Professional Documents
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Q1 (7 ) / ISO 9001:2000 QM
REVIEW CHECKLIST
API Spec Q1, 7th Edition
and
ISO 9001:2000
SECT
NO.
Client:
QM Edition:
Q1 (6th)
& ISO
1994
Equiv
QM
SEC
NO.
QM
PG
NO.
General Requirements
Organization has identified all exclusions that apply to the QMS (limited to Sections 7.3 & 7.5.4)
Organization shall: a) identify processes needed for QMS (4.2.2)
1.2
4.1
Documentation
4.2.1
4.2.2
4.2.3
4.2.1
c) documented procedures
4.2.2.a
4.2.3
e) records
4.16
4.2.2a
4.2.1
4.5.1
4.5.2
4.5.2
4.5.3
4.5.2.a
4.5.1
4.5.1
4.5.2.b
4.5.2.c
4.5.2
4.5.3
4.16
4.16
4.16
II 4.4
Management Responsibility
Top Management commitment to develop and implement QMS and continually improve effectiveness
5.1
5.2
Focus on the customer - requirements are determined and met with aim of enhancing customer satisfaction
5.3
Quality Policy: (b) includes commitment to comply and continually improve QMS
4.2.2.b
4.1.1
Top Management establishes quality objectives that are measurable and consistent with quality policy
4.2.3
5.4.2
4.2.3
5.5.1
4.1.2
5.5.2
Management representative: is identified and has authority to ensure that quality system is implemented and maintained
4.1.2.3
5.5.3
Top Management commits to establishing communication within the organization (internal communications)
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4.1.2
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SECT
NO.
5.6.1
Q1 (6th)
& ISO
1994
Equiv
4.1.3
4.1.3
4.1.3
QM
SEC
NO.
QM
PG
NO.
4.1.3
b) customer feedback
c) process performance (to include product nonconformity)
4.1.3
4.1.3
c) resource needs
Resource Management
6.2.1
Human Resources: Personnel shall be competent on the basis of education, training, skills and/or experience
4.18.2
6.2.2
Human Resources: a) Determine necessary competence (requirements) for personnel performing work affecting product
4.18.2
4.18.1
b) Provide training
c) Evaluate effectiveness of actions taken
d) Ensure personnel are aware of importance of their work with respect to QMS
4.18.1
4.18.3
4.18.1
4.18.1
6.3
6.4
Determine and manage work environment needed to achieve conformity to product requirements
4.9.1.b/e
4.9.1.g
Product Realization (Must Identify in Quality Manual All Parts of Section 7 as Not Applicable, See Section 4.2.2a)
Customer-related Processes Contract Review
7.1a
The organization shall determine the quality objectives and requirements for the product
7.1c
The organization shall determine verification, validation, monitoring, inspection and test activities
7.2.2
4.3.1.b
4.3.1.c
4.3.4
Organization shall ensure amendments are made and transferred to proper function
4.3.3
4.3.1.a
4.3.1
Organization shall manage the interfaces between different groups involved in design and development
4.4.3
4.4.2
4.4.1
4.4.4
7.3.4
4.4.4
4.4.5
4.4.5
4.4.5
d) specify the characteristics of the product that are essential for the safe and proper use
Review shall occur at suitable stages to evaluate design as it meets requirements
4.4.5
Participants of review shall include representatives of functions concerned with design and development
4.4.6
4.4.6
7.3.4.1 Final design reviews shall be conducted/documented by individual(s) other than the person(s) who developed the design
Verification shall be performed
7.3.5
7.3.6
4.4.2
4.4.6
4.4.6
4.4.7
4.4.7
4.4.8
4.4.9
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4.4.9
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SECT
NO.
Q1 (6th)
& ISO
1994
Equiv
QM
SEC
NO.
QM
PG
NO.
