ISO-9001-2015-Checklist

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ISO 9001 2015 Implementation Checklist
	
	
	
	
	
	
	
	
	
	
	
	
	
	Implementation Checklist for ISO 9001:2015 standard
	
	
	
	
	
	Organization evaluated:
	 
	
	
	
	
	
	Evaluator:
	 
	
	
	
	
	
	Evaluation date:
	 
	
	
	
	
	
	Chapter
	Article
	Questions
	
	Ch. 4 Organizational Context
	4.1 Understanding the organization and its context
	Are the internal and external issues related to the company identified?
	
	
	
	Is information on these internal and external issues monitored?
	
	
	
	Are these issues taken into account in the quality system?
	
	
	4.2 Understanding interested parties Needs and Expectations
	Are the relevant interested parties identified?
	
	
	
	Are the requirements of the interested parties identified?
	
	
	
	Are interested parties’ requirements monitored and reviewed?
	
	
	4.3 Determining the scope of the quality management system
	Is the scope of the QMS determined?
	
	
	
	Is the scope available in a documented form?
	
	
	4.4 QMS and its processes
	Have the processes been identified?
	
	
	
	Have the inputs and outputs of these processes been identified?
	
	
	
	Have the sequences and interactions of these processes been identified?
	
	
	
	Have the criteria and methods for ensuring the effectiveness of these processes been determined?
	
	
	
	Are the resources needed for these processes identified and available?
	
	
	
	Have responsibilities been defined?
	
	
	
	Have the risks and opportunities related to these processes been taken into account and appropriate actions planned?
	
	
	
	Are these processes evaluated, measured and analyzed? 
	
	
	
	Are actions taken if processes are not producing the expected results?
	
	
	
	Is the information related to these processes documented?
	
	Chapter 5 Leadership
	5.1 Leadership and commitment
	Management assumes and demonstrates its responsibility and commitment to the effectiveness of the QMS?
	
	
	
	Are the quality policy and objectives established and formalized?
	
	
	
	Does management promote the process approach and the risk-based approach?
	
	
	
	Does management ensure the availability of resources for the QMS?
	
	
	
	Does management communicate the importance of having an effective system and complying with requirements and encourage people to contribute to its effectiveness?
	
	
	
	Does management ensure that the QMS is achieving its intended results?
	
	
	
	Does management promote improvement?
	
	
	
	Does management support others with a relevant role in the system to demonstrate their responsibilities?
	
	
	
	Does management demonstrate its commitment to customer engagement?
	
	
	
	Are customer requirements identified and met?
	
	
	
	Are the risks and opportunities affecting product and service compliance identified and addressed?
	
	
	5.2 Policy
	Is the quality policy adapted to the organization's purpose?
	
	
	
	Is the policy established, reviewed and updated regularly by management?
	
	
	
	Does the quality policy take into account regulatory, legal and customer requirements?
	
	
	
	Does the quality policy define a framework for quality objectives?
	
	
	
	Does the quality policy include a commitment to meeting requirements and continuously improving the effectiveness of the QMS?
	
	
	
	Is the quality policy communicated within the organization?
	
	
	
	Is the quality policy made available to interested parties?
	
	
	5.3 Roles, responsibilities and authorities within the organization
	Are the responsibilities and authorities of all individuals in your organization clearly formalized and communicated within the organization?
	
	
	
	Has a manager been appointed by management to report to management on QMS performance and opportunities for improvement?
	
	
	
	Has a manager been appointed by management to ensure awareness of customer requirements and promote customer orientation throughout the organization?
	
	
	
	Has a manager been appointed by management to monitor the QMS?
	
	Chap. 6 Planning
	6.1 Actions to address to risks and opportunities
	Are the risks and opportunities for your organization identified?
	
	
	
	Does QMS planning take into account risks and opportunities?
	
	
	
	Are actions being taken to address risks and opportunities?
	
	
	
	Is the effectiveness of these actions measured?
	
	
	6.2 Quality objectives and planning to achieve them
	Are your quality objectives in line with the organization's quality policy? 
	
	
	
	Are your quality objectives adapted to the organization's purpose?
	
	
	
	Are your quality objectives measurable?
	
	
	
	Do your objectives take into account the applicable requirements?
	
	
	
	Are your quality objectives communicated and kept up to date as necessary?
	
	
	
	Are the modalities (Resources needed, responsible, deadline, evaluation of results) to monitor the achievement of the objectives defined?
	
	
	6.3 Planning of changes
	Are QMS changes planned?
	
	
	
	The purpose of any modification is taken into account as well as all the possible related consequences?
	
