Understanding the Requirements Qimpro Standards Organization ISO 9001: 2000 Understanding the Requirements Qimpro Standards Organization www.qimpro.com standards@qimpro.com April 2001 www.qimpro.com

1. Scope April 2001 www.qimpro.com

1.1 General Demonstrate ability to consistently provide product that meets customer and applicable regulatory requirements Enhances customer satisfaction, achieve continual improvement and assurance of conformity to customer and applicable regulatory requirements Product applies only to the product intended for, or required by, a customer. April 2001 www.qimpro.com

1.2 Application Requirements of the standard are generic - applicable to all organizations, regardless of type, size and product provided Permissible exclusions possible – only for clause 7 (exclusions should not affect ability, or responsibility, to provide product that meets customer and applicable regulatory requirements). April 2001 www.qimpro.com

2. Normative reference April 2001 www.qimpro.com

ISO 9000: 2000, Quality management systems – Fundamentals and vocabulary. April 2001 www.qimpro.com

3. Terms and definitions April 2001 www.qimpro.com

Refer terms and definitions given in ISO 9000 Supplier, organization, customer The term “organization” replaces the term “supplier” used in ISO 9001:1994, and refers to the unit to which this International Standard applies The term “supplier” now replaces the term “subcontractor” The term “product” also means “service”. April 2001 www.qimpro.com

4. Quality management system April 2001 www.qimpro.com

4.1 General requirements Establish, document, implement and maintain a QMS Continually improve effectiveness of QMS Identify processes needed for QMS and their application across the organization Determine the sequence and interaction of these processes Determine criteria and methods needed to ensure that operation and control of these processes are effective Cont… April 2001 www.qimpro.com

4.1 General requirements (Cont…) Ensure availability of resources and information necessary to support the operation and monitoring of these processes Monitor, measure and analyze these processes, and Implement actions necessary to achieve planned results and continual improvement of these processes. April 2001 www.qimpro.com

4.1 General requirements (Cont…) Organization is responsible for quality of outsourced process/material Processes include processes for management activities, provision of resources, product realization and measurement. April 2001 www.qimpro.com

4.2 Documentation requirements 4.2.1 General Documented statements of a quality policy and quality objectives A quality manual Documented procedures required by the standard Documents needed by the organization to ensure the effective planning, operation and control of its processes Records required by the standard Documented procedure - established, documented, implemented and maintained Cont… April 2001 www.qimpro.com

4.2.1 General (Cont…) Criteria for extent of the QMS documentation Size of organization and type of activities Complexity of processes and their interactions Competence of personnel Documentation can be in any form or type of medium – electronic is allowed. April 2001 www.qimpro.com

4.2.2 Quality manual Quality manual includes: Scope of QMS, including justification for exclusions Documented procedures or reference to them Description of interaction between processes of QMS. April 2001 www.qimpro.com

4.2.3 Control of documents QMS documents must be controlled Control includes Approval of documents for adequacy prior to issue Review and update Ensure that changes and revision status is identified Ensure that relevant versions are available at points of use Ensure that documents remain legible and readily identifiable Ensure that documents of external origin are identified controlled Prevent use of obsolete documents Documented procedure essential. April 2001 www.qimpro.com

4.2.4 Control of records Provide evidence of conformity to requirements and effective operation of QMS Must be legible, readily identifiable and retrievable Documented procedure essential - identification, storage, protection, retrieval, retention time and disposition of records. April 2001 www.qimpro.com

5. Management responsibility April 2001 www.qimpro.com

5.1 Management commitment Evidence of commitment to development and implementation of QMS and continually improving its effectiveness by: Communicating the importance of meeting customer and statutory/regulatory requirements Establishing the quality policy and quality objectives Conducting management reviews Provide resources. April 2001 www.qimpro.com

5.2 Customer focus Top management must ensure that customer requirements are determined and met Aim to enhance customer satisfaction. April 2001 www.qimpro.com

5.3 Quality policy Top management must ensure that the quality policy: Is appropriate to the purpose of the organization Includes a commitment to comply with requirements and continual improvement Provides a framework for establishing and reviewing quality objectives Is communicated and understood within the organization Is reviewed for continuing suitability. April 2001 www.qimpro.com

5.4 Planning 5.4.1 Quality objectives Top management must identify quality objectives Must be measurable and consistent with the quality policy. April 2001 www.qimpro.com

5.4.2 Quality management system planning Top management shall ensure that: QMS is planned to address in 4.1, and quality objectives Integrity of the QMS is maintained when changes are planned and implemented. April 2001 www.qimpro.com

