INTERNATIONAL ISOSTANDARD 10005 First edition 1995-09-15 Quality management — Guidelines for quality plans Management de la qualité — Lignes directrices pour les plans qualité Reference number ISO 10005:1995(E) ISO 10005:1995(E) Contents Page 1 Scope .............................................................................................. 1 2 Normative reference ....................................................................... 1 3 Definitions ................................................................................. 1 4 Preparation, review, acceptance and revision of the quality plan 2 4.1 Preparation .............................................................................. 2 4.2 Review and acceptance ......................................................... 3 4.3 Revision .................................................................................. 3 5 Contents of the quality plan ...................................................... 3 5.1 Management responsibilities ................................................. 4 5.2 Quality plan and quality system ............................................. 4 5.3 Contract review ...................................................................... 4 5.4 Design control ........................................................................ 4 5.5 Document and data control .................................................... 4 5.6 Purchasing .............................................................................. 4 5.7 Control of customer-supplied product .................................... 4 5.8 Product identification and traceability ..................................... 5 5.9 Process control ....................................................................... 5 5.10 Inspection and testing .......................................................... 5 5.11 Control of inspection, measuring and test equipment ......... 5 5.12 Inspection and test status .................................................... 5 5.13 Control of nonconforming product ....................................... 6 5.14 Corrective and preventive action .......................................... 6 5.15 Handling, storage, packaging, preservation and delivery ..... 6 5.16 Control of quality records ..................................................... 6 5.17 Quality audits ........................................................................ 6 ISO 1995 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from the publisher. International Organization for Standardization Case Postale 56 • CH-1211 Genève 20 • Switzerland Printed in Switzerland ii ................................ 7 Annexes A Simplified examples of formats for the presentation of quality plans ......... ISO ISO 10005:1995(E) 5...........................................18 Training ............................20 Statistical techniques ................................................... 15 iii ........................................................19 Servicing ...... 6 5...................................................................................................... 8 B Bibliography ................................. 6 5............................. International Standard ISO 10005 was prepared by Technical Committee ISO/TC 176. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. International organizations. Subcommittee SC 2. The work of preparing International Standards is normally carried out through ISO technical committees. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. in liaison with ISO. Annexes A and B of this International Standard are for information only. Quality systems. Quality management and quality assurance. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. governmental and non-governmental. iv . also take part in the work.ISO 10005:1995(E) ISO Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). v . A quality plan may be used within an organization to ensure that specific requirements for quality are being appropriately planned and addressed for identified products during production. project or contract. Its provisions should be considered advisory and not requirements. it may be beneficial to obtain customer input to the development of the quality plan. ISO ISO 10005:1995(E) Introduction This International Standard was prepared to address the need for a mechanism to relate generic requirements on quality system elements to the specific requirements of a particular product. In many cases. The quality plan should be compatible with other plans that may be pre- pared. A quality plan may be used to indi- cate the specific application of a quality system to a given development project. A quality plan may also be used by the supplier in a contractual situation to demonstrate to the customer how the specific requirements for quality of a particular contract will be met. whether for a marketable product or for an in-house facility. ISO 10005:1995(E) ISO vi . Mem- national Standard includes features that are covered bers of IEC and ISO maintain registers of currently in the generic requirements of ISO 9001. ance and revision of quality plans. They do not require the development of a comprehensive set of procedures or instructions over and above those al. here for clarity but have been defined in other Inter- project or contract. a quality plan when the supplier does not have through reference in this text. constitute provisions such a quality system. Quality management and quality as- Quality plans provide a mechanism to tie specific re- quirements of the product. 