The performance and quality objectives are constantly being monitored

What is the purpose of quality objectives?

The purpose of quality objectives is to determine conformity to (customer and regulatory) requirements, and facilitate the effective deployment and improvement of the quality management system (QMS).

Where should quality objectives originate from?

Quality objectives must orginate from the organization’s quality policy. Developing a QMS must be a strategic business decision and therefore top management must provide the necessary direction and leadership, starting with establishing the quality policy and objectives.

Your quality policy provides top management’s vision on quality management for the organization. It provides the organization with focused direction, i.e. high level goals and objectives for quality management.

Besides your own organization, requirements for quality policies and objectives (e.g., for product as well as product realization processes) may also come from the customer, regulatory bodies and industry standards or codes.

Your quality policy and objectives must be consistent with the scope of your QMS and must complement other business objectives of your organization such as those related to growth, finance, profitability, the environment and occupational health and safety. Aggressive sales or marketing strategies must not be at the expense of quality management.

The goal of an organization should be to integrate the various management systems (including quality management) used to achieve its strategic business goals and objectives. It is unfortunate that many organizations choose to dis-associate quality management from operational management.

What are these other strategic business goals and objectives?

Top management must integrate and keep quality management policies and objectives consistent with strategies, policies and objectives for other business, areas such as:
· Markets: share and growth, customer base and diversification, competitor information, pricing, sales, etc.

· Organization: size, structure, responsibilities and accountability, etc.

· Product: quality, performance, reliability, maintainability, design technology and innovation, demand, mix, packaging, pricing, warranty, support, etc.

· Processes: facility, capability, capacity, technology, reliability, quality

· Supplier management: quality, delivery, price, consistency, flexibility

· Workforce: labor availability, competence, mix, utilization, compensation, health and safety, etc.

· Capital: sourcing, availability, cost, prioritization of use, return, etc.

· Other: environment, regulatory issues, governmental policies, communications, etc.

What should an organization state in its Quality Policy?

Clause 4.1.a – requires that you document your quality policy and clause 5.3.c requires that you specify your commitment to ‘meet requirements’ and ‘continually improve the effectiveness of your QMS’. Clause 1 specifies requirements for the scope of your QMS. Therefore, it would be logical and useful to use the wording in clause 1 to define your quality policy?

The wording of the quality policy should preferably specify what requirements are being complied with (e.g., customer, regulatory, ISO 9001, etc.). It must also clearly state your commitment to continually improve the effectiveness of the QMS.

Beyond that, you may state other complementary and important policies (business growth; product or manufacturing technology; workforce competence; business flexibility, etc.)

How do quality objectives flow from the Quality Policy?

What you state in your quality policy, must lead to establishing quality objectives, e.g. if you state in your quality policy that you will “meet customer requirements”, then from this, you might derive customer focused objectives for – product defects; customer complaints and returns; on time delivery, etc.

Similarly, for the phrase -“meet ISO 9001 requirements”; from this you might derive process objectives for effectively using ISO 9001 requirements to manage and control your QMS processes to achieve conformity to the standard.

Stating that you will “continually improve the effectiveness of your QMS” in your quality policy – can lead to a number of objectives, as your QMS is comprised of many processes each with related risks; so it is possible to have one or more improvement objectives for each process.

Thus, we can see that each statement in your quality policy may result in one or more quality objectives. These quality objectives do not need to be stated in your quality policy, but top management must clearly be involved in providing direction, establishing and reviewing these objectives.

Who should be involved in setting quality objectives?
Top management must provide the leadership and direction for quality management within an organization. The establishment of quality objectives should be part of the business planning or QMS planning processes.

Top management must establish the organizational structure and internal environment that motivates personnel to achieve the organization’s quality management goals and objectives. They must provide adequate resources to develop, implement, maintain and improve the QMS.

Quality objectives may be set at various functional levels of the organization – top management; departments; processes; functional groups; work cells; project teams; individuals; etc. In determining quality objectives, top management must obtain input from these sources. Top management must also ensure that quality objectives from all sources are consistent with each other as well as other business objectives such as sales growth and profitability.