5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority Top management must ensure that responsibilities and authorities are defined and communicated within the organization. April 2001 www.qimpro.com

5.5.2 Management representative Must be appointed Member of management Irrespective of other responsibilities, must have responsibility and authority that includes: Ensuring that processes needed for QMS are established, implemented and maintained Reporting to top management on performance of QMS Ensuring the promotion of awareness of customer requirements throughout the organization. Will liaison with external parties on matters relating to QMS. April 2001 www.qimpro.com

5.5.3 Internal communication Top management must ensure that communication processes are established to communicate effectiveness of QMS. April 2001 www.qimpro.com

5.6 Management review 5.6.1 General Top management must review QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness Review must include assessment of opportunities for improvement Need for changes to QMS, including the quality policy and quality objectives must be reviewed Records from management reviews must be maintained. April 2001 www.qimpro.com

5.6.2 Review input Results of audits Customer feedback Process performance and product conformity Status of preventive and corrective actions Follow-up actions from previous management reviews Changes that could affect the quality management system Recommendations for improvement. April 2001 www.qimpro.com

5.6.3 Review output Improvement in effectiveness of QMS and its processes Improvement of the product related to customer requirements Resource needs. April 2001 www.qimpro.com

6. Resource management April 2001 www.qimpro.com

6.1 Provision of resources Implement and maintain the QMS and continually improve its effectiveness To enhance customer satisfaction by meeting customer requirements. April 2001 www.qimpro.com

6.2 Human resources 6.2.1 General Personnel performing work affecting product quality must be competent Competence includes appropriate education, training, skills and experience. April 2001 www.qimpro.com

6.2.2 Competence, awareness and training Determine the necessary competence for personnel performing work affecting product quality Provide training or take other actions to satisfy these needs Evaluate the effectiveness of the actions taken Ensure that personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives Maintain appropriate records of education, training, skills and experience. April 2001 www.qimpro.com

6.3 Infrastructure Determine, provide and maintain infrastructure needed to achieve conformity to product requirements Building, workspace and associated utilities Process equipment (both hardware and software) Supporting services (such as transport or communication). April 2001 www.qimpro.com

6.4 Work environment Determine and manage the work environment needed to achieve conformity to product requirements. April 2001 www.qimpro.com

7. Product realization April 2001 www.qimpro.com

7.1 Planning of product realization Plan and develop processes needed for product realization. Planning of product realization must be consistent with requirements of other processes of QMS. Determine quality objectives and requirements for the product Determine the need to establish processes, documents, and provide resources (Cont…) April 2001 www.qimpro.com

7.1 Planning of product realization (Cont…) Determine required verification, validation, monitoring, inspection and test activities and the criteria for product acceptance Determine records needed to provide evidence that the realization processes and resulting product meet requirements. The output of this planning must be in a form suitable for the organization’s method of operations. April 2001 www.qimpro.com

7.2 Customer-related processes 7.2.1 Determination of requirements related to the product Requirements specified by the customer, including the requirements for delivery and post-delivery activities Requirements not stated by the customer but necessary for specified or intended use Statutory and regulatory requirements related to the product Any additional requirements determined by the organization. April 2001 www.qimpro.com

7.2.2 Review of requirements related to the product Review the requirements related to the product Review must be conducted before commitment to supply Ensure that product requirements are defined Ensure that differences are resolved Ensure that the organization has the ability to meet defined requirements Records of the results of the review and actions must be maintained. (Cont…) April 2001 www.qimpro.com

7.2.2 Review of requirements related to the product (Cont…) Where customer requirement is not documented, confirm the same before acceptance Where product requirements are changed, amend documents and inform relevant personnel In some situations, such as Internet sales, a formal review is impractical for each order. April 2001 www.qimpro.com

7.2.3 Customer communication Must determine and implement effective arrangements for communicating with customers Product information Enquiries, contracts or order handling, including amendments, and Customer feedback, including customer complaints. April 2001 www.qimpro.com

7.3 Design and development 7.3.1 Design and development planning Must plan and control the design and development of product Determine the design and development stages Determine review, verification and validation at each stage Determine responsibilities and authorities for design and development Must manage the interfaces between different groups involved in design and development Planning output must be updated as the design and development progresses. April 2001 www.qimpro.com

