ISO9004英文标准第二部分
6.1 General guidance
6.1.1 Introduction
Top management should ensure that the resources essential to the implementation of strategy and the achievement of the organization’s objectives are identified and made available. This should include resources for operation and improvement of the quality management system, and the satisfaction of customers and other interested parties. Resources may be people, infrastructure, work environment, information, suppliers and partners, natural resources and financial resources.
6.1.2 Issue to be considered
Consideration should be given to resources to improve the performance of the organization, such as
- effective, efficient and timely provision of resources in relation to opportunities and constraints,
- tangible resources such as improved realization and support facilities,
- intangible resources such as intellectual property,
- resources and mechanisms to encourage innovative continual improvement,
- organization structures, including project and matrix management needs,
- information management and technology,
- enhancement of competence via focused training, education and learning,
- development of leadership skills and profiles for the future managers of the organization,
- use of natural resources and the impact of resources on the environment, and
- planning for future resource needs.
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ISO 9001:2000, Quality management systems – Requirements
6 Resource management
6.1 Provision of resources
The organization shall determine and provide the resources needed
a) to implement and maintain the quality management system and continually improve its effectiveness, and
b) to enhance customer satisfaction by meeting customer requirements.
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6.2 People
6.2.1 Involvement of people
Management should improve both the effectiveness and efficiency of the organization, including the quality management system, through the involvement and support of people. As an aid to achieving its performance improvement objectives, the organization should encourage the involvement and development of its people
- by providing ongoing training and career planning,
- by defining their responsibilities and authorities,
- by establishing individual and team objectives, managing process performance and evaluating results,
- by facilitating involvement in objective setting and decision making,
- by recognizing and rewarding,
- by facilitating the open, two-way communication of information,
- by continually reviewing the needs of its people,
- by creating conditions to encourage innovation,
- by ensuring effective teamwork,
- by communicating suggestions and opinions,
- by using measurements of its people’s satisfaction, and
- by investigating the reasons why people join and leave the organization.
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ISO 9001:2000, Quality management systems – Requirements
6.2 Human resources
6.2.1 General
Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience.
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6.2.2 Competence, awareness and training
6.2.2.1 Competence
Management should ensure that the necessary competence is available for the effective and efficient operation of the organization. Management should consider analysis of both the present and expected competence needs as compared to the competence already existing in the organization.
Consideration of the need for competence includes sources such as
-future demands related to strategic and operational plans and objectives,
-anticipated management and workforce succession needs,
-changes to the organization’s processes, tools and equipment,
-evaluation of the competence of individual people to perform defined activities, and
-statutory and regulatory requirements, and standards, affecting the organization and its interested parties.
6.2.2.2 Awareness and training
Planning for education and training needs should take account of change caused by the nature of the organization’s processes, the stages of development of people and the culture of the organization.
The objective is to provide people with knowledge and skills which, together with experience, improve their competence.
Education and training should emphasize the importance of meeting requirements and the needs and expectations of the customer and other interested parties. It should also include awareness of the consequences to the competence.
To support the achievement of the organization’s objectives and the development of its people, planning for education and training should consider
- experience of people,
- tacit and explicit knowledge,
- leadership and management skills,
- planning and improvement tools,
- teambuilding,
- problem solving,
- communication skills,
- culture and social behaviour,
- knowledge of markets and the needs and expectations of customers and other interested parties, and
- creativity and innovation.
To facilitate the involvement of people, education and training also include
- the vision for the future of the organization,
- the organization’s policies and objectives,
- organizational change and development,
- the initiation ad implementation of improvement processes,
- benefits from creativity and innovation,
- the organization’s impact on society,
- introductory programmes for new people, and
- periodic refresher programmes for people already trained.
Training plans should include
- objectives,
- programmes and methods,
- resources needed,
- identification of necessary internal support,
- evaluation in terms of enhanced competence of people, and
- measurement of the effectiveness and the impact on the organization.
The education and training provided should be evaluated in terms of expectations and impact on the effectiveness and efficiency of the organization as a means of improving future training plans.
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ISO 9001:2000, Quality management systems – Requirements
6.2.2 Competence, awareness and training
The organization shall
a) determine the necessary competence for personnel performing work affecting product quality,
b) provide training or take other actions to satisfy these needs,
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.
