QS-9000 QUALITY SYSTEM REQUIREMENTS

Transcript QS-9000 QUALITY SYSTEM REQUIREMENTS

ISO 9001: 2008 AUDITING

Module 2 – A Review of ISO 9001:2008 Requirements

Note: Standards and the comments of this section will be reviewed together. This is not an exact copy of the standard.

ISO 9001-2000 Review Module 2

ISO 9001:2000 Breakdown

0 Introduction 1 Scope 2 Normative Reference 3 Terms and Definitions 0.1 General 0.2 Process Approach 1.1 General 1.2 Application 0.3 Relationship with ISO 9004 0.4 Compatibility with Other Mgmt. Systems

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ISO 9001:2000 Breakdown

4 Quality Mgmt.

System 5 Mgmt.

Responsibility 6 Resource Mgmt.

7 Product Realization 8 Measurement, Analysis, & Improvement 4.1 General Requirements 4.2 Documentation Requirements 5.1 Mgmt Commitment 5.2 Customer Focus 5.3 Quality Policy 5.4 Planning 5.5 Responsibility, Authority & Communication 5.6 Mgmt. Review 6.1 Provision of Resources 6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment

7.1 Planning of Product Realization 7.2 Customer Related Processes 7.3 Design And Development 7.4 Purchasing 7.5 Production & Service Provision 7.6 Control of Monitoring & Meas. Devices 8.1 General 8.2 Monitoring & Measurement 8.3 Control of Non Conforming Product 8.4 Analysis of Data 8.5 Improvement

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O Introduction 0.2 Process Approach (see Process Model in Section 3)

– This standard promotes a process approach for development, implementation, and improving system effectiveness, as well as enhancing customer satisfaction by meeting customer requirements – Requires an organization to Determine and manage numerous linked activities. An activity or set of activities using resources and managed to enable transformation of input into outputs is considered a process – Identification and interactions of these processes as a system is considered the ‘process approach’ as it provides linkage between the individual processes and the overall system and their combination – Emphasizes the importance of – a) Understanding and meeting of the requirements b) The need to consider processes in terms of added value c) Obtaining results of process performance and effectiveness d) Continual improvement of processes based on objective measurement The model of a process-based QMS is shown in Figure 1, section 3 illustrates process linkages presented in clauses 4 to 8.

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O Introduction 0.3 Relationship with ISO 9004

– ISO 9001 and ISO 9004 have been developed as a ‘consistent pair’ designed to complement one another, but can be used independently; different scopes, but similar structure – ISO 9001 specifies requirements to use for internal applications by organizations, for certification or for contractual purposes, focusing on QMS effectiveness in meeting customer requirements – ISO 9004 provides guidance on a wider range of objectives of a QMS than ISO 9001, particularly for continual improvement of the organizations overall performance and efficiency as well as effectiveness. It is designed to help an organization to move beyond the requirements of ISO 9001 in pursuit of continual improvement of performance, but is not for certification or contractual purposes.

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1 Scope 1.2 Application

– All requirements of ISO 9001 are considered generic and are intended to be applicable to all organization, regardless of type, size and product – Any requirements that cannot be applied due to the nature of an organization and its product can be considered for exclusion – Any exclusions made cannot be considered as conforming to the standard unless they are limited to clause 7 where they do not affect the ability or responsibility of the organization to provide product that meets customer and applicable regulatory requirements

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2 Normative Reference

Reference standard ISO 9000: 2005 Quality Management Systems- Fundamentals and vocabulary.

2008 version is not available.

ISO 9004: 2005 (2008 is not available)

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3 Terms & Definitions

 Terms and definitions are to be reviewed  The terms to describe the supply chain: 2000 Standard: SUPPLIER ORGANIZATION CUSTOMER (Interested Parties) 1994 Standard: SUBCONTRACTOR SUPPLIER CUSTOMER Wherever the term “product” occurs, it can also mean “service”.

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ISO 9001:2008

The changes to the standard are in blue lettering.

Some word changes and notes added, no new requirements have been added.

The changes are meant to help clarify the ISO requirements.

