Our ref XXXX
Secretariat of ISO/TC 176/SC 2 Date: DecSeptember 1999
To the Members of ISO/TC 176/SC 2 - Quality Management and Quality Assurance/Quality
Systems
Transition Planning Guidance for ISO/DIS
9001:2000
6.0 SUMMARISED COMPARISON OF KEY ENHANCEMENTS BETWEEN ISO 9001:1994 / ISO 9001:2000
A comparison between ISO 9001:1994 and ISO 9001:2000 related to key enhancements is given in chapter 6.3 The Comparison Guidance Matrix has been developed to assist the user identify in identifying the scope of revisions to ISO 9001:2000. It is important to note that thise comparison matrix is not done a "word byfor word" ", it comparison of requirements and only contains a summary of salient issues relevant to ISO 9001:2000 in consideration of current ISO 9001:1994 requirements.
It is strongly recommended that the user obtain a copy of latest draft of ISO 9001:2000 from their respective ISO member body.
6.1 REQUIREMENTS CORRELATION TABLE BETWEEN ISO 9001:2000 AND
ISO 9001:1994
In the following table, the numbers in brackets show briefly how the quality system requirements of ISO 9001:1994 fit into the new ISO 9001:2000, clauses 5 to 8.
It should be noted that although some clauses in ISO 9001:2000 have the same title as in ISO 9001:1994, the contents may not be exactly the same and the requirements may have been enhanced.
6.2 PERMISSIBLE EXCLUSIONS
Currently an organization is able to seek certification against either ISO 9001:1994, ISO 9002:1994 or ISO 9003:1994 dependent on the scope of their business operations.
The publication of ISO 9001:2000 will result in ISO 9001:1994, ISO 9002:1994 and ISO 9003:1994 becoming obsolete, and will require all organizations to upgrade their certification to ISO 9001:2000.
However, it is recognized that owing to:
the nature of an organization's product;
customer requirements;
applicable regulatory requirements;
not all the requirements of ISO 9001:2000 may be appropriate to every organization.
Therefore ISO 9001:2000 will permit organizations to exclude compliance with specific quality management system requirements that neither affect their ability, nor absolve them from their responsibility, to provide product that meets customer and applicable regulatory requirements, yet still allow those organizations to claim conformity to the standard.
Permissible exclusions will be restricted to clause 7 Product realization of ISO 9001:2000 and will not apply to any other clauses of the standard.
It is recommended that users discuss any intention to exclude certain clauses of ISO 9001:2000 with their selected Certification/Registration Body (see annex A, item 5).
6.3 Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994
ISO 9001:1994 |
ISO/DIS 9001:2000 |
| 1 Scope | 1 |
| 2 Normative reference | 2 |
| 3 Definitions | 3 |
| 4.1 Management responsibility | |
| 4.1.1 Quality policy | 5.1 + 5.3 + 5.4.1 |
| 4.1.2 Organization | 5.5.2 |
| 4.1.2.1 Responsibility and authority | 5.5.2 + 6.2.1 |
| 4.1.2.2 Resources | 5.1 + 6.1 + 6.3 |
| 4.1.2.3 Management representative | 5.5.3 |
| 4.1.3 Management review | 5.6. |
| 4.2 Quality system | |
| 4.2.1 General | 4.1 + 5.1 + 5.4.1 + 5.5.5 |
| 4.2.2 Quality system procedures | 4.2 |
| 4.2.3 Quality planning | 5.4.2 + 7.1 |
| 4.3 Contract review | 7.2.2 |
| 4.4 Design control | 7.3 |
| 4.5 Document and data control | 5.5.6 |
| 4.6 Purchasing | 7.4 |
| 4.7 Control of customer-supplied product | 7.5.3 |
| 4.8 Product identification and traceability | 7.5.2 |
| 4.9 Process control | 7.1 + 7.5.1 + 7.5.5 |
| 4.10 Inspection and testing | 7.1 + 7.5.1 + 8.1 + 8.2.4 |
| 4.11 Control of inspection, measuring and test equipment | 7.6 |
| 4.12 Inspection and test status | 7.5.1 |
| 4.13 Control of nonconforming product | 8.3 |
| 4.14 Corrective and preventive action | 8.4 + 8.5.2 + 8.5.3 |
| 4.15 Handling, storage, packaging, preservation and delivery | 7.1 + 7.5.4 |