3 Definitions ready existing. the quality plan is supplemental to are subject to revision. project or contract to ex- surance — Vocabulary. A quality plan may also be used where a documented quality system 1. in which case procedures may need to assist suppliers in the preparation. and parties to agreements the supplier's generic quality system documentation based on this International Standard are encouraged and should not duplicate the generic documentation. to be developed to support the quality plan. isting generic quality system procedures. or 2 Normative reference b) as guidance to a supplier organization in preparing The following standard contains provisions which. to investigate the possibility of applying the most re- For convenience in situations of type b). ISO 9002 or ISO 9003 relative to the preparation of a quality plan. processed materials and ser. although some additional documented procedures may be necessary. vices) or industry/economic sectors.1 contract: Agreed requirements between a sup- A quality plan may be used to monitor and assess plier and customer transmitted by any means. Terms which are repeated a quality plan is to be used for a particular product. software. ISO 8402:1994. accept. ISO 9002 valid International Standards.1 This International Standard provides guidelines does not exist. and ISO 9003. adherence to the requirements for quality. A quality plan may be applicable national Standards are identified by the placement of to any product of the generic product categories the number of the standard after the term being de- (hardware. apply. this Inter- cent edition of the standard indicated below. review. of this International Standard. together with the fol- 1. For the purposes of this International Standard. At the time of publi- cation. the definitions given in ISO 8402. All standards In both situations.INTERNATIONAL STANDARD ISO ISO 10005:1995(E) Quality management — Guidelines for quality plans 1 Scope for compliance with requirements. but these guidelines are not intended to be used as a checklist [ISO 9001] 1 .2 This International Standard is applicable where lowing definitions. the edition indicated was valid. a) as guidance to a supplier organization in meeting the requirements of ISO 9001. 3. NOTE 1 Annex B contains a bibliography of International Standards which provide information that may prove helpful It is intended for use in two situations: to those involved in the preparation and review of quality plans. fined. procedures are documented (e.7 quality plan: Document setting out the specific coordinated and controlled activities with start and quality practices. resources and sequence of activities finish dates.g.g. forming to specific requirements. or a combination thereof. or a combination thereof. either directly or by tomers) or unintended (e. processed ity plan shows how the supplier's generic docu- materials. 3. [ISO 8402] ject proceeds.5 procedure: Specified way to perform an activity. and revision of the quality plan 7 A written or documented procedure usually contains the purpose and scope of an activity. The qual- 8 A product may include service. offering to cus. quality quality system elements may be required. 12 Depending on the scope of the plan.4 witness testing: Testing of a product in the 14 The quality system of an organization is designed pri- presence of the customer's representative or a third marily to satisfy the internal managerial needs of the or- party. project or contract. “quality assurance plan”.6 product: Result of activities or processes. software. project or contract in order to attain specified materials) or intangible (e.3 type test: Test or series of tests directed NOTES towards approval of a design conducted to determine that it is capable of meeting the requirements of the 13 The quality system should be as comprehensive as product specification. quality activities appli- how it shall be controlled and recorded. what materials. The quality plan should indicate. adapted and/or supplemented.8 quality system: Organizational structure. the project characteristics defined progressively as the pro. mented procedures are related to and applied to any necessary additional procedures peculiar to the prod- 9 A product can be tangible (e. polluant or unwanted effects). review.g. needed to meet the quality objectives. It is broader than the requirements of a particular customer who evaluates only the relevant part of the quality 3. “quality man- 3 In some types of projects. what shall be done and 4. knowledge or concepts). equipment and documents shall be used. [ISO 8402] 6 When a procedure is to be documented. reference to appropriate documented procedures or other documents. system procedures). ganization. 