Upgrade iso 9001 2000 to 2008 version

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  • About IAF 1. What is the IAF?  The International Accreditation Forum, Inc. (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment in the fields of management systems, products, services, personnel and other similar programmes of conformity assessment. Its primary function is to develop a single worldwide program of conformity assessment which reduces risk for business and its customers by assuring them that accredited certificates may be relied upon. Accreditation assures users of the competence and impartiality of the body accredited. IAF members accredit certification or registration bodies that issue certificates attesting that an organization's management, products or personnel comply with a specified standard (called conformity assessment). IAF has prepared an informative brochure which provides general information about IAF, its activities, membership and programs.  To access the  Brochure please click on the following link:  IAF Brochure 2. Role of IAF  The primary purpose of IAF is two-fold. Firstly, to ensure that its accreditation body members only accredit bodies that are competent to do the work they undertake and are not subject to conflicts of interest. The second purpose of the IAF is to establish mutual recognition arrangements, known as Multilateral Recognition Arrangements (MLA), between its accreditation body members which reduces risk to business and its customers by ensuring that an accredited certificate may be relied upon anywhere in the world. The MLA contributes to the freedom of world trade by eliminating technical barriers to trade. IAF works to find the most effective way of achieving a single system that will allow companies with an accredited conformity assessment certificate in one part of the world, to have that certificate recognized else where in the world. The objective of the MLA is that it will cover all accreditation bodies in all countries in the world, thus eliminating the need for suppliers of products or services to be certified in each country where they sell their products or services. Certified once - accepted everywhere.
  • The presentation is organized in such a way that we can move from one part (module) of the presentation to another. Also included are two ice breakers during or after the scheduled coffee break. Application form each module is also included although in such a way that it can be part of each or both module, although the advance application will require module 2 to better understand its application.
  • The change in 6.2.1 from “product quality” to “productrequirements” has been made to this sub-clause: a) determine the necessary competence for personnel performing work affecting conformity to product quality requirements, Use below of the phrase "where applicable" recognizes thattraining or other actions may not be necessary, since individuals may already have the necessary competence. And,since "these needs" could be taken out of context, the requirement has been revised to specifically mentioncompetence. b) where applicable, provide training or take other actions to satisfy these needs achieve the necessarycompetence,
  • NOTE The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather).
  • Although similar, identify and determine have slightly different meaning. To identify is to recognize or establish something as being a particular thing.To determine is to apply reason and reach a decision.To determine the process implies more analysis and judgment than merely listing them.4.1 General RequirementsSub-clause (a), the word "Identify" has been replaced with "Determine".a) IdentifyDetermine the processes needed for the quality management system and their application throughout the organization (see 1.2),Although similar, the words "Identify" and "Determine" used above have slightly different meanings. We recognize or establish something as being a particular thing when we identify but we apply reason and reach a decision when we determine - to determine the process implies more analysis and judgment.e) monitor, measure (where applicable), and analyze these processes, and ...Processes are monitored but may not need to be measured; therefore, the requirement change above indicates processes are only measured where applicable.Regarding outsourcing:Where an organization chooses to outsource any process that affects product conformity withto requirements, the organization shall ensure control over such processes. Control of suchThe type and extent of control to be applied to these outsourced processes shall be identifieddefined within the quality management system.This addition clarifies that specific controls are to be defined and applied, not just identified.The current Note under clause 4.1 has been expanded and two new Notes have been added:NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement.The text above expands from "measurement" to "measurement, analysis, and improvement" to match the title for clause 8 to clearly state that these processes are included rather than should be included.The new Note below provides an explanation of what is considered an outsourced process.NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system, but chosen to be performed by a party external to the organization.The new Note below identifies the factors influencing the control of an outsourced process.NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all Customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such asa) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements,b) the degree to which the control for the process is shared;c) the capability of achieving the necessary control through the application of clause 7.4.Outsourcing a process to another organization typically involves the purchase of those services; as a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply equally to the supplier selected to perform the outsourced process.