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6.3 Infrastructure
Management should define the infrastructure necessary for the realization of products while considering the needs and expectations of interested parties. The infrastructure includes resources such as plant, workspace, tools and equipment, support services, information and communication technology, and transport facilities.
The process to define the infrastructure necessary for achieving effective and efficient product realization should include the following:
a) provision of an infrastructure, defined in terms such as objectives, function, performance, availability, cost, safety, s3ecurity and renewal;
b) development and implementation of maintenance methods to ensure that the infrastructure continues to meet the organization’s needs; these methods should consider the type and frequency of maintenance and verification of operation of each infrastructure element, based on its criticality and usage;
c) evaluation of the infrastructure against the needs and expectations of interested parties;
d) consideration of environmental issues associated with infrastructure, such as conservation, pollution, waste and recycling.
Natural phenomena that cannot be controlled can impact the infrastructure. The plan for the infrastructure should consider the identification and mitigation of associated risks and should include strategies to protect the interests of interested parties.
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ISO 9001:2000, Quality management systems – Requirements
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) supporting services (such as transport or communication).
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6.4 Work environment
Management should ensure that the work environment has a positive influence on motivation, satisfaction and performance of people in order to enhance the performance of the organization. Creation of a suitable work environment, as a combination of human and physical factors, should include consideration of
- creative work methods and opportunities for greater involvement to realize the potential of people in the organization,
- safety rules and guidance, including the use of protective equipment,
- ergonomics,
- workplace location,
- social interaction,
- facilities for people in the organization,
- heat, humidity, light, airflow, and
- hygiene, cleanliness, noise, vibration and pollution.
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ISO 9001:2000, Quality management systems – Requirements
6.4 Work environment
The organization shall determine and manage the work environment needed to achieve conformity to product requirements.
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6.5 Information
Management should treat data as a fundamental resource for conversion to information and the continual development of an organization’s knowledge, which is essential for making factual decisions and can stimulate innovation. In order to manage information, the organization should
- identify its information needs,
- identify and access internal and external sources of information,
- convert information to knowledge of use to the organization,
- use the data, information and knowledge to set and meet its strategies and objectives,
- ensure appropriate security and confidentiality, and
- evaluate the benefits derived from use to the information in order to improve managing information and knowledge.
6.6 Suppliers and partnerships
Management should establish relationships with suppliers and partners to promote and facilitate communication with the aim of mutually improving the effectiveness and efficiency of processes that create value. There are various opportunities for organizations to increase value through working with their suppliers and partners, such as
- optimizing the number of suppliers and partners,
- establishing two-way communication at appropriate levels in both organizations to facilitate the rapid solution of problems, and to avoid costly delays or disputes,
- cooperating with suppliers in validation of the capability of their processes,
- monitoring the ability of suppliers to deliver conforming products with the aim of eliminating redundant verifications,
- encouraging suppliers to implement programmes for continual improvement of performance and to participate in other joint improvement initiatives,
- involving suppliers in the organization’s design and development activities to share knowledge and effectively and efficiently improve the realization and delivery processes for conforming products,
- involving partners in identification of purchasing needs and joint strategy development, and
- evaluating, recognizing and rewarding efforts and achievements by suppliers and partners.
6.7 Natural resources
Consideration should be given to the availability of natural resources that can influence the performance of the organization. While such resources are often out of the direct control of the organization, they can have significant positive or negative effects on its results, The organization should have plans, or contingency plans, to ensure the availability or replacement of these resources in order to prevent or minimize negative effects on the performance of the organization.
6.8 Financial resources
Resource management should include activities for determining the needs for, and sources of, financial resources. The control of financial resources should include activities for comparing actual usage against plans, and taking necessary action.
Management should plan, make available and control the financial resources necessary to implement and maintain an effective and efficient quality management system and to achieve the organization’s objectives. Management should also consider the development of innovative financial methods to support and encourage improvement of the organization’s performance.
Improving the effectiveness and efficiency of the quality management system can influence positively the financial results of the organization, for example
a) internally, by reducing process and product failures, or waste in material and time, or
b) externally, by reducing product failures, costs of compensation under guarantees and warrantie4s, and costs of lost customers and markets.
