ISO 9001 - The Coming 2000 Update

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Marc

Hunkered Down for the Duration
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ISO900x - The Update


This is from a listserve. The whole document was not there, but I'll try to get the remaining part:

-> From: <[email protected]> Subject: Re: REQ:
-> Proposed ISO 9001/Lusk/Darracott/coolj
->
-> ISO 9001: PHASE 2 REVISION WORKING DRAFT 4 QUALITY
-> SYSTEMS: MODEL FOR QUALITY ASSURANCE IN DESIGN
-> DEVELOPMENT, PRODUCTION, INSTALLATION AND SERVICING.
->
-> 0 INTRODUCTION 1 SCOPE 2 REFERENCES 3 DEFINITIONS 4
-> QUALITY SYSTEM REQUIREMENTS
->
-> 4.1 GENERAL
->
-> The Supplier shall establish, document and maintain a
-> quality system as a means of implementing the process
-> operations necessary to ensure that product conforms to
-> specified requirements. The quality system shall cover
-> all applicable requirements of this International
-> Standard.
->
-> 4.2 EXECUTIVE MANAGEMENT RESPONSIBILITY 4.2.1 QUALITY
-> POLICY
->
-> The supplier's management with executive responsibility
-> shall define and document:
->
-> a) its policy for quality. The policy shall be relevant
-> to the suppliers goals and the expectations and needs of
-> its customers. The supplier shall ensure that this policy
-> is understood and maintained at all levels in the
-> organisation.
->
-> b) its objectives for quality. The objectives shall be
-> expressed in terms that can be measured.
->
-> c) its commitment to quality shall be directed to the
-> satisfaction of customers and other stakeholders. 4.2.2
-> STRATEGIC PLANNING
->
-> The supplier shall develop plans for strategic planning.
-> The supplier shall:
->
-> - cover a defined period and relate to stated strategy; -
-> incorporate the requirements of this standard into the
-> business planning process; - define the sources of
-> information used during the planning process; -
-> prioritise the achievement of quality policy; - define
-> methods to deploy the planned requirements to work
-> activities
->
-> 4.2.3 MANAGEMENT REPRESENTATIVE
->
-> Supplier's management with executive responsibility shall
-> appoint a member of its own management who, irrespective
-> of other responsibilities shall have defined authority
-> for:
->
-> a) ensuring that quality system requirements are
-> established, implemented and maintained in accordance
-> with this International Standard.
->
-> b) reporting on the performance of the quality system to
-> the supplier's management for review and as a basis for
-> improvements of the quality system. (See 4.2.4)
->
-> NOTE: The responsibility of a management representative
-> may also include liaison with external bodies on matter
-> relating to the supplier's management system
->
-> 4.2.4 MANAGEMENT REVIEW
->
-> The supplier's management with executive responsibility
-> shall review the quality system at defined intervals
-> sufficient to ensure its continuing suitability and
-> effectiveness in satisfying the requirements of this
-> International Standard and the supplier's stated quality
-> policy and objectives. Records of such review shall be
-> maintained. (See 4.5.5.4)
->
-> 4.3 CUSTOMER REQUIREMENTS 4.3.1 EVALUATION OF CUSTOMER
-> REQUIREMENTS
->
-> The supplier shall:
->
-> a) establish, assess and define customer and market
-> requirements; b) confirm that all processes for the
-> introduction of a new product are in place; c) prepare
-> product information which shall accurately relate to the
-> specification of the product, its availability and
-> timeliness of delivery; d) define its obligation to
-> customers including warranties.
->
-> 4.3.2 REVIEW OF AGREEMENT 4.3.2.1 Review
->
-> Each accepted tender, contract and order (statement of
-> requirement) shall be reviewed by the supplier to ensure
-> that:
->
-> a) the requirements are adequately defined and
-> documented. Where no written statement of requirement is
-> available for an order received by verbal means, the
-> supplier shall ensure that the order requirements are
-> agreed before their acceptance. b) any contract or
-> accepted order requirements differing from those in their
-> tender are resolved
->
-> c) the supplier has the capability to meet contract or
-> accepted order requirements.
->
-> 4.3.2.2 Amendment to contract
->
-> The supplier shall identify how amendment to a contract
-> is made and correctly transferred to functions concerned
-> within the supplier's organisation.
->
-> 4.3.2.3 Records
->
-> Records of contract reviews shall be maintained
->
-> NOTE 1: Channels for communication and interface with the
-> customer's organisation in these contract matters should
-> be established
->
-> NOTE 2: For the purpose of this International Standard,
-> the terms "contact" or "accepted order" are defined as
-> "agreed requirements" between the supplier and customer
-> transmitted by any means.
->
-> 4.3.3 CUSTOMER INTERFACE REQUIREMENTS
->
-> The supplier shall:
->
-> a) regularly review the method used for promoting
-> customer contacts;
->
-> b) implement effective liaison with customers to enable
-> successful outcome to the contract/order agreement;
->
-> c) receive, record respond to and assess customer
-> complaints and reports of product nonconformities in
-> accordance with agreements;
->
-> d) inform customers of progress/results relating to their
-> requests and complaints;
->
-> e) monitor and summarise information and feedback of
-> customer's experience and expectations for review by the
-> functions concerned.
->
-> f) protect customer data and information
->
-> 4.4 RESOURCE MANAGEMENT 4.4.1 General
->
-> The supplier shall identify resource requirements,