Purchasing
7.4.1
Organization establish the criteria for evaluation/selection of a supplier ability to supply product in accord with requirements
4.6.2
4.6.2.3
Purchasing documents includes: a) products, procedures, processes, equipment, personnel and QMS requirements
4.6.1
4.6.2.2
4.6.3
Organization shall ensure adequacy of specified purchase requirements prior to communication to the supplier
7.4.2.1 Purchasing information to supplier includes type, class, grade, specifications, drawings, process requirements, other data
Organization established & implemented controls to ensure purchased product meets specified purchasing requirements
7.4.3
Organization has implemented controls for verification of product at suppliers premises (by itself or its customers)
4.6.3
7.4.3.1 Control features for the verification of purchased products (receiving inspection)
4.10.2.1
7.5.1
4.6.3
4.10.2.1
4.6.4
4.9.1.d
4.9.1.a
4.9.1.e
4.15.6
4.9.1.c
4.9.2
a) Define criteria for review and approval of processes where resulting output cannot be verified by subsequent m & m
b) Approval of equipment and qualification of personnel
c) Use of specified methods and procedures
d) Requirements for records
e) Revalidation
4.9.3
4.8
4.8
Organization shall identify the product status with respect to monitoring and measurement requirements
4.12
7.5.3.1 Control features for identification of product as required by organization, the customer, and applicable specifications
7.5.3.2 Controls include replacement of identification marks and identification records
4.8
4.12
7.5.4
Customer Property
Control of customer property while under organizations control
7.5.4.1 Control features for verification, storage, maintenance and control of customer property
4.8
4.7
4.7
Preservation of Product
7.5.5
4.15.2
4.15.4
4.15.3
4.15.6
7.5.5.1 Control features for describing methods used to preserve the conformity of product
7.5.5.2 Assessment of product or constituent parts in stock at specified intervals
Control of Monitoring and Measuring Devices
7.6
4.15.1
4.15.3
Determine the monitoring and measurements required and obtain the required devices
4.11.2.a
Equipment shall be: a) calibrated against standards traceable to international or national standards
4.11.2.b
4.11.2.c
4.11.2.d
4.11.2.i
e) protected from damage and deterioration during handling, maintenance and storage
4.11.2.h
Assess and record the validity of previous measuring results when the equipment is found not to conform to requirements
4.11.2.f
Action taken on monitoring and measurement equipment when found to be out of calibration
4.11.2.c
4.11.2e
7.6.1
Control features to control, calibrate and maintain monitoring and measuring devices
4.11.1
7.6.2
4.11.2g
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SECT
NO.
Q1 (6th)
& ISO
1994
Equiv
QM
SEC
NO.
QM
PG
NO.
Customer Satisfaction - monitor info relating to customer perception whether organization met customer requirements
8.2.2
4.17
4.17
results brought to the attention of the personnel responsible for area audited for follow-up
4.17
4.17
4.17
8.2.4
4.9.1.d
4.10.3.a
4.10.5.a
4.10.5.b
Product release and delivery shall not proceed until planned arrangements have been completed
4.10.3.b
4.10.1
4.10.4
Documented procedure to ensure nonconforming product is identified and controlled to prevent unintended use or delivery
4.13.1
Review of nonconforming product as repaired/reworked to meet requirements; accepted with/without repair by concession;
regraded for alternative applications; rejected/scrapped
4.13.2.1
4.13.2.1
4.13.2.3
4.13.2.4
When nonconformity is detected after delivery or use, organization shall take appropriate action
4.13.3
a) Controls for evaluation/disposition of accepting nonconforming product that does not meet manufacturing acceptance
4.13.2.2
b) Controls for evaluation/disposition of accepting nonconforming product that does not meet original design acceptance
Analysis of Data
4.13.2.2
8.4
Determine, collect & analyze data to demonstrate the suitability & effectiveness of QMS & evaluate continual improvement
4.20.1
Data provided relating to customer satisfaction, product conformity, process/product trends, supplier information
Control features for the identification and use of the techniques for analysis of data
Improvement
4.20.2
8.4.1
8.5.1
8.5.2
Documented procedure required to take action to eliminate the cause of nonconformities to prevent recurrence
4.14.1
Corrective action established and include: a) reviewing nonconformities (including customer complaints)
4.14.2.a
8.3
8.3.2
4.20.2
Corrective Action
4.14.2.b
c) evaluating the need for action to ensure that nonconformities do not recur
4.14.2.b
4.14.2.c
4.14.2.d
Preventive Action
8.5.3
Documented procedure required to take action to eliminate the cause of potential nonconformities to prevent occurrence
4.14.1
4.14.3.a
4.14.3b
4.14.3.c
4.14.3.d
a) Controls implemented to apply the Monogram, including license number and date of manufacture
II 4.3.a
II 4.3.b
e) Authority responsible for applying and removing the Monogram identified in Quality Management System
II 4.3.e
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