th
Q1 (7 ) / ISO 9001:2000 QM
REVIEW REVIEW CHECK CHECK L IST API Spec Q1, 7th Edition and
ISO 9001:2000
Client:
QM Editio Editio n:
For API Use Only: Reviewed Reviewed By: Review Date: Fac. No. th
SECT NO.
9001:2000 FORMAT - QUALITY MANAGEMENT MANA GEMENT SYSTEM SYSTEM REQUIREMENTS REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2000 Requirements
Q1 (6 ) & ISO 1994 Equiv
QM SEC NO.
QM PG NO.
General Requir Requir ements 1.2
Organization has identified all exclusions that apply to the QMS (limited to Sections 7.3 & 7.5.4) Organization shall: shall: a) identify processes processes needed for QMS (4.2.2)
4.1
b) determine sequence and interaction of processes (4.2.2) c) determine criteria & methods needed to ensure operation and control of processes are effective (8.2) d) ensure the availability of resources necessary to support the operation (6.1) e) monitor, measure and analyze processes (8.2.3 & 8.4) f) implement actions necessary to achieve results and continual improvement of processes (8.5) Organization shall control all processes that are outsourced (7.4)
Documentation 4.2.1
4.2.2
4.2.3
Documentation includes: a) statement of quality policy policy and quality objectives b) quality manual
4.2.1
c) documented procedures
4.2.2.a
d) that needed to ensure planning, operation and control of its processes
4.2.3
e) records
4.16
Quality Manual includes: a) scope of QMS and exclusions (with (with justifications) b) documented procedures or reference to them
4.2.2a
c) a description of interaction interaction between the processes processes of the QMS
4.2.1
Documented Procedure established and maintained for control of documents
4.5.1
a) Approve documents for adequacy prior to issue.
4.5.2
b) Review and update as necessary and re-approve documents
4.5.2
c) Changes to current revisions are identified
4.5.3
d) Relevant revisions of documents available at points of use
4.5.2.a
e) Ensure documents remain legible and readily identifiable
4.5.1
f) Ensure documents of external origin are identified and distribution controlled
4.5.1
g) Prevent unintended used of obsolete documents
4.5.2.b
Apply suitable identification identification to obsolete obsolete documents if they they are retained
4.5.2.c
4.2.3.1 Master list or equivalent established to identify current revisions
4.5.2
4.2.3.2 Changes to documents reviewed and approved by same function as original Documented Procedure for the id entification, storage, protection, retrieval and disposition of records 4.2.4
4.5.3 4.16 4.16
Retention times established and recorded 4.2.4.1 Documented Procedure includes the collection and maintenance of records
Records retained for minimum of 5 years or as specified in applicable industry standard
4.16 II 4.4
Manageme Management nt Responsib Responsib ility 5.1
Top Management commitment to develop and implement QMS and continually improve effectiveness
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 continually improve QMS
4.2.2.b
(c) provides a framework for establishing quality objectives (d) is communicated and understood within the organization
4.1.1
(e) is reviewed periodically 5.4.1
Top Management establishes quality objectives that are measurable and consistent with quality policy
4.2.3
5.4.2
Planning of QMS carried out to meet requirements of quality objectives
4.2.3
5.5.1
Responsibilities and authorities are defined
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
promotes awareness of customer requirements throughout organization 5.5.3
Top Management commits to establishing communication within the organization (internal communications)
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SECT NO. 5.6.1
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9001:2000 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2000 Requirements
Q1 (6 ) & ISO 1994 Equiv
Management Review of QMS conducted
4.1.3
Records of management reviews are maintained
4.1.3
5.6.1.1 Management Reviews are conducted as least annually
4.1.3
5.6.2
4.1.3
Management review includes: a) results of internal audits
QM SEC NO.
QM PG NO.