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4 Quality Management System 4.1 General Requirements

Organization establishes, documents, implements, maintains, and continually improves QMS – The organization shall; a) b) c) determine the processes needed and their application throughout the organization Determine the sequence and interaction of processes d) criteria and methods to ensure effective operation and control Ensure resource and information availability to support the operation and monitoring of processes e) f) Monitor, measure where applicable and analyze processes Implement actions to obtain planned results and continual improvement

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4.1 4 Quality Management System General Requirements (continued)

– Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system NOTE 1: Processes needed for the QMS referred to in this slide should include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

NOTE 2: An outsourced process is a process that the organization needs for the quality management system and which the organization chooses to have performed by an external party.

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4 Quality Management System

 4.1 Continued: NOTE 3: Ensuring control over outsourced processes does not absolve the organization from its 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 organizations 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 7.4

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Explanation of 4.1

 Leading and operating an organization requires its successful management in a systematic and visible manner; resulting from the implementation and maintenance of a QMS that has been designed to continually improve its performance.  Organizations need to become customer-oriented by defining its systems and processes and clearly communicating for effective understanding, management and improvement.  Performance is based on measures and data developed for the effective and efficient operation and control of processes  Examples of activities to create a customer-oriented process: – Defining and promoting processes for organizational performance toward continual improvement – – Acquiring and using process data regularly Using self assessments and management review to evaluate

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4 Quality Management System 4.2 Documentation Requirements 4.2.1 General

– QMS documentation shall include; a) b) c) Quality Policy and Quality Objectives Quality Manual Procedures and records required by ISO 9001: 2000 d) Documents and records shall be determined organization to ensure effective planning, operation and control of its processes by the – Extent of QMS dependent on size of organization, type of activities, complexity and interaction of the processes and the competence of personnel NOTE 1: “Documented Procedure” means that the procedure is established, documented, implemented & maintained. A single document may address the requirements of one or more procedures.

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4 Quality Management System

4.1 Note 1 continued; A requirement for a documented procedure may be covered by more then one document.

NOTE 2: The extent of the QMS documentation can differ from one organization to another due to: a.) the size of the organization and type of activities b.) the complexity of the processes and their interface c.) the competence of personnel NOTE 3: The documentation can be in any form or type of media

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4 Quality Management System 4.2.2 Quality Manual

– The Quality Manual shall be established and maintained, including; • The scope of QMS, with details of and justifications for any exclusions – Permissible exclusions may be required where certain functions are absent e.g. Design & Development, Servicing, Customer Property, etc.

• • This is excluded only from Element 7 : Product Realization.

The documented procedures or reference to them A description of the interaction between the processes of QMS

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4 Quality Management System 4.2.3 Control of Documents

– Documents required by the QMS shall be controlled. Records shall be controlled per the requirements given in 4.2.4. – Documented procedures shall be established to define the controls needed for the: a) Approval for adequacy prior to issue, b) c) Review, update and re-approve documents, To ensure changes and the current revisions status of documents are identified, d) e) f) Ensure relevant versions of applicable documents are available at points of use, Documents remain legible and readily identifiable Ensure that documents of external origin of the QMS determined by the organization to be necessary for the planning and operation are identified and their distribution controlled.

g) Prevent unintended use of obsolete documents & apply suitable identification to them if they are retained for any purpose

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4 Quality Management System 4.2.4 Control of Records

Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the QMS shall be controlled Records shall remain legible, readily identifiable, and retrievable Records shall be established to define the controls needed for the: • Identification, • Storage, • Protection, • Retrieval, • Retention Time, and • Disposition of Records Documented procedure is required

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5 Management Responsibility 5.1 Management Commitment

Top Management shall provide evidence of its commitment to the development and implementation of the QMS and continually improving its effectiveness by; a) Communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) c) Establishing the Quality Policy, Ensuring quality objectives are established, d) e) Conducting Management Reviews, and Ensuring the availability of resources

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Explanation of 5.1

Management should consider:

– Establishing vision, mission, policies, and strategy consistent with the organization’s purpose – Leading by example to develop trust – Communicating direction, objectives and values to all – Participating in improvement projects and programs – Obtaining feedback from all stakeholders – Identify processes that provide added value and the support processes that influence the effectiveness and efficiency of the realization processes – Create an environment to build involvement and development of people – Provide the structure and resources to support the goals and plans – Determine the measures for performance to gage success

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5 MANAGEMENT RESPONSIBILITY

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5.2 Customer Focus

– Top management shall ensure customer needs and expectations are determined and met with the aim of enhancing customer satisfaction