| 4.16 Control of quality records | 5.5.7 |
| 4.17 Internal quality audits | 8.2.2 |
| 4.18 Training | 6.2.2 |
| 4.19 Servicing | 7.1 + 7.5.1 |
| 4.20 Statistical techniques | 8.1 + 8.2.3 + 8.2.4 + 8.4 |
Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994 –continued
| ISO/DIS 9001::2000 | ISO 9001:1994 |
| 1 Scope | 1 |
| 1.1 General | |
| 1.2 Permissible exclusions | |
| 2 Normative references | 2 |
| 3 Terms and definitions | 3 |
| 4 Quality management system | |
| 4.1 General requirements | 4.2.1 |
| 4.2 General documentation requirements | 4.2.2 |
| 5 Management responsibility | |
| 5.1 Management commitment | 4.1 + 4.1.2.2 + 4.2.1 |
| 5.2 Customer focus | |
| 5.3 Quality policy | 4.1.1 |
| 5.4 Planning | |
| 5.4.1 Quality objectives | 4.1.1 + 4.2.1 |
| 5.4.2 Quality planning | 4.2.3 |
| 5.5 Administration | |
| 5.5.1 General | |
| 5.5.2 Responsibility and authority | 4.1.2 + 4.1.2.1 |
| 5.5.3 Management representative | 4.1.2.3 |
| 5.5.4 Internal communication | |
| 5.5.5 Quality Manual | 4.2.1 |
| 5.5.6 Control of documents | 4.5 |
| 5.5.7 Control of quality records | 4.16 |
| 5.6 Management review | 4.1.3 |
| 5.6.1 Review input | 4.1.3 |
| 5.6.2 Review output | 4.1.3 |
| 6 Resource management | 4.1.2.2 |
| 6.1 Provision of resources | 4.1.2.2 |
| 6.2 Human resources | |
| 6.2.1 Assignment of personnel | 4.1.2.1 |
| 6.2.2 Training, awareness and competency | 4.18 |
| 6.3 Facilities | 4.9 |
| 6.4 Work environment | 4.9 |
| 7 Product realization | |
| 7.1 Planning of realization processes | 4.2.3 + 4.9 + 4.10 + 4.15 + 4.19 |
| 7.2 Customer-related processes | |
| 7.2.1 Identification of customer requirements | |
| 7.2.2 Review of product requirements | 4.3 |
| 7.2.3 Customer communication |
Correspondence between ISO/DIS 9001:2000 and ISO 9001:1994 - continued
| ISO/DIS 9001::2000 | ISO 9001:1994 |
| 7.3 Design and/or development | 4.4 |
| 7.3.1 Design and/or development planning | 4.4.2 + 4.4.3 |
| 7.3.2 Design and/or development inputs | 4.4.4 |
| 7.3.3 Design and/or development outputs | 4.4.5 |
| 7.3.4 Design and/or development review | 4.4.6 |
| 7.3.5 Design and/or development verification | 4.4.7 |
| 7.3.6 Design and/or development validation | 4.4.8 |
| 7.3.7 Control of design and/or development changes | 4.4.9 |
| 7.4 Purchasing | |
| 7.4.1 Purchasing control | 4.6 |
| 7.4.2 Purchasing information | 4.6 |
| 7.4.3 Verification of purchased products | 4.6 |
| 7.5 Production and service operations | |
| 7.5.1 Operations control | 4.9 + 4.10 + 4.12 + 4.19 |
| 7.5.2 Identification and traceability | 4.8 |
| 7.5.3 Customer property | 4.7 |
| 7.5.4 Preservation of product | 4.15 |
| 7.5.5 Validation of processes | 4.9 |
| 7.6 Control of measuring and monitoring devices | 4.11 |
| 8 Measurement, analysis and improvement | |
| 8.1 Planning | 4.10 + 4.20 |
| 8.2 Measurement and monitoring | |
| 8.2.1 Customer satisfaction | |
| 8.2.2 Internal audit | 4.17 |
| 8.2.3 Measurement and monitoring of processes | 4.20 |
| 8.2.4 Measurement and monitoring of product | 4.10 + 4.20 |
| 8.3 Control of nonconformity | 4.13 |
| 8.4 Analysis of data | 4.14 + 4.20 |
| 8.5 Improvement | |
| 8.5.1 Planning for continual improvement | 4.1.3 + 4.9 |
| 8.5.2 Corrective action | 4.14 |
| 8.5.3 Preventive action | 4.14 |
6.4 SUMMARISED ANALYSIS OF KEY ENHANCEMENTS BETWEEN ISO 9001:1994 / ISO 9001:2000
SCOPE
ISO 9001:2000 - Clause 1.1 "General"
The Scope has been enhanced, including also the requirements to address customer satisfaction through the effective application of the system, including processes for continual improvement and the prevention of nonconformity
ISO 9001:1994 - Clause 1
The requirements specified are aimed primarily at achieving customer satisfaction by preventing nonconformity
ISO 9001:2000 - Clause 1.2 "Permissible exclusions"
This clause is new and is a general description of the application of the term "Permissible exclusions".