15 For contractual or mandatory quality assessment pur- NOTES poses. assemblies or processed uct. pro- 4 The outcome of a project may be one or several units of a product. 10 A product can be either intended (e. acceptance quently used. how the required activities are to [ISO 8402] be carried out.g. 3. relevant to a particular product. Much of the generic documentation needed may be 3.ISO 10005:1995(E) ISO 3. where and how it shall be done. cost and resources. and When preparing a quality plan. quality objectives. for example.g.1 Preparation by whom. 2 . including the con- straints of time. undertaken to achieve an objective con. processes and resources needed to imple- ment quality management. cable to the situation should be defined and docu- [ISO 8402] mented. 2 An individual project may form part of a larger project structure.2 project: Unique process consisting of a set of 3. when. contained in the supplier's quality manual and docu- NOTES mented procedures. NOTES NOTES 11 A quality plan usually makes reference to the parts of the quality manual applicable to the specific case. 4 Preparation. cedures. demonstration of the implementation of identified 5 In many cases. This documentation may need to be selected. the objectives are refined and agement plan”. hardware. 3. a qualifier may be used. system. the term “written procedure” or “documented procedure” is fre. where appropriate. such as for de.2 Review and acceptance graphs in this International Standard is only intended to ease use and understanding. The supplier should revise the plan.3 Revision A quality plan may be a stand-alone document when a supplier does not have a documented quality sys. quality plan follow the structure and numbering of any ISO 9000 standards and the alignment of the para- 4. depending on such things as customer re. which the product is produced or the service is pro- quirements or the business practices of a specific vided. (Simplified available to the customer. project and or contract quality When a quality plan is required by a contract. The plan should be as brief as possible. supplier. expressed in measurable terms wherever quired activities. product or pro.g. The elements described in the following subclauses cludes representatives from all affected functions should be addressed. which conducted the review of the original quality or for particular activities such as the dependability plan. purchasing. NOTE 16 When drafting a textural quality plan. each stage to the customer prior to the start of that the supplier's method of operation and the complexity stage. changes to the manner in ject plan). b) Scope of the quality plan mitted to the customer by the supplier for review and acceptance. — the product. and a contract is subsequently awarded. Where the contract is conducted in possible). production. either as part of the precontract award. a quality plan may be sub. proposed changes to the plan should be submitted to lowing conventions may be used: the customer for review and acceptance before they are implemented. uct. plan. — “shall” to express a provision that is binding between two or more parties. tem. consistent with meeting the pro. a) Structure — “should” to express a recommendation among other possibilities. Subject to the specific requirements of a contract. The scope of the quality plan should be defined and bidding process or after the contract has been should include. In contractual situations. It may be necessary to develop a quality plan that consists of a number of parts. — “will” to express a declaration of purpose or intent by 5 Contents of the quality plan one party. project or contract. The quality plan should be reviewed for adequacy and formally approved by an authorized group that in. The contents of the quality plan should be based on this International Standard and the supplier's docu- — “may” to indicate a course of action permissible within mented quality system. the plan should be reviewed and. Procedures referenced in the plan should be made visions of this International Standard. impact and adequacy by the same authorized group sign.) 4. each of which re. the fol. where relevant to the require- within the supplier's organization. Changes to the quality plan should be reviewed for presents a plan for a distinct stage. revised — the scope of the contract to which it is to be to reflect any changes in requirements that may have applied. 