Reporting of such matters an also provide a means of determining ineffective or inefficient activities, and initiating suitable improvement actions.
The financial reporting of activities related to the performance of the quality management system and product conformity should be used in management reviews.
7 Product realization
7.1 General guidance
7.1.1 Introduction
Top management should ensure the effective and efficient operation of realization and support processes and the associated process network so that the organization has the capability of satisfying its interested parties. While realization processes result in products that add value to the organization, support processes are also necessary to the organization and add value indirectly.
Any process is a sequence of related activities or an activity that has both input and output. Management should define the required outputs of processes, and should identify the necessary inputs and activities required for their effective and efficient achievement.
The interrelation of processes can be complex, resulting in process networks. To ensure the effective and efficient operation of the organization, management should recognize that the output of one process may become the input to one or more other processes.
7.1.2 Issues to be considered
Understanding that a process can be represented as sequence of activities aids management in defining the process inputs. Once the inputs have been defined, the necessary activities, actions and resources required for the process can be determined, in order to achieve the desired outputs.
Results from verification and validation of processes and outputs should also be considered as inputs to a process, to achieve continual improvement of performance and the promotion of excellence throughout the organization. Continual improvement of the organization’s processes will improve the effectiveness and efficiency of the quality management system and the organization’s performance. Annex B describes a “Process for continual improvement” that can be used to assist in the identification of actions needed for continual improvement of the effectiveness and efficiency of processes.
Processes should be documented to the extent necessary to support effective and efficient operation. Documentation related to processes should support
- identifying and communicating the significant features of the processes,
- training in the operation of processes,
- sharing knowledge and experience in teams and work groups,
- measurement and audit of processes, and
- analysis, review and improvement of processes.
The role of people within the processes should be evaluated in order
- to ensure the health and safety of people,
- to ensure that the necessary skills exist,
- to support coordination of processes,
- to provide for input from people in process analysis, and
- to promote innovation from people.
The drive for continual improvement of the organization’s performance should focus on the improvement of the effectiveness and efficiency of processes as the means by which beneficial results are achieved. Increased benefits, improved customer satisfaction, improved use of resources and reduction of waste are examples of measurable results achieved by greater effectiveness and efficiency of processes.
7.1.3 Managing processes
7.1.3.1 General
Management should identify processes needed to realize products to satisfy the requirements of customers and other interested parties. To ensure product realization, consideration should be given to associated support processes as well as desired outputs, process steps, activities, flows, control measures, training needs, equipment, methods, information, materials and other resources.
An operating plan should be defined to manage the processes, including
- input and output requirements (for example specifications and resources),
- activities within the processes,
- verification and validation of processes and products,
- analysis of the process including dependability,
- identification, assessment and mitigation of risk,
- corrective and preventive actions,
- opportunities and actions for process improvement, and
- control of changes to processes and products.
Examples of support processes include
- managing information,
- training of people,
- finance- related activities,
- infrastructure and service maintenance,
- application of industrial safety/protective equipment, and
- marketing.
7.1.3.2 Process inputs, outputs and review
The process approach ensures that process inputs are defined and recorded in order to provide a basis for formulation of requirements to be used for verification and validation of outputs. Inputs can be internal or external to the organization.
Resolution of ambiguous or conflicting input requirements can involve consultation with the affected internal and external parties. Input derived from activities not yet fully evaluated should be subject to evaluation through subsequent review, verification and validation. The organization should identify significant or critical features of products and processes in order to develop an effective and efficient plan for controlling and monitoring the activities within in its processes.
Examples of input issues to consider include
- competence of people,
- documentation,
- equipment capability and monitoring, and
- health, safety and work environment.
Process outputs that have been verified against process input requirements, including acceptance criteria, should consider the needs and expectations of customers and other interested parties. For verification purposes, the outputs should be r3ecorded and evaluated against input requirements and acceptance criteria. This evaluation
should identify necessary corrective actions, preventive actions or potential improvements in the effectiveness and efficiency of the process. Verification of the product can be carried out in the process in order to identify variation.