When customer requirements, the nature of the organization’s product, or the applicable regulatory requirements do not require certain quality management system requirements for the processes specified in ISO 9001:2000, then the organization is permitted to exclude those requirements of the standard to suit the specifics of the organization.
The organization may only exclude quality management requirements that neither affect the organization’s ability, or absolve it from its responsibility, to provide product that meets customer and applicable regulatory requirements.
Reduced Scope only applies to clause 7 "Product realization" of ISO 9001:2000. An organization is not permitted to reduce the scope of clauses 4, 5, 6 & 8.
There is no corresponding ISO 9001:1994 - Clause
TERMS AND DEFINITIONS
ISO 9001:2000 - Clause 3 "Terms and Definitions"
This clause states that the terms and definitions given in ISO 9000:2000 Quality management systems – Fundamentals and vocabulary, apply to ISO 9001:2000.
The term ‘organization’ used in ISO 9001:2000 replaces the term ‘supplier’, that was used previously to mean the unit to which ISO 9001 applied. The term. ‘supplier’ is now used instead of the previous term ‘subcontractor’
ISO 9001:1994 - Clause 3
The definitions that are given in ISO 8402 apply.
QUALITY MANAGEMENT SYSTEM REQUIREMENTS
ISO 9001:2000 - Clause 4.1 "General Requirements"
Under this clause more emphasis has been added on the need for continuous improvement.
Clarification of the necessary steps to implement a quality management system is given:
a) identify the processes needed for the quality management system,
b) determine the sequence and interaction of these processes,
c) determine criteria and methods required to ensure the effective operation and control of these processes
d) ensure the availability of information necessary to support the operation and monitoring of these processes;
e) measure, monitor and analyse these processes, and implement action necessary to achieve planned results and continual improvement.
ISO 9001:1994 – Clause 4.2.1 is corresponding
ISO 9001:2000 - Clause 4.2 "General Documentation requirements"
Under this clause an indication is given about the documentation required
"The quality management system documentation shall include:
a) documented procedures required in this International Standard
b) documents required by the organization to ensure the effective operation and control of this process
ISO 9001:1994 – Clause 4.2.2 is corresponding
MANAGEMENT RESPONSIBILITY
ISO 9001:2000 - Clause 5.1"Management commitment"
More emphasis is placed on Top Management commitment.
Particular attention should be given to sub-clauses (a), (b) and (e), the latter refers to resources and has a direct link to clause 6 "Resource Management".
a) communicating to the organization the importance of meeting customer as well as regulatory and legal requirements;
b) establishing the quality policy and the quality objectives;
e) ensuring the availability of necessary resources
ISO 9001:1994 – Clauses 4.1; 4.1.2.2 and 4.2.1 are corresponding
ISO 9001:2000 - Clause 5.2 "Customer focus"
This clause reinforces the involvement of top management with customer requirements.