They must ensure also buy-in and ownership of all quality objectives to facilitate their deployment and achievement. The Quality management representative can play a significant role in coordinating the development and deployment of quality policies and objectives.

Input from customers and regulatory authorities must also be considered.

Can you provide some examples of quality objectives for an organization?
Quality objectives may be established to measure the performance of products; processes; customer satisfaction; suppliers; use of resources; and the overall performance and effectiveness of the QMS. Quality objectives may be established for all QMS processes.

Examples of quality objectives:

Product – reduction in defect rates, PPM’s (defective parts per million), scrap rates, rework; improvement in on time delivery (see clause 7.1a).

Process – objectives generally focus on improving process productivity through the elimination or reduction of variation and waste in process – inputs, outputs, conversion activity and related use of resources.

Objectives may be used to monitor and improve process – productivity; reduction of cycle time, errors, omissions and failures; etc. Examples could include objectives for – set-up time; run rates; process cycle time; etc.

Customers – reduction in # of complaints; improvement in customer satisfaction rating; on time delivery; service; support, etc, (see clause 8.2).

Suppliers – material defects; on time delivery; # of complaints with supplier.

Resources – (includes facility; equipment; labor; etc.) – objectives could be established based on availability; capability; maintenance; personnel competency, absenteeism; production rates; efficiency; safety; etc.

Everything You Need To Know About Meeting ISO 9001 Requirement For Customer Satisfaction

What are the ISO 9001:2008 requirements for customer satisfaction (CS)?

Clause 8.2.1 of ISO 9001:2008 requires an organization to “monitor information relating to customer perception as to whether the organization has met requirements”. It also requires methods be determined for “obtaining and using this information”.

Clause 7.2.1 c) requires an organization to determine and implement effective arrangements for communicating with customers relating to customer feddback including customer complaints.

Clause 5.2 requires that top management shall “ensure that customer requirements are determined and met, with the aim of enhancing customer satisfaction”.

Customer satisfaction (feedback) is a tool (required by the standard) to gauge the health of your QMS, by measuring the degree of satisfaction customers have with your organization and its products from the customer’s point of view.
You want to find out what the customer’s evaluation is, of your performance with regard to their requirements.

Who should you obtain Customer Satisfaction feedback from?
Customers are primarily the end users of your product, but may also include intermediaries such as assemblers (internal or external) who integrate your product into theirs, and dealers and distributors who market and sell your product or the integrated product. You need to consider feedback from all these customers to determine whether or not you have met their specified and perceived requirements.

What are the customer requirements that the standard is referring to?
Customer requirements may relate to the design, manufacture, delivery, servicing and support of product; the quality management system (QMS); communication and financial requirements; etc. Your organization must have controls to identify and meet these requirements to the satisfaction of your customers.

You must continually gather information (about these activities), in a manner capable of being analyzed and evaluated to determine how well you performed them.

What are examples of Customer Satisfaction  indicators?
There are all kinds of customer satisfaction performance indicators for design, manufacture, delivery, service and support, etc. Gather information on these indicators from both the customer as well from internal processes. Examples of useful indicators include:

Product quality, value and competitiveness; on-time delivery; packaging; competitive pricing; billing and credit note timeliness and accuracy; timeliness and accuracy of shipping documentation; timeliness and accuracy of quality documentation; flexibility – order fulfilment cycle-time and ability to handle emergency orders; reliability of advance shipment notifications; technical capability, support and response; customer sales, support and response; contract conformity; QMS conformity; handling of customer complaints; etc.

Can one use a rating scale to gauge Customer Satisfaction ?
Organizations have flexibility in what indicators and rating scale they employ. The following is a simple customer response scale that can be used for each performance indicator or question:
1) very satisfied;
2) satisfied;
3) poor;
4) dissatisfied; and
5) very dissatisfied.

It is generally useful to ask customers for:
1. Improvement Suggestions:
2. Other Comments:

Depending upon your business and number of customers, you should try out different rating scales and performance indicators to find a combination that is effective.

What are some acceptable techniques to monitor Customer Satisfaction ?

Information should be obtained on both positive and negative feedback to get the full picture of the customers overall perception of customer satisfaction.