  • 2.2    Intent of Clause 4.1 The intent of Clause 4.1 of ISO 9001:2008 is to emphasize that when an organization chooses to outsource (either permanently or temporarily) a process that affects product conformity with requirements (see ISO 9001:2008 clause 7.2.1), it can not simply ignore this process, nor exclude it from the quality management system.The organization has to demonstrate that it exercises sufficient control to ensure that this process is performed according to the relevant requirements of ISO 9001:2008, and any other requirements of the organization’s quality management system. The nature of this control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier to meet the process requirements. Based on the nature of the control, it should consider the processes referred to quality management system for management activities, provision of resources, product realization and measurement, analysis and improvement. The outsourced organization does not necessarily have to have a certified Quality Management System, but it has to demonstrate the capability of the previously mentioned processes.Outsourced processes will interact with other processes from the organization's quality management system (these other processes may be carried out by the organization itself, or may themselves be outsourced processes). These interactions also need to be managed (see ISO 9001:2008 clause 4.1 (a) and (b)). 2.3    Control of outsourced processes 2.3.1    The acquisition of outsourced processes will normally be subject to the capability of achieving the necessary control through the application of requirements of both ISO 9001:2008 clause 7.4 (Purchasing) and clause 4.1 (General Requirements) As mentioned in the Note, in some situations, the organization might not “purchase” the outsourced process in the traditional sense; it might, for example, receive the service from a corporate head office or from another division within a group of organizations, without any monetary transaction taking place (see 2.1 above). Under these circumstances, however, ISO 9001:2008 Clauses 7.4 and 4.1 are still applicable.2.3.2    There are two situations that frequently need to be considered when deciding the appropriate level of control of an outsourced process:When an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons).In this situation the process control criteria should already have been defined, and can be transposed into requirements for the supplier of the outsourced process, if necessary. When the organization does not have the competence to carry out the process itself, and chooses to outsource it.In this situation the organization has to ensure that the controls proposed by the supplier of the outsourced process are adequate. In some cases it may be necessary to involve external specialists in making this evaluation.2.3.3    It may be convenient, or even necessary, to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. The potential impact of the outsourced process is based on the outsourcing’s capability to provide product that conforms to requirements. Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process. The organization’s control of the outsourced process has to be based on the need for product conformity to requirements. Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory and regulatory requirements. 2.3.4    In some situations it might not be possible to verify the output from the outsourced process by subsequent monitoring or measurement. In these cases, the organization needs to ensure that the control over the outsourced process includes process validation in accordance with ISO 9001:2008 clause 7.5.2.
  • 4.1 General RequirementsIn 4.1, General Requirements, sub-clause (a), the word "Identify" has been replaced with "Determine". a) Identify Determine the processes needed for the quality management system and their application throughout the organization (see 1.2), Although similar, the words "Identify" and "Determine" have slightly different meanings. To identify is to recognize or establish something as being a particular thing. To determine is to apply reason and reach a decision. To determine the processes implies more analysis and judgment than merely identifying them. e) monitor, measure (where applicable), and analyze these processes, and ... Processes are monitored, but may not need to be measured. Therefore, the requirement change above indicates processes are only measured where applicable. Later in clause 4.1, regarding outsourcing: Where an organization chooses to outsource any process that affects product conformity with to requirements, the organization shall ensure control over such processes. Control of such The type and extent of control to be applied to these outsourced processes shall be identified defined within the quality management system. This addition clarifies that specific controls are to be defined and applied, not just identified. See the new Note 3 below for an explanation of the type and extent of controls for an outsourced process. The current Note under clause 4.1 has been expanded and two new Notes have been added: NOTE 1: Processes needed for the quality management system referred to above should include processes for management activities, provision of resources, product realization, and measurement, analysis, and improvement. The text above expands from "measurement" to "measurement, analysis, and improvement" to match the title for clause 8. And, by deleting "should", it clearly states that these processes are included. The new Note below provides an explanation of what is considered an outsourced process. NOTE 2: An outsourced process is identified as one being needed for the organization's quality management system, but chosen to be performed by a party external to the organization. The new Note below identifies the factors influencing the control of an outsourced process. NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements, b) the degree to which the control for the process is shared; c) the capability of achieving the necessary control through the application of clause 7.4. Outsourcing a process to another organization typically involves the purchase of those services. As a result, the requirements of clause 7.4, including the controls mentioned in 7.4.1, apply equally to the supplier selected to perform the outsourced process.
  • 4.2 Documentation Requirements 4.2.1 GeneralThe changes in this section are basically just a restructuring of the sub-clauses c), d), and e). c) documentedprocedures and records required by this International Standard, and d) documents, including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes,and e) records required by this International Standard (see 4.2.4). You can see that adding "records" to sub-clause (c)allowed sub-clause (e) to be dropped. Sub-clause (d) has been expanded to include the necessary records. The firstNote for clause 4.2.1 has added two more sentences: A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. Anexample for the first sentence would be satisfying the requirements for documented procedures in 8.5.2, CorrectiveAction, and 8.5.3, Preventive Action, through one combined Corrective and Preventive Action procedure. An examplefor the second sentence would be splitting the required procedure for the Control of Documents into two separatedocumented procedures.
  • 4.2.4 Control of RecordsThe opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". Maintaining records would simply keep them in good condition. Controlling the records means to regulate their use. Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. Records shall remain legible, readily identifiable andretrievable. The organization shall establish a documented procedure shall be established to define the controls needed for the identification, storage, protection, retrieval, retention time, and disposition of records. Records shallremain legible, readily identifiable, and retrievable. The requirement for a documented Record Control procedure hasbeen rewritten, but the content is basically the same. It is now a separate paragraph for emphasis and moved up in thesection. Note that "retention time" has been reduced to "retention". And, you can see that records must still remain legible, readily identifiable, and retrievable. This requirement is now a separate paragraph and moved to the end ofclause 4.2.4.