It states that top management shall ensure that customer needs and expectations are determined and converted into requirements and fulfilled with the aim of achieving customer satisfaction
There is no corresponding ISO 9001:1994 - Clause
ISO 9001:2000 - Clause 5.3 "Quality Policy"
This clause has been enhanced to ensure that Top management establishes its policy for quality. Particular attention should be given to sub-clause (b) which includes a commitment to meeting requirements and to continual improvement, and sub-clause (c) now providing a framework for establishing and reviewing quality objectives;
ISO 9001:1994 - Clause 4.1.1 is corresponding
ISO 9001:2000 - Clause 5.4.1 "Quality objectives"
Under this clause the requirement for quality objectives, at relevant functions and levels within the organization has been enhanced.
It also state that the quality objectives shall be measurable and consistent with the quality policy including the commitment to continual improvement.
ISO 9001:1994 - Clause 4.1.1 and 4.2.1 are corresponding
ISO 9001:2000 - Clause 5.4.2 "Quality Planning"
This clause has been revised for clarity and to ensure that managing change is included in planning.
Planning shall cover:
a) the processes of the quality management system, considering permissible exclusions .
b) the resources needed;
c) continual improvement of the quality management system.
Planning shall ensure that change in conducted in a controlled manner and that the integrity of the quality management system is maintained during this change.
ISO 9001:1994 - Clause 4.2.3 is corresponding
ISO 9001:2000 - Clause 5.5.3 "Management Representative"
This clause now further clarifies that Top management shall appoint a member(s) of the management who, irrespective of other responsibilities, shall have defined authority that includes:
(c) promoting awareness of customer requirements throughout the organization
ISO 9001:1994 - Clause 4.1.2.3 is corresponding
ISO 9001:2000 - Clause 5.5.4 "Internal Communication"
This is a new clause that requires the organization to ensure communication between the various levels and functions regarding the processes of the quality management system and their effectiveness
There is no corresponding ISO 9001:1994 - Clause
ISO 9001:2000 - Clause 5.5.5 "Quality Manual"
This clause has been enhanced to include the requirement for an organization to specify and justify any exclusion performed in the quality manual. (refer to clause 1.2 of ISO 9001:2000).
The quality manual shall also have a description of the sequence and interaction of the processes included in the quality management system
ISO 9001:1994 - Clause 4.2.1 is corresponding
ISO 9001:2000 - Clause 5.6 "Management Review"
Further text has been included to address key input and output requirements of a Management review.
Attention should be given to input related sub-clauses:
(b) customer feedback; (c) process performance and product conformance; and (d) status of preventive, and corrective (f) changes that could affect the quality management system.
And output related sub-clauses:
(a) improvement of the quality management system and its processes and (b) improvement of product related to customer requirements
ISO 9001:1994 - Clause 4.1.3 is corresponding
RESOURCE MANAGEMENT
ISO 9001:2000 - Clause 6.1 "Provision of resources"
This clause further clarifies the requirement for an organization to determine and provide, in a timely manner, resources needed to implement and improve the processes of the quality management system and to address customer satisfaction.
ISO 9001:1994 - Clause 4.1.2.2 is corresponding
ISO 9001:2000 - Clause 6.2.2 "Training, awareness and competency"
The scope of this clause has been enhanced to include not only training needs but competence and awareness. The organization shall:
a) identify competency needs for personnel performing activities affecting quality,
b) provide training to satisfy these needs
c) evaluate the effectiveness of training provided
d) ensure that its employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objetives;
d) maintain appropriate records of education, training, skill and experience.
ISO 9001:1994 - Clause 4.18 is corresponding
ISO 9001:2000 - Clause 6.3 "Facilities"
The organization shall identify, provide and maintain the facilities needed to achieve the conformity of product
This shall include:
a) workspace and associated facilities
b) equipment, hardware and software
c) supporting services.
ISO 9001:1994 - Clause 4.9 is corresponding
Under this clause the primary requirement is to ensure processes are carried out under controlled conditions.
ISO 9001:2000 - Clause 6.4 "Work Environment"
The organization shall identify and manage those human and physical factors of the work environment needed to achieve conformity of product.
ISO 9001:1994 - Clause 4.9 is corresponding
PRODUCT REALIZATION
Note: The title of Process Control as traditionally referred to in ISO 9001:1994 has been replaced with the title "Product Realization".