3 . ISO ISO 10005:1995(E) The format and level of detail in the plan should be stages. of the activities to be performed. it should objectives (these quality objectives should be normally be submitted prior to the start of the re. when appropriate. where agreed in the con- examples of alternative presentations of quality plans tract. the supplier should submit the quality plan for consistent with any agreed customer requirement. but not be limited to: awarded. project or contract. are contained in annex A. occurred as a result of precontract negotiations. ments of the product. A quality plan may also be included as part of to reflect changes that have been made to the prod- another document or documents (e. or changes in quality assurance practices. or inspection and test. — the product or project to which it is to be ap- If the plan is submitted as part of the bidding process plied. It is not essential that the the limits of the quality plan. access to such documents d) authorizing requests for exemption from quality and data can be obtained. subcontractor quality plans. The quality plan need only refer to this a) any important products that are to be purchased. a) how products provided by the customer (such as material. c) requirements for. c) where applicable. project or contract to all affected departments.1 Management responsibilities tomer is to be involved in design activities. im. input requirements. dards. 5.5 Document and data control b) communicating requirements peculiar to the The plan shoud indicate: specific product. The plan should indicate when. stan- a) ensuring that the activities required by the speci.3 Contract review d) the methods to be used to satisfy regulatory re- quirements which apply to purchased products. and from whom. such documents and data are e) controlling corrective actions (see 5. 5. such as participation in design reviews and design The plan should identify individuals within the sup. how and by whom the requirements specified for the product. 5. d) how. and a) the documents and data applicable to the product. and by whom. between such groups. documentation and show how it is to be applied to from whom. of such documentation does not already exist but is b) the methods to be used to evaluate.ISO 10005:1995(E) ISO — specific exclusions. 5. c) reviewing the results of any audits conducted. reviewed and approved. data or services) are identified and controlled. verification. resolving problems that arise at the interfaces project or contract. a) when. specifications and regulatory requirements. identify when. c) how. how and by whom it will be prepared and approved. the extent to which the cus- 5. forming products. controlled and documented. select and required. Where an element requirements. project or contract are to be reviewed. b) the arrangements for the review.2 Quality plan and quality system 5.4 Design control b) the methods to be used to verify that customer- The plan should indicate: supplied products meet specified requirements. as fied quality system or contract are planned. plier's organization who are responsible for: The plan should reference applicable codes. tooling.7 Control of customer-supplied product The plan should also indicate how the results of this The plan should indicate: review are to be recorded and how conflicts or ambi- guities in requirements are to be resolved. how and by whom the design process is c) the methods to be used to deal with noncon- to be carried out. 5. software. 4 . appropriate.6 Purchasing Much of the necessary quality plan documentation The plan should indicate: will normally exist as part of the quality system docu- mentation. test equipment. system elements. plemented and controlled and their progress monitored. the quality plan should identify it and also control subcontractors. where appropriate. verification and validation of design output conformity to design — the conditions of its validity. subcontractors and customers. b) how such documents and data will be identified.14). and reference to. and the relevant quality assurance the specific situation in question. The plan should indicate how the production. ence but should not be limited to: 5) material. to use third parties to perform: 5. witnessed or performed by regulatory authorities. quired. 3) product verification. and test equipment d) acceptability criteria for workmanship.10 Inspection and testing be maintained so that the validity of previous re- sults can be determined when such equipment is The plan should indicate: found to be out of calibration. the procedures and accept- should also be considered when traceability is not re. or is required by the customer or regulatory authorities. when and how the supplier intends. working documents. 5 . or contract. the plan should include or refer- 4) product validation.12 Inspection and test status plan). instal- 2) witness testing (including on-site acceptance). ance criteria to be used. c) methods to be used to monitor and control pro. including how affected d) what characteristics are to be inspected and products are to be identified. and any special tools. lation and servicing processes will be controlled to ensure that specified requirements are met. a) any relevant inspection and test plan (the items below may all be part of an inspection and test 5. The plan should indicate any specific requirements b) how the supplier will verify subcontractor product and methods for the identification of the inspection conformance to specified requirements. the plan should define its scope and extent. product.8 Product identification and traceability c) where each inspection and test point is located in the process sequence. The plan should indicate: e) where the