-> provide adequate resource requirements, provide adequate
-> resources and assign trained personnel for management,
-> performance of work and verification activities including
-> quality audits.
->
-> 4.4.2 PEOPLE MANAGEMENT 4.4.2.1 People performance
->
-> The supplier shall:
->
-> - select people on the basis of capability to satisfy the
-> skills needed for the defined work;
->
-> - ensure effective communication of quality related
-> information needed to perform defined tasks;
->
-> - periodically assess the quality related performance of
-> personnel.
->
-> 4.4.2.2 People development
->
-> (a) Education
->
-> The supplier shall:
->
-> - educate people to accept personal responsibility for
-> the achievement and improvement of quality work;
->
-> - educate personnel to have an active involvement and
-> influence on the quality of product provided to
-> customers.
->
-> (b) Training
->
-> The supplier shall:
->
-> - identify the training needs of personnel;
->
-> - establish planned action for updating the skills of
-> personnel;
->
-> - provide training of all personnel performing activities
-> affecting quality;
->
-> - qualify personnel required to perform specific assigned
-> tasks (Qualifications shall be on the basis of
-> appropriate education, training and/or experience, as
-> required);
->
-> - maintain appropriate records of training.
->
-> 4.4.2.3 People support
->
-> (a) Safety
->
-> The supplier shall ensure that:
->
-> - all personnel are educated as to their responsibility
-> towards safety.
->
-> - appropriate safety training is provided. This shall
-> include awareness of any applicable statutory or
-> regulatory requirements and recognised codes of practice.
->
-> - management takes a positive lead in encouraging and
-> giving recognition to safe working practices.
->
-> - all accidents are recorded and that appropriate
-> corrective action is taken to prevent their recurrence.
->
-> (b) work environment
->
-> The supplier shall provide a working environment that is
-> suitable for executing the type of work that is
-> performed.
->
-> 4.4.3 MATERIALS MANAGEMENT 4.4.3.1 General
->
-> The supplier shall define the methods used for materials
-> management. This shall include the control of all
-> equipment, stores and material items incorporated into
-> the product to ensure the conformance to specified
-> requirements.
->
-> 4.4.3.2 Purchasing
->
-> (a) Evaluation of sub-contractors
->
-> The supplier shall:
->
-> - evaluate and select sub-contractors on the basis of
-> their ability to meet sub-contract requirements including
-> quality system and quality assurance requirements;
->
-> - define the type and extent of control exercised by the
-> supplier over sub-contractors. This shall be dependent on
-> the type of product, the impact of the subcontracted
-> product on the quality of the final product and where
-> applicable, on quality audit reports and/or quality
-> records of sub-contractors previously demonstrated
-> capability and performance;
->
-> - establish and maintain quality records of acceptable
-> sub-contractors (see 4.5.5.4)
->
-> (b) Purchasing data
->
-> Purchasing documents shall contain data clearly
-> describing the product ordered, including where
-> applicable:
->
-> (i) the type, class, grade or other precise
-> identification;
->
-> (ii) the title or other identification and applicable
-> issue of specifications, drawings, process requirements,
-> inspection instructions and other relevant technical
-> data, including requirements for approval or
-> qualification of product, procedures, process equipment
-> and personnel;
->
-> (iii) the title, number and issue of the quality system
-> Standard to be applied.
->
-> The supplier shall review and approve purchasing
-> documents for adequacy of specified requirements prior to
-> release.
->
-> (c) Verification of purchased product
->
-> (i) Supplier verification at sub-contractors
->
-> Where the supplier verifies purchased product at the
-> sub-contractors premises the supplier shall specify the
-> verification arrangements and the method of product
-> release in the purchasing document.
->
-> (ii) Customer verification of sub-contracted product
->
-> Where specified in the contract, the supplier's customer
-> or representative shall be afforded the right to verify
-> at the sub-contractors premises and the supplier's
-> premises that sub-contracted product conforms to
-> specified requirements. Such verification shall not be
-> used by the supplier as evidence of effective control of
-> quality by the sub-contractor.
->
-> Verification by the customer shall not absolve the
-> supplier of the responsibility to provide acceptable
-> product nor shall it preclude subsequent rejection by the
-> customer.
->
-> 4.4.3.3 Customer supplied product
->
-> The supplier shall provide for the verification, storage
-> and maintenance of customer supplied product provided for
-> incorporation into the finished product.
->
-> The supplier shall:
->
-> (a) examine customer supplied product on receipt for
-> completeness, proper type and to detect transit damage;
->
-> (b) control such product from receipt onwards according
-> to the requirements of this International Standard;
->
-> (c) ensure the customer supplied product is suitably
-> identified and that the product is only used for the
-> designated purpose. Any such product that is lost,
-> damaged or is otherwise unsuitable for use shall be
-> recorded and reported to the supplier's customer. (see
-> 4.5.5.4)
->
-> NOTE: Verification by the supplier does not absolve the
-> customer of the responsibility to provide acceptable
-> product.
->
