Article: Records required by ISO 9001:2008

Records required by ISO 9001:2008

5.6.1 Management reviews

6.2.2 e) Education, training, skills and experience

7.1 d) Evidence that the realization processes and resulting product fulfil requirements

7.2.2 Results of the review of requirements related to the product and actions arising from the review

7.3.2 Design and development inputs relating to product requirements

7.3.4 Results of design and development reviews and any necessary actions

7.3.5 Results of design and development verification and any necessary actions

7.3.6 Results of design and development validation and any necessary actions

7.3.7 Results of the review of design and development changes and any necessary actions

7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations

7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement

7.5.3 The unique identification of the product, where traceability is a requirement

Article: Terms and Definitions relating to Documents

Terms and Definitions relating to Documents

• Document 3.7.2 information and its supporting medium
• Procedure 3.4.5 specified way to carry out an activity or a process (Note: Procedures can be documented or not)
• Quality Manual 3.7.4 document specifying the quality management system of an organization
• Quality Plan 3.7.5 document specifying which procedures and associated resources shall be applied by whom and when to a specific project, product, process or contract

Article: Demonstrating conformity with ISO 9001:2008

Demonstrating conformity with ISO 9001:2008

For organizations wishing to demonstrate conformity with the requirements of ISO 9001:2008, for the purposes of certification/registration, contractual, or other reasons, it is important to remember the need to provide evidence of the effective implementation of the QMS.

• Organizations may be able to demonstrate conformity without the need for extensive documentation.
• To claim conformity with ISO 9001:2008, the organization has to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Clause 3.8.1 of ISO 9000:2005 defines “objective evidence” as “data supporting the existence or verity of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”

Article: Organizations wishing to adapt an existing QMS

Organizations wishing to adapt an existing QMS

For organizations that currently have a QMS the following comments are intended to assist in understanding the changes to documentation that may be required or facilitated by the transition to ISO 9001:2008

• An organization with an existing QMS should not need to rewrite all of its documentation in order to meet the requirements of ISO 9001:2008. This is particularly true if an organization has structured its QMS based on the way it effectively operates, using a process approach. In this case, the existing documentation may be adequate and can be simply referenced in the revised quality manual.
• An organization that has not used a process approach in the past will need to pay particular attention to the definition of its processes, their sequence and interaction.

Article: Organizations preparing to implement a QMS

Organizations preparing to implement a QMS

For organizations that are in the process of implementing a QMS, and wish to meet the requirements of ISO 9001:2008, the following comments may be useful.

− For organizations that are in the process of implementing or have yet to implement a QMS, ISO 9001:2008 emphasizes a process approach. This includes:

• determining the processes necessary for the effective implementation of the quality management system
• determining the interactions between these processes.
• documenting the processes to the extent necessary to assure their effective operation and control. (It may be appropriate to document the processes using process maps. It is emphasized, however, that documented process maps are not a requirement of ISO 9001:2008.)

Article: Guidance on Clause 4.2 of ISO 9001:2008

Guidance on Clause 4.2 of ISO 9001:2008

The following comments are intended to assist users of ISO 9001:2008 in understanding the intent of the general documentation requirements of the International Standard.

a) Documented statements of a quality policy and objectives:

− Requirements for the quality policy are defined in clause 5.3 of ISO 9001:2008. The documented quality policy has to be controlled according to the requirements of clause 4.2.3. Note Organizations that are revising their quality policy for the first time, or in order to meet the amended requirements in ISO 9001:2008, should pay particular attention to clause 4.2.3 (c), (d) and (g).

− Requirements for quality objectives are defined in clause 5.4.1 of ISO 9001:2008. These documented quality objectives are also subject to the document control requirements of clause 4.2.3.

b) Quality Manual:

− Clause 4.2.2 of ISO 9001:2008 specifies the minimum content for a quality manual. The format and structure of the manual is a decision for each organization, and will depend on the organization’s size, culture and complexity. Some organizations may choose to use the quality manual for other purposes besides that of simply documenting the QMS

− A small organization may find it appropriate to include the description of its entire QMS within a single manual, including all the documented procedures required by the standard.

− Large, multi-national organizations may need several manuals at the global, national or regional level, and a more complex hierarchy of documentation.

− The quality manual is a document that has to be controlled in accordance with the requirements of clause 4.2.3.

Article: ISO 9001:2008 Documentation Requirements

ISO 9001:2008 Documentation Requirements

ISO 9001:2008 clause 4.1 General requirements requires an organization to “establish, document, implement, and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standard”

Clause 4.2.1 General explains that the quality management system documentation shall include:

a) documented statements of a quality policy and quality objectives;

b) a quality manual

c) documented procedures required by this International Standard

d) documents needed by the organization to ensure the effective planning, operation and control of its processes, and

e) records required by this International Standard;

Requirements of ISO 9001:2008 - What is a document

Article: Requirements of ISO 9001:2008 - What is a document

What is a “document”? - Definitions and references

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;

a) Communication of Information

- as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

b) Evidence of conformity

- provision of evidence that what was planned, has actually been done.

c) Knowledge sharing

- to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

Guidance on the Documentation Requirements of ISO 9001:2008 - Introduction

Article: Guidance on the Documentation Requirements of ISO 9001:2008 - Introduction

Introduction

Two of the most important objectives in the revision of the ISO 9000 series of standards have been
a) to develop a simplified set of standards that will be equally applicable to small as well as medium and large organizations, and
b) for the amount and detail of documentation required to be more relevant to the desired results of the organization’s process activities.