	
	
	Do changes to the QMS take into account resource availability and assignment of responsibilities?
	
	Chap. 7 Support
	7.1 Resources
	Does management ensure the availability of resources necessary for the QMS, its continuous improvement, and increased customer satisfaction?
	
	
	
	Do the required resources take into account the constraints of existing internal resources?
	
	
	
	Are the resources to be sourced externally identified?
	
	
	
	Are the human resources required to implement the QMS identified and implemented?
	
	
	
	Has management identified and provided the necessary infrastructure and support services to achieve product/service compliance? 
	
	
	
	Does management maintain this infrastructure?
	
	
	
	Is the work environment necessary to achieve product conformity managed and monitored by management (physical, environmental, ergonomic, psychological conditions, etc.)?
	
	
	
	Are the necessary resources identified and provided to ensure reliable monitoring and measurement results for products/services?
	
	
	
	Documented information regarding the adequacy of resources for monitoring and measurement is maintained?
	
	
	
	Are your measuring instruments calibrated, identified and protected?
	
	
	
	When such standards do not exist, do you keep a record of the reference used for calibration or verification?
	
	
	
	When an instrument is found to be defective, you determine if the validity of previous measurement results has been compromised and take appropriate corrective action, if necessary?
	
	
	
	The knowledge required to implement its processes and to obtain product conformity is determined?
	
	
	7.2 Competencies
	Does management identify the necessary personnel skills whose work impacts the QMS? 
	
	
	
	Does management provide for the training needs of staff whose work affects the QMS (acquisition of necessary skills)
	
	
	
	Has an indicator been put in place to evaluate/measure the effectiveness of actions undertaken in the area of skills management, awareness, training? 
	
	
	
	Does management ensure that staff are aware of the relevance and importance of their activities and how they contribute to the achievement of quality objectives?
	
	
	
	Do you keep records describing the skills of your staff (initial and professional training, know-how, experience)
	
	
	7.3 Awareness
	Is the staff aware of the quality policy and its objectives?
	
	
	
	Is the personnel aware of the importance of their contribution to the effectiveness of the QMS, including the improvement of its performance?
	
	
	
	Do you ensure that staff are aware of the relevance, importance of their activities, implications of non-conformities?
	
	
	7.4 Communication
	Are the internal and external communication needs determined, and are their modalities defined?
	
	
	7.5 Documented Information
	Does your QMS include the documented information required by the standard and that which you have determined to be necessary?
	
	
	
	Is the documented information available, identifiable,suitable for the intended use and protected (loss of confidentiality, inappropriate use ...)?
	
	
	
	Is the documented information approved?
	
	
	
	Are activities implemented to control documented information (distribution, access, storage, retention, etc.)?
	
	
	
	Is documented information from outside sources identified?
	
	
	
	Is the documented information maintained as evidence of compliance protected from inadvertent alteration?
	
	Chap. 8 OPERATIONS
	8.1 Operational planning and control
	Are the processes necessary to achieve the product developed and planned?
	
	
	
	Does product planning and execution take into account product/service requirements?
	
	
	
	Have the acceptance criteria for products/services been defined?
	
	
	
	Have the necessary resources been planned for the product/service?
	
	
	
	Is documented information maintained to ensure that processes have been carried out as intended and to demonstrate compliance of products and services with applicable requirements?
	
	
	
	Are the planned changes scheduled?
	
	
	
	Are unanticipated changes analyzed and actions taken to limit any negative effects?
	
	
	8.2 Requirements for Product and Service
	Have specific customer requirements for emergency actions been determined by the organization?
	
	
	
	Do you take steps to preserve the conformity of the service and its components from completion to delivery to the intended destination? (take care of the customer's property)
	
	
	
	Do you communicate with the customer about feedback and complaints?
	
	
	
	Have stated and unstated customer requirements (necessary for use), as well as regulatory and legal requirements been determined by the organization?
	
	
	
	Are reviews of product/service requirements conducted regularly?
	
	
	
	Does the organization ensure that discrepancies between the requirements of a contract or order and those previously expressed have been resolved?
	
	
	
	Is there documented evidence of the results of product reviews and resulting actions? 
	
	
	
	Is there documented evidence that any new product/service requirements are documented?
	
	
	
	When product and service requirements change, do you ensure that the corresponding documented information is amended and that affected personnel are informed?
	
	
	8.3 Design and development for products and services 
	Is the design and development of the product/service planned?
	
	
	
	Have the design and development stages and review and validation activities been identified?
	
