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PECB Webinar: ISO 29001:2010 – Supplemental Requirements & Impact of ISO 9001:2015

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If you have wondered what are the similarities and differences of ISO 29001 and ISO 9001, this is your chance to learn it. You will also see the requirements and what impact does Quality Management System has in Oil and Gas industry, especially the requirements of ISO 29001.
You will learn all this in two sessions, which will be presented by PECB trainer David Smart, Managing Director of Smart ISO Systems / Smart Mentoring. David’s personal experience spans more than 40 years as a Manager, Auditor and Consultant, specializing in multiple fields related to ISO standards. He is a Lead auditor for ISO 27001, ISO 13485, ISO 9001, ISO 14001, ISO 29001, ISO 17025 and OHSAS 18001, and an active member of various institutes.

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PECB Webinar: ISO 29001:2010 – Supplemental Requirements & Impact of ISO 9001:2015

  1. 1. ISO29001:2010 SUPPLEMENTAL REQUIREMENTS & IMPACT OF ISO9001:2015 Presenter: David S Smart v Transport | Telecommunication | Energy ISO TS 29001:2010 www.smartmentoring.co Transport | Telecommunication | Energy
  2. 2. NOTES 1. Annex A of ISO9001:2008 is not considered part of this technical specification. If the comparison of ISO9001:2008 is required the reader is encouraged to review Annex A of the referenced ISO9001:2008 documents 2. The requirements of ISO9001 are contained within the boxes of the Standard whereas the supplemental requirements (API) are documented below the relevant clause box
  3. 3. GLOSSARY OF TERMS  Customer – The receiver of the service  Purchaser – The provider of the service  Control feature – Organisation’s documented method for performing an activity under controlled conditions to achieve conformity to specified requirements  Product realisation - The work that the organization goes through to develop, manufacture, and deliver the finished goods or services. An effective Quality Management System (QMS) includes a comprehensive approach to getting from the product concept to the finished product
  4. 4. CLAUSE 1.2.1 APPLICATION “Where exclusions are made, claims of conformity to this Technical Specification are not acceptable unless these exclusions are limited to requirements within the sub clauses listed below, in this sub clause and such exclusions do not effect the organisation’s ability, or responsibility to provide product that meets customer and applicable regulatory requirements”  7.3 Design & development  7.5.1 Control of production and service provision  7.5.2 Validation of processes for production and service provision  7 .5.4 Customer property
  5. 5. CLAUSE 4.1.1 OUTSOURCED PROCESSES AND/OR SERVICES “The organisation shall maintain responsibility for product conformance to specified requirements when processes are outsourced”
  6. 6. CLAUSE 4.2.2.1 QUALITY MANUAL “The Quality Manual shall identify the manner in which the organisation addresses each specific requirement of this technical specification, including both the requirements of ISO9001:2008 and the supplemental requirements”
  7. 7. CLAUSE 4.2.3.1 – CONTROL OF DOCUMENTS “A master list or equivalent control feature shall be used to identify the documents required by the quality management system and their current revision status”
  8. 8. CLAUSE 4.2.3.2 – CONTROL OF DOCUMENT CHANGES “Changes to documents shall be reviewed and approved by the same functions that performed the original review and approval”
  9. 9. CLAUSE 4.2.4.1 – CONTROL OF RECORDS “The documented procedure shall identify the functions responsible for the collection and maintenance of records” Note: collection is the process of obtaining , assembling and/or organising applicable documentation with the intent of meeting the requirements of 4.2.4 Records required by applicable industry product standards shall be retained for not less than the period of time specified by the industry standard or five years, which ever is the longer. Records required to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be retained for a minimum of five years
  10. 10. CLAUSE 5.3.1 – QUALITY POLICY “Top management shall document the approval of the quality policy”
  11. 11. CLAUSE 5.6.1.1 – MANAGEMENT REVIEW (GENERAL) “The management review shall be conducted at least annually” Note: This includes monitoring of quality objectives as part of the management review
  12. 12. CLAUSE 5.6.2 – MANAGEMENT REVIEW INPUT C) Process performance and product conformity Notes: 1.In conjunction with 8.4 included trends of product nonconformity 2. Includes reports and analysis of field nonconformities f) Changes that could effect the QMS and recommendations for improvement Note: includes applicable changes to petroleum, petrochemical and natural gas industry standards
  13. 13. CLAUSE 6.2.2.1 TRAINING “The organisation shall establish control features for identifying training needs and providing training of personnel who perform activities addressed in the QMS. The raining requirements shall provide for quality management training and for job raining of personnel. The frequency of training shall be defined by the organisation.” Note 1; 6.2.2.1 provides on-the job training for personnel in any new or modified ob affecting product quality, including contract or agency personnel. Note 2: 6.2.2.1 includes having a process to measure the extent to which its personnel are aware of the relevance and importance of their activities and how hey contribute to the achievement of the quality objectives (see 6.2.2d) It is advisable that personnel whose work affect quality be informed about the consequences brought to bear on the customer of nonconformity to quality equirements