The management of the organization should undertake periodic review of process performance to ensure the process is consistent with the operating plan. Examples of topics for this review include
- reliability and repeatability of the process,
- identification and prevention of potential nonconformities,
- adequacy of design and development inputs and outputs,
- consistency of inputs and outputs with planned objectives,
- potential for improvements, and
- unresolved issues.
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ISO 9001:2000, Quality management systems – Requirements
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 quality management system.
In planning product realization, the organization shall determine the following, as appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes, documents, and provide resources specific to the product;
c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;
d) records needed to provide evidence that the realization processes and resulting product meet requirements.
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 quality management system (including the product realization processes and the resources to be applied to a specific product, project or contract, can be referred to as a 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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7.1.3.3 product and process validation and changes
Management should ensure that the validation of products demonstrates that they meet the needs and expectations of customers and other interested parties. Validation activities include modeling, simulation and trials, as well as reviews involving customers or other interested parties.
Issues to consider should include
- quality policy and objectives,
- capability or qualification of equipment,
- operating conditions for the product,
- use or application of the product,
- disposal of the product,
- product life cycle,
- environmental impact of the product, and
- impact of the use of natural resources including materials and energy.
Process validation should be carried out at appropriate intervals to ensure timely reaction to changes impacting the process. Particular attention should be given to validation of processes
- for high value and safety critical products,
- where deficiency in product will only be apparent in use,
- which cannot be repeated, and
- where verification of product is not possible.
The organization should implement a process for effective and efficient control of changes to ensure that product or process changes benefit the organization and satisfy the needs and expectations of interested parties. Changes should be identified, recorded, evaluated, reviewed, and controlled in order to understand the effect on other processes and the needs an expectations of customers and other interested parties.
Any changes in the process affecting product characteristics should be recorded and communicated in order to maintain the conformity of the product and provide information for corrective action or performance improvement of the organization. Authority for initiating change should be defined in order to maintain control.
Outputs in the form of products should be validated after any related change, to ensure that the change has had the desired effect.
Use of simulation techniques can also be considered in order to plan for prevention of failures or faults in processes.
Risk assessment should be undertaken to assess the potential for, and the effect of , possible failures or faults in processes. The results should be used to define and implement preventive actions to mitigate identified risks. Examples of tools for risk assessment include
- fault modes and effects analysis,
- fault tree analysis,
- relationship diagrams,
- simulation techniques, and
- reliability prediction.
7.2 Processes related to interested parties
Management should ensure that the organization has defined mutually acceptable processes for communicating effectively and efficiently with its customers and other interested parties. The organization should implement and maintain such process to ensure adequate understanding of the needs and expectations of its interested parties, and for translation into requirements for the organization. These processes should include identification ad review of relevant information and should actively involve customers and other interested parties. Examples of relevant process information include
- requirements of the customer or other interested parties,
- market research, including sector and end-user data,
- contract requirements,
- competitor analysis,
- benchmarking, and
- processes due to statutory or regulatory requirements.
The organization should have a full understanding of the process requirements of the customer, or other interested party, before initiating its action to comply. This understanding and its impact should be mutually acceptable to the participants.
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ISO9001:2000, Quality management systems – Requirements
7.2 Customer-related processes
7.2.1 Determination of requirements related to the product
The Organization shall determine
a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,
b) requirements not stated by the customer but necessary for specified or intended use, where known,
c) statutory and regulatory requirements related to the product, and
d) any additional requirements determined by the organization.
7.2.2 Review of requirements related to the product
The 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) product requirements are defined,
b) contract or order requirements differing from those previously expressed are resolved, and
c) the organizations has the ability to meet the defined requirements.
Records of the results 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 hanged 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.
7.2.3 Customer communication
The organization shall determine and implement effective arrangements for communicating with customers in relation to
a) product information,
b) enquiries, contracts or order handling, including amendments, and
c) customer feedback, including customer complaints.
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7.3 Design and development
7.3.1 General guidance
Top management should ensure that the organization has defined, implemented and maintained the necessary design and development processes to respond effectively and efficiently to the needs and expectations of its customers and other interested parties.
When designing and developing products or processes, management should ensure that the organization is not only capable of considering their basic performance and function, but all factors that contribute to meeting the product and process performance expected by customers and other interested parties. For example, the organization should consider life cycle, safety and health, testability, usability, usability, user-friendliness, dependability, durability, ergonomics, the environment, product disposal and identified risks.
