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API Spec Q1, 8th Edition
Reviewed By: Review Date: Fac. No.
9001:2008 FORMAT - QUALITY MANAGEMENT SYSTEM REQUIREMENTS
Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements
QM SEC NO.
QM PG NO.
1.2 4.1 4.1.1 Organization has identified all exclusions that apply to the QMS (limited to Sections 7.3 & 7.5.4) Organization shall control all processes that are outsourced (7.4) Organization shall maintain responsibility for product conformance when processes are outsourced*
4.2.1 Documentation includes: a) statement of quality policy and quality objectives b) quality manual c) documented procedures and records d) those determined necessary to ensure planning, operation and control of its processes 4.2.2 Quality Manual includes: a) scope of QMS and exclusions (with justifications) b) documented procedures or reference to them c) a description of interaction between the processes of the QMS 4.2.3 Documented Procedure established and maintained for control of documents a) Approve documents for adequacy prior to issue b) Review and update as necessary and re-approve documents c) Changes to current revisions are identified d) Relevant revisions of documents available at points of use e) Ensure documents remain legible and readily identifiable f) Ensure documents of external origin are identified and distribution controlled g) Prevent unintended used of obsolete documents Apply suitable identification to obsolete documents if they are retained 220.127.116.11 Master list or equivalent established to identify current revisions 18.104.22.168 Changes to documents reviewed and approved by same function as original Documented Procedure for the identification, storage, protection, retrieval, retention and disposition of records 4.2.4 22.214.171.124 Documented Procedure identifies the function responsible for collection and maintenance of records Records retained for minimum of 5 years or as specified in applicable industry standard
5.1 5.2 5.3 Top Management commitment to develop and implement QMS and continually improve effectiveness Focus on the customer - requirements are determined and met with aim of enhancing customer satisfaction Quality Policy: (b) includes commitment to comply and continually improve QMS (c) provides a framework for establishing quality objectives (d) is communicated and understood within the organization (e) is reviewed periodically 5.4.1 5.4.2 5.5.1 5.5.2 5.5.3 5.6.1 Top Management establishes quality objectives that are measurable and consistent with quality policy Planning of QMS carried out to meet requirements of quality objectives Responsibilities and authorities are defined Management representative: is identified and has authority to ensure that quality system is implemented and maintained promotes awareness of customer requirements throughout organization Top Management commits to establishing communication within the organization (internal communications) Management Review of QMS conducted Records of management reviews are maintained 126.96.36.199 Management Reviews are conducted as least annually
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assumptions.2 Design development includes methods.3 Management review output includes: a) improvement of effectiveness of QMS b) improvement of product to meet customer needs c) resource needs Resource Management 6.2.4 Determine the frequency of training Provide and maintain the infrastructure (equipment. verified.1a 7.1 Changes require the same control as the original design and design documentation Product Realization (Must Identify in Quality Manual All Parts of Section 7 that are Not Applicable.1 Input includes customer specified requirements Output shall: a) meet the input requirements 7.5 Verification results shall be recorded 7.3. monitoring.6 188.8.131.52.1 Control features for the design of the product 184.108.40.206.SECT NO.3. reviewed.2. validated and records maintained Evaluation of design changes on constituent parts and delivered product 7. inspection and test activities Contract review ensure that: a) product requirements are defined b) requirements differing from those previously expressed are resolved c) organization has ability to meet defined requirements Records of the results of reviews shall be maintained Organization shall ensure amendments are made and transferred to proper function 7.1 Control Features for review of requirements related to product Determine and implement arrangements for communication with customers 7.2.3 6.7. QM PG NO.3.3.1 Organization shall manage the interfaces between different groups involved in design and development Design output updated as the design and development progresses 7. training.1 Control Features for Training 6.1c 7.1 Final design reviews shall be conducted/documented by individual(s) other than the person(s) who developed the design Verification shall be performed 7.QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Management review includes: a) results of internal audits b) customer feedback c) process performance (to include product nonconformity) d) status of corrective and preventive actions 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 QM SEC NO.6. buildings. production and service c) contain or reference product acceptance criteria d) specify the characteristics of the product that are essential for the safe and proper use 7.4 Participants of review shall include representatives of functions concerned with design and development Records of review shall be maintained 7.3. formulations and calculations Input includes: a) functional and performance requirements 7. measurement.3. 