ISO 9001 Management Representative

Posted by everise | iso 9001 standard | Monday 31 August 2009 12:57 pm

The ISO 9001 Management Representative is appointed by the top management of an organization. Irrespective of other responsibilities, he/she is responsible and has the authority in

  • ensuring that processes needed for the quality management system are established, implemented and maintained,
  • reporting to top management on the performance of the quality management system and any need for improvement, and
  • ensuring the promotion of awareness of customer requirements throughout the organization.

The responsibility of the Management Representative also includes liaison with external parties on matters relating to the quality management system.

The Management Representative is usually assisted at the departmental level by Quality Representatives. This position is assumed by the respective Department Managers. The Quality Representatives are responsible for the quality processes which are applicable to their respective departments.

The Quality Representatives head their respective Quality Improvement Teams which are established for the purpose of monitoring processes and identifying opportunities for improvements. Members of the Quality Improvement Teams comprise of key personnel within the departments/process areas who are appointed by the Quality Representative to assist him/her at the process-level.

The Management Representative is also assisted by an appointed Document Controller whose responsibility is to implement the Control of Documents and Control of records procedures.

Collectively, the Management Representative, Quality Representatives and the Document Controller make up the Quality Management System Committee. This committee meets regularly to provide relevant inputs and resolutions for the quality management system. The structure of the Quality Management System Committee is as follows:

  • Management Representative – Chairman
  • Document Controller – Secretary
  • Quality Representatives – Members

[Note: The above is just an example. If you are a small organization, a QMS Committee and Quality Improvement Teams may not be necessary]

To facilitate effecetive communications, the Quality Management System Committee and the Quality Improvement Teams, respectively, meet regularly in order to ensure that communication regarding the effectiveness of the quality management system takes place. Pertinent information regarding the quality management system is then posted by the Management Representative on the Bulletin Board for the benefit of all employees. Employees are generally encouraged to provide their inputs towards the quality management system through suggestion boxes which are located at strategic locations within the organization’s premises.

Note: Some organizations employ this method but results may vary among other organizations. The key is to continually improve on these methods/processes.

ISO 9001:2008 General Requirements

Posted by everise | iso 9001 standard | Monday 31 August 2009 12:52 pm

4.1 General requirements

The organization shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of this International Standards. The organization

  • shall determine the processes needed for the quality management system and their application throughout the organizations,
  • determine the sequence and interaction of these processes,
  • determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
  • ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
  • monitor, measure (where applicable) and analyze these processes, and
  • implement actions necessary to achieve planned results and continual improvement of these processes.

These processes shall be managed by the organization in accordance with the requirements of this International Standard.

Where an organization chooses to outsource any process that affects product conformity to requirements, the organization shall ensure control over such processes. The type and extent of control to be applied to these outsourced processes shall be defined within the quality management system.

NOTE 1: Processes needed for the quality management system referred to above include processes for management activities, provision of resources, product realization and measurement, analysis and improvement.

NOTE 2: An outsourced process is identified as one being needed for the organization’s quality management system, but chosen to be performed by a party external to the organization.

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.

Clause 4.2 Documentation requirements

4.2.1 General

The quality management system documentation shall include
documented statements of a quality policy and quality objectives,

  • a quality manual,
  • documented procedures and records required by this International Standard,
  • documents including records, needed determined by the organization to be necessary to ensure the effective planning, operation and control of its processes

NOTE 1: Where the term “documented procedure” appears within this International Standard, this means that the procedure is established, documented, implemented and maintained. 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.

NOTE 2: The extent of the quality management system documentation can differ from one organization to another due to the size of organization and type of activities, the complexity of processes and their interactions, and the competence of personnel.

NOTE 3: The documentation can be in any form or type of medium.

4.2.2 Quality Manual

The organization shall establish and maintain a quality manual that includes the scope of the quality management system, including details of and justification for any exclusions (see 1.2), the documented procedures established for the quality management system, or reference to them, and a description of the interaction between the processes of the quality management.

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed

  • to approve documents for adequacy prior to issue,
  • to review and update as necessary and re-approve documents,
  • to ensure that the changes and the current revision status of documents are identified,
  • to ensure that relevant versions of applicable documents are available at points of use,
  • to ensure that documents of external origin are identified and their distribution controlled, and
  • to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

4.2.4 Control of records

Records established to provide evidence of conformity to requirements and of the effective operation of the quality management system shall be controlled. The organization shall establish a documented procedure to define the controls needed for the identification, storage, protection, retrieval, retention, and disposition of records. Records shall remain legible, readily identifiable, and retrievable.