There are many ways to monitor customer satisfaction feedback (positive and negative). These may include – customer complaints; direct communications with customers; questionnaires and surveys; using outside agencies to collect and analyze performance data (see clause 8.4); email and website forms, customer complaints, product returns; trip reports; field and service reports; customer scorecards; focus groups; recognition awards; reports from consumer organizations; reports in various media; sector and industry studies;etc.

Many customers routinely provide feedback on some of the methods indicated above. You must continually review this customer feedback to ensure you maintain and improve your customer satisfaction rating. Customer complaints are a common indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction.

Even when requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.

What should your process for determining Customer Satisfaction  include?
You are expected to have a process that:

· Identifies your customer satisfaction indicators;
· Defines the frequency and cycle time for completion
· Describes the method of data collection;
· Summarizes of data in a way that it can be used for making decisions,
· Reviews and evaluates the data;
· Facilitates actions to improve customer satisfaction feedback,
· Defines the responsibility and authority,
· Describes the follow-up method and actions (see 5.6 management review).

You must monitor trends in customer satisfaction indicators and use these as a baseline for continual improvement. You should consider monitoring, both external as well as internal customer satisfaction.

What happens if the Customer Satisfaction  process is performed for your organization by head office or an outside agency?

If any or all of your customer satisfaction process activities are done off-site, your QMS must include the off-site process within your QMS and ensure that such processes comply with ISO 9001 requirements.

You must show the interaction with the off-site organization (head office perhaps) in addressing these requirements and show how customer feedback information from Head office is used by your facility for continual improvement and enhancing customer satisfaction.

Do we need a documented procedure for the Customer Satisfaction  process?
Clause 8.2.1 does not require a ‘documented’ procedure for customer satisfaction. However, you should identify and document the process addressing this clause as part of your QMS (see clause 4.1). You could use a documented procedure or other combination of specific practices, procedures, documents, methods, controls and resources (see clause 4.2.1d. and 7.1b.).

Look at the risks, process complexity and competence of personnel in determining the extent of documented controls you need to have (also see clause 4.2.1 notes).

What are useful indicators to measure the performance of the Customer Satisfaction  process itself?
Performance indicators to measure the effectiveness of the customer satisfaction may include – improvement in customer feedback ratings; reduction in customer complaints; increase in the number of customers providing feedback; increase in feedback that leads to QMS and product improvement opportunities.

Outsourced Processes

ISO 9001 Outsourced Processes

What is the ISO 9001:2008 requirement for outsourced processes?

This article provides guidance on the intent of ISO 9001:2008 clause 4.1 on the control of outsourced processes. ISO 9001:2008 clause 4.1 states:

What is the definition of an outsourced process?
An “outsourced process” is a process that the organization has identified as being needed for its operations and quality management system (QMS), but one which it has chosen to be carried out by an external party outside the managerial control of your facility and may not be subject to the same QMS as your organization.

An outsourced process may be performed by a supplier that is totally independent from the organization, or which is owned by the same parent organization (e.g., a separate department or division not subject to the same QMS). It may be provided on-site within the physical premises or work environment of the organization or off-site at an independent site.

Examples of such processes include: – strategic planning done at head office; purchasing or design done at head office or another location; heat treating; painting; welding, calibration; testing; sort; human resources; information technology; etc., peformed by an outside organization. A manufacturing company may outsource welding, heat treatment or painting of product. A software company may outsource software development. A bank may outsource check clearing services.

How should outsourced processes be controlled?

The intent of Clause 4.1 is to emphasize that when an organization chooses to outsource (permanently or temporarily) a process that affects product conformity with requirements, it cannot simply ignore this process or exclude it from the QMS. The organization has to demonstrate it exercises sufficient control to ensure the process is performed according to the relevant ISO 9001:2008 requirements, as well as, the requirements of the organizations QMS.

The nature of control will depend on the importance of the outsourced process, the risk involved, and the competence of the supplier. Also, the outsourced process will interact with other processes (either carried out by the organization or outsourced). These interactions must be managed as required by ISO 9001:2008 clauses 4.1.a and 4.1.b.