-> 4.4.3.4 Product Identification and Traceability
->
-> Where appropriate, the supplier shall identify the
-> product by suitable means from receipt and during all
-> stages of production, delivery and installation.
->
-> Where, and to the extent that, traceability is a
-> specified requirement, individual product or batches
-> shall have a unique identification. This identification
-> shall be recorded on related records and provide a means
-> for traceability (see 4.5.5.4).
->
-> 4.5 PROCESS MANAGEMENT 4.5.1 GENERAL
->
-> The supplier shall identify, manage and control all
-> processes that together constitute the work operations
-> necessary to meet customer requirements. This shall
-> include process ownership, the internal structure of each
-> process and shared support systems. The requirements for
-> interface between processes shall be specified.
->
-> 4.5.2 RESPONSIBILITY and AUTHORITY
->
-> The responsibility, authority, reporting structure and
-> the interrelation of all personnel, performing work in
-> process operations shall be defined and documented. 4.5.3
-> DOCUMENTED PROCEDURES
->
-> The supplier shall:
->
-> a) prepare documented procedures describing the work
-> methods to be used in process operations which directly
-> affect quality. The work methods employed shall reflect
-> the policies and capabilities of the supplier's
-> organisation as well as any legislative requirements.
->
-> b) effectively implement the documented procedure
->
-> For the purpose of this International Standard the degree
-> of documentation required for the procedure that form
-> part of the quality system shall be dependent on the
-> methods used, skills needed and the training acquired by
-> personnel involved with carrying out the activity.
->
-> 4.5.4 WORK PREPARATION AND CONTROL
->
-> 4.5.4.1 Work definition
->
-> The requirements for work that influence product quality
-> shall be clearly specified and accurately communicated.
-> Acceptance criteria shall be established for the
-> specified requirements for work and for workmanship.
-> Incomplete, ambiguous or conflicting requirements shall
-> be resolved with those responsible for imposing these
-> requirements.
->
-> 4.5.4.2 Work planning
->
-> The supplier shall identify and plan the work activities
-> within the process operations. The plans shall describe
-> or reference these activities.
->
-> 4.5.4.3 Work Control
->
-> The supplier shall ensure that controlled conditions are
-> established for carryout the performance of work in
-> accordance with planned arrangements. This shall include
-> a verification of the capability of process operations to
-> produce in accordance with thew specified requirements
-> for work.
->
-> 4.5.4.3 Review of Legislation
->
-> The supplier shall comply with applicable statutory and
-> regulatory requirements for health, safety and
-> environment and relevant national and international
-> standards and codes.
->
-> 4.5.5 DOCUMENTATION AND DATA CONTROL
->
-> 4.4.4.1 General
->
-> The supplier shall define the structure of the
-> documentation used in operating the quality system used
-> in a quality manual. The quality manual shall include or
-> reference the documented procedures that form part of the
-> quality system. The supplier shall control all documents
-> and data that relate to the requirements of this
-> international standard including, to the extent
-> applicable, documents of external origin such as
-> standards and customer drawings.
->
-> NOTE; Documentation and data can be in the form of any
-> hard copy media or they can be in electronic or other
-> media.
->
-> 4.5.5.2 Approval and issue
->
-> The documents and data shall be reviewed and approved for
-> adequacy by authorised personnel prior to issue. A master
-> list or equivalent document control procedure identifying
-> the current revision status of documents shall be
-> established and be readily available to preclude the use
-> of invalid and/or obsolete documents.
->
-> Controls shall also ensure that:
->
-> a) the pertinent issues of appropriate documents are
-> available at all locations where process operations
-> essential to the effective functioning of the quality
-> system are performed. b) Invalid and/or obsolete
-> documents are promptly removed from all points of issue
-> or use, or otherwise assured against unintended use. c)
-> Any obsolete documents retained for legal and/or
-> knowledge preservation purposes are suitably identified.
->
-> 4.5.5.3 Document Changes
->
-> Changes to documents shall be reviewed and approved by
-> the same functions/organisations that performed the
-> original review and approval unless specifically
-> designated otherwise. The designated
-> functions/organisations shall have access to pertinent
-> background information upon which to base their review
-> and approval. Where practicable, the nature of the change
-> shall be identified in the document or appropriate
-> attachments.
->
-> 4.5.5.4 Control of Quality Records
->
-> The supplier shall provide for the identification,
-> collection, indexing, access, filing, storage,
-> maintenance and disposition of quality records. Quality
-> records shall be maintained to demonstrate conformance to
-> specified requirements and the effective operation of the
-> quality system. Pertinent sub-contractor quality records
-> shall be an element of these data. All quality records
-> shall be legible and stored and retained in such a way
-> that they are readily retrievable in facilities that
-> provide a suitable environment to minimise deterioration
-> or damage and to prevent loss. Retention times of quality
-> records shall be established and recorded. Where agreed