Structure Of ISO 9001

Posted by everise | iso 9001 standard | Monday 31 August 2009 12:49 pm
ISO 9001 was first published in 1987. Later, it went through three revisions in 1994, 2000 and 2008. The latest version version of the ISO 9001 standard was published on 14th November 2008. This is the structure of the standard:
  • Clause 1 Scope
  • Clause 2 Normative reference
  • Clause 3 Terms and definitions
  • Clause 4 Quality management system
  • Clause 5 Management responsibility
  • Clause 6 Resource management
  • Clause 7 Product realization
  • Clause 8 Measurement, analysis and improvement

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REQUIREMENTS OF ISO 14001

Posted by everise | iso 14001 | Saturday 29 August 2009 3:29 pm
REQUIREMENTS OF ISO 14001
In order to effectively implement and benefit from an ISO 14001 EMS, it is important to
have an understanding of the standard’s requirements. A quick review of the standard
shows that it is structured following the Plan, Do, Check, Improve philosophy of the
Total Quality Management movement, as follows:

PLAN
4.2 Policy
4.3 Planning

DO
4.4 Implementation and Operation

CHECK
4.5 Checking and Corrective Action

IMPROVE
4.6 Management Review

Within these five elements are 17 sub-elements stating the various requirements.

4.2 Policy

4.3 Planning
4.3.1 Environmental Aspects
4.3.2 Legal and Other Requirements
4.3.3 Objectives and Targets
4.4.4 Environmental Management Programs

4.4 Implementation and Operation
4.4.1 Structure and Responsibility
4.4.2 Training Awareness and Competence
4.4.3 Communications
4.4.4 EMS Documentation
4.4.5 Document Control
4.4.6 Operation Control
4.4.7 Emergency Planning and Response

4.5 Checking and Corrective Action
4.5.1 Monitoring and Measurement
4.5.2 Nonconformance, Corrective, and Preventive Action
4.5.3 Records
4.5.4 EMS Audit

4.6 Management Review

Within these 17 sub-elements are all of the requirements, or “shalls”, necessary to
conform to ISO 14001. There is no substitute for reading the standard in terms of
recognizing the requirements. As a matter of fact, no auditor should embark on an audit
without having easily available the criteria to which they are doing the audit. However,
below we briefly summarize the key points of the sub-elements. This summary is not
intended to be a replacement for ISO 14001, and should not be used exclusively as such
during an audit.

Detailed Section by Section Summary

4.2 Policy
ISO 14001 requires that the organization have a policy statement to drive the EMS.
These tend to be short, one page or less documents, and simply affirm the commitments.
There is no expectation that specific details be noted in the policy. For example, the
commitment to pollution prevention can simply be stated saying, “we are committed to
prevention of pollution”. The policy must be clearly endorsed by top management and
be available to the public and employees. Although the availability to the public can be
rather passive; i.e. “is here if they want it”, there is an expectation that the employee
awareness is more proactive. Section 4.2 of ISO 14001 lists the other requirements of the
policy.

4.3.1 Environmental Aspects
This element requires a procedure that not only identifies the aspects and impacts, but
also provides for determination of significance, and keeping the information up to date.
ISO 14001 does not prescribe what aspects should be significant, or even how to
determine significance. However, it is expected the organization will develop a
consistent and verifiable process to do so.

4.3.2 Legal and Other Requirements
This is a requirement for a procedure that explains how the organization obtains
information regarding its legal and other requirements, and makes that information
known to key functions. This is not the assessment or compliance audit requirement, but
rather a more up front determination of requirements.

4.3.3 Objectives and Targets
There is no requirement for a procedure in this element, only that objectives and targets
be documented. It does require that certain items be considered in developing the
objectives, such as legal requirements and prevention of pollution. It is sometimes
easiest to develop a procedure anyway for this element to be able to verify these
considerations were made.

4.3.4 Environmental Management Programs (EMP)
EMPs are the detailed plans and programs explaining how the objectives and targets will
be accomplished. These EMPs usually note responsible personnel, milestones and dates,
and measurements of success. Noting monitoring and measurement parameters directly
in the EMP facilitates conforming to 4.5.1 on Monitoring and Measurement discussed
below.