The outsourcing of a needed process will normally be subject to the requirements of both ISO 9001:2008 clause 7.4 (Purchasing) and clause 4.1 (General Requirements). In some situations, the organization might not actually “purchase” the outsourced process. It might receive the service from head office or from another division, without a monetary transaction taking place. Regardless of these circumstances, ISO 9001:2008 Clauses 7.4 and 4.1 are still applicable.

An organization will typically face two situations that frequently must be considered when deciding the appropriate level of control of an outsourced process:

1. Where an organization has the competence and ability to carry out a process, but chooses to outsource that process (for commercial or other reasons), the process control criteria should already have been defined and can be transposed into requirements for the supplier to comply with, if
necessary. Evidence of compliance to such defined requirements should be obtained from the organization providing the outsourced activity.

2. Where the organization does not have the competence to carry out the process itself, and chooses to outsource it, the organization has to ensure the controls proposed by the supplier of the outsourced process are clearly defined and are adequate. In some cases, it may be necessary to involve external specialists in making this evaluation. Evidence of compliance to such defined requirements should be obtained from the organization providing the outsourced activity.

It may be convenient, or even necessary, to define some or all of the methods to be used for control of the outsourced processes in a contract between the organization and the supplier. Care should be taken, however, not to inhibit the supplier from proposing innovations to the outsourced process.

In some situations, it might not be possible to verify the output from the outsourced process by subsequent monitoring or measurement. In these cases, the organization needs to ensure that the control over the outsourced process includes process validation in accordance with ISO 9001:2000 clause 7.5.2.
Important tips

1.Make sure you include all outsourced processes affecting product quality, in the scope of your QMS. You must be able to identify, define and demonstrate evidence of sufficient controls over outsourced processes to ensure that such processes are performed according to the relevant requirements of ISO 9001:2008. The nature and scope of such control will depend on the nature of the outsourced or subcontracted process and the risk involved.

2.Outsourced processes may be controlled in any number of ways, e.g., providing the outsourcer with product specifications; your supplier quality manual that they must meet; asking for inspection and test results or certificates of compliance; validation of outsourced process; conducting product and QMS audits of your outsourcer; providing drawings, checklists and forms, etc. The expectation here is that you flow down to your supplier, the relevant ISO 9001requirements that you would have to implement had the process been performed in your own facility under your QMS control.

ISO 9001 Documentation:

What is a document?
Let’s begin with some definitions. A document is information that is written or recorded on some medium such as paper or computer. A document may specify requirements (e.g. a drawing or technical specification); provide direction (e.g. quality plan); or show results or evidence of activities performed (e.g. records).

What is a procedure?
A procedure is a specific way to perform an activity or process (methods or practice used by an organization) and it may or may not be written. If it is written, it is called a documented procedure. The same reasoning applies to work instructions (which are ways to perform a discrete task) which may or not be documented.

What purpose do quality management system documentation serve?
QMS documentation provide the following benefits and objectives:

1. Communication of Information – needed by the organization to plan, operate and control its processes. The type and extent of the documentation will depend on the criteria listed above, as well as the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

2. Evidence of conformity – provides evidence that what was planned and what has actually been done.

3. Knowledge reservoir and sharing – to preserve and disseminate the organization’s experiences; business and technical know-how. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

4. Training tool – to train personnel in performing their responsibilities

5. Consistency of performance – by having all personnel perform to the same method, practice or procedure

6. Promote best practice – document the best way of performing activity using internal and external knowledge

What are the ISO 9001 requirements for quality management system documentation?
Clause 4.2.1 specifies all the different types of documentation needed for your QMS. You must have documented statements of your quality policy and objectives. Specific requirements for these documents are stated elsewhere in clause 5 of the standard.

You must have a documented Quality Manual. There are many ways to document your Quality Manual; and this would be determined by the size, structure and complexity of your organization. Clause 4.2.2 specifies more requirements for the contents of the quality manual.

This standard is not heavy on documented (written) procedures as was the case with previous standards. Clause 4.2.1d requires you to have documents needed to ensure the effective planning, operation and control for QMS processes. The nature and extent of such documentation will vary from organization to organization, based on factors listed below.