  • One example may be outsourcing where it is now concluded that it cannot be part of any exclusion to the requirement.
  • Upgrade iso 9001 2000 to 2008 version

    1. 1. By Sid Calayag – QMS Lead AuditorPresented on November 26, 2009Ver. 0 11.25.09
    2. 2. IntroductionThis is a summary of the update of *TPI‟s QMS manualand procedure brought about by the new guidelinesissued by International Organization for Standardizationin agreement with IAF. According to them:1. Certification to ISO 9001:2008 will only be issued after a routine surveillance audit or re-certification audit against ISO 9001:2008.2. All certifications issued (new certifications and re- certifications) must be to ISO 9001:2008.3. Two years after publication of ISO 9001:2008, existing ISO 9001:2000 certifications will not be valid.*TPI – Taikisha Philippines, Inc. NOTE: The new standard has a release date of November 14, 2008 2
    3. 3. Main modifications• Outsourcing process defined.• Training to achieve competence.• Work environment includes physical and environmental factors.• Process measurement focused to effectiveness. 3
    4. 4. The Changes• The update in ISO 9001:2008 brought about a number of changes in QMS manual and procedures. – 48 lines in the manual – 93 lines in procedures• There are also some changes based on actual practice 4
    5. 5. The obvious . . . . . . the NOT so obvious . . . and for further review 5
    6. 6. HOME PAGE• The obvious• The NOT so obvious• For further review• Changes to current Procedures• Changes to the ISO Standard
    7. 7. Information to the readerThe differences in ISO 9001:2008 vs. ISO 9001:2000 aredescribed as follows.• Deleted ISO 9001:2000 text is indicated by strikethroughs.• New ISO 9001:2008 text is highlighted and underlined. The underlining will allow readers to distinguish the new text, even if this paper is printed without color. 7
    8. 8. HOME 8
    9. 9. Section 6.2: Human ResourcesCLAUSE CHANGES6.2.1 To ensure competence of our personnel, job descriptions have been prepared identifying the qualifications required for each position that affects product quality conformity to product requirements.6.2.2 Competence, Training and Awareness and Training Reference ISO 9001:2008 Section 6 9
    10. 10. However:Clause 6.2.2: Human Resources There is no other revision in this clause of QMS since the new requirements are already stated in the present manual. To quote Clause 6.2.2: “Qualifications are reviewed upon hire, when an employee changes positions or the requirements for a position change. Personnel Division maintains records of employee qualifications. If any differences between the employee‟s qualifications and the requirements for the job are found, training or other action is taken to provide the employee with the necessary competence for the job. The results are then evaluated to determine if they were effective. Training and evaluation are conducted according to the Competence, Training and Awareness Procedure. (TPI-02-622)” “All employees are trained on the relevance and importance of their activities and how they contribute to the achievement of the quality objectives.” 10
    11. 11. 6.3: Resource ManagementCLAUSE CHANGES6.3 . . ..The infrastructure has been provided, and includesSecond buildings, workspace, utilities, process equipment andSentence. supporting services (such as transport, communication or information systems).6.4 No revision in the manual but Note was added in the ISO standard requirement to clarify definition of work environment. NOTE :The term "work environment" relates to those conditions under which work is performed including physical, environmental and other factors (such as noise, temperature, humidity, lighting or weather). 11
    12. 12. 7.1 Planning of Product RealizationCLAUSE CHANGES7.1 Quality planning is required before new products or processes are implemented . . .Bullet (2) • The need to establish processes, and documents, and to provide resources specific to the product.Bullet (3) • Processes, documentation and resources requiredBullet (4) • Required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance.Bullet (5) • Records needed to provide evidence that the realization processes and resulting product meet requirements. Reference ISO 9001:2008 Section 4 and Section 7 12
    13. 13. Section 7: Product RealizationCLAUSE CHANGES7.5.3 Par. 2 TPI controls and records the unique identification of the product and maintains record wherever traceability is a specified requirement.7.5.4 Par. 1 If any customer property is lost, damaged or otherwise found to be unsuitable for use, this is reported to the customer and records maintained. TPI shall report to the customer and maintains its records7.5.5 TPI preserves the conformity of product during internal processing and installation in order to maintain conformity to requirements. This As applicable, preservation includes identification, handling, packaging, storage and protection. Preservation also applies to the constituent parts of a product. Reference ISO 9001:2008 Section 7 13
    14. 14. Section 7: Product RealizationCLAUSE CHANGES7.6 Title Control of Monitoring and Measuring Devices Equipment7.6 Par 1 TPI has determined the monitoring and measurement to be undertaken and the monitoring and measuring devices equipment needed to provide evidence of conformity of product to determined requirements7.6 Bullet (1) Calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards7.6 Bullet (3) Identified to enable the calibration status to be determined in order to determine its calibration status Reference ISO 9001:2008 Section 7 14