4.4.1 Structure and Responsibility
ISO 14001 requires that the relevant management and accountability structure be defined
in this element. This usually takes the form of an organizational chart. Also, the
organization must denote the Management Representative who is responsible to oversee
the EMS and report to management on its operation.

4.4.2 Training Awareness and Competence
The key point in this element is that personnel must receive applicable training regarding
the EMS. Specific requirements are itemized in ISO 14001, and include general,
company-wide items such as knowing the policy, to more function-specific training on
aspects and emergency response. An organization usually responds to this element with a
training matrix, cross-referencing to training materials and records.

4.4.3 Communications
Procedures are required for both internal and external communications. Note that ISO
14001 only requires procedures, and allows the organization to decide for itself the
degree of openness and disclosure of information. Whatever the decision in terms of
disclosure, that decision process must be recorded.

4.4.4 EMS Documentation
This requirement is simply that the organization has documented the system in either
electronic or paper form such that it addresses the elements of the standard and provides
direction to related documentation. Not all ISO 14001-required procedures need to be
documented, as long as the system requirements can be verified.

4.4.5 Document Control.
Procedures are required to control documents, such as system procedures and work
instructions, and to ensure that current versions are distributed and obsolete versions are
removed from the system.

4.4.6 Operational Control
This element is the one which connects the EMS with the organization as a whole. Here,
the critical functions related to significant aspects and objectives and targets are identified
and procedures and work instructions created to ensure proper execution of activities.
Requirements for communicating applicable system requirements to contractors are also
addressed.

4.4.7 Emergency Planning and Response
Although typically addressed through conventional emergency response plans, this
element also requires that a process exist for identifying the potential emergencies, in
addition to planning and mitigating them. A linkage to the aspects analysis, where
impacts are assessed, is appropriate. Emergency incidents include those that may not be
regulated, but may still cause significant impact as defined by the organization.

4.5.1 Monitoring and Measurement
Procedures are required describing how the organization will monitor and measure key
parameters of operations. These parameters relate to the significant aspects, objectives
and targets and legal and regulatory compliance. In order to properly manage the system,
measurements must be taken of its performance to provide data for action. Responses to
this element usually cross reference to many other specific procedures and work
instructions describing measurement and equipment calibration. It is in this element that
we find the requirement for what is commonly referred to as a compliance audit.

4.5.2 Nonconformance, Corrective, and Preventive Action
This element requires procedures for acting on Non-conformances identified in the system,
including corrective and preventive action. Non-conformances may be identified through
audits, monitoring and measurement, and communications. The intent is to correct the
system flaws. Typically, Corrective Action Report (CAR) forms are the norm, noting the
nonconformance, the suggested fix, and closure of the action when completed. Note that
this requirement does not imply in any way that the party identifying the nonconformance
must be the one to suggest the fix. Instead, it is expected that the system provide for the
information to be routed to the most appropriate party to address the concern.

4.5.3 Records
Records are expected to exist to serve as verification of the system operating. For
example, records include audit reports and training records. Unlike controlled
documents, records are “once and done” documents, resulting from the execution of some
process or procedure. Procedures in this element are required for the maintenance of
records.

4.5.4 EMS Audits
ISO 14001 requires that the system provide for internal audits. This procedures(s) will
include methodologies, schedules, and processes to conduct the audits. Interestingly, the
EMS audit will in essence, audit the audit process itself!

4.6 Management Review
This element requires that periodically, top management will review the EMS to ensure it
is operating as planned. If not, resources must be provided for corrective action. For
areas where there are no problems, the expectation is that with time, management will
provide for improvement programs. Usually there is no detailed procedure for this
element, although records of agendas, attendance, and agreed upon action items are
maintained as verification.

ISO 9001:2008 Quality Management System Standard

Posted by everise | iso 9001 standard | Saturday 29 August 2009 3:04 pm
ISO 9001:2008 is the world most successful standard addressing best practice in the application of quality management systems.

The standard is based around the principles of customer satisfaction, continual improvement and the development of a process based quality management system. Although not referenced in the standard itself the ISO 9001:2008 document is underpinned by eight key quality management principles;

  • a customer focused organisation
  • leadership
  • the involvement of people
  • ensuring a process approach
  • a systematic approach to management
  • a factual approach to decision making
  • mutually beneficial supplier relations
  • continuous improvement

ISO 9001:2008 has been written to ensure that its guiding principles are equally relevant to all sectors of industry and to all types of organisation. Although containing requirements to control the key processes within an organisation, it only requires six documented procedures. The standard emphasises the need for an organisation to continually monitor their own processes and systems, with many clauses making reference to self monitoring or measurement or both. This emphasis aims for an integrated approach to business processes. Instead of operating to a business plan on one hand and a quality management system on the other, the standard aims to integrate both of these functions into one system.

