ISO 9001:2008

Frequently Asked Questions (FAQ)

Please read this FAQ in conjunction with the ISO 9001:2000 FAQ and “Understanding ISO 9001”. 

What Are The More Significant Changes In ISO 9001:2008 From ISO 9001:2000? 

As indicated earlier in this FAQ, most of the changes in ISO 9001:2008 focus on clarifying requirements; providing greater consistency; resolving perceived ambiguities; correcting improper English; updating internal links; use of active instead of passive tense; and improving compatibility with ISO 14001.

Here are the changes that may require you to fine-tune your QMS: 

Clause 0 - The words “organizational environment”, “change”, and “risk” are added to the list of factors that influence the design and implementation of a QMS. It also adds "regulatory" to "statutory and regulatory” and clarifies that the customer, statutory, and regulatory requirements are applicable to both the product and organization’s own requirements. 

A Note about the upcoming revision to ISO 9004. ISO plans extensive changes to ISO 9004:2000 expected to be published in 2009, which will include a new clause structure that will no longer match that of ISO 9001. As a result, ISO 9001:2008 no longer refers to the two standards as having, "similar structures in order to assist their application as a consistent pair." The title of the revamped ISO 9004 is expected to be, “Managing for the Sustained Success of an Organization - A Quality Management Approach”.   

Compatibility with Other Management Systems - reference is now made to ISO 14001:2004 instead of ISO 14001:1996, and also to the appendix that compares the clauses of ISO 9001:2008 to the clauses of ISO 14001:2004.

Clause 1 – Scope -    ISO 9001:2008 has expanded the term "regulatory" to "statutory and regulatory" and in the note expanded Product to include any intended output resulting from the product realization processes. A second Note is added to explain that “statutory and regulatory” requirements can be expressed as “legal” requirements.

Clause 2 and 3 – Minor Changes 

Clause 4 - Quality Management System 

General Requirements - with regard to outsourced processes -  instead of previously just identifying controls over outsourced processes, you must now define the type and extent of control to be applied to these outsourced processes. A new note 3  identifies the factors that influence the control of an outsourced process.

NOTE 3: Ensuring control over outsourced processes does not absolve the organization of the responsibility of conformity to all customer, statutory, and regulatory requirements. The type and extent of control to be applied to the outsourced process can be influenced by factors such as: 

a) the potential impact of the outsourced process on the organization's capability to provide product that conforms to requirements;

b) the degree to which the control for the process is shared;

c) the capability of achieving the necessary control through the application of clause 7.4. 

Documentation Requirements 

General – greater flexibility is provided in documenting QMS procedures - A single document may include the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document. 

An example for the first sentence would be a single procedure covering the requirements for 4.2.3, Control of Documents, and 4.2.4 Control of Records. An example for the second sentence would be splitting the required procedure for the Control of Documents into two separate documented procedures.

Control of Documents – only control those external documents determined by the organization to be necessary for the planning and operation of the QMS…...

Control of Records – QMS Records must be controlled instead of just being maintained and “retention time” is substituted by just “retention”.

Clause 5 - Management Responsibility

Management Representative – the   Management Representative must now be a member of the organization’s own management team. Some companies outsource the Management Representative role to someone in a different organization, or perhaps a consultant. This text change may be aimed at detering that practice.

Clause 6 - Resource Management 

Human Resources – a new note has been added indicating that: Conformity to product requirements can be affected directly or indirectly by personnel performing any task within the QMS. This suggests that all personnel performing, verifying, or managing work within the scope of the QMS, must be competent. 

Infrastructure – now includes "information systems" as an example of a supporting service

Work Environment – a new note clarifies the term "work environment" as relating to those conditions under which work is performed including physical, environmental, and other factors (such as noise, temperature, humidity, lighting, or weather). 

Clause 7 - Product Realization 

Planning of Product Realization – The word "measurement" is added as one of the required activities to be determined during the planning of product realization.

