, corrective actions and effectiveness evaluation of the corrective actions?

Do you conduct regular Management Reviews and does input for such reviews include specific points of context, policy, objectives, risk opportunity, processes, complaints, NCs, customer satisfaction, process performance, product / service conformity, improvement opportunities etc.?

Do you generate output end of each Management Reviews covering minutes of meeting and action plans?

Do you generate output end of each Management Reviews covering minutes of meeting and action plans?

Do you document process non conformity / deviations with correction, root cause analysis, corrective action & effectiveness evaluation of corrective actions?

Do you have a Quality Manual though not mandatory but if required by the organization with scope of QMS, any exclusions with justification, SOPs or reference to them and process interaction.

Procedures on documented information, internal audit, non conformity management, corrective actions etc. if required by the organization

Have you identified what knowledge is required for various process / stage in the organization and making sure right kind of knowledge is made available to employees.

Do you have a formal change management process and ensure that any significant change affecting your QMS is a controlled change with risks identification if any.

Has the organization ensured that people doing work under their control are at least aware of the quality policy, relevant quality objectives, their contribution to these and the implications of not conforming to the QMS?

Has the organization determined internal and external communications relevant to the QMS?

Is Identification and traceability maintained during process execution and for output generated ?

If there is a requirement for post-delivery activities associated with the products and services such as warranty, maintenance services, recycling or final disposal, are these defined and managed?

Statistical analysis of process performance / objectives / KPIs / supplier performance / customer perception / complaints / non conformities etc.

Identification of improvements / continual improvements projects in the organization.

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