    15. 15. Section 8: Measurement . . .CLAUSE CHANGES8.1 To demonstrate conformity of the product to product requirements8.2.2 The management responsible for the area being audited is responsible for ensuring that actions any necessary correction and corrective action are taken without undue delay to eliminate detected8.2.3 When planned results are not achieved, correction and corrective action is taken, as appropriate, to ensure conformity of the product. Evidence of conformity with the acceptance criteria is maintained. Records indicate the person authorizing release of product for delivery to the customer. Reference ISO 9001:2008 Section 8 15
    16. 16. Section 8: Measurement . . .CLAUSE CHANGES8.2.4 Par (3) Product release and service delivery to the customer does not proceed until all the planned arrangements have been satisfactorily completed, . . .8.3 Par (2) Where applicable, the organization shall deal with nonconforming product by one or more of the following ways:8.3 Bullet (1) By containment of correction of the detected nonconformity and corrective action appropriate to the effects or potential effect to eliminate its cause to prevent its recurrence.8.3 Bullet (2) By authorizing its use, release or acceptance with the approval of the relevant authority Reference ISO 9001:2008 Section 8 16
    17. 17. Section 8: Measurement . . .CLAUSE CHANGES8.3 Par (3) TPI shall re-evaluate the result of the corrective action by testing and inspection to demonstrate conformity to the requirements.8.3 Par (4) Records of the noted nonconformities and any subsequent actions taken, including concessions obtained shall be maintained.8.5.2 Par (1) TPI takes action to eliminate the cause causes of nonconformities in order to prevent recurrence.8.5.2 Bullet (6) Reviewing the effectiveness of the corrective action taken8.5.3 Bullet (5) Reviewing the effectiveness of the preventive action taken Reference ISO 9001:2008 Section 8 17
    18. 18. 8.2.2 Internal auditRequirements for the audit evidence andresults had been added. It is made clearernow that the management is responsible toensure preventive and corrective action willbe taken.The reference to the ISO 10011 had beenupdated to ISO 19011. 18
    19. 19. 8.2.3 Monitoring and Measurement of ProcessesMinor change of words i.e. "to ensureconformity of the product" had been removed.A note had been added to clarify that theorganization should determine the type of themonitoring and measuring according to theprocesses and, how will this affect the qualitymanagement system. 19
    20. 20. ExplanationParagraph 8.2.4Change of words: "maintainevidence of conformity withacceptance criteria" had beenremoved but it is still aperceived requirement. 20
    21. 21. 8.3 Control of Non-conforming ProductAn addition sub-clause (d) that specifies howto deal with a nonconforming product that wasdiscovered after delivery.(Nothing new as it had always been addressedunder Warranty or After-sales protocol.) 21
    22. 22. 19.Non conforming product(8.3)• Dealing with non conforming product now includes the analysis of potential effects of non conformity after the use has started. – FMEA for every non conformity not corrected /correctable could be a requirement. 22
    23. 23. HOME 23
    24. 24. Section 4: General RequirementCLAUSE CHANGES4.1 Bullet (1) Identified Determined the processes needed for the QMS . . .4.1 Bullet (2) TPI shall ensure control of all outsourced processes that affects product conformity to the requirement.4.1 Bullet (6) Established systems to monitor, measure where applicable and analyze these processes, and … Reference ISO 9001:2008 Section 4 Clause 4.1 24
    25. 25. ExplanationClause 4.1 Bullet 1: • 2000 version standard says IDENTIFY the processes meaning recognize or establish something as being a particular thing. – List them • to determine is to apply reason and reach a decision. – Implies more analysis and judgment than merely listing them 25
    26. 26. ExplanationClause 4.1 Bullet 2: On outsourcing • All outsourced processes must be defined in the quality management system Normally, “outsourcing” is a process owned by Purchasing Department. But since selection, negotiation and control is left to the end-user (department), it can also be part of the department(s) involved. • PURCHASING is buying a product • OUTSOURCING is buying capability 26
    27. 27. TC 176 Interpretation: – No exclusion on outsourced processRFI: ISO 9001:2000 Clause(s): 1.2Question: Does the standard requires an organization that purchases a complete design , then manufactures a product to the design and sells it under its own brand name to include “design” as one of the processes needed for the Quality Management System?Interpretation: Yes
    28. 28. Example:If TPI purchases or employs a subcontractorto design a system, then the design of theproduct is identified and established as one ofthe outsourced processes needed to becontrolled and included in the qualityManagement System. 28
    29. 29. ExplanationClause 4.1 Bullet 2: Cont‟n • Control the “outsourcing” process by considering: – What is the potential impact of the processes on the product requirements? – What are the controls and are they shared? – Is there Existing control through Purchasing? NOTE 2 on Clause 4.1 of ISO 9001:2008 An "outsourced process" is a process that the organization needs for its quality management system and which the organization chooses to have performed by an external party. 29