-> contractually, quality records shall be made available
-> for evaluation by the customer or his representative for
-> an agreed period.
->
-> Note: Records can be in the form of any hard copy media
-> or they can be in electronic or other media. 4.5.5.5
-> Handling and Delivery
->
-> (a) General
->
-> The supplier shall provide for the handling, storage,
-> packaging, preservation and delivery of product. This
-> shall include:
->
-> i) Handling:
->
-> -providing methods of handling product that prevent
-> damage or deterioration,
->
-> ii) Storage:
->
-> -providing designated storage areas or stock rooms to
-> prevent damage or deterioration of product, pending use
-> or delivery. Appropriate methods for authorising receipt
-> and the dispatch to and from such areas shall be defined.
-> In order to detect deterioration, the condition of
-> product in stock shall be assessed at appropriate
-> intervals.
->
-> iii) Packaging:
->
-> - the control of packing, packaging and marking processes
-> ( including materials used ) to the extent necessary to
-> retain the conformity of product quality to specified
-> requirements.
->
-> iv) Preservation:
->
-> -appropriate methods for preservation and segregation of
-> product shall be applied when such product is under the
-> supplier's control.
->
-> v) Delivery:
->
-> - the protection of the quality of product when delivery
-> of the finished product to destination is part of the
-> suppliers undertaking.
->
-> 4.6 MEASUREMENT
->
-> 4.6.1 GENERAL
->
-> The supplier shall provide for the measurement of process
-> performance, product characteristics and quality system
-> operation to verify the achievement of results.
->
-> This shall include collecting, analysing, summarizing and
-> disseminating pertinent measurement data on the quality
-> of process, product, and quality system from all relevant
-> sources.
->
-> 6.6.2 PROCESS PERFORMANCE MEASUREMENT
->
-> This shall include:
->
-> a) criteria for selecting the quality characteristics of
-> process performance requiring measurement:
->
-> b) the scope, type and frequency of measurement:
->
-> c) methods for ensuring consistency, validity,
-> standardisation, security, review, update and timely
-> access of quality measurement data throughout the
-> suppliers organisation and to customers and
-> sub-contractors, as appropriate.
->
-> 4.6.2 PRODUCT VERIFICATION MEASUREMENT
->
-> This shall include all measurement activities necessary
-> to assure that the specified requirements for product are
-> met.
->
-> 4.6.3.1 Inspection and Testing
->
-> The supplier shall:
->
-> a) determine inspection and testing needs which are
-> necessary to verify that that specified requirements are
-> met. Required inspection and testing needs and the
-> records to be established shall be documented in the
-> product quality plan (see <4.2.2.a>); b) Carry out all
-> specified inspection and tests, including those specified
-> on receipt of product, in-process or at final inspection
-> in accordance with the product quality plan (see
-> <4.2.2.a>). Establish and maintain quality records (see
-> 4.5.5.4) of the results of inspection and testing to
-> provide evidence of conformance of the completed product
-> to specified requirements with defined acceptance
-> criteria. Non conforming inspection and test results
-> shall be included in the quality records. Records shall
-> identify the inspection authority responsible for the
-> release of conforming product (see 4.5.5.4). c)
-> Positively identify and record any product that is
-> released for urgent production or installation purposes
-> in order to permit immediate recall and replacement in
-> the event of non-conformance to specified requirements.
-> This should not preclude activities required by the
-> product quality plan. d) Not deliver finished product
-> until all the activities specified in the product quality
-> plan have been satisfactorily completed and the
-> associated data and documentation is available and
-> authorised.
->
-> 4.6.3.2 Inspection and Test Status
->
-> The status of the product with regard to the verification
-> activities shall be identified as follows:
->
-> a) awaiting inspection and test, or b) passed inspection
-> and test, or c) nonconforming.
->
-> The inspection and test status of product shall be
-> identified by suitable means which distinguishes product
-> with differing inspection and test status. The
-> identification of inspection and test status shall be
-> maintained as defined in the quality plan throughout
-> production, installation and servicing of the product (or
-> delivery of the service) to ensure that only product that
-> has passed the required inspection and test is
-> dispatched, delivered, used or installed.
->
-> 4.6.4 AUDIT MEASUREMENT
->
-> 4.6.4.1 General
->
-> Audits shall be used to verify that the stated policies,
-> objectives, plans, processes, written procedures and all
-> other elements of the quality system have been
-> implemented and are operating effectively in achieving
-> the expectations and needs of the supplier's organisation
-> and customer satisfaction.
->
-> NOTE: Guidance on quality audit is given in ISO 10011
->
-> 4.6.4.2 Internal Quality Audits
->
-> The supplier shall carry out a system of planned internal
-> quality audits of the quality system, process and / or
-> product.
->
-> Internal audits shall be scheduled on the basis of the
-> status and importance of the activity and shall be
-> conducted by trained personnel independent of those
-> having direct responsibility for the work being
-> performed.
->
-> The results of the audit shall be documented and brought