5. N 5.2.2a) CKLT-Q1Manual Page 2 of 4 02-25-09 .1 Design and development outputs shall be documented* Review shall occur at suitable stages to evaluate design as it meets requirements 220.127.116.11.2 b) applicable statutory and regulatory requirements 7. etc) needed to achieve conformity to product requirements Determine and manage work environment needed to achieve conformity to product requirements Customer-related Processes – Contract Review 7.2. validation.2.7 Validation shall be performed Validation results shall be recorded Changes shall be identified.1 6.3.2 The organization shall determine the quality objectives and requirements for the product The organization shall determine verification.1.3. skills and experience Human Resources: a) Determine necessary competence (requirements) for personnel performing work affecting conformity b) Provide training c) Evaluate effectiveness of actions taken d) Ensure personnel are aware of importance of their work with respect to QMS e) Maintain records of education.2 9001:2008 FORMAT .1.3 Design and Development 7.3 b) provide information for purchasing. See Section 18.104.22.168. training.2 Human Resources: Personnel shall be competent on the basis of education. skills and experience 6.
4.1 22.214.171.124 Control features to control.1 Control features for identification of product as required by organization.5.5.3 Identification and traceability Organization shall identify product by suitable means throughout product realization Where traceability is requirement.1.1 Control of Production and Service Provision Controlled conditions include: a) information that describes the characteristics of the product b) availability of work instructions c) use of suitable equipment f) implementation of product release. codes.2 Purchasing documents includes: a) products. and applicable specifications 7. organization shall control and maintain records Organization shall identify the product status with respect to monitoring and measurement requirements 7. specifications.3.1 Control features for verification. d) Conforms to Minimum QMS 7. plans.6. process requirements.1. Process controls are documented and include reference to specified requirements and acceptance criteria Validation of Processes for Production and Service Provision 7. the customer. calibrate and maintain monitoring and measuring devices Environmental conditions suitable for inspection and measurements performed 7.QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Purchasing Organization establish the criteria for evaluation/selection of a supplier ability to supply product in accord with requirements Quality records of acceptable suppliers maintained QM SEC NO.1 Control features for production and service activities 7. maintenance and storage Assess and record the validity of previous measuring results when the equipment is found not to conform to requirements Action taken on monitoring and measurement equipment when found to be out of calibration Calibration records of equipment maintained 7.2 Process controls include compliance with control features.1 Customer Satisfaction .2 Controls include replacement of identification marks and identification records 126.96.36.199.5. grade. etc.188.8.131.52 Control features for identification of product status Customer Property 7.5.monitor info relating to customer perception whether organization met customer requirements Page 3 of 4 02-25-09 CKLT-Q1Manual .5.2 Assessment of product or constituent parts in stock at specified intervals Control of Monitoring and Measuring Devices 7.6. Analysis and Improvement Monitoring and Measurement 8.1.1 Control features for the purchasing process 7.1. procedures.4. evaluation and re-evaluation of suppliers shall include one or more of the following: a) Inspection at supplier facility.5 Preservation of product during handling Preservation of product during packaging Preservation of product during storage Preservation of product during delivery 7. standards. b) Inspection upon delivery.2. drawings.5. QM PG NO.5.4.4. other data Organization established & implemented controls to ensure purchased product meets specified purchasing requirements 7. personnel and QMS requirements Organization shall ensure adequacy of specified purchase requirements prior to communication to the supplier 7.5. processes. c) Surveillance of supplier.5.1 Purchasing information to supplier includes type.1 Control features for describing methods used to preserve the conformity of product 7.SECT NO.5.3. storage.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 7. N 7.2. equipment.4 Control of customer property while under organization’s control Preservation of Product 7. maintenance and control of customer property Measurement.5. delivery and post-delivery activities 7. 9001:2008 FORMAT .6 Determine the monitoring and measurements required and obtain the required equipment Equipment shall be: a) calibrated against standards traceable to international or national standards b) adjusted or re-adjusted as necessary c) identified to determine calibration status d) safeguarded from adjustments that would invalidate the measurement results e) protected from damage and deterioration during handling.1 Control features for the verification of purchased products (receiving inspection) Organization shall maintain records of verification activities* 7. class.3.5.1 7.2 Criteria for the selection.3 Organization has implemented controls for verification of product at supplier’s premises (by itself or its customers) 7.