    30. 30. ExplanationClause 4.1 Bullet 6:• In the new version, ISO clarifies the intention by replacing the “management” with “measurement, analysis and improvement” in the NOTE(S). 30
    31. 31. Section 4.1: General Requirement• NOTE on ISO 9001:2000 Processes needed for the QMS referred to above include processes for management activities, provision of resources, product realization and management• NOTE1 on ISO 9001:2008 Processes needed for the QMS referred to above include processes for management activities, provision of resources, product realization, measurement, analysis and improvement. 31
    32. 32. Section 4.2: Documentation RequirementsCLAUSE CHANGES4.2.1 Bullet (3) • documented procedures and records.4.2.1 Bullet (4) • documents identified as needed determined to be necessary for the effective planning, . . .4.2.1 Bullet (5) • quality records Reference ISO 9001:2008 Section 4 Clause 4.2 32
    33. 33. ExplanationClause 4.2.1 Bullet 3 and 6: This is to emphasize that “documentation” can also include “records” and that mandatory procedures may be in the form of combined documents, or that requirements may be covered by more than one document. Clarified that external documentation are the ones needed for the quality management system. 33
    34. 34. Section 4.2.3: Control of DocumentsCLAUSE CHANGES4.2.3 Bullet (6) • Ensuring that documents of external origin determined by the management to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and . . Reference ISO 9001:2008 Section 4 Clause 4.2.3. 34
    35. 35. ExplanationClause 4.2.3 Bullet 6: Clarified that external documentation are the ones needed for the quality management system. 35
    36. 36. Section 4.2.4: Control of RecordsCLAUSE CHANGES4.2.4 Quality records are maintained established to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled. The records are maintained according to the Control of Quality Records Procedure (TPI-02- 424). This procedure requires that quality records shall remain legible, readily identifiable and retrievable. The procedure defines the controls needed for identification, storage, protection, retrieval, retention time and disposition of quality records. Reference ISO 9001:2008 Section 4 Clause 4.2.1/4.2.4. 36
    37. 37. ExplanationClause 4.2.4: Control of Records • The opening sentence for clause 4.2.4 has expanded from records being "maintained" to having them "controlled". – Maintaining records would simply keep them in good condition. – Controlling the records means to regulate their use. 37
    38. 38. Section 5.5.2: Management RepresentativeCLAUSE CHANGES5.5.2 The Vice President has been appointed by top management as Management Representative. There is no change in the QMS Manual Reference ISO 9001:2008 Section 5 Clause 5.5.2. 38
    39. 39. ExplanationClause 5.5.2: Management Representative An addition for a demand that the management representative would have to be a member of the organizations management. 39
    40. 40. ExplanationClause 5.5.2: Management RepresentativeAn addition for a demand that the managementrepresentative would have to be a member of theorganizations management. Outsourcing of the Management Representative (MR) is NOT conforming. 40
    41. 41. HOME3. FOR FURTHER REVIEW 41
    42. 42. Section 7: Product RealizationCLAUSE CHANGES7.2.1 Customer requirements include those:Bullet (4) • Statutory and regulatory requirements related applicable to the productBullet (5) • Additional requirements determined considered necessary by TPI7.3.1 • A note had been added to clarify that design review, verification and validation are separated processes but they can be conducted together. • No revision in the manual yet – for deliberation7.3.3 • . . .They are documented in a form suitable for format that enables verification against the design and development inputs, and are approved prior to release. Reference ISO 9001:2008 Section 7 42
    43. 43. Section 7: Product RealizationCLAUSE CHANGES7.5.1 . . . Controlled conditions include, as applicable:Bullet (4) • The availability and use of monitoring and measuring devices equipmentBullet (6) • The implementation of product release, delivery and post-delivery activities7.5.2 TPI validates any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement. This includes any processes where and as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation demonstrates the ability of these processes to achieve planned results. Reference ISO 9001:2008 Section 7 43
    44. 44. ExplanationClause 7.2.1 Customer Related Process Bullet (4) – the word applicable replaced related„ means laws or regulation that affect the quality of the product will be considered as customer requirement.Clause 7.3.1: Design and Development Planning Revision in this clause is subject for deliberation due to “validation” requirement.Clause 7.3.3: Design and Development Output The revisions are just rewording and do not require additional action or change in the manual . 44
    45. 45. ExplanationClause 7.5.1 Control of Production and Service Provision Bullet (4) – the word equipment replaced devices„ corresponds to the change in the title of Clause 7.6: Control of Monitoring and Measuring Devices Equipment Bullet (6) – the insertion of the word “product” clarifies the subject being discussedClause 7.5.2: Validation of Processes for Production and Service Provision - Subject for deliberation 45
