a)     to approve documents for adequacy prior to issue,

Approval of documents comes without first defining the responsibilities for preparation, review and approval of documents. Defined responsibilities and accountabilities will ensure that documents are really adequate prior to issue. Below is an example of responsibility matrix for a government institution.

b)    to review and update as necessary and re-approve documents,

Controlled documents that make up the QMS are many times being called “living documents”. As such, documents must be reviewed for continuing suitability to meet changes in customer requirements, regulations or even internal needs of the organization. To ensure that this will be done, it is recommended that management reviews include action plan for cross-functional review of documents to be facilitated by the MR.

c)     to ensure that changes and the current revision status of documents are identified,

This is practically identifying the changes made in the documents. Common approach is to underline the changes or put a small triangle with a revision # inside which is common for engineering drawings. Revision history page may also be used to provide information on description of changes.

d)    to ensure that relevant versions of applicable documents are available at points of use,

This is where document distribution comes in. Distribution of print documents is quite tedious to do but still necessary for effective communication of QMS requirements as in the case of manufacturing industries where customer product and process specifications are crucial. However, distribution of electronic documents through the company’s intranet is the emerging approach and this would definitely do well.

e)     to ensure that documents remain legible and readily identifiable,

One of the purposes of having documents is to communicate intent and to have legible documents is just rationale. Identification of documents would require you to use some coding system and appropriate document title.

f)     to ensure that documents of external origin determined by the organization to be necessary for the planning and operation of the quality management system are identified and their distribution controlled,

The requirements being discussed so far are just for internally-generated documents. But just like any other organization, documents from external entities such as drawings from customers, IRRs and circulars from regulatory agencies are likewise being required to be controlled in terms of distribution, identification and disposition of obsolete versions. For some instances where the latest versions of guidelines and circulars of government institutions are posted in their website, the organization may just have to reference in document control policy the websites URLs to address requirement for distribution and identification.

g)    to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

As practiced, obsolete documents are being retained to preserve knowledge, technologies, etc. for possible future research and other purposes. Common approach to identify them is to stamp them with “obsolete” to prevent their unintended use and provide storage area for them.

The Quality Policy, as defined in ISO 9000 – Fundamentals and Vocabulary, is “The overall intentions and direction of an organization related to quality as formally expressed by top management.” In writing the Quality Policy, one must first understand the requirements of the ISO 9001 standard. Sub-clause 5.3 Quality policy requires:

Top management shall ensure that the quality policy

a)     is appropriate to the purpose of the organization,

This requires the Top Management to express the nature of business of the organization in their quality policy, (e.g.  …provides quality electronic sub-contracting services…; …provides quality Hard Disk Drive Sub-assemblies…; provides quality third party logistics services…). Depending on the direction of the top management on its quality commitment to the customers and with due consideration on the organization’s capability to deliver products or services, the Top Management may even use the specific and appropriate quality dimension. Thus replacing the word “quality”, one might have the following statements instead: …provides efficient electronic sub-contracting services…; …provides Hard Disk Drive Sub-assemblies at six sigma quality…; …provides reliable third party logistics services.

b)    includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

Simply, there should be a stated commitment to comply with customer, statutory and regulatory requirements and commitment to continually improve the effectiveness of the QMS.

c)     provides a framework for establishing and reviewing quality objectives,

This requires that the quality objectives are specifically established to achieve what the quality policy commits to deliver to its customers or stakeholders.

d)    is communicated and understood within the organization,

Communicating the quality policy is more of articulating it during meetings or general assemblies other than the common approach of distributing quality policy cards to employees. As always, it is best understood when leaders “walk the talk”.

e)     is reviewed for continuing suitability.

Many times, business directions change over time brought by economic circumstances as often determined during strategic planning. Therefore, it is the responsibility of the top management to review the suitability of the quality policy in terms of new business ventures or diversification.

While items a and b are commonly stated in the quality policy, items c, d and e are typically expressed as postscripts in section of the quality manual where quality policy is stated. For better appreciation, below are the sample quality policies:

Quality Policy

We provide efficient and effective total logistics and business process outsourcing services;

We exceed customers’ expectations;

We adhere to statutory and regulatory requirements; and

We involve the whole organization;

So that we can deliver products and services to all our external and internal customers

On-time, every time!

In order to do these:

Management spearheads the implementation of this quality policy to both our customers and our personnel through the following:

-         Ensuring that quality objectives are established in support to the achievement of the Quality Policy.

-         Continuously reviewing and improving the effectiveness of the Quality Management System.

-         Reviewing the continuing suitability of the quality policy to the company’s services during Management Review.

-         Articulating the Quality Policy through the organization’s Internal Communication processes.

Quality Policy

We provide proactive, timely and accurate executive decisions to effectively carry out the mission and functions of THE INSTITUTION.

We commit to fulfill legal and stakeholder requirements by:

Empowering our people,

Involving the whole organization and

Continually improving the effectiveness of our Quality Management System

In order to do these:

Management spearheads the implementation of this quality policy to both our stakeholders and personnel through the following:

-         Ensuring that quality objectives are established in support to the achievement of the Quality Policy.

-         Reviewing the continuing suitability of the quality policy to the institution’s services during Management Review.

-         Articulating the Quality Policy through the institution’s Internal Communication processes.

This article discusses the recommended phases that an organizations may wish to adopt in establishing their Environmental Management System (EMS) whether standalone or to be integrated with existing management systems such as Quality Management System (QMS).