N
b) customer feedback c) process performance (to include product nonconformity)
4.1.3
d) status of corrective and preventive actions
4.1.3
e) follow-up actions from last management reviews f) changes that could affect the QMS (to include oil/gas industry standards) g) recommendations for improvement 5.6.3
Management review output includes: a) improvement of effectiveness of QMS b) improvement of product to meet customer needs 4.1.2.2
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
e) Maintain records of education, training, skills and experience
4.18.3
6.2.2.1 Control Features for Training
4.18.1
Determine the frequency of training
4.18.1
6.3
Provide and maintain the infrastructure (equipment, buildings, etc) needed to achieve conformity to product requirements
4.9.1.g
6.4
Determine and manage work environment needed to achieve conformity to product requirements
4.9.1.b/e
Produc t Realization (Must Ident ify i n Quality Manual Al l Parts of Sectio n 7 as Not Appli cable, See Sectio n 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
Contract review ensure that: a) product requirements are defined
4.3.1.a
b) requirements differing from those previously expressed are resolved
4.3.1.b
c) organization has ability to meet defined requirements
4.3.1.c
Records of the results of reviews shall be maintained
4.3.4
Organization shall ensure amendments are made and transferred to proper function
4.3.3 4.3.1
7.2.2.1 Control Features for review of requirements related to product
7.2.3
Determine and implement arrangements for communication with customers Design and Development
7.3.1
Organization shall manage the interfaces between different groups involved in design and development
4.4.3
Design output updated as the design and development progresses
4.4.2
7.3.1.1 Control features for the design of the product
4.4.1
7.3.1.2 Design development includes methods, assumptions, formulations and calculations
4.4.2
7.3.2
Input includes: a) functional and performance requirements
b) applicable statutory and regulatory requirements 7.3.2.1 Input includes customer specified requirements 7.3.3
7.3.4
7.3.6
4.4.4 4.4.5
Output shall: a) meet the input requirements. b) provide information for purchasing, production and service
4.4.5
c) contain or reference product acceptance criteria
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
Records of review shall be maintained
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
7.3.5
4.4.4
4.4.6
4.4.6
Verification shall be performed
4.4.7
Verification results shall be recorded
4.4.7
Validation shall be performed
4.4.8
Validation results shall be recorded 7.3.7
Changes shall be identified, reviewed, verified, validated and records maintained
4.4.9
Evaluation of design changes on constituent parts and delivered product 7.3.7.1 Changes require the same control as the original design and design documentation CKLT-Q1Manual
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9001:2000 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2000 Requirements
Q1 (6 ) & ISO 1994 Equiv
QM SEC NO.
QM PG NO.
N
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
Quality records of acceptable suppliers maintained
4.6.2.3
7.4.1.1 Control features for the purchasing process
4.6.1
7.4.1.2 Criteria for the selection, evaluation and re-evaluation of suppliers shall include one or more of the following: a) Inspection at supplier facility; b) Inspection upon delivery; c) Surveillance of supplier; d) Conforms to Minimum QMS
4.6.2.2
7.4.2
Purchasing documents includes: a) products, procedures, processes, equipment, personnel and QMS requirements
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 supplier’s premises (by itself or its customers) 7.4.3.1 Control features for the verification of purchased products (receiving inspection)
4.6.3 4.6.3 4.6.3 4.10.2.1 4.6.4 4.10.2.1
Control of Production and Service Provision 7.5.1
Controlled conditions include: a) information that describes the characteristics of the product
4.9.1.d
b) availability of work instructions
4.9.1.a
c) use of suitable equipment
4.9.1.e
f) implementation of release, delivery and post-delivery activities
4.15.6
7.5.1.1 Control features for production and service activities 7.5.1.2 Process controls include compliance with control features, plans, codes, standards, etc.