    46. 46. 8.2.1 Customer Satisfaction NOTE was added as follows: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data o delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports. 46
    47. 47. Explanation A note had been added to throw light on some of the means for conducting customer satisfaction evaluation. The standard balances perception with data and relies on warranty failures, dealer feedback, product quality data, user surveys, lost business analysis etc. Formula for Delighting Customers 47
    48. 48. HOMERevisions in the procedures brought about by changes in the QMS manual 48
    49. 49. Section 7: Product RealizationPROCEDURE CHANGES02-423 The author is responsible for writing the document, creating related forms, getting a number and submitting the documents to all concerned department/division heads for review02-424 Quality Records are maintained as established and listed in the Quality Records Index (DCC 102). The index contains the following information02-424 Access to TPI controlled records is limited to employees and authorized visitors02-424 Controlled records are readily retrievable by referring to the Quality Records Index for location 49
    50. 50. Section 7: Product RealizationPROCEDURE CHANGES02-424 . . .. At the end of the project, all project records concerning the project shall be transferred to the Central Document/Data Controller (CDDC) for storage.02-424 After records are no longer needed and the retention period has been reached, the records are archived or disposed of in coordination with CDDC.02-424 DCC101 - Controlled Document Master List.02 - 710 HSE – Health Safety and Environment02 - 710 As new processes or projects are introduced, quality objectives and product requirements and documents are determined as appropriate and provide resources specific to the product. 50
    51. 51. Section 7: Product RealizationPROCEDURE CHANGES02 - 710 Engineering – Senior Manager assigns responsibility to initiate a project quality plan or design project. The Design and Estimate Manager initiates the project quality plan and a project manager completes it before the project is started.02 - 710 The Project Manager initiate implements project quality plan02 - 710 Conduct the required verification, validation, monitoring, measurement, inspection, and test activities, specific to the product and the criteria for product acceptance.02 - 710 Provide records as evidence that the processes and resulting product meet requirements. 51
    52. 52. Section 7: Product RealizationPROCEDURE CHANGES02 - 710 Project Quality Plan includes but not limited to:02 - 710 Quality objectives and project requirements for the project02 - 710 Verification, validation, monitoring, inspection and test activities02 - 710 HSE Program02 - 710 The Project Manager investigates and completes each applicable section of the Project Quality Plan (ENG 104).02 - 710 When the project is completed, management reviews the quality planning table project output against the quality plan to make sure that all requirements have been met. and signs to indicate approval 52
    53. 53. Section 7: Product RealizationPROCEDURE CHANGES02 - 710 Testing Report Forms02 - 710 HSE 105 - Job Safety Analysis02 - 720 Assists in review of Tender Documents02 - 720 Assist Engineering Department in the preparation of bid Quotation in accordance with the requirements02 - 720 Assists in the coordination of Coordinate status of on- going projects between Client and Construction Department02 - 720 Prepare sales forecast on a monthly, quarterly or and annual basis based on the requirement of the top management 53
    54. 54. Section 7: Product RealizationPROCEDURE CHANGES02 - 720 Inquiry of document Request is received by e-mail, phone, and fax or post mail or during pre-bid conference.02 - 720 When Sales and Marketing representative receives a request for quotation, client the representative he identifies and documents customer‟s requirement.02 - 720 Queries from Engineering Department (Technical) and Sales and Marketing (Commercial) base based on the Tender Documents are submitted and discussed to clients during Pre Bid Conference.02 - 720 Sales Department and Marketing and Engineering Department prepare the proposal in accordance with Tender Requirements incorporating if any all the changes in the Tender Documents 54
    55. 55. Section 7: Product RealizationPROCEDURE CHANGES02 - 720 Whenever required by the Client, Sales and Marketing together with or the Engineering Department representative will discuss the Technical and Commercial details of the Tender to Customer‟s Authorized Representatives02 - 720 Proposal shall have a unique identification using the quotations job number order which will be provided by the Management Data Control.02 - 720 For closed sales, Sales and Marketing reviews and evaluates Contract versus Tender Documents. . . . Discusses deviations to Engineering Department and other departments concerned. Contract Document with comments of Department concerned are sent to Legal for final comment. These comments deviations are discussed and negotiated to the customer. . . . 55
    56. 56. Section 7: Product RealizationPROCEDURE CHANGES02 - 730 The Design Team shall be responsible for the preparation of tender documents with the assistance of Sales Department02 - 730 Design Team Leader: Senior Engineer or Engineer III as minimum required requirement02 - 730 Estimates: Owner provides the design drawing, specification and TPI to do an estimation work estimates only02 - 730 The Design Manager designates a Design Team Leader for the project02 - 730 Design outputs are documented and filed in the design file. Design outputs are documented in a manner that enables them are suitable to be verified against the design inputs 56