Customer-Related Processes - post delivery activities include, for example - actions under warranty provisions, contractual obligations such as maintenance services, and supplementary services such as recycling or final disposal. 

Design and Development – a  new note has been added: Information for production and service provision can include details for the preservation of product .This ties in with clause 7, Production and Service Provision, sub-clause 7.5.5, Preservation of Product.

Identification and Traceability – you must identify product status with respect to monitoring and measurement requirements throughout product realization and you must keep records of traceability. 

Customer Property - Customer property now includes personal data. 

Preservation of product – the word “as applicable” is added to provide flexibility in using preservation controls.  

Control of Monitoring and Measuring Equipment – the word “equipment” is substituted for “devices”. A new note states that - confirmation of the ability of computer software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use. 

Clause 8 - Measurement, Analysis, and Improvement  

Customer Satisfaction - A new Note has been added to provide examples of monitoring customer perceptions: Monitoring customer perception can include obtaining input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, dealer reports. 

Internal Audit – actions taken by management responsible for the area being audited now include any necessary corrections and corrective  actions…... 

Monitoring and Measurement of Processes - a note added to elaborate on determining suitable methods: When determining suitable methods, it is advisable that the organization consider the type and extent of monitoring or measurement appropriate to each of its processes in relation to their impact on the conformity to product requirements and on the effectiveness of the QMS. 

Monitoring and Measurement of Product – the control for release of product is clarified to mean release of product for delivery to the customer.

Corrective Action and Preventive action – the word “review” has been clarified to mean reviewing the “effectiveness” of corrective and preventive actions taken.  

Annex A - Table A.1 in the Annex was revised to show the correspondence of ISO 9001:2008 clauses with ISO 14001:2004 (instead of ISO 14001:1996). Table A.2 shows the reverse correspondence, from ISO 14001:2004 clauses to ISO 9001:2008 clauses.

Annex B – The new Annex B (Table B.1) identifies the text changes from ISO 9001:2000 to ISO 9001:2008. The clause structure of ISO 9001:2000 and ISO 9001:2008 remain the same.

Bibliography – The Bibliography for ISO 9001:2008 has been updated to reflect new standards, new editions of standards, and withdrawn standards since the publication of ISO 9001:2000. These include:

New Standards 

·      ISO 10001:2007, Customer satisfaction - Guidelines for codes of conduct for organizations 

·      ISO 10002:2004, Customer satisfaction - Guidelines for complaints handling in organizations 

·      ISO 10003:2007, Customer satisfaction - Guidelines for dispute resolution external to organizations 

·      ISO 10019:2005, Guidelines for the selection of quality management system consultants and use of their services  

·       ISO 19011:2002, Guidelines for quality and/or environmental management systems auditing  

·      IEC 61160:2006, Design review I 

·       ISO 90003:2004, Software engineering - Guidelines for the application of ISO 9001:2000 to computer software 

New Editions 

·      ISO 9004:200x, Managing for the sustained success of an organization - A quality management approach

·       ISO 10005:2005, Quality management systems - Guidelines for quality plans  

·       ISO 10006:2003, Quality management systems - Guidelines for quality management in projects  

·       ISO 10007:2003, Quality management systems - Guidelines for configuration management  

·       ISO 10012:2003, Requirements for measurement processes and measuring equipment  

·      ISO/TR 10013:2001, Guidelines for quality management system documentation  

·      ISO 10014:2006, Quality management - Guidelines for realizing financial and economic benefits  

·       ISO/TR 10017:2003, Guidance on statistical techniques for ISO 9001:2000  

·      ISO 14001:2004, Environmental management systems - Requirements with guidance for use  

·      IEC 60300-1:2003, Dependability management - Part 1: Dependability management systems 

ISO References

·      Introduction and Support to ISO 9001:2008

AskartSolutions References

·     Understanding ISO 9001

·      ISO 9001:2000 FAQ

·     ISO 9001 Lead Auditor Course