customer has established points for witness or verification of selected characteristics a) how contractual and regulatory traceability re. techniques and methods to be used to a) identification of such equipment. of a product or its production and installation pro- quirements are identified and incorporated into cesses. achieve specified requirements. fication. associated equipment specifically intended for use for the product. Identification methods tested at each point. project and personnel. f) where inspections or tests are required to be b) what records relating to such traceability require. Where traceability is a requirement. ments are to be generated and how they are to be controlled and distributed. status. documents and data.9 Process control 1) type tests. measuring and test equipment e) use of qualified processes. process or personnel certi- a) relevant documented procedures. Where installation is a requirement. measuring cesses and product characteristics. The plan should indicate the control system to be used for inspection. and test status of products. d) what records of usage of such equipment are to 5. Where appropriate. b) the process steps. including: f) tools. 5. g) where.11 Control of inspection. techniques or personnel qualifications required. ISO ISO 10005:1995(E) 5. the plan should indicate how the product will be installed and which c) method of indicating and recording calibration characteristics have to be verified at that time. b) method of calibration. tration purposes. and confidentiality requirements will be defined and satisfied. quality audits to be undertaken and how the results bility and authoritiy to accept or reject such con. including those car- ried out for quality system certification/regis- 5. specific to the product. are available when required.19 Servicing a) what records are to be kept. Such audits may include: 5. the plan should indicate: f) what records are to be supplied to the customer. The plan should address how and under what cir- cumstances the supplier would request a concession e) what methods will be used to ensure that records for a product which does not meet specified require. a) training of new personnel. storage. The plan should indicate how nonconforming products are identified and controlled to prevent misuse until c) what form the records will take (such as hard proper disposal. d) how legibility. where Where servicing is a specified requirement. packaging and delivery are to be met. retrievability. ments. site in a manner that will ensure that its required This should include: characteristics are not degraded. for personnel carrying out a process that is a subject of the plan. The plan should indicate the nature and extent of d) who has been identified as having the responsi. 5.14 Corrective and preventive action a) internal audits by the supplier. Those responsible for initiation and approval of cor- rective and preventive action should be identified. are to be used to correct and prevent recurrence of cessions. In doing so. The quality plan shoud indicate the preventive and corrective actions and follow-up activities that are b) customer audits of the supplier.15 Handling.13 Control of nonconforming product b) what the legal or regulatory requirements are and how they are to be satistied. disposition such as the degree or type of rework allowed. storage. g) in what language the records will be provided. The plan should indicate how records specific to the product. the plan and by whom. a) who would have the responsibility to request such when and by what means.ISO 10005:1995(E) ISO 5. c) what information is to be provided and in what 5. and how such training is to be ac- b) how the product will be delivered to the specified complished and recorded. b) how such a request would be made. The plan should address any specific training required storage. for how long.16 Control of quality records b) training of existing personnel in new or revised operating methods. project or contract in order to avoid the appearance or repetition of nonconformities. in- cluding: 5. preservation and delivery The plan should indicate: 5. concessions. copy or electronic media). d) third-party or regulatory authority audits of the supplier and subcontractors. nonconformities which affect the product. project or contract. packaging.18 Training a) how the specified requirements for handling. project or contract are to be controlled.17 Quality audits form. c) supplier/customer audits of subcontractors. should indicate how the supplier intends to assure 6 . Quality plans may need to define specific limitations. 7 . during the agreed time period. ISO ISO 10005:1995(E) conformance to applicable servicing requirements. such as: e) availability of initial and on-going technical support a) regulatory and legislative requirements. they should be indicated in the plan. b) industry codes and practices.20 Statistical techniques c) service level agreements. 