	
	
	Are the interfaces between the people involved in Design and Development managed (responsibilities and authorities)
	
	
	
	Are internal and external resource requirements determined?
	
	
	
	Are the inputs to the product/service requirements determined and records kept?
	
	
	
	Do the inputs include: - functional and performance requirements- information 
from previous similar designs- legal and regulatory requirements- applicable standards or internal art rules- consequences of a potential failure
	
	
	
	The expected results of the design and development process activities are controlled and reviews are conducted to assess the ability to achieve these results?
	
	
	
	Do you verify compliance and/or measure variances between output items and C&D input requirements?
	
	
	
	Are validation activities implemented to ensure that the products or services meet the intended requirements prior to implementation?
	
	
	
	When results are not achieved at the time of review, verification and validation, are actions taken?
	
	
	
	Documented information related to the proper functioning of the design and development process is maintained?
	
	
	
	Are changes verified and validated before implementation? Is information about these changes kept?
	
	
	8.4 Control of processes, products and services provided by external providers
	Are criteria established for the evaluation, selection, performance monitoring, and re-evaluation of external providers? Is this information maintained in documented form?
	
	
	
	Are the risks of the impact of outsourcing processes, products and services taken into account?
	
	
	
	Are there defined means to verify that the product/service provided meets your requirements?
	
	
	
	Is the compliance of products and services provided by external providers verified?
	
	
	
	Do you communicate your requirements to the service providers (elements to be provided, skills, means of control, verification to be carried out)
	
	
	8.5 Production and service provision 
	Are the production and service activities planned and implemented in a controlled manner from the implementation of the activities to the after-delivery service?
	
	
	
	Do you monitor the ability of the process of preparing expected services, whose outputs cannot be verified by monitoring or measurement after the fact, to achieve planned outcomes?
	
	
	
	Are the output elements identified throughout the process? Is this identification controlled, as well as the related records?
	
	
	
	Do you take steps to safeguard client or external provider property while it is under your control?
	
	
	8.6 Release of products and services
	The release of products and services to the customer is carried out only if the execution is satisfactory to the planned provisions; unless approved by a competent authority or by the customer? 
	
	
	
	Is documented information about the release kept?
	
	
	8.7 Control of Nonconforming Outputs
	Are process/product/service outputs that do not meet requirements identified and controlled to prevent their use?
	
	
	
	Are actions taken to deal with these non-compliant elements (correction, isolation, customer information, derogation ...)?
	
	
	
	Is documented information about the non-compliance and the actions taken kept?
	
	Chap. 9 Performance Evaluation
	9.1 Monitoring, Measurement, Analysis and Evaluation
	
Are monitoring activities defined and implemented?
	
	
	
	Are the results of this monitoring analyzed and evaluated?
	
	
	
	Is documented information kept as evidence of monitoring results?
	
	
	
	Do you monitor the customer's perception of how well these requirements are being met?
	
	
	
	Is the monitoring of this perception planned, are methods defined?
	
	
	9.2 Internal Audit
	Are audits planned at regular intervals?
	
	
	
	The audit criteria and scope are defined; the selected auditors are impartial and objective on the audited process?
	
	
	
	The results of the audits are communicated to management and actions are implemented?
	
	
	
	Is documented information maintained as evidence of the implementation of the audit program and audit results?
	
	
	9.3 Management review
	Are your management reviews planned and carried out? Does it take into account all the elements listed in the standard?
	
	
	
	Do your management reviews take into account all the elements listed in the standard?
	
	
	
	Following the management review, are decisions and actions related to improvement opportunities and possible changes taken?
	
	
	
	Is documented information from management reviews retained?
	
	Chap.10 Improvement
	10.1 General information
	Are actions taken to meet customer requirements and increase customer satisfaction?
	
	
	10.2 non-conformity and corrective action
	Do you react to the appearance of a non-conformity or customer complaint? (Control, correction, measure of consequences)
	
	
	
	Are non-conformities/customer complaints analyzed and evaluated?
	
	
	
	Do you take corrective actions to eliminate the causes of the detected nonconformities to avoid their recurrence?
	
	
	
	Is the effectiveness of corrective actions measured?
	
	
	
	Documented information is kept as proof of non-conformities and actions taken.
	
	
	
	You will update the risks and opportunities identified during planning if necessary?
	
	
	
	Do you modify your QMS if necessary?
	
	
	10.3 Continuous Improvement
	Do you ensure the continuous improvement of your QMS effectiveness?
ISO 9001 2015 Checklist	QSE-academy.com	1