  14. 14. CLAUSE 7.1.1 PLANNING OF PRODUCT REALISATION “When product requirements are provided from external sources the organisation shall define the methods and shall establish control features (3.1.1) used to translate These requirements into the product realisation process”
  15. 15. CLAUSE 7.2.2.1 REVIEW OF REQUIREMENTS RELATED TO THE PRODUCT “The organisati0n shall establish control features (3.1.1) to review requirements related to the product”
  16. 16. CLAUSE 7.3.1.1 DESIGN & DEVELOPMENT PLANNING “The organisation shall establish control features for the design of the product”
  17. 17. CLAUSE 7.3.1.2 DESIGN DOCUMENTATION “Design documentation shall include methods, assumptions , formulae and calculations”
  18. 18. CLAUSE 7.3.2.1 DESIGN & DEVELOPMENT INPUTS “The organisation shall identify, document and review product design input requirements. Design and development inputs shall include customer specified requirements”
  19. 19. CLAUSE 7.3.3.1 DESIGN & DEVELOPMENT OUTPUTS “Design & development outputs shall be documented”
  20. 20. CLAUSE 7.3.4.1 DESIGN & DEVELOPMENT REVIEW “A final design review shall be conducted and documented individual(s) other than the person or persons who developed the design shall approve the final design”
  21. 21. CLAUSE 7.3.5 DESIGN & DEVELOPMENT VERIFICATION Note: design verification activities includes one or more of the following:  Confirming the accuracy of design results through the performance of alternative calculations  Review of design output documents independent of activities of 7.3.4  Comparing new designs to similar proven designs
  22. 22. CLAUSE 7.3.6 DESIGN & DEVELOPMENT VALIDATION Note: design validation includes one or more of the following  Prototype tests  Functional and/or operational tests of production products  Field performance tests and reviews
  23. 23. CLAUSE 7.3.7.1 CONTROL OF DESIGN CHANGES “Design and development changes including changes to design documents shall require the same controls as the original design and development , as well as design documentation”
  24. 24. CLAUSE 7.4.1.1 PURCHASING PROCESS “The organisation shall establish control features for the purchasing process and supplier selection”
  25. 25. CLAUSE 7.4.1.2 CRITERIA FOR SUPPLIER SELECTION, EVALUATION AND RE-EVALUATION “Criteria for the selection, evaluation and re-evaluation of suppliers shall include one or more of the following”  Inspection of suppliers product by the organisation at suppliers facility  Inspection of suppliers final product by the organisation on delivery  Surveillance of suppliers conformance to the organisation’s purchasing requirements  Verification by the organisation that the suppliers QMS conforms to an internationally recognised QMS standard/technical specification Note: where there are mergers, acquisitions or affiliations associated with suppliers consideration includes the organisation verifying the continuity of the suppliers QMS and its effectiveness
  26. 26. CLAUSE 7.4.1.3 SUPPLIER PROVIDED PROCESSES THAT REQUIRE VALIDATION “Where an organisation chooses to outsource any process that requires validation , the organisation shall require that the supplier comply with the requirements of 7.5.2 as applicable (see 4.1)”
  27. 27. CLAUSE 7.4.2.1 PURCHASING INFORMATION “Purchasing information provided to the supplier shall be documented and shall describe the product to be purchased including where appropriate the items in 7.4.2 as well as type, class grade or other precise identification, the title or other positive identification and applicable issues of specification drawings, process requirements, inspection instructions or other relevant technical data”
  28. 28. CLAUSE 7.4.3.1 VERIFICATION OF PURCHASED PRODUCT “The organisation shall establish control features for the verification of purchased product. The organisation shall maintain records of verification activities (see 4.2.4)”
  29. 29. CLAUSE 7.5.1.1 CONTROL OF PRODUCTION & SERVICE PROVISION “The organisation shall establish control features that describe the control of production and service activities performed”
  30. 30. CLAUSE 7.5.1.2 PROCESS CONTROLS “Process controls shall be documented in routings, travellers, checklists, process sheets or other types of control features and shall include requirements for verifying compliance with quality plans, control features and reference standards/codes. The process control documents shall include or reference instructions, workmanship and acceptance criteria for processes, tests inspections and customer inspection hold or witness points”
  31. 31. CLAUSE 7.5.2.1 VALIDATION OF PROCESSES FOR PRODUCTION & SERVICE PROVISION “The organisation shall validate those processes identified by the applicable product specification as requiring validation. If these processes are not identified or there is no product specification involved the processes requiring validation shall include as a minimum non-destructive examination welding and heat treating , if applicable to the product”
  32. 32. CLAUSE 7.5.3.1 IDENTIFICATION & TRACEABILITY “The organisation shall establish control features for identification and traceability of the product by suitable means from receipt and during all stages of production , delivery and installation, as required by the organisation, the customer and the applicable product specifications”