5. Where specific statistical techniques are required. d) training of customer personnel. It would normally matic form may be supplemented with text. 8 . unless under some exceptional circumstance they do not apply to the case under review. be expected that all of the elements would be cov- ered. Even though the examples shown are in the form of flow diagrams.) ments.1 to A. (See figures deemed suitable for meeting the agreed require- A. a diagram- quality plans may be more complex.ISO 10005:1995(E) ISO Annex A (informative) Simplified examples of formats for the presentation of quality plans This annex provides examples of some of the ways Presentation of quality plans can be in any form in which quality plans may be presented.1.4 and table A. other forms better suited to a The examples shown should not be taken as being specific situation may be used. Similarly. A textual presentation complete as regards the quality plan content defined rather than a diagrammatic one may be more appro- in clause 5 of this International Standard. Actual priate in certain circumstances. — product traceability. — nonconformance. such as: — document control. ISO ISO 10005:1995(E) NOTE — The service quality plan should also contain written descriptions and/or references to procedures or other documents for activities not shown on the flowchart. — third-party involvement. Figure A. — management responsibilities. — quality audits. — quality records.1 — Example of a format for a quality plan for services 9 . ISO 10005:1995(E) ISO 10 . ISO ISO 10005:1995(E) Figure A.2 — Example of a format for a quality plan for manufactured product 11 . 29 Preheating WI . 2 Cutting Length C Measure length Control chart D Ref.22 Workstation VI . No. No.321 Temperature.12 ISO 10005:1995(E) Quality Process control Inspection characteristic Figure A. No.3 — Example of a format of a quality plan for a processed material Process Work to be Instruction Process Part flow instruction controlled for process Control Responsible Verification. Check sheet B pressure Ref.6 1) Symbols are as follows: Manufacturing Inspection and testing Storage ISO . Procedure stage Parameters chart 1) number (process control method function instruction number condition to be number checked) IPC . 1 Yield Length IT .123 Temperature Check sheet A Ref. 1 Part A Forming WI . ISO ISO 10005:1995(E) Figure A.4 — Simplified example of a software life cycle 13 . 8 Client witnessing only 13 Technical transfer PMM 5.9 14 .4) Approval Ref.7 10 System test QM 5.4 GT 3 Requirements review QM 5.6 Use expert review SME 6 Software implementation SDM 5. Activity description Procedure Comment Assigned to authority 1 Contract review QM 5.2 Contract M&P 1091 AMM 2 Review plans PMM 5. RS001 SME 4 Design PMM 5.ISO 10005:1995(E) ISO Table A.7 Use customer data 11 Clear nonconformances QM 5.7 Use Fagan inspection 8 Unit tests SDM 5. DS001 UT 5 Design review QM 5.6 Produce Doc.3 Produce Doc.1 — Software quality plan — Activity reference (see figure A.7 9 System integration SDM 5.7 12 User acceptance tests QM 5.6 Use C+ + 7 Code review QM 5. Quality management and Guidelines for configuration management. [7] ISO 9003:1994. [12] ISO 10011-1:1990. equipment. ISO for processed materials. Dependability programme man- quality system elements — Part 1: Guidelines. supply and maintenance of ity systems — Part 1: Auditing. Quality assurance require- [6] ISO 9002:1994. 1) To be published. duction. [14] ISO 10011-3:1991. ISO ISO 10005:1995(E) Annex B (informative) Bibliography [1] ISO 9000-1:1994. installation and Metrological confirmation system for measuring servicing. Quality systems — Model for [16] ISO 10013:1995. 15 . programmes. pro. Guidelines for developing quality assurance in final inspection and test. software. [11] ISO 10007:1995. Quality management and [9] ISO 9004-2:1991. Guidelines for auditing qual- [4] ISO 9000-4:1993. quality assurance standards — Part 3: Guide- lines for the application of ISO 9001 to the de. for services. Quality management — [3] ISO 9000-3:1991. Quality management and quality assurance standards — Part 2: Generic quality system elements — Part 3: Guidelines guidelines for the application of ISO 9001. Quality management and quality assurance standards — Part 1: Guide. Quality systems — Model for ity systems — Part 3: Management of audit quality assurance in design. [8] ISO 9004-1:1994. agement — Part 2: Dependability programme elements and tasks. Guidelines for auditing qual- [5] ISO 9001:1994. [2] ISO 9000-2:1993. Quality systems — Model for ments for measuring equipment — Part 1: quality assurance in production. Guidelines for auditing qual- velopment. Quality management and [17] IEC 300-2:—1). quality manuals. development. installation and servicing. 9002 and ISO 9003. quality system elements — Part 2: Guidelines lines for selection and use. Quality management and ity systems — Part 2: Qualification criteria for quality assurance standards — Part 4: Guide to quality systems auditors. [15] ISO 10012-1:1992. dependability programme management. [13] ISO 10011-2:1991. Quality management and [10] ISO 9004-3:1993. quality assurance systems. components.ISO 10005:1995(E) ISO ICS 03. Price based on 15 pages .120. quality assurance.10 Descriptors: quality management. general conditions.