7.3.2 Design and development inputs Inputs relating to product requirements must be determined and records maintained Functional and performance requirements Applicable statutory and regulatory requirements Where applicable, information derived from previous similar designs Other requirements essential for design and development Inputs must be reviewed for adequacy Requirements must be complete, unambiguous and not in conflict with each other. April 2001 www.qimpro.com

7.3.3 Design and development outputs Outputs must be provided in a form that enables verification against inputs Outputs must be approved prior to release Meet the input requirements for design and development Provide appropriate information for purchasing, production and for service provision Contain or reference product acceptance criteria Specify the characteristics of the product that are essential for its safe and proper use. April 2001 www.qimpro.com

7.3.4 Design and development review Systematic and at suitable stages and as planned Evaluate the ability of the results to meet requirements To identify any problems and propose necessary action Participants must include representatives of functions concerned with the design and development Records of the results of the reviews and any necessary actions must be maintained. April 2001 www.qimpro.com

7.3.5 Design and development verification Verification must be performed as planned Ensure that outputs have met input requirements Records of verification and any necessary actions must be maintained. April 2001 www.qimpro.com

7.3.6 Design and development validation Must be performed as planned Ensure that resulting product is capable of meeting requirements for specified application / intended use Validation must be completed prior to delivery or implementation Records of results of validation and any necessary action must be maintained. April 2001 www.qimpro.com

7.3.7 Control of design and development changes Design and development changes must be identified and recorded Changes must be reviewed, verified and validated, and approved before implementation Review of changes must include evaluation of effect of changes on parts and product already delivered Records of the results of the review of changes and any necessary actions must be maintained. April 2001 www.qimpro.com

7.4 Purchasing 7.4.1 Purchasing process Must ensure that purchased product conforms to specified purchase requirements Type and extent of control on supplier and purchased product will depend on the effect of the purchased product on subsequent product realization or final product Must evaluate and select suppliers based on their ability to supply product in accordance requirements Cont… April 2001 www.qimpro.com

7.4.1 Purchasing process (Cont…) Criteria for selection, evaluation and re-evaluation must be established Records of the results of evaluations and any necessary actions arising from the evaluation must be maintained. April 2001 www.qimpro.com

7.4.2 Purchasing information Must describe the product to be purchased Requirements for approval of product, procedures, processes and equipment Requirements for qualification of personnel Quality management system requirements Must ensure adequacy of specified purchase requirements prior to their communication to the supplier. April 2001 www.qimpro.com

7.4.3 Verification of purchased product Must establish inspection/other activities to ensure that purchased product meets purchase requirements For self-certification/verification state intended verification arrangements and method of product release in the purchasing information. April 2001 www.qimpro.com

7.5 Production and service provision 7.5.1 Control of production and service provision Must plan and carry out production and service provision under controlled conditions Information that describes the characteristics of the product Work instructions Use of suitable equipment Use of monitoring and measuring devices Implementation of monitoring and measurement Implementation of release, delivery and post-delivery activities. April 2001 www.qimpro.com

7.5.2 Validation of processes for production and service provision Must validate any processes where output cannot be verified by subsequent monitoring/measurement. Validation must demonstrate ability of these processes to achieve planned results Defined criteria for review and approval of the processes Cont… April 2001 www.qimpro.com

7. 5. 2. Validation of processes for production 7.5.2 Validation of processes for production and service provision (Cont…) Approval of equipment and qualification of personnel Use of specific methods and procedures Requirements for records Revalidation. April 2001 www.qimpro.com

7.5.3 Identification and traceability Must identify product throughout product realization Must identify product status with respect to monitoring and measurement requirements Must control and record the unique identification of the product In software, configuration management is used for identification and traceability. April 2001 www.qimpro.com

7.5.4 Customer property Provided for use or incorporation into the product Must take care with customer property while it is under your control Must identify, verify, protect and safeguard customer property In case of loss, damage or unsuitability for use, inform customer and maintain records Customer property includes intellectual property. April 2001 www.qimpro.com

7.5.5 Preservation of product Must preserve conformity of product during internal processing and delivery Preservation includes identification, handling, packaging, storage and protection Preservation must apply to the constituent parts of a product. April 2001 www.qimpro.com

7.6 Control of monitoring and measuring devices Must determine the monitoring and measurement requirements and devices Needed to provide evidence of conformity of product to determined requirements Measurement equipment must be calibrated or verified Specific intervals, or prior to use, against standards traceable to international or national standards Where no such standards exist, the basis used for calibration or verification must be recorded Adjust or re-adjust Cont… April 2001 www.qimpro.com