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Explanation of 5.2

        Determine the interested parties • • Customers, end users People within the organization • • • Owners, bankers, investors, public sector/community, unions Suppliers, partners Society affected by the organization or its products Understand the needs and expectations of the customer (internal and external) Translate needs into requirements Identify and assess competition and market opportunities Identify resources and develop programs to maintain them Determine the potential benefits of supplier partnerships Consider relationships with suppliers Understand and apply statutory and regulatory requirements

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5 Management Responsibility 5.3 Quality Policy

– Top management shall ensure that the Quality Policy: a) b) c) d) e) Is appropriate to the purpose of the organization, Includes commitment to comply with requirements and continually improve the effectiveness of the QMS, Provides a framework for establishing and reviewing quality objectives, Is communicated and understood within the organization, and Is reviewed for continuing suitability.

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5 Management Responsibility 5.4 Planning 5.4.1 Quality Objectives

– Top management shall ensure that quality objectives, including those needed to meet requirements for product (see 7.1a) are established at relevant functions and levels within the organization. These quality objectives shall be measurable and consistent with the Quality Policy.

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5 Management Responsibility 5.4.2 Quality Management System Planning

– Top Management shall ensure that a. the planning for the QMS is carried out to meet the requirement given in 4.1 as well as quality objectives, and b. Integrity of system is maintained when changes are planned and implemented to the QMS

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5 Management Responsibility 5.5 Responsibility, Authority and Communication 5.5.1 Responsibility and Authority

– Top management shall ensure that the responsibilities and authorities are defined and communicated within the organization.

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5 Management Responsibility 5.5.2

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Management Representative

Top management appoints a member of the organizations management who shall have responsibility & authority that includes: a) Ensuring processes for QMS are established, implemented and maintained, b) Reporting to top management on performance on QMS and any need for improvement, and c) Ensuring the promotion of awareness of customer requirements throughout the organization Note: The responsibility of the management representative can include liaison with external parties on matters relating to the QMS

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5 Management Responsibility 5.5.3

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Internal Communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS.

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Explanation of 5.5.3

   Define and communicate the responsibility and authority for maintaining the system Appoint Management Representative and provide appropriate authority Define and implement the process to communicate the policies, requirements, objectives, and accomplishments – Meetings, recognition programs, postings, surveys, etc.

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5 Management Responsibility 5.6 Management Review

5.6.1 General

– Top management shall review the organization’s QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness – Management Review shall include assessing opportunities for improvement and the need for changes to the QMS, including the Quality Policy and Quality Objectives.

– Records from Management Reviews shall be maintained (see 4.2.4).

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5 Management Responsibility 5.6.2

Review Input

– Includes a. audit results, b. customer feedback, c. process performance, product conformity, d. status of preventive and corrective actions, e. follow-up actions from previous reviews; f.

changes that could affect the QMS; g. improvement recommendations

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5 Management Responsibility 5.6.3

Review Output

– The output from the Management Review shall include any decisions and actions related to: a) Improvement of the effectiveness of the QMS and its processes, b) Improvement of product related to customer requirements, and c) Resource needs.

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Explanation of 5.6

    Management Review should be developed as a tool to go beyond the requirements and provide a constant opportunity to make the system more efficient and effective A platform to exchange input, ideas, discuss and evaluate the system and the business in an open format Frequency is determined by the needs of the organization Use the output from Reviews as a springboard toward improvement

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6 Resource Management 6.1 Provision of Resources

– The organization shall determine and provide the resources needed to: a) implement, maintain and continually improve the effectiveness of the quality management system b) To enhance customer satisfaction by meeting customer requirements

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Explanation of 6.1 Provision of Resources

  Identify resources and make available to process performers – People – Infrastructure – Work environment – Information – Suppliers – Partners – Natural resources – Financial Consider what is needed to improve the organization

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6 Resource Management 6.2 Human Resources 6.2.1 General

Personnel performing work affecting conformity to product requirements shall be competent on the basis of appropriate education, training, skills and experience.

NOTE; conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS.

