Outsourced Processes In ISO 9001 Standards

Outsourced Processes In ISO 9001 Standards

One of the changes in ISO 9001:2008 is clarification of the role of outsourced processes in aquality management system. Guidance on ‘Outsourced processes’ helps clarify the intent and shows the linkage between Clause 4.2, where outsourced processes appear, and the purchasing controls in clause 7.4.
An outsourced process is a process that the organization needs for its quality management system and is performed by an external party. This party could be another company, a corporate service, another division, etc.
The organization needs to ensure the outsourced process is conducted in accordance with ISO 9001:2008 and other requirements of the quality management system. This brings in the purchasing controls of 7.4. The service may not be purchased in the traditional sense of a monetary transaction. The guidance document explains that the controls in clause 4.2 and 7.4 apply. For example, a “no charge” service from a corporate head office requires documentation of supplier selection and, most importantly, control.
The guidance document addresses two important cases and gives guidance on the appropriate level of control. The cases are:
• The organization has the competence and ability to carry out a process, but chooses to outsource it (for commercial or other reasons).
• The organization does not have the competence to carry out the process itself, and chooses to outsource it.

Update on ISO 9001:2008

Update on ISO 9001:2008

Following a recent meeting of ISO’s Technical Committee TC176 in Helsinki, Finland, from June

11 – 15t, 2007, publication of the new version of ISO 9001 has been brought forward from 2009

and is now scheduled to be published in October 2008. Experts representing over 70 ISO member

bodies, met to discuss the comments received during circulation of the Committee Draft (”CD”) of

the new standard, and concluded that in view of the very limited changes being proposed, the draft

is now sufficiently mature to progress directly to the DIS (Draft International Standard).

The main changes being introduced into the new standard are as follows:

Clause 0.2 (Process approach)

Text added to emphasize the importance of processes being capable of achieving desired outputs

Clause 1.1 (Scope)

Clarification that “product” also includes intermediate product

Explanation regarding statutory, regulatory and legal requirements

Clause 4.1 (General requirements)

Notes added to explain more about outsourcing

Types of control that may be applied to outsourced processes

Relationship to clause 7.4 (Purchasing)

Clarification that outsourced processes are still responsibility of the organization and must be

included in the quality management system

Clause 4.2.1 (Documentation)

Clarification that QMS documentation also includes records

Documents required by the standard may be combined

ISO 9001 requirements may be covered by more than one documented procedure

Clause 4.2.3 (Document control)

Clarification that only external documents relevant to the QMS need to be controlled

Clause 4.2.4 (Records control)

Editorial changes only (better alignment with ISO 14001)

Clause 5.5.2 (Management rep)

Clarifies that this must be a member of the organization’s own management

Clause 6.2.1 (Human resources)

Clarification that competence requirements are relevant for any personnel who are involved in the

operation of the quality management system

Clause 6.3 (Infrastructure)

Includes information systems as example

Clause 6.4 (Work environment)

Clarifies that this includes conditions under which work is performed and includes, for example

physical, environmental and other factors such as noise, temperature, humidity, lighting, or weather

Clause 7.2.1 (Customer related processes)

Clarifies that post-delivery activities may include:

- Actions under warranty provisions

- Contractual obligations such as maintenance services

- Supplementary services such as recycling or final disposal

Clause 7.3.1 (Design & development planning)

Clarifies that design and development review, verification and validation have distinct purposes

These may be conducted and recorded separately or in any combination as suitable for the product

and the organization

Clause 7.3.3(Design & development outputs)

Clarifies that information needed for production and service provision includes preservation of the product

Clause 7.5.4 (Customer property)

Explains that both intellectual property and personal data should be considered as customer property

Clause 7.6 (Now retitled Control of Monitoring and Measuring equipment)

Explanatory notes added regarding the use of computer software: “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 8.2.1 (Customer satisfaction)

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

Clause 8.2.3 (Monitoring / Measurement of process)

Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

ISO 9001:2008 Requirements – Documentation Requirements

ISO 9001:2008 Requirements – Documentation Requirements

Include in the quality management system documentation:
? Documented statements of a quality policy and quality objectives
? A quality manual
? Documented procedures and records required by ISO 9001
? Documents and records determined by the organization to be necessary for the effective planning, operation, and control of its processes
NOTE 1: Where “documented procedure” appears within the Standard, this means that the procedure is established, documented, implemented, and maintained. A single document may address the requirements for one or more procedures. A requirement for a documented procedure may be covered by more than one document.
NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to:
? Size of the organization and type of activities
? Complexity of processes and their interactions
? Competence of personnel
NOTE 3: The documentation can be in any form or type of medium.
4.2.2 Quality Manual
Establish and maintain a quality manual with:
? Scope of the quality management system
? Details and justification for any exclusions
? Procedures or references to the procedures
? Description of interaction between processes
4.2.3 Control of Documents
Control the documents required by the quality management system. Records are a special type of document and must be controlled as required by clause 4.2.4.

Establish a documented procedure to:
? Approve documents for adequacy prior to issue
? Review, update as necessary, and re-approve documents
? Identify the changes and current document revision status
? Make relevant documents available at points of use
? Ensure the documents remain legible and readily identifiable
? Identify external documents and control their distribution
? Prevent obsolete documents from unintended use
? Apply suitable identification if obsolete documents are retained
4.2.4 Control of Records
Establish and control records as evidence of conformity to requirements and to demonstrate the effective operation of the quality management system.
Establish a documented procedure to define the controls needed for record:
? Identification
? Storage
? Protection
? Retrieval
? Retention
? Disposition
Keep records legible, readily identifiable, and retrievable.