-> to the attention of the personnel having responsibility
-> in the area audited.
->
-> The management personnel responsible for the area audited
-> shall take timely corrective action on the deficiencies
-> found by the audit.
->
-> NOTE 1: The results of the internal and external audit
-> are normally included in Management Review of the system
-> (see 4.2.4).
->
-> NOTE 2: All audit reports and records should be retained
-> for a minimum of two years, unless specified otherwise.
->
-> 4.6.5 CUSTOMER SATISFACTION MEASUREMENT
->
-> The supplier shall identify the means by which customer
-> satisfaction is measured and monitored.
->
-> 4.6.6 MEASUREMENT DATA ANALYSIS
->
-> The supplier shall analyse the measurement data to
-> determine progress on the achievement of quality
-> objectives and customer satisfaction.
->
-> The analysed results shall be reported to the functions
-> concerned and to executive management for review of the
-> quality system.
->
-> 4.6.7 STATISTICAL TECHNIQUES
->
-> The supplier shall identify the need for statistical
-> techniques required for establishing, controlling and
-> verifying process capability and product characteristics.
->
-> 4.6.8 INSPECTION, MEASURING AND TEST EQUIPMENT.
->
-> The supplier shall control, calibrate and maintain
-> inspection, measuring and test equipment (including test
-> software) used by the supplier to demonstrate the
-> conformance of product and process conditions to the
-> specified requirements. Inspection, measuring and test
-> equipment shall be used in a manner which ensures that
-> measurement uncertainty is known and is consistent with
-> the required measurement capability.
->
-> The measurement of calibration system for inspection,
-> measuring and test equipment shall be in accordance with
-> the requirements of ISO 10012
->
-> Where test software or comparative references or test
-> hardware is used as suitable forms of inspection, they
-> shall be checked, to prove that they are capable of
-> verifying the acceptability of product, prior to release
-> for use during production, installation or servicing and
-> shall be rechecked at prescribed intervals. The supplier
-> shall establish the extent and frequency of such checks
-> and shall maintain records as evidence of control (see
-> 4.5.5.4).
->
-> Where and to the extent that the availability of
-> technical data pertaining to the measurement devices is a
-> specified requirement, such data shall be made available,
-> when required by the customer or customer's
-> representative, for verification that the devices are
-> functionally adequate.
->
-> 4.7 CONTROL OF NONCONFORMING PRODUCT
->
-> 4.7.1 GENERAL
->
-> The supplier shall ensure that nonconforming product to
-> specified requirements is prevented from unintended use
-> or installation. Control shall provide for
-> identification, documentation, evaluation, segregation
-> (when practical, ) review, disposition of nonconforming
-> product and for notification to the functions concerned.
->
-> 4.7.2 NONCONFORMING PRODUCT REVIEW AND DISPOSITION
->
-> Nonconforming product shall be reviewed with regard to
-> the action to be taken. It may be:
->
-> a) reworked to meet specified requirements, or b)
-> accepted with or without repair by concession, or c)
-> regraded for alternative applications, or d) rejected or
-> scrapped.
->
-> The responsibility for review and authority for the
-> disposition of nonconforming shall be defined.
->
-> When required by the contract, the proposed use or repair
-> of nonconforming product (see 4.7.2 b) shall be reported
-> for concession to the customer or customer's
-> representative. The description of the nonconformity that
-> has been accepted, and of repairs, shall be recorded to
-> denote the actual condition ( see 4.5.5.4).
->
-> Repaired and reworked product shall be re-inspected in
-> accordance with the quality plan and/or documented
-> procedure requirements.
->
-> 4.8 CORRECTIVE ACTION
->
-> The supplier shall:
->
-> a) investigate the cause of nonconformities relating to
-> product, process, and quality system and recording the
-> results of the investigation. (see 4.5.5.4). b) determine
-> the corrective action to prevent the recurrence of non
-> conformities; c) apply controls to ensure that corrective
-> action is taken and that it is effective; d) implement
-> and recording changes to processes resulting from
-> corrective action; e) provide for feedback of relevant
-> information for quality performance analysis (see 4.6.6).
->
-> 4.9 MANAGEMENT OF CHANGE AND PROCESS IMPROVEMENT
->
-> The supplier shall provide for the management of change
-> and implementation of improvement of the process
-> operations that form part of the quality system.
->
-> This shall include:
->
-> a) setting objectives for the improvement of process
-> performance consistent with the objectives for the
-> quality policy; b) establishing criteria for the
-> improvement process; c) evaluating and identifying
-> potential sources for improvement to process operations
-> that form part of the quality system; d) assigning
-> priorities to specific improvements; e) authorising
-> proposals for change; f) initiating preventive actions to
-> deal with potential causes of nonconformities to a level
-> corresponding to the risks encountered; g) initiating
-> necessary changes for the improvement of process
-> effectiveness h) applying controls to ensure that
-> preventative action and improvement is effective; i)
-> validating changes prior to implementation; j) recording
-> changes to processes; k) submitting relevant information
-> on changes to the functions concerned and for management
-> review (see 4.2.2).