establishing records and reporting results Internal audits: consider the results of previous audits auditors shall not audit their own work audit criteria.2 Determine.1 8. acceptance under concession.2 8.1 8. and analysis of field nonconformities Organization shall notify customers in the event that product not conforming to design acceptance criteria has been delivered* Organization shall maintain records of customer notifications* Analysis of Data 8.1 Internal audits scheduled and conducted at least annually 8. N 8. it shall be re-verified to demonstrate conformity to requirements 8. 8.2.3 a) Controls implemented to apply the Monogram.QUALITY MANAGEMENT SYSTEM REQUIREMENTS Italicized and Shaded Items Represent Requirements Specific to API Spec Q1 and Outside ISO 9001:2008 Requirements Procedure includes responsibilities for planning and conducting audits.1 Control features for required inspection and testing 8.2 9001:2008 FORMAT . frequency and methods shall be defined management responsible shall ensure that any actions are taken to eliminate nonconformities follow up includes verification of action taken and reporting results QM SEC NO. collect & analyze data to demonstrate the suitability & effectiveness of QMS & evaluate continual improvement Data provided relating to customer satisfaction.2.3 a) Controls for evaluation/disposition of accepting nonconforming product that does not meet manufacturing acceptance criteria b) Controls for evaluation/disposition of accepting nonconforming product that does not meet original design acceptance criteria Documented procedure shall include identifying.3 8.5. process/product trends.184.108.40.206.5.1 8. scope.5. or by taking action to preclude its intended use or application Organization shall take appropriate action when nonconformity is detected after delivery or use Responsibility for review and disposition defined Records of nonconformities and any subsequent actions maintained When nonconformity is corrected.2 Final acceptance inspection/testing is controlled by independent personnel Control of Nonconforming Product 8.4.SECT NO. product conformity. supplier information Control features for the identification and use of the techniques for analysis of data Improvement Continually improve the effectiveness of the QMS Corrective Action Documented procedure required to take action to eliminate the causes of nonconformities to prevent recurrence Corrective action established and include: a) reviewing nonconformities (including customer complaints) b) determining the cause of nonconformities c) evaluating the need for action to ensure that nonconformities do not recur d) determining and implementing action to eliminate nonconformity e) records of results taken f) reviewing the effectiveness of corrective action taken 8. reporting.4.2 The organization shall identify response times for addressing nonconformities* 8.2.3 Documented procedure established for dealing with nonconforming product Nonconforming product controlled by taking action to eliminate nonconformity.220.127.116.11 Apply suitable methods of monitoring and measurement of QMS conformity Monitor characteristics of product to verify it meets requirements Monitoring carried out at appropriate stages of product realization process Evidence of product conformity maintained Records indicate the person(s) authorizing release of product for delivery Product release and delivery to customer shall not proceed until planned arrangements have been completed 18.104.22.168 Organization shall identify response times for addressing corrective action* Preventive Action 8.2.3 Documented procedure required to take action to eliminate the cause of potential nonconformities to prevent occurrence Preventive action established: a) to determine potential nonconformities and their causes b) evaluating the need for action to prevent nonconformities c) determining and implementing action needed d) records of results taken e) reviewing the effectiveness of preventive action taken API Spec Q1. including license number and date of manufacture b) Subsequent removal of Monogram and license number controlled on nonconforming product e) Authority responsible for applying and removing the Monogram identified in Quality Management System CKLT-Q1Manual Page 4 of 4 02-25-09 . Annex A (API Monogram Program Requirements) API Monogram Program: Licensee Responsibilities A3. QM PG NO.3.4 8.3. documenting.
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