Management also has the responsibility to ensure that steps are taken to identify and mitigate potential risk to the users of the products and processes of the organization. Risk assessment should be undertaken to assess the potential for, and the effect of, possible failures or faults in products or processes. The results of the assessment should be used to define and implement preventive actions to mitigate the identified risks. Examples of tools for risk assessment of design and development include
- design fault modes and effects analysis,
- fault tree analysis,
- reliability prediction,
- relationship diagrams,
- ranking techniques, and
- simulation techniques.
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ISO 9001:2000, Quality management systems – Requirements
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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7.3.2 Design and development input and output
The organization should identify process inputs that affect the design and development of products and facilitate effective and efficient process performance in order to satisfy the needs and expectations of customers, and those of other interested parties. These external needs and expectations, coupled with those internal to the organization, should be suitable for translation into input requirements for the design and development processes.
Examples are as follows:
a) external inputs such as
- customer or marketplace needs and expectations,
- needs and expectation of other interested parties,
- supplier’s contributions,
- user input to achieve robust design and development,
- changes in relevant statutory and regulatory requirements,
- international or national standards, and
- industry codes of practice;
b) internal inputs such as
- policies and objectives,
- needs and expectations of people in the organization, including those receiving the output of the process,
- technological developments,
- competence requirements for people performing design and development,
- feedback information from past experience,
- records and data on existing processes and products, and
- outputs from other processes;
c) inputs that identify those characteristics of processes or products that are crucial to safe and proper functioning and maintenance, such as
- operation, installation and application,
- storage, handling and delivery,
- physical parameters and the environment, and
- requirements for disposal of the products.
Product-related inputs based on an appreciation of the needs and expectations of end users, as well as those of the direct customer, can be important. Such inputs should be formulated in a way that permits the product to be verified and validated effectively and efficiently.
The output should include information to enable verification and validation to planned requirements. Examples of the output of design and development include
- data demonstrating the comparison of process inputs to process outputs,
- product specifications, including acceptance criteria,
- process specifications,
- material specifications,
- testing specifications,
- training requirements,
- user and consumer information,
- purchase requirements, and
- reports of qualification tests.
Design and development outputs should be reviewed against inputs to provide objective evidence that outputs have effectively and efficiently met the requirements for the process and product.
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ISO 9001:2000, Quality management systems – Requirements
7.3.2 Design and development inputs
Inputs relating to product requirements shall be determined and records maintained. These shall include
a) functional and performance requirements,
b) applicable statutory and regulatory requirements,
c) where applicable, information derived from previous similar designs, and
d) other requirements essential for design and development.
These inputs shall be reviewed for adequacy. Requirements shall be complete, unambiguous and not in conflict with each other.
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7.3.3 Design and development outputs
The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.
Design and development outputs shall
a) meet the input requirements for design and development,
b) provide appropriate information for purchasing, production and for service provision,
c) contain or reference product acceptance criteria, and
d) specify the characteristics of the product that are essential for its safe and proper use.
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7.3.3 Design and development review
Top management should ensure that appropriate people are assigned to manage and conduct systematic reviews to determine that design and development objectives are achieved. These reviews may be conducted at selected points in the design and development process as well as at completion.
Examples of topics for such reviews include
- adequacy of input to perform the design and development tasks,
- progress of the planned design and development process,
- meeting verification and validation goals,
- evaluation of potential hazards or fault modes in product use,
- life-cycle data on performance of the product,
- control of changes and their effect during the design and development process,
- identification and correction of problems,
- opportunities for design and development process improvement, and
- potential impact of the product on the environment.
At suitable stages, the organization should also undertake reviews of design and development outputs, as well as the processes, in order to satisfy the needs and expectations of customers and people within the organization who receive the process output. Consideration should also be given to the needs and expectations of other interested parties.
Examples of verification activities for output of the design and development process include
- comparisons of input requirements with the output of the process,
- comparative methods, such as alternative design and development calculations,
- evaluation against similar products,
- testing, simulations or trials to check compliance with specific input requirements, and
- evaluation against lessons learned from past process experience, such as nonconformities and deficiencies.
Validation of the output of the design and development processes is important for the successful reception and use by customers, suppliers, people in the organization and other interested parties.