  33. 33. CLAUSE 7.5.3.2 IDENTIFICATION & TRACEABILITY MAINTENANCE AND REPLACEMENT “Control feature shall include requirements for maintenance or replacement of identification and traceability marks and records”
  34. 34. CLAUSE 7.5.3.3 PRODUCT STATUS “The organisation shall establish control features for the identification of product status”
  35. 35. CLAUSE 7.5.4.1 CUSTOMER PROPERTY “The organisation shall establish control features for the verification, storage maintenance and control of customer property”
  36. 36. CLAUSE 7.5.5.1 PRESERVATION OF PRODUCT “The organisation shall establish control features describing the methods used to preserve the conformity of product for the activities of 7.5.5”
  37. 37. CLAUSE 7.5.5.2 PERIODIC ASSESSMENT OF STOCK “In order to detect deterioration, the condition of product or constituent parts in stock shall be assessed at specified intervals” Note: 7.5.2.2 includes the possible use of inventory management to optimise inventory turnover time and ensure stock rotation such as FIFO
  38. 38. CLAUSE 7.6.1 CONTROL OF MONITORING & MEASURING EQUIPMENT “The organisation shall establish control features to control calibrate and maintain monitoring and measuring equipment. Control features shall include equipment type, unique identification, location, frequency of checks, check method and acceptance criteria”
  39. 39. CLAUSE 7.6.2 ENVIRONMENTAL CONDITIONS “The organisation shall ensure that the environmental conditions are suitable for the calibrations, inspections, measurements and tests being carried out” Note; records of the calibration /verification activity for all gauges, measuring and test equipment needed to provide evidence of product conformity to determine requirements, including employee and customer owned equipment should include  Equipment identification, including the measurement standard against which the equipment is calibrated  Revision following engineering changes  Any out-of-spec readings as received for calibration/verification  An assessment of the impact of out-of-spec condition and  Notification to the customer if suspect product or material has been shipped
  40. 40. CLAUSE 8.2.2.1 INTERNAL AUDIT “Internal audits shall be scheduled and conducted at least annually by personnel independent of those who performed or directly supervised the activity being audited”
  41. 41. CLAUSE 8.2.2.2 RESPONSE TIMES “The organisation shall identify response times for addressing detected non-conformities”
  42. 42. CLAUSE 8.2.4.1 MONITORING & MEASUREMENT OF PRODUCT “The organisation shall establish control features to monitor and measure the characteristics of the product”
  43. 43. CLAUSE 8.3.1 RELEASE OR ACCEPTANCE OF NONCONFORMING PRODUCT The process of evaluation, release and acceptance of nonconforming product shall include one or more of the following: - Accepting products that do not satisfy manufacturing acceptance criteria provided that: -  Products satisfy the design acceptance criteria  The violated manufacturing acceptance criteria are categorized as unnecessary to satisfy the design criteria or  Products are repaired or reworked to satisy the design acceptance criteria  Accepting products that do not satisfy the original design criteria provided that the original acceptance criteria are changed in accordance with 7.3.7 and the materials or products satisfy the new design criteria
  44. 44. CLAUSE 8.3.2 FIELD CONFORMITY ANALYSIS “The documented procedure for nonconforming product shall include requirements for identifying, documenting and reporting incidents of field nonconformities (3.1.90 or product failures. The documented procedure shall ensure the analysis of field nonconformities, provided the product or documented evidence supporting the nonconformity is available to facilitate the determination of the cause”
  45. 45. CLAUSE 8.3.3 CUSTOMER NOTIFICATION “The organisation shall notify customers if product that does not conform to design acceptance criteria(3.1.6) has been delivered . The organisation shall maintain records of such notifications”
  46. 46. CLAUSE 8.4.1 ANALYSIS OF DATA “The organisation shall establish control features (3.1.4) for the identification and use of techniques for data analysis”
  47. 47. CLAUSE 8.5.2.1 CORRECTIVE ACTION “The organisation shall ensure that any corrective action is effective”
  48. 48. CLAUSE 8.5.2.2 RESPONSE TIMES “The organisation shall identify response times for addressing corrective action”
  49. 49. CLAUSE 8.5.3.1 PREVENTIVE ACTION “The organisation shall ensure that the preventive action is effective”
  50. 50. CORRELATION MATRIX ISO9001:2008 AGAINST ISO9001:2015
  51. 51. A.1 – STRUCTURE AND TERMINOLOGY  The clause structure and some of the terminology of this international Standard in comparison with ISO9001:2008, have been changed to improve alignment with other management system standards  The consequent changes in the structure and terminology do not need to be reflected in the documentation of an organisation’s QMS  The structure of clauses is intended to provide a coherent presentation of requirements rather than a model for documenting an organisation’s policies, objectives and processes. There is no requirement for the structure of an organisation’s QMS documentation to mirror that of this international Standard
  52. 52. THANK YOU! Questions? Email: d.smart18@yahoo.co.uk

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