What criteria should an organization use to determine how much quality management system documentation it should have?

The need to have additional documentation beyond those specified in this standard may depend upon – customer, regulatory and your own organizational requirements. Other factors to consider may include – complexity of products and processes; effect on quality; risk of customer dissatisfaction; economic risk; effectiveness and efficiency; competence of personnel; workforce stability and past quality problems and non-conformances.

For example, the more complex your products or processes are, the greater the risk of problems occurring. The use of documentation and other controls serve to prevent or reduce these risks.

If you have a highly educated and stable workforce, then the amount of documentation needed may be significantly less than an organization that has a high workforce turnover and lower educational requirements.

Regardless of how and to what extent you document your QMS, you must demonstrate the effective implementation of your QMS in terms of conformity to ISO 9001, customer, regulatory and your own organizational requirements.

In what medium should QMS documents be communicated?
Any combination of media is acceptable for documents and records provided they conform to requirements specified in clause 4.2.3 control of documents and clause 4.2.4 control of records. These may include, but not limited to: paper, magnetic. Electronic or optical computer disc, photograph, audio-visual, etc.

What are the mandatory documented procedures required by ISO 9001:2000?

Under ISO 9001, you must have documented procedures for – clause 4.2.3 – Control of documents; clause 4.2.4 – Control of records; clause 8.2.2 – Internal audit; clause 8.3 – control of nonconforming product; clause 8.5.2 – Corrective action and clause 8.5.3 – Preventive action.

These documented procedures have to be controlled in accordance with the requirements of clause 4.2.3

You may choose to include your procedures and lower level documentation in your quality manual or organize them in some other fashion. The practicality of this would depend on the size of your organization, complexity of products and processes; competency of personnel, media used for documentation (hard copy versus computerized); ease of use and understanding by personnel; maintainability; etc.

Depending on these same criteria, you may decide to have additional procedures (beyond the mandatory six) or carry over some or all the procedures you had under previous QMS systems.

Some of the mandatory procedures can be combined, e.g., correction and preventive action may be combined as long as you address the specific requirements of each clause 8.5.2 and 8.5.3. You could also have more than one procedure for any of the mandatory clauses listed above.

Note there are several ways to write procedures, other than the conventional narrative form. In fact, narrative documentation has been found to be the least effective way to promote user comprehension and ease of use. Procedures may be documented graphically (e.g. flowchart; video; series of pictures or photographs, etc.).

Everything You Need To Know About Understanding the ISO 9001 Process Approach

What is the definition of a process?
A “Process” can be defined as a “Set of interrelated or interacting activities, which transforms inputs into outputs”. These activities require allocation of resources such as people and materials.

What is the definition of the ‘process approach’?
The application of a system of processes within an organization, together with the identification and interactions of these processes, and their management, can be referred to as the “process approach”.

The processes are managed as a system, by creating and understanding a network of the processes and their interactions. The consistent operation of this network is often referred to as the “system approach” to management.
The performance of an organization can be improved through the use of the process approach.

What are the characteristics of processes?
Processes are the foundation upon which your quality management system (QMS) must be developed. Let’s understand some basics about processes.

All work generally involves a process – things go in (inputs); get worked upon (conversion); and come out differently (output). The value-adding conversion activity within a process transforms inputs into outputs, e.g. takes raw materials (the input) and manufactures (the value-adding conversion activity using various resources) a product (the output).
Process inputs and outputs can be tangible (raw materials or finished product) or intangible (information – e.g. computerized drawing or specification).

All process has a supplier and a customer. These suppliers and customers may be internal processes or external to your organization. Each process must have an accountable owner, i.e., having defined responsibility and authority to operate, control and improve their process.

All processes require the use of resources, e.g. – people, equipment, materials, technology etc. These resources can be used as inputs (raw materials or information such as a customer specification) as well as for the value-adding conversion activity (e.g. use of machinery, equipment, computers, technology, people, etc.) to transform raw material (input) into finished product (output).

The purpose of the process approach is to enhance an organization’s effectiveness and efficiency in achieving its defined objectives. Process effectiveness and efficiency can be assessed through internal or external review processes.

