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ISO 9001 - TS 16949 Information Exchange

The following document is provided as a service to those seeking
to achieve and/or maintain ISO and/or QS 9000 compliance.
This particular document is now OBSOLETE but does serve as a historical interest as the ISO900x series evolves.

Changes Made in the 1994 Version of ISO 9001 from the 1987 Version

Directives of the International Organization for Standardization require that all standards be reviewed every five years. The purpose of this review is to ensure that:

• The standards reflect experience gained from its practical application.The standards remain stable to facilitate ongoing training and use.
• The standards are usable by companies regardless of size, industry or product offering.

New definitionsFollowing the changes to the Standard, the term "product" is defined as "the result of activities or processes". With the introduction of generic product categories, the term "product" will also encompass"hardware", "software", "processed material" and "services", or any combination of these.Furthermore, the Standard will apply only to "intended product" and not "waste products". Where "by-products" are produced, these may be referenced accordingly in the agreed scope of the assessment.

As a result, the ISO 9000 series of standards has been revised and officially adopted in July 1994. The most significant changes from the 1987 version of ISO 9001 are as follows:

• The importance of using third-party registration agencies is now recognized by the language of the Standard.The term "customer" replaces the term "purchaser".
• The introduction mentions the assessment of quality capabilities by external parties (i.e., third party registration agencies).

Quality Policy
Subclause 4.1.1
The revised standard now contains an additional requirement for "the quality policy to be relevant to the supplier's organization and goals and the expectations and needs of its customers". In practice,, this change should have little impact on organizations with an existing well thought out quality policy. It must, however, be considered in relation to the new changes to 4.1.3 'Management Review'. These introduce a requirement for reviews to be performed at defined intervals, and for each review to ensure suitability and effectiveness in satisfying both the standard and the company's declared quality policy and objectives. The immediate effect of the changes significant. However, over a period of time,, assessors will look for evidence that the policy is being reviewed and revised to reflect changes in the company's and its customers' needs and expectations.Organization
Subclause 4.1.2.1 'Responsibility and Authority'There is now a clear requirement fot "The responsibility, authority, and interrelation of personnel who manage, perform and verify work affecting quality" to be documented,, where previously was only implied. Also, the requirements relating to prevention and recording of non-conformities and problems, has been extended to include areas relating to process and quality systems.Policy Statement (extract)
We Must:

• Listen to our CustomersUnderstand each Customers' RequirementsComplete each Task CorrectlyComplete each Task On TimeCommunicate Effectively With Each OtherNever Make Promises We Cannot Keep
• Treat All Customers and Each Other with Respect