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6 Resource Management 6.2.2 Competence,

Training & Awareness

– The organization shall: a) determine the necessary competence for personnel performing work affecting product quality, b) where applicable provide training or take other actions to achieve the necessary competence c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) maintain appropriate records of education, training, skills and experience (see 4.2.4)

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6 Resource Management 6.3 Infrastructure

– The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable; a. Buildings, workspace and associated utilities b. Process equipment (both hardware and software), and c. Support services (such as transport and communication or information systems )

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6 Resource Management 6.4 Work Environment

– Determine and manage the work environment needed to achieve conformity to product requirements NOTE: the term work environment relates to those conditions under which work is performed including physical, environment and other factors (such as noise, temperature, humidity, lighting or weather)

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Explanation of 6.4

Ensure environment has a positive influence on the people:         Open doors, creative thinking, positive attitude Safety rules and guidance Ergonomics Workplace location Social interaction Facility Utilities Physical environment

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7 Product Realization 7.1 Planning of Product Realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the QMS (see 4.1) -- In planning product realization, the organization shall determine the following, as appropriate: a) b) c) d) Quality objectives and requirements for the product; The need to establish processes and resources specific to the product; documents and to provide Required verification, validation, monitoring, criteria for product acceptance; measurements, inspection, and test activities specific to the product and the Records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4)

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7 Product Realization 7.1 Planning of Product Realization

--The output of this planning shall be in a form suitable for the organization’s method of operations.

NOTE 1: A document specifying the processes of the QMS (including product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as the quality plan.

NOTE 2: The organization may also apply the requirements given in 7.3 to the development of product realization processes.

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Explanation of 7.1

      Driven by the need for continual improvement Define the outputs of core processes as well as the necessary inputs and activities required for efficient and effective achievement Define the interrelationships of processes Consider verification and validation activities Procedures should document processes necessary to support effective and efficient system operation Process should considered performers for skills, safety, coordination of processes, review of process performance and potential for innovation

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7 Product Realization 7.2 Customer Related Processes 7.2.1 Determination of Requirements Related to the Product

--The organization shall determine a. Requirements specified by customer including delivery and post-delivery activities, b. Requirements not stated by the customer but necessary for the specified or intended use where known and, c. Statutory and regulatory requirements applicable product, and to the d. Any additional requirements considered necessary organization by the NOTE: Post delivery activities include, for example, actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposition.

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7 Product Realization 7.2.2 Review of Requirements Related to the Product

– Organization shall review the requirements related to the product. This review shall be conducted prior to the organization’s commitment to supply a product to the customer (e.g. submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and shall ensure that: a) b) c) Product requirements are defined, Contract or order requirements differing from those previously expressed are resolved, and Organization has the ability to meet the defined requirements Records of the results of the review and actions arising from the review shall be maintained. (4.2.4)

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7 Product Realization

7.2.2 Review of Requirements Related to the Product (cont.)

– Records of the Review and actions arising from the review shall be maintained – Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the organization before acceptance – Where product requirements are changed, the organization shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

NOTE: In some situations, such as internet sales, a formal review is impractical for each order. Instead the review can cover relevant product information such as catalogues or advertising material.

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7 Product Realization

7.2.3 Customer Communication

– Determine and implement effective arrangements for customer communication in relation to: a) b) c) Product information Enquiries, contracts or order handling (including amendments) Customer feedback, including complaints

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Explanation of 7.2

   Define the mutually acceptable processes to communicate efficiently and effectively with all interested parties Implement and maintain processes to ensure the understanding of needs and expectations as well as translating requirements for the organization Understand the impact of the processes before initiating action; assure its mutual acceptability

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7 Product Realization

7.3 Design and Development 7.3.1 Design and Development Planning

-- The organization shall plan and control the design and development of product.

--During the design and development planning, the organization shall determine a) The design and development stages, b) The review, verification and validation that are appropriate to each design and development stage, and c) The responsibilities and authorities for design and development.

--The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

--Planning output shall be updated, as appropriate, as the design and development progresses.

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7 Product Realization

7.3.1 continued: NOTE: Design and development review, verification and validation have distinct purposes. They can be conducted and recorded separately or in any combination, as suitable for the product and the organization.

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7 Product Realization 7.3.2 Design/Development Inputs

– Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include: a) Functional and performance requirements, b) Applicable statutory and regulatory requirements, c) Where applicable, information derived from previous designs, and d) Other requirements essential for design and development.

- The inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.