All processes must also meet (customer, organizational and applicable regulatory) requirements. The performance of all processes can be monitored and measured. Gather performance data that can be analyzed to determine process effectiveness and whether any corrective action or improvement is needed.

What are the characteristics of the process approach?
A major advantage of the process approach, when compared to other approaches, is in the management and control of the interactions between these processes and the interfaces between the functional structure of the organization.

Your QMS is made up of a network of these value-adding processes that link, combine and interact with one another to collectively provide product or service. These processes are inter-dependent and can be defined by complex interactions. For example, any of the COP processes, could interact with some or all of the MOP’s, SOP’s; QMP’s. Also note that resources (SOP’s) and QMP’s may also be applied to all other processes. (See types of processes below).

Interactions between QMS processes may occur at any of the three process stages (input, output or conversion activity). The interaction may occur in many different ways – physical, documentary, verbal, electronic, etc. For each process, we must identify these interactions; assess the risks of problems that may occur and implement appropriate controls to prevent them, e.g., if orders are communicated verbally by sales personnel to production, what is the risk that production errors will occur?

What benefits does the process approach provide?

The process approach:

• Focuses on integrating, aligning and linking processes effectively to achieve planned goals and objectives
• Allows the organization to focus on improving process effectiveness and efficiency.
• Facilitates consistent performance which in turn provides assurance to customers about the organization’s quality and capability.
• Promotes the smooth and transparent flow of operations within the organization.
• Contributes to lower costs and shorter cycle times, through the effective use of resources.
• Focus on continual improvement of processes results in improved, consistent and predictable results.
• Facilitates the involvement and empowerment of people and the clarification of their responsibilities.

How is the process approach different from a departmental approach?
The process approach is an effective way to organize and manage business activities to create value for the customer and other interested parties.
Organizations are often structured into a hierarchy of functional departments.

These departments are usually managed vertically, with responsibility for the intended outputs being divided among functional units. The end customer or other interested party is not always visible to all involved. Consequently, problems that occur at the interface between departments are often given less priority than the short-term goals of the departments. This leads to little or no improvement to the customer, as actions are usually focused on the departmental functions, rather than overall benefit to the organization.

The process approach introduces horizontal management of activities, by removing the barriers between different departments and focusing their collective effort to the main goals of the organization.

How can QMS processes be grouped or categorized?
An organization’s QMS processes may be grouped or categorized in many ways. One logical way would include the following:

·  Customer Oriented Processes(COP’s) - These are product realization processes (see clause 7) that determine customer requirements (inputs), design, make, deliver and service product (outputs) to customers and determine customer satisfaction. These processes generally have the greatest degree of interaction with external customers. COP’s include – marketing and sales; design and development; production; shipping; packaging; servicing/ warranty; customer satisfaction; etc., whether performed onsite or off-site.

·  Support Oriented Processes(SOP’s) – These processes provide the necessary resources to COP’s to facilitate product realization and measurement and monitoring activities. These processes generally have the greatest degree of interaction at an operational level with COP’s and to a lesser degree with other internal QMS processes. SOP’s include – human resources; information technology; purchasing and receiving; laboratory; maintenance; tooling; facility management; etc, whether performed onsite or off-site. See clause 6 and 7.

·  Management Oriented Processes(MOP’s) – These processes provide the strategic planning, commitment, leadership, resources, review and decision-making by top management (see clause 5).  These processes generally interact with all QMS processes at the QMS planning and review level. MOP’s include – business planning; management review; quality planning; resource planning; communication, etc., whether performed offsite or on-site.

·  Quality Management Processes (QMP’s) to document, measure, analyze and improve all processes – These processes provide quality management support to and interact with all QMS processes. QMP’s include – document control; records control; monitoring and measurement of processes and product; internal audits; control of nonconforming product; corrective and preventive action; continual improvement; etc whether performed onsite or off-site. See clause 4 & 8.

Outsourced Processes (OP’s) – These are COP’s or SOP’s that are performed by a function or organization outside the ownership or managerial control of your facility. They may be performed onsite or off-site. These processes include – heat treating; painting; welding, calibration; testing; sort; HR; etc.

