Documente Academic
Documente Profesional
Documente Cultură
Management Sales
Requirements
Clause
Clause Description
Number
4.1 Understanding the organization and its context X
4.2 Needs and Expectations of the Interested Parties X X
4.3 Determining the scope of the quality management system X
4.4 Quality Management System and its processes X
5.1 Leadership and commitment X
5.2 Quality Policy X X
5.3 Organizational roles, responsibilities and authorities X X
6.1 Actions to address risks and opportunities X X
6.2 Quality objectives and planning to achieve them X X
6.3 Planning of changes D
7.1 Resources X X
7.1.1 General
7..1.2 People D D
7.1.3 Infrastructure X X
7.1.4 Environment for the operation of processes X X
7.1.5 Monitoring and Measuring
7.1.6 Organizational Knowledge X X
7.2 Competence X X
7.3 Awareness X X
7.4 Communication X
7.5 Documented Information X X
7.5.1 General X
7.5.2 Creating and updating X
7.5.3 Control of documented Information X
8.1 Operational planning and control X X
8.2 Determination of requirements D D
8.2.1 Customer communication X X
8.2.2 Determination of requirements related to products and services x
8.2.3 Review of requirements related to products and services X
8.2.4 Changes to requirements X
8.3 Design and Development X
8.3.1 General X X
8.3.2 Design and development planning X
8.3.3 Design and development inputs X
8.3.4 Design and development controls. D
8.3.5 Design and development Outputs
8.3.6 Design and development changes
8.4.2 Type and extent of control of external provision
8.4.3 Information for external providers
8.5.1 Control of production and Service X
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 X
8.5.6 Control of changes X X
8.6 Release of products and services
8.7 Control of nonconforming products
9.1.1 Monitoring, measurement, analysis X X
9.1.2 Customer Satisfaction X X
9.1.3 Analysis and evaluation X X
9..2 Internal Audits X
9.3 Management Review X
10.1 Improvement – General X X
10.2 Nonconformity/Corrective Action
10.3 Continual improvement X X
X X X X X X X X
X X X X X X X X
X X D X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X X
X
D D D D D
X
X X
X D X
X X X X X X X X
X X X X X X X X
X X X X X X X X
X X X X X X X X
X
X
X X D
D D D
X
X
X X X X
X X D
X
X
X ®
X
X
X
X
X
X
D
X
X X
X X X X X X X X
X
X X X X X X X X
X
X X X X X X X X
X X
X X X X X X X X
Discrepancy Reference Number
Internal Audits Mgt. Review Accounting
X
X X
X
X X X
X X X
X X X
X X X
X X X
X
X
X X X
X X X
X X X
X
X X X
X X
X X
X
X X
X X
1
1.1
1.2
1.3
1.4
2
2.2
2.3
2.4
3
4
4.1.2
4.1.3
4.1.4
4.1.5
4.1.6
4.2
4.3
4.4
4.5
5
5.2
5.3
5.3.3
5.3.4
5.3.5
5.3.6
5.4
5.4.2
5.4.3
5.5
5.5.1
5.5.2
5.5.3
5.5.4
5.5.5
5.5.6
5.6
5.7
6
6.1.2
6.1.3
6.2
6.3
7.1
7.2
Quality Management System Checklist
Context of the organization
Understanding the organization and its context
Has the organization identified all external and internal issues relevant to its purpose and direction?
What is the process for monitoring and review of the external and internal issues?
Understanding the needs and expectations of interested parties
Has the organization identified all relevant interested party requirements that are relevant to the
quality management system? How is the information monitored?
Determining the scope of the Quality Management System
Is the scope of the quality management system, including products and services provided and
justification for any exclusion, defined?
Is the scope of the quality management system maintained as documented information?
Are the following considered when determining the scope?
• External and Internal Issues
• Requirements of relevant interested parties
• The products and services provided.
Is there assurance that all requirements of the standard that can be applied, have been applied by the
organization and those determined non- applicable do not affect the organization’s ability or
responsibility to ensure conformity?
Quality Management System and its processes
Have the processes of the organization been identified?
• Inputs and Outputs
• Sequence and interaction
• Criteria, method and performance indicators
• Resources needed
• Defined responsibility and authority for all personnel.
• Risks and Opportunities
• Method for monitoring and change to ensure intended results
• Opportunities for improvement of the processes
Has the organization defined
• Needed documented information to support the operation of its processes?
• Documented information to be retained as evidence that the processes are being carried out as
planned?
Leadership
Has top management demonstrated leadership by
• Taking accountability of the process?
• Establishing the Quality Policy and Objectives?
• Communicating the Policy?