[Note: This message was edited by Marc Smith]
 
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R

Roger Eastin

#2
Marc,
I know this is a draft, but is it understood that this draft will probably be accepted and published? There are quite a few changes! (There are also quite a few areas that stayed the same - surprises here too!) I'll be very interested to see the rest of this draft. Thanks for the info.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#3
If/when I get more info I will post it right away.

If you know anyone who gets 'Quality Systems Update', there's a good article in there as well. I may try to paraphrase some of it if I get time. It's in Volume 8, No. 5 from May 1998.

Yes - there are supposed to be some serious changes in ISO9001...
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
From: Bill Cox <[email protected]>
Subject: Re: FYI: Proposed ISO 9001 Standard, draft 4/Hubbard/Cox

ISO 9001:2000 *will* be restructured. That's a done deal. It will have 4 major sections of reqmts, subdivided into others, of course. According to TC176 WD3 (which will change significantly to CD level end of July)--

Clauses 0-4 are introductory, then there is:
5. Mgmt. Resp.
6. Resource Mgmt.
7. Mgmt. of Processes
8. Measurement, Analysis and Improvement

HOWEVER, YOU WILL **NOT** HAVE TO RE-WRITE YOUR Q. MANUAL TO ALIGN WITH THESE ELEMENTS. Quoting from the introduction:

"It is not the intention that organization's [sic] should be obliged to change the structure of their quality management system and/or its documentation to align with the structure of this International Standard. The documentation of the organization's quality management system should be configured in a manner that is appropriate to its unique activities, while still encompassing the requirements of this International Standard."