    57. 57. Section 7: Product RealizationPROCEDURE CHANGES02-750 Site Safety Officer shall be responsible in the execution of Project HSE indicators.02-750 HSE Indicator: field of measurements and monitoring how a project complies with the HSE program02-750 Use the same unique identification of project provided by the Management Data Control in the approved proposal02-750 TPI preserves the product during internal processing and installation in order to maintain conformity to requirements. TPI also exercises care with customer property while it is under the organizations control or being used. Preservation includes identification, verification, protection and safeguarding of customer property provided for use. If any customer property is lost, damaged or otherwise found to be unsuitable for use, TPI shall report to the customer and maintains its records. 57
    58. 58. Section 7: Product RealizationPROCEDURE CHANGES02-750 The VP - Engineering - Senior Manager President or his designee shall conduct a monthly project progress meeting to discuss the progress of the project. The following shall attend the meeting: Chairman : Engineering - Vice President Senior Manager President Members : President or his designate Project Managers / Project Engineers Any other personnel deemed necessary02-760 Calibrate and maintain equipment as assigned.02-760 Designate an Equipment Controller.02-760 Assign responsibility for calibration and maintenance of equipment. 58
    59. 59. Section 7: Product RealizationPROCEDURE CHANGES02-750 All listed equipment that is out of calibration period can only be used after being validated verified by a current calibrated unit of the same type.02-760 All Testing Equipment and Devices which are not calibrated for more than a year can be used as Preliminary Testing Equipment only prior to final testing. by a calibrated equipment and device. Official Calibration Certificate is no longer required for this preliminary testing.02-822 The management staff person responsible for the area being audited shall take timely corrective action on nonconformities found during the audit. The management of the area being audited is responsible for ensuring that any necessary corrections and corrective actions are taken without undue delay to eliminate detected non conformities and their causes. 59
    60. 60. Section 8: Measurement . . .PROCEDURE CHANGES02-824 In process checks on completed part of the work shall be carried out together with the customers representatives, in case required.02-824 The final inspection and commissioning shall be authorized, monitored and approved for hand-over to the customer by the Project Manager.02-824 The final inspection and commissioning shall be monitored by the GM - Engineering Project Engineer02-830 The Area Project / Site Manager or Section Head may determine to scrap the item. The scrap is logged on their scrap report.02-830 All reworked/repaired products/materials shall be re- inspected with the approval of the authorizing body and where applicable by the customer. 60
    61. 61. Section 8: Measurement . . .PROCEDURE CHANGES02-830 The works must be identified as non-conforming and a Non Conformance form is initiated. The work is identified: a) The nonconformity is described b) The location of the work is identified.02-830 Quality control or Project/Site Manager reviews the NCR form and identifies the disposition of the product or material as: a) Scrap b) Rework to correct c) Use as is02-830 Quality control or Project/Sites Manager determines if a corrective action will be initiated.02-830 Quality control or Project/Sites Manager determines if a corrective action will be initiated. 61
    62. 62. Section 8: Measurement . . .PROCEDURE CHANGES02-830 If product will be “Used as is”, quality control or management is responsible for determining and obtaining any necessary customer concession. If there are certain uses that are not appropriate it will be noted on the NCR form.02-830 If nonconforming product is detected after delivery or use, sales representative or the project manager will contact the customer and take appropriate correction and initiate a corrective 62
    63. 63. HOMEHere are the revisions in the INTERNATIONAL STANDARD Quality Management System Requirements 63
    64. 64. The Changes to the StandardCLAUSE CHANGES0.1 Para. 3 Text added to include statutory requirements as well as customer and regulatory and clarifies that these requirements are applicable to the product.0.2 Para. 3 Text added to focus on importance of processes producing the desired outcome.0.3 Para. 2 Text added to include statutory and regulatory requirements. 64
    65. 65. The Changes to the StandardCLAUSE CHANGES1.1 Text added to include statutory requirements. Note 1 expanded to include purchased product and output from product realization processes. Note 2 added indicating that statutory and regulatory requirements may be expressed as legal requirements.1.2 Text added to include statutory requirements.2 Reference to ISO 9000 now indicates 2005 version.3 Definition of supplier, organization and customer has been deleted. 65