ISO 9001:2000 - Clause 7.1 "Planing of realization processes""
Special attention shall be put on subclauses (a) to (d) that further clarify requirements that shall be met to ensure product realization processes are under control.
ISO 9001:1994 - Clause 4.2.3; 4.9; 4.10; 4.15 and 4.19 are corresponding
ISO 9001:2000 - Clause 7.2.1 "Identification of customer requirements""
Under this clause two new requirements have been added in the process of determining customers needs.
b) product requirements not specified by the customer but necessary for intended or specified use;
c) obligations related to product, including regulatory and legal requirements
There is not a corresponding ISO 9001:1994 clause
ISO 9001:2000 - Clause 7.2.3 "Customer Communication"
This clause is essentially a new requirement, the organization is required to implement effective liaison with customers, with the aim of meeting customer requirements.
In defining its communication requirements the organization is required to meet a number of sub-clause requirements from (a) to (c)
There is not a corresponding SO 9001:1994 Clause
ISO 9001:2000 - Clause 7.3.2 "Design and/or Development Inputs"
This clause has been enhanced to include clarification of the design input requirements that are to be met. Particular attention should be given to the following sub-clauses:
a) performance requirements from customer or market
ISO 9001:1994 - Clause 4.4.4 is corresponding
ISO 9001:2000 - Clause 7.3.4 "Design and/or Development Review"
This clause has been enhanced to clarify that design and development reviews must be systematic in ensuring conformance with input requirements. If during the review process a problem is identified the organization shall propose the follow up actions.
In addition to recording reviews, the results of subsequent follow-up actions SHALL be recorded.
ISO 9001:1994 - Clause 4.4.6 is corresponding
ISO 9001:2000 - Clause 7.3.7 "Control of design and/or development changes"
This clause now includes a requirement for the organization to determine the effect of change on constituent parts and delivered product. The changes shall be verify and validated before implementation.
ISO 9001:1994 - Clause 4.4.9 is corresponding
ISO 9001:2000 - Clause 7.5.5 "Validation of processes"
This clause now includes a requirement for the organization to carry out process validation.
The organization shall define arrangements for validation that shall include the following, as applicable:
a) qualification of processes
b) qualification of equipment and personnel
c) use of defined methodologies and procedures
d) requirements for records
e) re-validation
ISO 9001:1994 - Clause 4.9 is corresponding
MEASUREMENT, ANALYSIS AND IMPROVEMENT
ISO 9001:2000 - Clause 8.1 "Planning"
This clause requires that measurement and monitoring activities needed to assure conformity and achieve improvement shall be defined, planned and implemented.
This shall include the determination of the need for, and use of, applicable methodologies including statistical techniques.
ISO 9001:1994 - Clause 4.10 and 4.20 are corresponding
ISO 9001:2000 - Clause 8.2.1 "Customer satisfaction"
This clause is new and emphasizes that the organization shall monitoring information on customer satisfaction and/or dissatisfaction as one of the measurement of performance of the quality management system.
There is no corresponding ISO 9001:1994 - Clause
ISO 9001:2000 - Clause 8.2.3 "Measuring and monitoring of processes"
This clause has been enhanced by:
These methods shall confirm the continuing ability of each process to satisfy its intended purpose
ISO 9001:1994 – Clause 4.20 is corresponding
ISO 9001:2000 - Clause 8.4 "Analysis of Data"
In addition to the traditional statistical technique requirement of the 1994 version, this clause focuses on the Analysis of applicable data as one means of determining where quality management system improvements can be made.
The organization SHALL analyze this data to provide information on:
customer satisfaction, and dissatisfaction
conformance to customer requirements
c) characteristics of processes, products and their trends;
d) suppliers
ISO 9001:1994 – Clauses 4.14 and 4.20 are corresponding
ISO 9001:2000 - Clause 8.5.1 "Planning for continual improvement"
The organization shall plan and manage the processes for the continual improvement of the quality management system. The organization shall use the quality policy, objectives, internal audit results, analysis of data, corrective and preventive action and management review to facilitate continual improvement.
ISO 9001:1994 - Clauses 4.13 and 4.9 are corresponding