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7 Product Realization 7.3.3 Design/Development Outputs

– Outputs shall be provided in a form suitable for verification against the design and development input and shall be approved prior to release – Design and Development Outputs shall: a) Meet input requirements for design and development b) Provide appropriate information for production and service provision c) Contain or reference product acceptance criteria d) Specify product characteristics essential to safe and proper use NOTE: Information for production and service provision can include details for the preservation of product.

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7 Product Realization 7.3.4 Design/Development Review

-- At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) to: a) Evaluate the ability of results of design and development to meet requirements, and b) Identify any problems and propose necessary actions -- Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4)

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7 Product Realization 7.3.5 Design/Development Verification

– Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure design and development outputs have satisfied the design and development input requirements – Records of the results of the verification and any necessary actions shall be maintained ( see 4.2.4)

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7 Product Realization 7.3.6 Design/Development Validation

– Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting requirements for the specified application or intended use where known.

– Wherever practicable, validation shall be completed prior to the delivery or implementation of the product.

– Records of the results of validation and any necessary actions shall be maintained (see 4.2.4)

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7 Product Realization 7.3.7 Control of Design/Development Changes

– Design and development changes shall be identified and records maintained – Changes shall be reviewed, verified, validated (as appropriate), and approved before implementation – Review of design and development changes shall include evaluation of the effect of the changes on constituent parts and product already delivered. – Records of the results of the review of changes any necessary actions shall be maintained (see 4.2.4)

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7 Product Realization 7.4 Purchasing 7.4.1 Purchasing Process

– Ensure purchased product conforms to specified requirements — type and extent of control applied shall be dependent on the effect of the purchased product on subsequent product realization or the final product – Suppliers shall be evaluated and selected based on their ability to supply to the organization’s requirements; a) Criteria for selection, evaluation and re-evaluation must be established b) Records of this evaluation shall be maintained (4.2.4)

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7 Product Realization 7.4.2 Purchasing Information

– Information shall describe the product to be purchased including (as appropriate): a) b) c) Approval requirements for product

procedures, processes, equipment Qualification requirements of personnel Quality management system requirements Specified purchase requirements shall be ensured for adequacy prior to communication to supplier

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7 Product Realization 7.4.3 Verification of Purchased Product

– The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

– Where the organization or its customer intends to perform verification at the supplier’s premises, the organization shall state the intended verification arrangements and method of product release in the purchasing information.

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7 Product Realization 7.5 Production and Service Provision 7.5.1 Control of Production and Service Provision

– Provisions for production and service shall be carried out under controlled conditions including: a) Availability of information describing product characteristics b) Availability of work instructions as necessary c) Use of suitable equipment d) Availability and use of monitoring and measuring equipment e) Implementation of monitoring and measurement f) Implementation of product release, delivery, and post delivery activities

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7 Product Realization 7.5.2 Validation of Processes for Production and Service Provision

– Any processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement delivered and as a consequence the desired results deficiencies become apparent only after product is in use or the service has been – Demonstrate that the processes have the ability to achieve – Establish arrangements for these processes including: a) Defined criteria for review and approval of processes b) Equipment approval and personnel qualification c) Use of specific methods and procedures d) Record requirement (4.2.4) e) Revalidation

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7 Product Realization 7.5.3 Identification and Traceability

– Where appropriate, the organization shall identify product by suitable means throughout product realization – The organization shall identify product status with respect to monitoring and measuring requirements – Where traceability is a requirement, the organization shall control and record unique identification of the product and maintain records (4.2.4) NOTE: In some industry sectors, configuration management is a means by which identification and traceability are maintained.

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7 Product Realization 7.5.4 Customer Property

– Exercise care and identify, verify, protect and safeguard customer property for use or incorporation into product while under control of organization – Damaged, lost or unsuitable for use. The organization shall report to the customer and records of occurrence are maintained (4.2.4) Note: Customer property can include intellectual property. And personal data

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7 Product Realization 7.5.5 Preservation of Product

– The organization shall preserve the product during internal processing and delivery to the intended destination in order to maintain conformity to requirements. As applicable , preservation shall include identification, handling, storage and protection. Preservation shall also apply to the constituent parts of a product.

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Explanation of 7.5

Go beyond realization to achieve both compliance to requirements and provide benefit to interested parties by: – Training employees – Communicating and recording information – Reducing waste – Developing suppliers – Improving infrastructure and environment – Monitor processes and prevent problems

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7 Product Realization 7.6 Control of Monitoring and Measuring Equipment

– The organization shall determine the monitoring and measurement to be taken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirements (see 7.2.1).

