ISO 9001:2008; TS 16949; ISO 13485; ISO 14001 (EMS); ISO 22000; Registrar Services,EEOC/Title 7 Training,AS9100 Rev. C;  IECQ QC 080000; ISO 26000;  ISO/IEC 17025;  A2LA ,OHSAS 18001; HACCP; Healthcare; Social Services,International Consulting; Medical Device,Quality Management Systems; QMS Quality Consulting and TrainingCT NY NJ MA Connecticut New York New Jersey Mass   ISO 9001:2008 A summary of changes
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On November 15, 2008 the revision to ISO 9001:2000, ISO 9001:2008 was published.  While the changes represent no new requirements, it does serve to clarify and place emphasis on requirements inherent in the 2000 revision that may not have been fully understood or incorporated in many implementations. Below, we have provided a clause-by-clause description of the changes that are now part of ISO 9001:2008. ISO 9001:2000 certifications will remain valid until November 2010, but organizations are urged to study the changes and evaluate their current degree of compliance and address deficiencies sooner rather than later.

 0.1 General
The standard provides the ability to meet any statutory requirements along with regulatory requirements. 
It's also clarified that these requirements are restricted to those which are applicable to the product.


0.2 – Process approach
Text added to identify a process as "an activity or set of activities"


0.3 - Relationship with ISO 9004
Revised to emphasize continual improvement. Now specifies that ISO 9004 can be used "to move beyond the requirements of ISO 9001."


0.4 - Compatibility with other management systems
Added reference to Annex A, which compares ISO 9001:2008 and ISO 14001:2004.


1.1 and 1.2 - Scope
First note clarifies that the term product can be any intended output from the product realization process. A second note explains that a statutory requirement can also be a legal requirement.


2 - Normative references
Clarification for current reference - the ISO 9000:2000 is now replaced by ISO 9000:2005.


3 - Terms and definitions
Explanation of "customer," "organization" and "supplier" terms have been removed.


4.1 - General requirements
Clause a - The word "determine" replaces the word "identify" for processes.
Notes cover definition of outsourced process and types of control that may be applied to these processes. Reference to clause 7.4 has been added.


4.2.1 – Documentation requirements, general
Clarification that QMS documentation also includes records. Note 1 was changed - a single document may address the requirements for one or more procedures, and a requirement for a documented procedure may be covered by more than one document.


4.2.3 (f) - Control of documents
Clarification that only external documents determined by the organization to be necessary for the planning and operation of the QMS need to be identified and have their distribution controlled.


4.2.4 - Control of records
Editorial changes to better align with ISO 14001.


5.5.2 - Management representative
Additional clarification that the management representative be a part of the organization’s management.


6.2.2 - Competence, training and awareness
Clause b – "provide training or take other actions to satisfy these needs" changed to "where applicable, provide training or take other action to achieve the necessary competence"


6.3 - Infrastructure
Clause c – Clarification that "information systems" are included as part of the infrastructure.


6.4 - Work environment
Clarification of "work environment" to include conditions under which work is performed. These conditions include noise, temperature, humidity, lighting, and weather as part of the working environment.


7.1 (c) - Planning of product realization
The term "measurement" had been added to the activities.


7.2.1 - Determination of requirements related to the product
Note includes clarification of the meaning of "post delivery activities."


7.3.1 - Design and development planning
A note has been added clarifying that design and development review, verification and validation have distinct purposes. However, they can be conducted and recorded separately or in any combination, as suitable for the product and the organization.


7.3.3 - Design and development outputs
Note added to clarify that information needed for production and service provision may include details for preservation of the product.


7.5.3 - Identification and traceability
Added/clarified that the organization shall identify product status with respect to monitoring and measuring requirements throughout product realization.


7.5.4 - Customer property
Slight wording change in the requirement to inform the customer of any problem regarding his property. 

The note has been amended to specify that personal data is "customer property."

7.5.5 - Preservation of product
Slight wording changes:
– Added "in order to maintain conformity to requirements."
– Addition of the term "As applicable," preservation shall include …”


7.6 - Control of monitoring and measuring equipment
7.6 has changed from monitoring and measuring “devices” to “equipment”
The reference to paragraph 7.2.1 has been removed.
Clause a – Changed "and/or" to "or," so it now reads "be calibrated or verified, or both."
Clause c – from "be identified to enable the" to "have identification in order to"
Note 1 – the references to ISO 10012-1 and ISO 10012-2 have been removed
Note added – 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.


8.2.1 - Customer satisfaction
Note added to explain that monitoring of customer perception can include input from sources such as customer satisfaction surveys, customer data on delivered product quality, user opinion surveys, lost business analysis, compliments, warranty claims, and dealer reports.


8.2.2 - Internal audit
The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay to eliminate detected nonconformities and their causes.  

Records of audits include audit results.
The references to ISO 10011-1, ISO 10011-2, and ISO 10011-3 are now changed to ISO 19011.


8.2.3 - Monitoring and measurement of processes
A change of words: "to ensure conformity of the product" was removed at the end of the last sentence. 
Note added:  "When determining suitable methods, it is advisable that the organization should 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 quality management system."


8.3 - Control of nonconforming product
Editorial changes only – rearrangement of the paragraphs.


8.4 - Analysis of data

References to other clauses updated in items b), c), and d).


8.5.2 - Corrective action

Item f) updated to read "reviewing the effectiveness of the corrective action taken."


8.5.3 - Preventive action
Item e) updated to read "reviewing the effectiveness of the preventative action taken."


Need more information on the details of the 2008 revision, or help implementing changes, training staff, auditing, etc.?

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