Organizations preparing to implement a QMS For ISO 9001 Posted by everise | iso 9001 standard | Friday 9 October 2009 4:13 am

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:
- Identifying the processes necessary for the effective implementation of the quality management system
- understanding 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.)
These processes include the management, resource, product realization and measurement processes that are relevant
to the effective operation of the QMS.
Analysis of the processes should be the driving force for defining the amount of documentation needed for the quality
management system, taking into account the requirements of ISO 9001:2008. It should not be the documentation that
drives the processes.

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 a quality 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.

Records required by ISO 9001:2008

Records required by ISO 9001:2008

Clause Record required
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
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action

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 variety of something” and notes that “objective evidence may be obtained through observation, measurement, test, or other means.”
Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d)
Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.

ISO 14001 ENVIRONMENTAL POLICY

The Environmental Policy statement required under ISO 14001 is the keystone upon which the entire environmental management system is constructed. It is not a public relations document that is posted on the conference room wall or handed out to potentially impacted stakeholder groups. The Environmental Policy is the central focus of the environmental management system. It must contain and clearly communicate the following for the organization:
· Mission and core values with respect to the environment, and· Commitments to control and improve environmental performance withrespect to significant environmental aspects of the organization’s products,services and/or activities.
The commitment to control and improve environmental performance with respect to the environment leads to the development of Environmental Objectives and Targets (4.3.3).Once those items have been delineated the rest of the environmental management system is devoted to accomplishing the objectives and targets which fulfil the EnvironmentalPolicy. ISO 14001 requires that a coherent and cogent Environmental Policy be developed and implemented.

ISO 14001 ENVIRONMENTAL MANAGEMENT PROGRAMME

In order to be in conformance with this provision of ISO 14001 an organization must be able to demonstrate four specific points. First, it must demonstrate that it has established management programs for achieving the Environmental Objectives and Targets. Second, it must demonstrate that it has assigned responsibility at each appropriate level of the organization in order to achieve the Environmental Objectives and Targets. Third, the organization must specify the time frames and the mechanisms needed to achieve the Environmental Objectives and Targets. Fourth, under the principle of continual improvement, the organization must modify its environmental management program for “changed” conditions if they occur.
In general a program designed to achieve the desired endpoint must support every objective and subsequent target. Responsibility for management and leadership must also be assigned where it is necessary and appropriate to complete the task. Timeframes should be clearly outlined within the management program. If additional technology, equipment, staffing, etc. are needed to accomplish the tasks, then these “mechanisms” must be supplied. Continual improvement is referenced within this section of ISO 14001 in order to reinforce its importance within the standard.

ISO 14001 ENVIRONMENTAL MANAGEMENT SYSTEM AUDIT

In order to be in conformance with this provision of ISO 14001 an organization must be able to answer the overall question: “How does the organization conduct environmental audits of the EMS?”. In order to answer that question four specific tasks must be addressed under the Management System Audit section of the standard.
First, the organization must develop a program and related procedures that define an audit plan of the environmental management system. In addition the program must define frequency of the audit process. Second, the procedures must specify the methodology of the audit process, including the qualifications of the auditors. Third, the audit reports must be submitted to top management. Fourth, the audit reports must provide recommendations directed at correcting any reported nonconformance that was discovered in the audit process.
The audit process discussed in this section of the standard is directed at internal audits. The standard is silent on the frequency issue. Generally accepted practice with a mature ISO 14001 system is a total audit of the system once a year. In the implementation phase of an environmental management system a more frequent audit process might be appropriate. In addition any part of the environmental management system that has been previously determined to be in nonconformance should be audited with an increased frequency. The methodology of the audit process required by the standard requires two distinct steps:
A. determine whether the environmental management system conforms to the requirements of ISO 14001, andB. that the system has been managed as described in the Environmental Policy statement, the Environmental Objectives and Targets, and the related work descriptions and procedures.
It is critical that an audit report that relates a nonconformance be forwarded to top management promptly. The internal audit staff must be competent with respect to the requirements of ISO 14001.

ISO 14001 ENVIRONMENTAL ASPECTS

The key to a successful registration for conformance with ISO 14001 is to accurately determine the organization’s Environmental Aspects and Impacts, arrive at which are the most significant and therefore require the most attention. Two definitions should be reviewed at this point.
Environmental AspectElement of an organization’s activities, products or services that can interact with the environment.
NOTE — A significant environmental aspect is an environmental aspect that has or can have a significant environmental impact.”
and
Environmental ImpactAny change to the environment, whether adverse or beneficial, wholly or partially resulting from an organization’s activities, products or services.”
There are three distinct requirements contained within this section of ISO 14001.
First, the organization shall identify the environmental aspects of its activities, products and/or services. In other words the organization must understand how it interacts with the environment.
Second, the organization shall identify the specific environmental aspects that can be controlled, and over which it can be expected to have influence.
Third, arrive at a list of significant environmental aspects based upon the individual environmental impact of each environmental aspect. The importance of this third step cannot be underestimated.
The final list of significant environmental aspects will provide the basis for the Environmental Policy statement, and the Environmental Objective(s) and Targets. In other words the list of significant environmental aspects drives the entire content and scope of the operational portion of the environmental management system.