Resources
Subclause 4.1.2.2Is now broader than"verification resources and personnel" was. It now includes reference to management, trained personnel, work performance, and verification activities. The requirement for independent personnel carrying out design reviews has been removed. The requirement for independence of audit personnel has been moved to 4.17. It is not anticipated that this will result in changed methods of assessment or any additional examination to determine the adequacy of resources. However, if there ie evidence of a resource-related problem, the reporting mechanism will link to this section.
Until now,, assessments have not traditionally directly evaluated what resource is required and whether it is adequate. Even when problems were directly attributable to resource issues, they were generally measured against some other area of the standard, rather than resourcing elements. If, for example, a calibration system had broken down due to lack of personnel, the problem would have been noted under the3 calibration section of the standard rather than resourcing. This change should aloow assessors to identify more accurately occasions where resourcing is the root cause of the problemManagement Representative
Subclause 4.1.2.3
The Management Representative must now be appointed by "management with executive responsibility." The Management Representative is now explicitly required to report on the Quality System for the purpose of management review and improvement. Note that the overall responsibility for review must be with Executive Management. This does not, however,, prevent the Management Rep from delegating tasks such as the production of reports which form the basis of the management review. It also hi-lights the report and the review as a basis of and for quality improvement. So in effect, the changes tocurrent assessment practices is minimal. The statement contained within clause 4.1.2.3 relating to "own management" is notconsidered to be significant and should not affect organizations with established systems such as "Q-Share" for sharing a quality manager. Attention will be paid to quality and general systems maintenance as well as quality improvement through corrective actions and management review systems.Management Review
Subclause 4.1.3
This now gives a clear requirement for reviews to be performed at defined intervals. There is also a requirement for each review to measure suitability and effectiveness against the declared quality policy and objectives in addition to the requirements of the standards. The changes in 4.1.2.3 and other sections of the standard are probably more significant for management review than changes to 4.1.3. Their combined effect is to emphasize the importance and nature of management review.Quality System - General
Subclause 4.2.1
Now includes an explicit requirement for a quality manual that defines the documentation structure of the Quality System, including "reference to the quality system procedures and outline [of] the structure of the documentation used in the quality system."
A large portion of approved companies will already ahve a heirarchical system consisting of a quality manual and procedures. Action may be needed to ensure this is adequately described or cross-referenced. The quality manual its self does not need to be called a "Quality" manual. You must be able to demonstrate (read EXPLAIN) how you meet the quality manual requirements.Quality System Procedures
Subclause 4.2.2
Now clarifies the degree of documentation required for the Quality System. It states that the extent of documented procedures required for work activities shall depend upon "the complexity of the work, the methods used, and the skills and training needed by personnel involved in carrying out the activity."
In the main, this is a re-statement of the existing requirements with the additional requirement to produce documented procedures "consistent with" as opposed to "in accordance with" the requirements of the standard and the supplier's stated quality policy. It is assumed it will facilitate the taoiloring of the standard as set out in section 0 (the introduction).
It is intended that the use of the term "consistent with" will also encourage assessors to deal with any "tailoring" in a practical and constructive manner. This should give companies under assessment the opportunity to challenge suggestions made by the assessor which they feel would result in over documentation of the system. This requirement has always been implied and is not expected to change methods of assessment.Quality Planning
Subclause 4.2.3
Is entirely new. It replaces section 4.2 (ISO 9001-1987.). It formalizes the requirement for suppliers to document precisely how the requirement for quality will be met in a format which suits their ownparticular methods of operation. It covers Quality System planning and product quality plans. It states that the quality plan for a product, project, or contract may be in the form of a detailed reference to those documented procedures of the Quality System that are appropriate to providing complete assurance of product quality. Most of the information to be considered was in the "Note" in the 1987 version of the Standard.Note that there is no specific requirement for "quality palns" as such. This revision is intended to stress the importance of planning for quality but it is unlikely to make any difference in assessmentrterms.Contract Review
Subclause 4.3
Now includes pre-contract tender arrangements as well as contracts and ordering requirements within its scope. It also includes provisions for orders received by verbal means and requires identifying how amendments to a contract will be handled.Subclause 4.3.1
GeneralThe requirement for documented procedures, which was previously only implied, has been clearly defined.Subclause 4.3.2
ReviewThe scope of contract review has been clarified to cover accepted tenders, contracts and orders, and also identifies specific requirements relating to verbal orders. For verbal orders, a written statement of the requirement may already exist in the form of a specification, catelogue entry,, etc. References should be made to such written statements. In the absence of written statements, the supplier has a duty to ensure that all customer requiremetns are clearly understood and agreed to before accepting the order. Typically this involves recording the customer's requirements and then either reaem back or providing a documented statement to form the basis of agreement for the subsequent order.Subclause 4.3.3
Amendment to ContractOrganizations must now identify how contract amendments are handled. This should not be a problem as it only clarifys the earlier implication.Design Control
Subclause 4.4
Has been expanded to include design validation, and separate requirements for design review and design verification.Design Input
Subclause 4.4.4
Must include applicable statutory and regulatory requirements.Design Output
Subclause 4.4.5
Specifically states that documents shall be reviewed before release.Design Reviews
Subclause 4.4.6
Is a new section stating that design reviews are mandatory and must be planned, conducted and documented.Design Verification
Subclause 4.4.7
States that design verification must be carried out at appropriate stages of design and must ensure that "design stage output meets the design stage input requirements."Design Validation
Subclause 4.4.8
Is new and is in addition to "design verification." Design validation must ensure that the product conforms to defined user needs or requirements. This is in addition to design verification which must ensure that design stage output meets design stage input requirements. Design validation follows successful design verification and is normally performed on the final product.Design Changes
Subclause 4.4.9<br> Still requires controls, but no longer requires design control "procedures", since this control naturally falls within the requirement for document and data control.Document and Data Control
Subclause 4.5
Is expanded to include "data" and "documents of external origin such as standards and customer drawings." The use of electronic media is recognized in a note. Fortunately, "obsolete documents" may be "retained for legal or knowledge-preservation purposes" if they are "suitably identified."Purchasing, General
Subclause 4.6.1
Now requires documented procedures to "ensure that purchased product (see 3.1) conforms to specified requirements."Supplier Verification at Subcontractor's Premises
Subclause 4.6.4.1
New. Requires that if source inspection is to be used, it must be specified in the purchasing documents.Product Identification and Traceability
Subclause 4.8
Requires traceability,where applicable, to begin at receipt rather than during production.Process Control
Subclause 4.9
Now includes servicing and has added requirements for maintaining process equipment to ensure continuing process capability. The previous section 4.9.2 on "special processes" has been incorporated into the text of section 4.9. The requirements for qualification of equipment and personnel to carry out process operations shall be specified.Inspection and Testing
Subclause 4.10.1
Requires the quality plan or documented procedures to specify the required inspection, testing, and quality records.Inspection and Test Status
Subclause 4.12
Specifies that status "shall be maintained , as defined in the quality plan and/or documented procedures, throughout production, installation and servicing of the product."Corrective and Preventive Action
Subclause 4.14
Now includes separate requirements for corrective and preventive action. Corrective action refers to eliminating the causes of actual nonconformities, and preventive action refers to eliminating the causes of potential nonconformities. Requirements to implement and record changes in documented procedures and the use of formal procedures for handling customer complaints have been clarified and strengthened.Preventive Action
Subclause 4.14.3
Now requires that "relevant information on actions taken is submitted for management review."Control of Quality Records
Subclause 4.16
Allows for storage on electronic or other media. Procedures must address access to quality records. Records no longer have to be "identifiable to the product involved."Training
Subclause 4.18
Now requires documented procedures.

Statistical Techniques
Subclause 4.20
Requires statistical techniques to be identified and the methodology of doing so.

This page last reviewed or edited: Sun, 2007-02-04 16:57 (Coordinated Universal Time [ZULU] -5 hours)

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