– The organization shall establish processes to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements.

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7 Product Realization 7.6 Control of Monitoring and Measuring Devices

– Where necessary to ensure valid results, measuring equipment shall: a) b) c) d) e) Be calibrated or verified or both at specified intervals, or prior to use, against measurement standards traceable to international or national measurement standards; where no such standards exist, the basis used for calibration or verification shall be recorded; (4.2.4) Be adjusted or re-adjusted as necessary; Have identification in order to determine its calibration status ; Be safeguarded from adjustments that would invalidate the measurement result; Be protected from damage and deterioration during handling, maintenance and storage.

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7 Product Realization 7.6 Control of Monitoring and Measuring Devices (cont.)

– The organization shall assess and record the validity of previous measuring results when the equipment is found not to conform to requirements. The organization shall take appropriate action on the equipment and any product affected. Records of the results of the calibration and verification shall be maintained (see 4.2.4).

– When used in the monitoring and measuring of specified requirements, the ability of computer software to satisfy the intended application shall be confirmed. This shall be undertaken prior to initial use and reconfirmed as necessary. (see ISO 10012-1 and ISO 10012-2 for guidance) Note: Conformation of the ability of computer software to satisfy the intended application would typically include the verification and configuration management to maintain its suitability for use.

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8 Measurement, Analysis & Improvement 8.1 General

– Processes for monitoring, measurement, analysis and improvement shall be planned and implemented to: – a) b) Demonstrate conformity to product requirements Ensure conformity of QMS c) Continually improve QMS effectiveness Includes determining applicable methods (including statistical techniques) and the extent of their use

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8 Measurement, Analysis & Improvement 8.2 Monitoring and Measurement 8.2.1 Customer Satisfaction

– As one of the measurements of the performance of the QMS, the organization shall monitor information relating to customer perception as to whether the organization has met customer requirements. The methods for obtaining and using this information shall be determined.

Note: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims and dealer reports.

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8 Measurement, Analysis & Improvement 8.2.2 Internal Audit

– The organization shall conduct internal audits at planned intervals to determine whether the QMS – – – a) Conforms to the planned arrangements (see 7.1), to the requirements of ISO9001 and to the QMS requirements of the organization, and Is effectively implemented and maintained b) Audit programs shall be planned, taking into consideration the status and importance of the processes and the areas to be audited as well as previous audit results Audit criteria, scope, frequency and methods shall be defined.

The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work.

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8 Measurement, Analysis & Improvement 8.2.2 Internal Audit (cont.)

– Responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records (see 4.2.4) shall be defined in documented procedure – Management responsible for the area being audited shall ensure that actions are taken without undue delay to eliminate detected nonconformities and their causes. Follow-up activities shall include the verification of actions taken and reporting of verification results – NOTE: See ISO 19011 for guidance

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8 Measurement, Analysis & Improvement 8.2.3 Monitoring and Measurement of Processes

– The organization shall apply suitable methods for monitoring and, where applicable, measurement of the QMS processes. These methods shall demonstrate the ability of the processes to achieve planned results.

– When planned results are not achieved, correction and corrective actions shall be taken, as appropriate, to ensure conformity of the product Note: When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring and measurement appropriate to each of its processes. In relation to their impact on the conformity to the product requirements and on the effectiveness of the quality management system.

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8 Measurement, Analysis & Improvement 8.2.4 Monitoring and Measurement of Product

The organization shall monitor and measure characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with planned arrangements. (see 7.1) Evidence of conformity with acceptance criteria shall be maintained.

Records shall indicate the person (s) authorizing release of the product for delivery to the customer . (see 4.2.4) The release of the product and delivery of the service to the customer shall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed, unless otherwise approved by a relevant authority and where applicable, by the customer.

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement 8.3 Control of Nonconforming Product

– The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery – Controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure – Where applicable the organization shall deal with Nonconforming by one or more of the following ways: a) b) c) d) Taking action to eliminate the detected nonconformity; Authorizing use, release or acceptance under concession by a relevant authority and, where applicable, by the customer; Taking action to preclude its original intended use or application By taking action appropriate to the effects, or potential effects, of the nonconformity when nonconforming product is detected after delivery or use has started.