In other words, you can number it 1-20, or 1-99, or A-J, or whatever works for you. This, by the way, has always been the case. ISO will include a cross-ref. matrix btwn. 2000 and 1994 versions.
[Note: This message was edited by Marc Smith]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Subject: Re: REQ: Proposed ISO 9001/Lusk/Darracott/coolj/cox
Date: Fri, 10 Jul 1998 08:54:07 -0600
From: ISO Standards Discussion <[email protected]>

From: Bill Cox <[email protected]>
Subject: Re: REQ: Proposed ISO 9001/Lusk/Darracott/coolj/cox

I don't know where the so-called ISO 9001 draft 4 came
from, but it bears no resemblance to the WD3 that is the
most recent version from TC176, who just finished meeting
in Stockholm, and will issue another draft (CD) by the
end of July.
- - - -
Regards,
Bill Cox
TQM Consulting

>From: <[email protected]>
>Subject: Re: REQ: Proposed ISO 9001/Lusk/Darracott/coolj
>
>ISO 9001: PHASE 2 REVISION WORKING DRAFT 4
>QUALITY SYSTEMS: MODEL FOR QUALITY ASSURANCE IN DESIGN DEVELOPMENT,
>PRODUCTION, INSTALLATION AND SERVICING.
>
>0 INTRODUCTION
>1 SCOPE
>2 REFERENCES
>3 DEFINITIONS
>4 QUALITY SYSTEM REQUIREMENTS
>
>4.1 GENERAL
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
--> From: R2 Innovations <[email protected]>
--> Subject: Supposed Draft #4 of ISO 9000:2000
-->
--> As you can probably guess from the subject line, the posting of a
--> purported draft #4 of ISO 9000:2000 IS NOT official in any way,
--> shape, or form. The Manager of Internal Audit at my employer sits on
--> the Canadian Advisory Committee to TC 176 and he assures me the ONLY
--> official working draft of ISO 9000:2000 is ISO/WD3 dated May 1998.
-->
--> To address some of the questions that have been proposed to the list
--> I offer this information, culled from a copy of ISO/WD3 9000:2000 and
--> its attached cross reference matrix to ISO 900:1994
-->
--> Item #1 - Section 7.3 of the proposed revision is titled Design and
--> Development, and the words design and development are liberally used
--> throughout its text, showing up in the titles of subclauses 7.3.3,
--> 7.3.4, and 7.3.5. There can be no doubt that the standard contains
--> requirements governing development activities.
-->
--> Item #2 - There are no paras. 4.6.3.1 or 4.2.2a
-->
--> Brian Charles Kohn's post of July 12
-->
--> Item #1 - According to the cross reference matrix enclosed as part of
--> ISO/WD#, 4.4 is covered in 7.1 and 7.3 and it's subclauses; 4.7 is
--> covered by 7.5.3; 4.11 is covered by 7.5.2 and 8.1 and it's
--> subclauses; 4.19 is covered by 7.1 and 7.7; and 4.20 is covered by
--> 8.1.7.
-->
--> Item #2 - None of these paras exist in the proposed standard. Para
--> 4.1 contains only a general requirement for the Quality Management
--> System, the meat of the standard begins with section 5.
-->
--> I think that the person who posted the hypothetical draft #4 might
--> want to chek his/her source and verify its authenticity. As far as I
--> can determine, draft #4 does NOT exist.
-->
--> While this revision represents a significant restructuring of the way the
--> requirements are presented, ISO, and I quote, "It is not the intention that
--> organization's shall be obliged to change the structure of their
--> quality management system and/or its documentation to align with the
--> structure of this International Standard. The documentation of the
--> organization's quality management system should be configured in a
--> manner that is appropriate to its unique activities, while still
--> encompassing the requiremetns of this International Standard."
-->
--> I hope that this information will allay some fears and get us back on
--> track. According to my contact, even this draft (WD3) is likely to be
--> revised and respresents, at best guess, approximately 80-90osted as to where they are
--> going with the new standard, what version is really in circulation, and what
--> the estimated release date might be.
-->
--> Ralph E. Robinson...