• Ensuring QMS Requirements are integrated into the processes?
• Making available adequate resources?
• Communicating QMS effectiveness?
• Ensuring achievement of results?
• Engaging/directing/supporting process effectiveness?
• Promoting continual improvement?
• Supporting other management roles within the organization to do the same?
Can top management demonstrate evidence of commitment to the development, implementation and
improvement of the effectiveness of the quality management system by:
• Communicating to the organization the importance of meeting customer requirements?
• Establishing the quality policy?
• Ensuring that quality objectives are established?
• Conducting management reviews?
• Ensuring the availability of resources?
Customer Focus
Has top management demonstrated leadership by
• Identifying customer requirements?
• Identifying regulatory requirements?
• Identifying statutory requirements?
• Risks and Opportunities determined and addressed?
• Focus to consistently provide products/services that meet customer requirements?
• Enhancing customer satisfaction?
Quality Policy
Has top management established a quality policy that
• Is appropriate to the organization?
• Allows for review of process indicators and objectives?
• Includes a commitment to satisfy applicable requirements?
• Includes a commitment to continual improvement?
• Is communicated and understood throughout the organization
• Is reviewed for continuing suitability?
Are the quality objectives measurable and consistent with the quality policy? Is the quality policy
• Documented?
• Communicated and understood?
• Available to relevant interested parties?
Organizational roles, responsibilities and authorities
Has top management defined
• Responsibility and authority for all personnel affecting quality?
• Ensuring that the processes are effective and delivering their intended results?
• Reporting on the performance of the QMS and opportunities?
• Ensuring Customer Focus throughout the organization?
• Maintaining the integrity of QMS when changes are implemented?
Planning for the Quality Management System
Has the organization considered risks and opportunities noted in 4.1 and 4.2 and hav eassurances
that QMS
• Can achieve its intended results?
• Mitigate Risk by prevention or reduction of undesired effects?
• Enhance desirable effects?
• Achieve improvements? Does the organization plan
• Actions needed to address risks and opportunities?
• Integrate actions into its QMS processes?
• Evaluate the effectiveness of actions?
Has the organization established Quality objectives that are:
• Consistent with the Quality Policy?
• Are measurable?
• Considered applicable requirements?
• Relevant?
• Monitored?
• Communicated?
• Updated?
Has the organization planned how to achieve its quality objectives by
• Identifying what has to be done?
• Identifying the needed resources?
• Identifying the responsibility for achievement?
• Due date for achievement?
• Evaluation of the results?
For changes to the QMS, has the organization proceeded in a planned and systemic manner by
• Identifying the changes and their consequence?
• The integrity of the QMS?
• Availability of resources?
• Allocation or reallocation of responsibilities and authorities?
Support
Has the organization determined the needed resources while considering
• Limitations of internal resources?
• What has to be obtained from external providers?
People
Are adequate human resources in place to ensure compliance with the customer and applicable
regulatory and statutory requirements?
Infrastructure
Has the organization identified the infrastructure
needed for effective operation of the QMS, ,
including
• Maintenance of equipment?
• Buildings and associated utilities?
• Transportation?
• Information and Communication Technology?
Environment for the operation of processes
How will it be demonstrated that the organization
determines and manages the work environment
needed to achieve conformity to product and service requirements?
Monitoring and measuring resources
Has the organization determined the monitoring and measurement to be undertaken, and the
monitoring and measurement resources needed to provide evidence of conformity to determined
requirements?
Are suitable monitoring and measuring resources
available to ensure valid and reliable results,
including
• Ensuring suitable resources?
• Resources are maintained to ensure their continued fitness for their purpose?
• Maintaining documented information as evidence of fitness of the monitoring and measuring
resources?
• Determining suitability of the specific type of monitoring and measurement activities?
Have all monitoring and measuring activities
determined?
Are monitoring and measuring resources
• Suitability maintained?
What documented information is maintained as evidence of fitness for the monitoring and
measurement resources?
* Is measuring equipment calibrated or verified, or both, at specified intervals or prior to use
against traceable international or national measurement standards? (If international or national
measurement standards are not available, the basis for calibration or verification shall be defined)
• Identified in order to determine its calibration status?
• Safeguarded from adjustments that would invalidate the measurement result?
• Protected from damage and deterioration during handling, maintenance and storage?
How will it be demonstrated that:
• The validity of previous measuring results are assessed by the organization when equipment is
found not to conform to requirements?
• Appropriate action is taken on the equipment and any affected product?
Organizational Knowledge
What evidence is available to ensure that the organization has determined the knowledge necessary
for effective operation of its processes? Is the knowledge necessary for the operation of