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement 8.3 Control of Nonconforming Product

– Records of the nature of nonconformity and any subsequent actions taken shall be maintained (4.2.4) – Nonconforming product corrections shall be subject to re-verification to demonstrate conformity to requirements

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement 8.4 Analysis of Data

– Determine, collect and analyze appropriate data to demonstrate suitability and effectiveness of QMS and the opportunities to improve it – Includes data generated as result of monitoring and measurement and from other relevant sources – Analysis shall provide information relating to: a) Customer satisfaction b) c) d) Conformity to product requirements ( see 8.2.4) Product and process characteristics and trends including opportunities for preventive action. ( see 8.2.3 & 8.2.4) Suppliers (see 7.4)

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement 8.5 Improvement 8.5.1 Continual Improvement

– Effectiveness of QMS shall be continually improved through use of the Quality Policy, quality objectives, audit results, data analysis, corrective and preventive actions, and management review.

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement 8.5.2 Corrective Action

– Action shall be taken to eliminate the causes of nonconformities in order to prevent recurrence and shall be appropriate to the effects of the nonconformities encountered – Procedure shall be documented to define requirements for: a) b) c) d) e) f) Reviewing nonconformities (including customer complaints) Determining causes of nonconformities Evaluating a need for action to avoid recurrence Determining and implementing action needed Recording results of actions taken (4.2.4) Reviewing the effectiveness of corrective actions taken

ISO 9001-2000 Review Module 2

8 Measurement, Analysis & Improvement

8.5.3 Preventive Action

– Action shall be determined to eliminate the causes of potential nonconformities in order to prevent occurrence. Preventive actions shall be appropriate to the effects of the potential problems – Procedure shall be established to define requirements for: a) b) c) d) e) Determining potential nonconformities and their causes Evaluating need for action to prevent occurrence of nonconformities Determining and implementing action needed Records of results for actions taken (see 4.2.4) Reviewing the effectiveness of preventive action taken

ISO 9001-2000 Review Module 2

Quiz

1. The difference between Corrective actions and Preventive actions is : a. Corrective actions are short term and Preventive actions are long term b. Corrective actions are for correction of the problem and preventive actions are to prevent the reoccurrence c. Corrective actions are for problems occurred and preventive actions for potential problem solving. d. None of the above

ISO 9001-2000 Review Module 2

Quiz

2. The Continual Improvement process should consider : a. Quality Objectives b. Corrective and preventive actions c. Management Review d. All of the above

ISO 9001-2000 Review Module 2

Quiz

3. Which one of the following clauses addresses product inspection on the production floor? a. 7.5.1

b. 7.5.3

c. 7.5.4

d. 8.2.4

ISO 9001-2000 Review Module 2

Quiz

4. Which clause addresses Customer satisfaction? a. 8.2.1

b. 7.5.4

c. 7.5.1

d. 7.2.2

ISO 9001-2000 Review Module 2

Quiz

5. Which clause addresses Human resources? a. 6.2

b. 5.1

c. 6.3

d. 8.5

ISO 9001-2000 Review Module 2

Quiz

6. Which of the following is a requirement of ISO 9001:2000?

a. Business Plan communication b. Management Meetings for quality objectives c. Employee meetings d. Communications methods

ISO 9001-2000 Review Module 2

Quiz

6. Which of the following is required to identify the competency of employees? a. Education and Training b. Skills needed for the job c. Experience against the requirement d. All of the above

ISO 9001-2000 Review Module 2

Quiz

7. Which one of the following is not a requirement to review in Management review meetings? a. Preventive actions b. Changes in Quality objectives c. Employee performance reviews d. Continual improvement logs

ISO 9001-2000 Review Module 2

Quiz

8. The Contract review process must address all of the following requirements except: a. Regulatory requirements b. Customer specific requirements c. Future years contracts d. None of the above

ISO 9001-2000 Review Module 2

Quiz

9. What does it mean when you see (4,2,4)?

The document is controlled b.

The form must be completed A record is required d.

All the above

ISO 9001-2000 Review Module 2

Quiz

10. Which of the following does not require a Record?

a. Maintenance breakdown time b. Inspection results c. Management review minutes d. Design review minutes

ISO 9001-2000 Review Module 2