And then there is this:

--> From: "Woodcock, Robert RA" <[email protected]>
--> Subject: FYI: Proposed ISO 9001:2000/Woodcock
-->
--> There is NO ISO sanctioned WD4 for ISO 9001:2000.
-->
--> The recent TC176 meeting in Stockholm was called to revise WD 3. Two of
--> SAA's representatives were there.
-->
--> I understand from that meeting there will be a CD issued at the end of
--> July. This will be distributed in hard copy only, due to ISO copyright
--> provisions, so it will probably take a little longer to get about. It
--> will then be issued as a Committee draft (CD) for public comment,
--> probably in September.
-->
--> It has been reported that there are copies and copies of copies falling
--> off the backs of trucks all around the world, and I suspect that many of
--> these are bogus versions or what some think should happen.
-->
--> We have to be a bit conservative and wait for the genuine article.
-->
--> It also has been decided that the drafts will have two rounds,
--> so there will be plenty of opportunity for comment, and planning for
--> implementation.
-->
--> Attached is a Word 6 version of the WD3 as it was before the Stockholm
--> meeting.
-->
--> Regards,
-->
--> Bob Woodcock
--> CDO Quality & Systems Development
--> BHP Integrated Steel
--> Port Kembla Steelworks...
[Note: This message was edited by Marc Smith]
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#7
Another source says:

--> From: "Dennis R. Arter" <[email protected]>
--> Subject: RE: Proposed ISO 9001/Cox/Andrews/Oliveira/Arter
-->
--> Marcos Oliveira recently wrote:
-->
--> It is important that someone that participates of TC 176 meetings
--> explain if ISO9001 draft 4 is the final one or not.
-->
--> The ISO 9000, 9001, and 9004 standards have a long, long way to go
--> before they are ready for publication. For the first time in the
--> history of Technical Committee 176, a "very rough draft" was
--> released to the national bodies. Unofficially, this means that
--> these very rough working drafts get out to the general public. In
--> fact, some might even post these working documents to the internet!
--> (I suspect that the working draft 4 was some national group's
--> effort to enfluence the committee deliberations.)
-->
--> We expect that Subcommittee 2 of Technical Committee 176 (in
--> standards shorthand, this is shown as: TC 176/SC 2), will have a
--> "committee draft" document available for comment very soon. Many
--> folks are saying end of July or early August. In the old way of
--> standards writing, the main TC 176 would never even see a "working
--> draft." It was for committee members only and kept locked up in the
--> safe at night. [smile] The "committee draft" is the first time they
--> let the work out of the safe and show it to the whole group. After
--> the whole group slices and dices the document, it is often
--> rewritten. Finally, the item is ready to be released to the general
--> public as a "draft international standard." Even then, changes can be
--> (and are) made. At the end of the process, a "final draft
--> international standard" is produced. This gets a short, up or down,
--> vote and no changes are allowed. If the vote is favorable, then the
--> document is sent to Geneva for publication. The national standards
--> groups get the document a few weeks after Geneva.
-->
--> As I have shown, this is a long, long process. It should be! We
--> don't want these documents published without extensive thought and
--> debate. They must be accepted. That's what "consensus" is all
--> about. All the data I am getting lately tell me that a second
--> committee draft of the proposed changes to both ISO 9001 and 9004
--> (called the "consistent pair") will be issued in late 1998. That
--> means it will be 1999 before they reach the draft international
--> standard stage of development. To further complicate matters, there
--> is intense pressure to combine (or at least integrate) the ISO 9000
--> series on quality management with the ISO 14000 series on
--> environmental management. Technical Committee 207 folks, who worked
--> on the environmental standards, are not in a hurry to revise the
--> documents they worked so hard on and just recently released.
-->
--> We specifically scheduled an extra day of meetings in the USA in
--> October to deal with the expected public input. Remember folks,
--> this is the first time a document such as this has been released to
--> the general public so early in its life. We want and need your
--> thoughts and comments. I encourage USA folks (sorry Marcos) to
--> attend the meetings in Washington, DC. I suspect that the
--> Canadians, British, South Africans, Chinese, and other
--> nations will be holding similar meetings. Further information and
--> registration forms for the USA meetings can be found on the US
--> Standards Group web site, <http://standardsgroup.asq.org>. The
--> meetings are free. You pay your own travel expenses.
-->
--> In summary, it will be a long time until the proposed changes to
--> ISO 9000, 9001 and 9004 are ready for publication. This is NOT the
--> time to start taking positions and strutting around like a rooster.
--> Accept the material in the spirit it is offered. Look at it. Rather
--> than pick at the details, see if the overall concepts are any good.
--> Participate in the national deliberations. Help to make these
--> documents YOUR standards.
-->
--> Dennis Arter, Deputy Chair-Standards
--> ASQ General Technical Council...
 
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