Participation by the affected parties permits the actual users to evaluate the output by such means as
- validation of engineering designs prior to construction, installation or application,
- validation of software outputs prior to installation or use, and
- validation of services prior to widespread introduction.
Partial validation of the design and development outputs may be necessary to provide confidence in their future application.
Sufficient data should be generated through verification and validation activities to enable design and development methods and decisions to be reviewed. The review of methods should include
- process and product improvement,
- usability of output,
- adequacy of process and review records,
- failure investigation activities, and
- future design and development process needs.
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ISO 9001:2000, Quality management systems – Requirements
7.3.4 Design and development review
At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements
a) to evaluate the ability of the results of design and development to meet requirements, and
b) to identify any problems and propose necessary actions.
Participants in such reviews shall include representatives of functions concerned with th e design and development stage(s) being reviewed. Records of the results of the reviews and any necessary actions shall be maintained.
7.3.5 Design and development verification
Verification shall be performed in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and any necessary actions shall the maintained.
7.3.6 Design and development validation
Design and development validation shall be performed in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use, when 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.
7.3.7 Control of design and development changes
Design and development changes shall; be identified and records maintained. The changes shall be reviewed, verified and validated, as appropriate, and approved before implementation. The 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 and any necessary actions shall be maintained.
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7.4 Purchasing
7.4.1 Purchasing process
Top management of the organization should ensure that effective and efficient purchasing processes are defined and implemented for the evaluation and control of purchased products, in order that purchased products satisfy the organization’s needs and requirements, as well as those of interested parties.
Use of electronic linkage with suppliers should be considered in order to optimize communication of requirements.
To ensure the effective and efficient performance of the organization, management should ensure that purchasing processes consider the following activities:
- timely, effective and accurate identification of needs and purchased product specifications;
- evaluation of the cost of purchased product, taking account of product performance, price and delivery;
- the organization’s need and criteria for verifying purchased products;
- unique supplier processes;
- consideration of contract administration, for both supplier and partner arrangements;
- warranty replacement for nonconforming purchased products;
- logistic requirements;
- product identification and traceability;
- preservation of product;
- documentation, including records;
- control of purchased product which deviates from requirements;
- access to suppliers’ premises;
- product delivery, installation or application history;
- supplier development;
- identification and mitigation of risks associated with the purchased product.
Requirements for suppliers’ processes and product specifications should be developed with suppliers in order to benefit from available supplier knowledge. The organization could also involve suppliers in the purchasing process in relation to their products in order to improve the effectiveness and efficiency of the organization’s purchasing process. This could also assist the organization in its control and availability of inventory.
The organization should define the needs for records of purchased product verification, communication and response to nonconformities in order to demonstrate its own conformity to specification.
7.4.2 Supplier control process
The organization should establish effective and efficient processes to identify potential sources for purchased materials, to develop existing suppliers or partners, and to evaluate their ability to supply the required products in order to ensure the effectiveness and efficiency of overall purchasing processes.
Examples of inputs to the supplier control process include
-evaluation of relevant experience,
-performance of suppliers against competitors,
-review of purchased product quality, price, delivery performance and response to problems,
-audits of supplier management systems and evaluation of their potential capability to provide the required products effectively and efficiently and within schedule,
- checking supplier references and available data on customer satisfaction,
- financial assessment to assure the viability of the supplier throughout the intended period of supply and cooperation,
- supplier response to inquiries, quotations and tendering,
- supplier service, installation and support capability and history of performance to requirements,
- supplier awareness of and compliance with relevant statutory and regulatory requirements,
- the supplier’s logistic capability including locations and resources, and
- the supplier’s standing and role in the community, as well as perception in society.
Management should consider actions needed to maintain the organization’s performance and to satisfy interested parties in the event of supplier failure.
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ISO 9001:2000, Quality management systems – Requirements
7.4 Purchasing
7.4.1 Purchasing process
The organization shall ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realization or the final product.
The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained.
7.4.2 Purchasing information
Purchasing information shall describe the product to be purchased, including where appropriate
a) requirements for approval of product, procedures, processes and equipment,
b) requirements for qualification of personnel, and
c) quality management system requirements.
The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the suppliers.
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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