ISO 9001:2000 AUDIT CHECKLIST No.Question Proc. Ref.Comments
4 Quality Management System补肝的食物有哪些
4.1General Requirements
1Has the organization established, documented,
implemented and maintained a quality management
system in accordance with the requirements of ISO 9001?
2Is the effectiveness of the quality management system
continually improved?
3Has the organization:
a)Identified the process needed for the quality
management system including their applications
throughout the organization?
b)Determined the quence and interaction of the
process?
c)Determined the criteria and methods needed to
ensure that both the operation and control of the
process are effective?
d)Ensured the availability of resources and
information necessary to support the operation and
monitoring of the process?
e)Measured, monitored and analyzed the
process?
f)Implemented actions needed to achieve
planned results and continual improvement of
the process?
4Does the organization manage the process in
accordance with the requirements of ISO 9001?
5Where process that affect product conformity with
requirements are outsourced, are the controls for
the process identified within the quality
management system?
4.2 Documentation Requirements
4.3 4.2.1 General
6Does the quality management system documentation
include:
a)Documented statement of a quality policy and
quality objectives?
b)Quality Manual?
c)Documented procedures required by ISO 9001?
d)Documents needed by the organization to ensure
the effective planning, operation and control of its
process?
e) Records required by ISO 9001?
4.2.2Quality Manual
7Has a quality manual been established and maintained
that includes:
a)The scope of the quality management system,
including details of, and justification for any
exclusions?
b)Documented procedures established for the quality
management system, or reference to them?
c)Description of the interaction between the
process of the quality management system?
4.2.3Control of Documents
8Are documents required for the quality management system controlled?
9Has a documented procedure been established
identifying the following controls needed?
a)Approval of documents for adequacy prior to issue?
b)Review, update as necessary and re-approval of
documents?
竹依依c)Ensure that changes and the current revision status
of documents are identified?
d)Ensure that relevant versions of applicable
documents are available at points of u?
e)Ensure that documents remain legible and
readily identifiable.
cif贸易术语f)Ensure that documents of external origin are
identified and their distribution controlled?
g)Preventing the unintended u of obsolete
documents, and to apply suitable identification to
them if they are retained?
4.2.4Control of Records
10Have records been established and maintained to provide evidence of conformity to requirements and of the
effective operation of the quality management system?
11Has a documented procedure been established to define the following controls needed?
a)Identification?
b)Storage?
c)Retrieval?
d)Protection?
e)Retention time?bl动漫在线观看
f)Disposition?
5 Management Responsibility
5.1Management Commitment
1Has top management provided evidence of its
commitment to the development and implementation of
the quality management system and for the continual
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improvement of its effectiveness by:
a)Communicating to the organization the
importance of meeting customer as well as
regulatory and legal requirements?
b)Establishing the quality policy?
c)Ensuring that quality objectives are
established?
d)Conducting management reviews?
e)Ensuring the availability of resources?
5.2Customer Focus
2Has top management ensured that customer
requirements are determined and met with the aim of
enhancing customer satisfaction?
5.3Quality Policy
3Has top management ensured that the quality policy:
a)Is appropriate to the purpo of the organization?
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b)Includes a commitment to comply with
requirements and to continually improve the
effectiveness of the quality management
system?
c)Provides a framework for establishing and
reviewing quality objectives?
d)Is communicated and understood within the
organization?
e)Is reviewed for continuing suitability?
5.4Planning
5.4.1Quality Objectives
4Has top management ensured that quality objectives are established at relevant functions and levels within
the organization?
5Have quality objectives needed to meet the
requirements of the product been established?
6Are quality objectives measurable and consistent with the quality policy?
5.4.2Quality Management System Planning
7Has top management ensured that the resources needed to achieve the quality objectives are identified and
planned?
8Is the output of the planning documented? (e.g., quality manual, procedures, work instructions, quality plans, etc.)
9Does top management ensure that the integrity of the quality management system is maintained when
changes are planned and implemented?
5.5 Responsibility, Authority and
Communication
5.5.1Responsibility and Authority
10Has top management ensured that responsibilities, authorities are defined and communicated within the
organization?
5.5.2Management Reprentative
11Has top management appointed member(s) of
management who have responsibility and authority for:
a)Ensuring that process are established,
implemented and maintained?
b)Reporting to top management on the performance
of the quality management system, including
needs for improvement?
c)Promoting awareness of customer
requirements throughout the organization?
5.5.3Internal Communication
12Has top management ensured that appropriate communication process have been established
within the organization?
13Does communication take place regarding the
effectiveness of the quality management system?
5.6Management Review
5.6.1General
14Does the top management review the quality
management system, at planned intervals, to ensure its
continuing suitability, adequacy and effectiveness?
15Are opportunities for improvement and the need for changes to the quality management system, including
quality policy and objectives, reviewed during the
review?
16Are records of management reviews maintained as quality records?
5.6.2Review Input
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17Do the inputs to management review include information on:
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a)Results of audits?
b)Customer feedback?
c)Process performance and product conformity?
d)Status of preventive and corrective actions?
e)Follow-up actions from previous management
reviews?
f)Planned changes that could affect the quality
management system?
g)Recommendations for improvement?
5.6.3Review Output
18Do the outputs from the management review include the decisions and actions related to:
a)Improvement of the effectiveness of the quality
management system and its process?
b)Improvement of the product related to customer
requirements?
c)Resources needed?
6 Resource Management
6Resource Management
6.1Provision of Resources
1Have the resources been determined and provided for:
a) Implementing and maintaining quality
management system and continually improving
its effectiveness?
b) Enhancing customer satisfaction by meeting
customer requirements?
6.2Human Resources
6.2.1General
2Is competency for personnel who perform work affecting product quality bad on appropriate
education, training, skills, and experience?
6.2.2Competency, awareness and training
3Has the organization:
a)Determined the necessary competency for
personnel performing work affecting product
quality?
b)Provided training or take other actions to satisfy
the needs?
c)Evaluated the effectiveness of the actions
taken?
d)Ensured that employees are aware of the
relevance and importance of their activities and
how they contribute to the achievement of the
quality objectives?
e)Maintained appropriate records of education,
training, skills and experience
6.3Infrastructure
4To achieve conformity of product, does the organization identify, provide, and maintain the facilities including:
a)Buildings, Workspace and associated utilities?
b)Process Equipment, hardware and software?
c)Supporting rvices?
6.4Work Environment
5Has the environment needed to achieve conformity of product requirements been determined and
managed?
7 Product Realization
7Product Realization
7.1Planning of Realization Process
1Is planning of the organization’s product realization consistent with the requirements of the other process of
the quality management system?
2Are the following being determined when planning the product realization:
a)Quality objectives and requirements for the
product?
b)The need to establish process, documents, and
provide resources specific to the product?