    66. 66. The Changes to the StandardCLAUSE CHANGES4.1 a. – The word ‘determine’ has replaced ‘identify.’ e. - The phrase ‘where applicable’ was added after ‘measure.’ Note. 1 - The wording ‘analysis and improvement’ was added. Note 2 - Added to define outsourced process. Note 3 - Added to define type and nature of control applied to outsourced processes.4.2.1 Revised to clarify that QMS documentation includes records. Note 1 expanded to clarify that one document may include the requirements of one or more procedures and the requirements of one procedure may be covered by more than one document. 66
    67. 67. The Changes to the StandardCLAUSE CHANGES4.2.3 Text added to clarify that external documents are those needed for use in the QMS.5.5.2 Clarifies that management representative must be a member of the organization’s own management.6.2.1 Note added to clarify that conformity to product requirements may be affected directly or indirectly by personnel performing any task within the QMS. 67
    68. 68. The Changes to the StandardCLAUSE CHANGES6.2.2 Change in title from ‘Competence, awareness and training’ to ‘Competence, training and awareness.’ a. – Wording change from ‘affecting product quality’ to ‘conformity to product requirements.’ b. - The phrase ‘where applicable’ was added. c. - Revised to require assurance that the necessary competence has been achieved, rather than evaluating the effectiveness of training.6.3 c. - Revised to include information systems.6.4 Note added to clarify definition of work environment. 68
    69. 69. The Changes to the StandardCLAUSE CHANGES7.1 c. – The word ‘measurement’ was added.7.2.1 a. – Slightly reworded c. - The word ‘related’ was replaced with ‘applicable.’ d. – The word ‘determined’ was replaced with ‘considered necessary.’ Note added to clarify that post-delivery activities include actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal.7.3.1 Note added to clarify that design and development review, verification and validation have distinct purposes and may be performed separately or in any combination as suitable for the product and the organization. 69
    70. 70. The Changes to the StandardCLAUSE CHANGES7.3.2 In last paragraph, ‘these’ changed to ‘the.’7.3.3 First paragraph – The word ‘provided’ was omitted and the phrase ‘that enables’ was replaced by ‘suitable for.’ Note added to clarify that production and service provision may include details for the preservation of product.7.5.3 Second paragraph – The phrase ‘throughout product realization’ was added. Last paragraph – The phrase ‘and maintain records’ was added.7.5.4 Note – The phrase ‘and personal data’ was added as part of customer property. 70
    71. 71. The Changes to the StandardCLAUSE CHANGES7.5.5 Phrase ‘conformity of’ was changed to ‘in order to maintain conformity to requirements’ and ‘where appropriate’ was changed to ‘as applicable.’7.6 Title of clause changed from ‘devices’ to ‘equipment.’ The reference to 7.2.1 was removed. a. – The phrase ‘or both’ was added. c. – The phrase ‘be identified to enable’ was replaced with ‘have identification.’ Note referencing ISO 10012-1 and ISO 10012-2 was deleted and replaced with a note related to the confirmation of computer software used as monitoring and measuring equipment. 71
    72. 72. The Changes to the StandardCLAUSE CHANGES8.1 a. – The word ‘requirements’ was added.8.2.1 Note added to provide examples of how customer satisfaction data can be measured.8.2.2 Editorial changes to clause to clarify requirements. Reworded requirement for documented procedure Clarified record requirements by adding ‘records of the audits and their results’ Clarified that management responsible for the area being audited shall ensure that ‘any necessary corrections and corrective actions are taken.’ Note – Reference to ISO 10011-1, 10011-2 and 10011-3 changed to ISO 19011. 72
    73. 73. The Changes to the StandardCLAUSE CHANGES8.2.3 The phrase ‘to ensure conformity of the product’ was deleted. Note added to clarify that the organization should consider the type of monitoring and measuring of processes and the extent to which they effect conformity to product requirements and the effectiveness of the QMS.8.2.4 The phrase ‘for delivery to the customer’ was added to clarify that the release of the product relates to the delivery to the customer.8.3 Reworded requirement for documented procedure. Second paragraph – The phrase ‘where practicable’ was added. 73
    74. 74. SummaryNo new requirements were introduced in ISO9001:2008 edition but, in order to benefit fromthe clarifications of ISO 9001:2008, we willneed to take into consideration whether theclarifications introduced have an impact on ourcurrent interpretation of ISO 9001:2000, aschanges may be necessary to the QualityManagement System. 74
    75. 75. Prepared and Presented by: Sid Calayag - QMS Lead AuditorDate: November 25, 2009Venue: TPI Conference Room No. 2Attendees: Mr. Enrico Concepcion – Vice President Mr. Nelson Tan – Purchasing Manager and QA/QC Manager Ms. Wilma Corpuz - Sr. Personnel Officer Mr. Norman Joseph – Sr. Info. Officer Ms. Rose Llanera - Central Docs. and Data Controller 75
    76. 76. ReferencesISO 9000: 2005 Fundamentals and vocabularyISO 9001: 2008 RequirementsISO/TC 176 PublicationsInternational Register of Certified Auditors PublicationsInternational Accreditation Forum PublicationsAuditing Practices Group PublicationsTPI QMS 9001:2000 Manual and Procedures 76
    77. 77. Thank You… 77

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