1. Policy – basically this is the Environmental Policy that the top management should establish, first and foremost, so as to set the direction for the whole organization to follow. As the ISO 14001:2004 puts it, “The environmental policy is the driver for implementing and improving an organization’s environmental management system so that it can maintain and potentially improve its environmental performance. This policy should therefore reflect the commitment of top management to comply with applicable legal requirements and other requirements, to prevent pollution and to continually improve. The environmental policy forms the basis upon which the organization sets its objectives and targets. The environmental policy should be sufficiently clear to be able to be understood by internal and external interested parties, and should be periodically reviewed and revised to reflect changing conditions and information.”
2. Organization and Personnel – as always, human resource is one of the most valuable resources for an effective implementation EMS. Organization may include a team or a committee composed by the Pollution Control Officer (PCO), Internal EMS Auditors and the Management Representative; an Emergency Response Team (ERT) which may include fire fighting team, medical team, spill response team and evacuation and response team.
3. Regulations, aspects and impacts – at the onset, organization must determine the applicable legal and other requirements to which the organizations subscribes related to its environmental aspects. Moreover, access to regulatory requirements and environmental laws is crucial. As practiced, this responsibility is given to the PCO to monitor updates on environmental regulations and how will it affect the organization’s environmental aspects. Aspect and Impacts Assessment is then performed as basis for establishing the EMS in terms of targets and objectives, programs, procedures and operational controls.
4. Objectives and targets – just like the QMS, specific measures for EMS effectiveness must be established which must be reviewed regularly (e.g. management reviews).
5. Management Programmes – to quote ISO 14001:2004, “Each programme should describe how the organization’s objectives and targets will be achieved, including timescales, necessary resources and personnel responsible for implementing the programme(s).” Programmes may include waste management, research and use of alternative non-toxic/hazardous raw materials, recall and recycling/treatment of salvaged products among others.
6. Management Procedures – as defined, a procedure is specified way to carry out an activity or a process which may be documented or not. For an organization who opts to document and with existing QMS, documenting a procedure is a little less cumbersome. The organization may just have to do business process review to determine  which procedures will have to be revised to integrate environmental requirements. Examples of which are maintenance procedures to include proper collection and staging of hazardous waste to be performed by the same personnel.
7. Operational Controls – these are the difference ways by which an organization can prevent pollution from its operations. These controls may include pollution control equipment, preventive maintenance activities, etc. To be able to determine the necessary operational controls, the organization must be able to determine those activities that are associated with significant environmental aspects (i.e. aspects that are with corresponding environmental regulations).
8. Records – the organization must have an effective records management to be able to provide evidence of its environmental compliance and improved environmental performance. This is another requirement that may be integrated with existing management systems.
9. EMS Audits – audits may be 1st party assessment, that is, performed by internal auditors or 2nd party assessments which is performed by other stakeholders such as customers and regulatory bodies. This is necessary to determine compliance to requirements and areas for improvement. 3rd party assessment, which is performed by certification bodies, may also form part of this phase but not without management review first.
10. Management Reviews – this is the venue for assessing the EMS to ensure its continuing suitability, adequacy and effectiveness. Reviews must include assessing opportunities for
    improvement and the need for changes to the EMS, including the environmental policy and environmental objectives and targets.

Learning the difference between the two is actually a CRITICAL requirement in establishing Quality Management System in accordance with ISO 9001 standard. If we are to look at the standard, objectives are primarily mentioned both in sub-clause 5.4.1 (Quality Objectives) and in sub-clause 7.1 (Planning of Product Realization). Looking merely at the standard’s requirement, as stated in these two sub-clauses, one would suppose that they are basically one and the same. That is why many organizations that were certified in ISO 9001:2000 have set of functional quality objectives and, at the same time, having some of those objectives written in either quality plans or procedures. As a result, REDUNDANCIES became apparent. There were even findings being raised during certification audits related to this. In this article, I will be presenting an approach in establishing Outcome Objectives and Process Objectives which is aimed to address this problem.  The key here is to put boundaries between the two objectives. Outcome Objectives can be documented using Balanced Scorecard or can be established as stand-alone objective statements per Department or Area, while Process Objectives MUST be documented using Quality Plan. To demonstrate, look at the set of Outcome Objectives below established by a Third Party Vendor-Managed Inventory (VMI) as our sample company.

Outcome Objectives

1. To achieve 100% accuracy in inventory by year end.
2. To attain 0 damage on stocks by year end.
3. To reduce customer complaints by 50% by year end.

Quality Plan

It must be noted that the above outcome objectives were based on customer requirements or the needed end result to maintain viability of the business. To attain such customer-oriented outcome objectives, the company established the processes with its objectives in the form of process standard that must be adhered to by person responsible. Such document is called the Quality Plan. Such document specifies the service or product realization processes.

Each process is composed of a combination or all of the 4M’s: man, machine, method and materials.  Each ‘M’ demonstrates some critical characteristics that need ‘controlling’ and minimize its variations. Inability to do so, problems such as erroneous documents, damage to properties and wrong data, among others, may occur. As such, ‘Item to control’ must be carefully determined. Notice also the dimensions accuracy, timeliness, quality and completeness. These dimensions are the bases for establishing the needed process standards (or the process objectives). Such are the ones to describe the critical aspect/s of the ‘Items to be controlled’ that will serve as guide in determining the needed standard. For instance, if the critical aspect of the “Item to be controlled” is timeliness, then standard must be in the form of the needed Turn-Around time (TAT)/or time-frame to do a certain requirement.

Collectively, the dimensions that were mapped-out in the quality plan, if properly addressed should fulfill one or a combination of the above outcome objectives. To ascertain adherence to the standard, a control methodology is established which serve as the check and balance for the person responsible in the process. To further the needed controls, the company established the procedures as referenced in the Support Documentation column which may detail the step-by-step activities to execute the process and ensure compliance with the set standard.

To conclude, and as mentioned, the key to value-adding QMS documentation is to avoid redundancies. That is, to document requirements where they can be relevant and will facilitate monitoring.