What is a quality management system?
ISO 9001:2008 is a standard that specifies criteria for a quality management system (QMS). A QMS incorporates those elements of an organisations management system that direct and control it with regard to quality. Such a system will need to be supported by top management who will need to be able to demonstrate management commitment.

How do you demonstrate management commitment?
Management commitment is one of the cornerstones of ISO 9001:2008, requiring top management to develop and improve the QMS throughout the organisation. This commitment can be demonstrated by a number of methods including creating a quality policy, conducting management reviews and establishing quality objectives.

What is a quality policy?
ISO 9001:2008 specifies that an organisation must have a quality policy that documents the organisations overall intentions and direction related to quality as formally expressed by top management. Such a policy will include a commitment to comply with ISO 9001:2008, to continuously improve the QMS and to set and monitor measurable quality objectives.

What are quality objectives?
The quality objectives are those targets sought or aimed for by the organisation that are related to quality. These quality objectives must be SMART (suitable, measurable, achievable, reviewed and timely). Examples of quality objectives might be; to reduce machine down time by 20% or to reduce rework costs by ?00 p/m. Whatever quality objectives are chosen they must be meaningful and adequately resourced by the organisation.

What is a management review?
A management review is a key element of how the top management of an organisation can assess its performance in terms of the objectives it sets itself, the requirements set by the standard and how its systems are operating. Normally, a management review is a regular meeting of the top management team and uses the information that the organisation? systems have derived. It is a useful forum to review and revise quality objectives.

What are internal audits and why do I need to carry them out?
Internal audit is one of the key monitoring processes required by the standard and functions as a check on the organisation? systems. It is the opportunity for an organisation to determine compliance to the systems it has established and maintained to meet the needs of its customers and identify opportunities for improvement. Internal audit can be seen as a ealth check?for an organisation.

The ore?of ISO 9001:2008, Product realisation
Clause 7 of ISO 9001:2008 contains the core processes that most organisations carry out. Any clause or sub-clause in section 7 can be excluded from an organisations quality management system if it can be justifiably excluded. Examples of common exclusions are clause 7.3 design and development, clause 7.5.3 traceability and clause 7.6 the control of monitoring and measuring devices. Clauses can only be excluded if their exclusion does not affect the company? ability to provide a product or service that meets customer requirements.

These core processes should be managed and controlled via the quality management system, and are evaluated for effectiveness and suitability by the internal audits with feed back into the management review.

This is a clear demonstration of one of the key principles of ISO 9001:2008, continuous improvement by critical self-evaluation. The output from the self-evaluation is fed into a planning stage to determine actions needed to improve the system. Following the planning and consultation comes the action phase where the proposed changes are implemented. Then the cycle starts again by checking that the changes are effective and meaningful by self-evaluation.

Other requirements of section 7 are;
Product planning to ascertain and then implement the necessary controls and resources to ensure product realisation.

Purchasing control to verify purchased product against comprehensive purchasing information and the selection and evaluation of suppliers.

Production and service provision to ensure that this activity is carried out in controlled conditions and that any processes that cannot be verified during production are validated to ensure capability. Where appropriate the product must be identified, and if required, traceable at all stages of production. Any customer property must be identified and protected from harm and all products must be stored and handled in such a way to preserve product conformity.

Any monitoring and measuring devices needed to provide evidence of product conformity must be identified and if necessary calibrated.

But what about the customer?
All of the clauses in ISO 9001:2008 are in some way focused towards meeting and exceeding the customer? expectations. For example the requirement of management to determine and communicate the importance of customer requirements throughout the organisation, and the review of customer orders to ensure that they can be met. Companies are required to implement methods for effective communication with the client at all stages of the business including ascertaining customer satisfaction after the product or service has been delivered as well as resolving customer complaints.

Finally?
ISO 9001:2008 is widely acclaimed as being the pre-eminent specification for quality management systems, it requires a company to look at itself and ask the question, ‘how can we improve?’ An ISO 9001:2008 management system should be an essential part of any business process, requiring continual improvement by self-evaluation with a goal of ensuring that current and future customer expectation can be met and exceeded.

If you have any queries concerning ISO 9001:2008 please visit http://www.iso-consults.com/

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