7.6 Control of monitoring and measuring devices (cont…) Identification to enable the calibration status to be determined Safeguarded from adjustments that would invalidate the measurement result Protected from damage and deterioration during handling, maintenance and storage Must assess and record validity of the previous measuring results when the equipment is found not to conform to requirements Cont… April 2001 www.qimpro.com

7.6 Control of monitoring and measuring devices (cont…) Must take action on the equipment and any product affected Records of the results of calibration and verification must be maintained When used for monitoring and measurement, computer software must be calibrated ISO 10012-1 and ISO 10012-2 for guidance. April 2001 www.qimpro.com

8. Measurement, analysis and improvement April 2001 www.qimpro.com

8.1 General Must plan and implement monitoring, measurement, analysis and improvement processes Demonstrate conformity of the product Ensure conformity of QMS Continually improve the effectiveness of QMS. Determine applicable methods, including statistical techniques, and the extent of their use. April 2001 www.qimpro.com

8.2 Monitoring and measurement 8.2.1 Customer satisfaction Must monitor information about customer perception w.r.t customer requirements Determine methods for obtaining and using this information. April 2001 www.qimpro.com

8.2.2 Internal audit Must conduct internal audits at planned intervals Conformance of QMS to the planned arrangements Conformance of QMS to the requirements of ISO 9001: 2000 Conformance of QMS to requirements of the organization Effective implementation of QMS Plan audits taking considering status and importance of processes and results of previous audits Audit criteria, scope, frequency and methods must be defined Cont… April 2001 www.qimpro.com

8.2.2 Internal audit (Cont…) Selection of auditors and conduct of audits must ensure objectivity and impartiality of the audit process Auditors shall not audit their own work. Documented procedure is a must Auditee must ensure that actions are taken without undue delay Follow-up activities must include verification of actions taken ISO 10011-1, ISO 10011-2 and ISO 10011-3 for guidance. April 2001 www.qimpro.com

8.2.3 Monitoring and measurement of processes Must monitor and measure QMS processes Must demonstrate ability of the processes to achieve planned results Initiate correction and corrective action to ensure conformity of the product. April 2001 www.qimpro.com

8.2.4 Monitoring and measurement of product Must monitor and measure characteristics of the product to verify that product requirements have been met Must be done at stages of the product realization process as per plan Evidence of conformity must be maintained Records must indicate the person(s) authorizing release of product Product release and service delivery shall not proceed until requirements are met Waiver by relevant authority or customer. April 2001 www.qimpro.com

8.3 Control of nonconforming product Must ensure nonconforming is identified and controlled to prevent unintended use or delivery Must establish a documented procedure Take action to eliminate the detected nonconformity Authorize use, release or acceptance under concession by a relevant authority or customer Take action to preclude its original intended use or application Records of non-conformities and any subsequent actions taken must be maintained (Cont…) April 2001 www.qimpro.com

8.3 Control of nonconforming product (Cont…) After correction, the product must be re-verified to demonstrate conformity If detected after delivery or use the organization must take action appropriate to the effects, or potential effects, of the nonconformity. April 2001 www.qimpro.com

8.4 Analysis of data Must determine, collect and analyze data to demonstrate suitability and effectiveness of QMS Evaluate opportunities for continual improvement of effectiveness of QMS Data can be generated from other relevant sources. Analysis of customer satisfaction data Analysis of conformity to product requirements Analysis of characteristics and trends of processes and product including opportunities for preventive action Analysis of information on suppliers. April 2001 www.qimpro.com

8.5 Improvement 8.5.1 Continual improvement Must improve effectiveness of QMS continually Improvement traceable to quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. April 2001 www.qimpro.com

8.5.2 Corrective action Must take action to eliminate cause of non-conformities in order to prevent recurrence Corrective actions must be appropriate to the effects of the non-conformities Documented procedure must be established Review non-conformities (including customer complaints) Determine causes of non-conformities Evaluate need for action to ensure that non-conformities do not recur Determine and implement action needed Records of results of action taken Review corrective action taken. April 2001 www.qimpro.com

8.5.3 Preventive action Must take action to eliminate the causes of potential non-conformities to prevent occurrence. Preventive actions must be appropriate to the effects of potential problems Documented procedure must be established Determine potential non-conformities and their causes Evaluate the need for action to prevent occurrence of non-conformities Determine and implement action needed Records of results of action taken Review preventive action taken. April 2001 www.qimpro.com

Thank You standards@qimpro.com www.qimpro.com April 2001