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7.3.1 Design and Development Planning Plan design stages, activities, and responsibilities
7.3.2 Design and Development Inputs Identify and review input requirements for design
7.3.3 Design and Development Outputs Prepare design outputs and approve before release
7.3.4 Design and Development Review Review ability of design results to meet requirements
7.3.5 Design and Development Verification Verify the design outputs meet input requirements
7.3.6 Design and Development Validation Validate the product is okay for application or use
7.3.7 Control of Design and Development Changes Review, verify, and validate any design changes
7.4 Purchasing
7.4.1 Purchasing Process Evaluate, select, monitor, and control your suppliers
7.4.2 Purchasing Information Create purchase orders describing supplier products
7.4.3 Verification of Purchased Product Check purchases to ensure they meet requirements
7.5 Production and Service Provision
7.5.1 Control of Production and Service Provision Plan and control production and service activities
7.5.2 Validation of Production & Service Processes Examine the process if you can’t check the product
7.5.3 Identification and Traceability Identify the product and its inspection and test status
7.5.4 Customer Property Exercise care with any customer property
7.5.5 Preservation of Product Handle, store, package, and protect the product
7.6 Control of Monitoring and Measuring Equipment Calibrate measuring equipment for valid results
8. Measurement, Analysis, and Improvement
8.1 General Plan, measure, analyze, and improve processes
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction Ask customers what they think about your products
8.2.2 Internal Audit Evaluate conformity and effectiveness of system
8.2.3 Monitoring and Measurement of Processes See if processes are achieving planned results
8.2.4 Monitoring and Measurement of Product Verify products meet acceptance criteria
8.3 Control of Nonconforming Product Prevent use or delivery of nonconforming product
8.4 Analysis of Data Analyze effectiveness and identify improvements
8.5 Improvement
8.5.1 Continual Improvement Continually improve effectiveness of quality system
8.5.2 Corrective Action Fix detected problems and prevent recurrence
8.5.3 Preventive Action Avoid potential problems by preventing occurrence
Gap Analysis Report Summary
Result/Observations
Gap Analysis Report Summary
Result/Observations
ISO/TS 16949:2009 Gap Analysis Checklist
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Ask how they are able to know if resources and information needed
4.1
to support processes have been provided.
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4.2.1 General
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Can users easily identify documents? Can users easily read the
4.2.3 documents? Are the documents easy and accessible for the
employees use?
How are old documents handled? Are they removed from use?
Are they labeled?
4.2.3 Is a copy maintained for reference?
Is there any chance that an old document could be used by
accident?
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5 MANAGEMENT RESPONSIBILITY
5.1 Management Commitment
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Are all types of customers: consumer, client, end user, retailer, and
5.2
beneficiary identified?
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Is the quality policy appropriate for the organization and aligned with
5.3 customer expectations, business environment, and management
goals?
5.3 Does the quality policy inspire and lead organization forward?
5.4 Planning
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Does the planning include all the appropriate processes? (such as:
5.4.2 Customer Oriented Processes-COPS, Management Oriented
Processes-MOPS, Support Oriented Processes-SOPS)
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Will the plan accomplish the task of meeting the customers’ needs
5.4.2
and expectations expressed in 5.2 Customer Focus?
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5.5.3 What tools does the organization use for internal communication?
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5.6.1 General
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6 RESOURCE MANAGEMENT
6.1 Provision of Resources
Verify that resources are available for the QMS. Assess resources
for addressing customer satisfaction, implementing and improving
6.1 the QMS processes. Are resources available in a timely manner?
Resources can be people, information, supplies, equipment, facility,
work environment, or financial resources.
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6.2.1 General
Verify the training records of personnel, especially as related to
sections 4.0, 5.0, 6.0, 7.0, & 8.0 of the standard. If you have a
6.2.1
training document, assess the document for compliance to the
standard.
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Are there records for all employees indicating their training, skills
6.2.2
education and experience?
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6.3 Infrastructure
6.3 Are there adequate facilities (lab) for returned product analysis?
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7 PRODUCT REALIZATION
7.1 Planning or Product Realization
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Does the plan identify the records necessary for process and
7.1
product conformance?
7.1 Is the plan output appropriate to the operation?
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Does the review make sure that they have the ability to meet all
7.2.2
requirements before commitment to supply?
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How does your organization plan and control the design and
7.3.1
development of product?
Sample various products.
7.3.1 For each product that was designed or developed check the
following:
7.3.1 Was there a plan for the design and development of the product?
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How was the interface between the different groups managed for
7.3.1
effective communication and clarity of responsibilities?
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7.3.2 Is there evidence that the inputs were reviewed for adequacy?
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Did the review evaluate the ability to meet the requirements needed
7.3.4
at the stage, and identify problems and proposed follow up actions?
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This clause asks your organization to base the type and extent of
control of suppliers on the effect of the purchased material on both
7.4.1
the product realization processes and products produced. Assess
the records of supplier evaluations and follow up actions.
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7.4.1 Does the list include all the appropriate types of suppliers?
Were the suppliers evaluated and selected based upon their ability
7.4.1
to supply product in accordance with requirements?
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Assess how the organization has defined the inspection process for
compliance and verify evidence of product acceptance. Verification
7.4.3
of purchased product performed at the supplier’s premises is
seldom used. If being done assess the process for compliance.
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Does the validation process include defined criteria for review and
7.5.2
approval of the process?
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Does the organization validate all of its processes for all its
7.5.2 production and service provision where the resulting output cannot
be verified by subsequent monitoring or measurement?
7.5.3 How does the operator know what has and has not been checked?
7.5.3 How do they track the product to the traceability level required?
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Acceptance criteria?
Handling, storage and preservation of inspection, measuring and
test equipment?
Environmental conditions? Location?
7.6
Corrective actions? Frequency of checks?
Audit the calibration program.
NOTE: Monitoring and measuring equipment should be trailed from
processes audited in Production and Service Provision (7.5)
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What measures are in place to ensure the audits and auditors are
8.2.2
objective and impartial in the audit process?
How does the management responsible for the area audited take
8.2.2
timely action to eliminate nonconformities and their causes?
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Does the internal audit cover the full scope of the standard as well
8.2.2
as any customer specific requirements?
Do the audit schedule and the audit process indicate that the
8.2.2 current auditing process audits effective implementation and
maintenance of the system?
Have audits, scope and frequency, and methodologies been
8.2.2
defined?
8.2.2 Are the auditors independent of the area audited?
Are audit questions comprehensive?
8.2.2 Are they focused on the performance of the process meeting
planned objectives?
Is the objective evidence recorded for each question?
8.2.2 There should be objective evidence for both conformance and non-
conformances.
Do the questions and the evidence indicate that the audit is
8.2.2 checking whether the QMS is effectively implemented and
maintained?
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8.2.3 Do the criteria and methods used effectively control the process?
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Is there evidence that product release and service delivery does not
8.2.4 proceed until all activities have been completed (unless otherwise
approved by a relevant authority or customer)?
8.2.4 What are the criteria and methods used to control the process?
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8.2.4 Do the criteria and methods used effectively control the process?
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Based on internal and external reject and rework data, are there
8.3 problems indicated related to handling, packaging, storage and
delivery?
Assess the methods used to collect and analyze the data required
below. Confirm the analysis of the data is used to demonstrate the
8.4
suitability and effectiveness of the QMS and the system continues
to improve.
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8.5 Improvement
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8.5.2 Does the data show that the corrective action is effective?
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8.5.3 Does the data show that the preventative action is effective?