Process controls are documented and include reference to specified requirements and acceptance criteria Validation of Processes for Production and Service Provision 7.5.2
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
7.5.2.1 Control features established for special processes
Identification and traceability 7.5.3
Organization shall identify product by suitable means throughout product realization
4.8
Where traceability is requirement, organization shall control and record
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
4.8
7.5.3.2 Controls include replacement of identification marks and identification records
4.8
7.5.3.3 Control features for identification of product status
4.12
Customer Property 7.5.4
Control of customer property while under organization’s control
4.7
7.5.4.1 Control features for verification, storage, maintenance and control of customer property
4.7
Preservation of Produc t 7.5.5
Preservation of product during handling
4.15.2
Preservation of product during packaging
4.15.4
Preservation of product during storage
4.15.3
Preservation of product during delivery
4.15.6
7.5.5.1 Control features for describing methods used to preserve the conformity of product
4.15.1
7.5.5.2 Assessment of product or constituent parts in stock at specified intervals Control of Monito ring and Measuring Devices
4.15.3
7.6
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
b) adjusted or re-adjusted as necessary
4.11.2.c
c) identified to enable calibration status to be determined
4.11.2.d
d) safeguarded from adjustments that would invalidate the measurement results
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
Calibration records of equipment maintained
4.11.2e
7.6.1
Control features to control, calibrate and maintain monitoring and measuring devices
4.11.1
7.6.2
Environmental conditions suitable for inspection and measurements performed
4.11.2g
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SECT NO.
9001:2000 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2000 Requirements
th
Q1 (6 ) & ISO 1994 Equiv
QM SEC NO.
QM PG NO.
N
8 Measurement, Analysis and Improvement Monitoring and Measurement 8.2.1
Customer Satisfaction - monitor info relating to customer perception whether organization met customer requirements
8.2.2
Documented procedure implemented to ensure QMS effectively implemented and maintained
4.17
Internal audits: consider the results of previous audits auditors shall not audit their own work
4.17
results brought to the attention of the personnel responsible for area audited for follow-up
4.17
corrective action taken, implemented and verified
4.17 4.17
8.2.2.1 Internal audits scheduled and conducted at least annually
8.2.3
Apply suitable methods of monitoring and measurement of QMS conformity
8.2.4
Monitor characteristics of product to verify it meets requirements
4.9.1.d
Monitoring carried out at appropriate stages of product realization process
4.10.3.a
Evidence of product conformity maintained
4.10.5.a
Records indicate the person(s) authorizing release of product
4.10.5.b
Product release and delivery shall not proceed until planned arrangements have been completed
4.10.3.b
8.2.4.1 Control features for required inspection and testing
4.10.1
8.2.4.2 Final (acceptance) inspection/testing is controlled by independent personnel Control of Nonconforming Product
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
Responsibility for review and disposition defined
4.13.2.1
Records of nonconformities and any subsequent actions maintained
4.13.2.3
When nonconformity is corrected, it shall be re-verified to demonstrate conformity to requirements
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 Anal ysi s o f Data
4.13.2.2
8.4
Determine, collect & analyze data to demonstrate the suitability & effectiveness of QMS & evaluate continual improvement
4.20.1 4.20.2
8.4.1
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
8.3
8.3.2
4.20.2
Improvement 8.5.1
Continually improve the effectiveness of the QMS Corrective Action
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
b) determining the cause of nonconformities
4.14.2.b
c) evaluating the need for action to ensure that nonconformities do not recur
4.14.2.b
d) determining and implementing action to eliminate nonconformity
4.14.2.c
e) records of results taken f) reviewing corrective action taken
4.14.2.d
Preventive Actio n 8.5.3
Documented procedure required to take action to eliminate the cause of potential nonconformities to prevent occurrence
4.14.1
Preventive action established: a) to determine potential nonconformities and their causes
4.14.3.a
b) evaluating the need for action to prevent nonconformities
4.14.3b
c) determining and implementing action needed
4.14.3.c
d) records of results taken e) reviewing preventive action taken
4.14.3.d
API Spec Q1, Ann ex A (API Mon ogram Progr am Requ ir ements ) API Mo no gr am Pr og ram : L ic ensee Res po ns ib il it ies
A4.3
a) Controls implemented to apply the Monogram, including license number and date of manufacture
II 4.3.a
b) Subsequent removal of Monogram and license number controlled on nonconforming product
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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