How should a QMS be implemented using the process approach?

Plan – To plan your QMS using the ‘Process Approach’, you must:

• Start by identifying your customers and their requirements (see clause 5.2, 7.1 and 7.2).
• Identify applicable requirements of regulatory bodies (see clause 7.1, 7.2 and 7.3).
• Define organizational strategic and quality goals, objectives and policies for products and management systems.
• Identify the processes needed for the QMS (see listing above).
• Determine their sequence and interaction (show the sequence and interaction of your COP’s). There are many ways to document this, e.g., a high level flowchart or a process map.
• Determine the application of QMS processes throughout the organization (show how MOP’s; SOP’s and QMP’s are applied to each COP and to each other). There are many ways of documenting this. A popular way is through graphical representation, e.g. process maps.
• Determine (plan) the criteria, methods, information, controls and resources needed for each QMS process. These include:

• Implement your QMS according to your plan.
  Use project management tools that include, but is not limited to communication; awareness; training; change management; management involvement; review activities 

  Monitor and measure each QMS process and its interaction with other processes. Performance indicators to monitor and measure process performance may come from the management system standard; customer; regulatory and your own organizational requirements. Performance indicators may relate to the process output as well as the process activity.

  Evaluate process data obtained from monitoring and measuring, in order to quantify process performance. Where appropriate, use statistical methods.

  Compare process performance measurement results with the defined requirements of the process to confirm process effectiveness, efficiency and any need for corrective action. Identify process improvement opportunities based on process performance data. Report to top management on the performance of the process, as appropriate.

  Improve QMS processes
  Define the corrective action process that will be used to eliminate the root causes of problems (examples of problems include errors, defects, lack of adequate process controls). Implement the corrective action process and verify its effectiveness.

  Once the planned process requirements are achieved, the organization should focus ion actions to improve process performance to higher levels, on a continual basis.

  Identify areas for improvement (e.g., process simplification, enhancement of efficiency, improvement of effectiveness, reduction of process cycle time). Verify the effectiveness of the improvement.

  Use risk analysis tools to identify potential problems. The root cause(s) of these potential problems should also be identified and corrected, preventing occurrence in all processes with similarly identified risks.

• • Identify the internal/external customer-required output.
  • Identify process owners and their responsibilities.
  • Describe the process activity that produces the output.
  • Identify the resources (facility; equipment; utilities; materials; labor, finances, etc.) needed for the process activity.
  • Identify the inputs for the process – information, materials, supplies, etc.
  • Define the process methods, procedures, forms, etc., that may be needed to produce the output.
  • Define the controls to prevent or eliminate risk of errors, omissions, ornonconformities in the process activity. These controls may come from themanagement system standard; customer; regulatory and your ownorganizational requirements (more details provided in clause 4.1).
  • Interaction – with sources that provide the inputs (internal process or external supplier); uses the output (internal process or external customer); or provide the resources (internal support process) to perform the process activity.

Useful tips

1.  Performance indicators for process output must focus on meeting customer and regulatory requirements. Performance indicators for process activity should focus on measuring process effectiveness and efficiency. See clause 5.4.2 for quality objectives.

2.  It is useful to point out that while we do need to identify all QMS processes and describe their interaction, not all identified QMS processes need to be documented or documented in the detail described above. Review notes on clause 4.1 General Requirements in conjunction with the above notes on the process approach, for more insight on process documentation.

Keep in mind that the above notes and reference are for guidance and the manner and detail of application and documentation of the ‘process approach’ will vary from organization to organization, due to a variety of factors such as size and complexity of the organization; products, processes; customers; etc. See clause 4.1 for more details on applying the process approach.

What is the PDCA approach to process implementation?

PLAN-DO-CHECK-ACT (PDCA) – is a very effective tool for business management and the ISO 9001 standard strongly recommends its use.  PDCA is a dynamic cycle that can be applied to each of the organization’s processes, and also to the system of processes as a whole. It may be used to plan, implement, control and continually improve both product realization and other QMS processes.

Maintenance and continual improvement of QMS processes can be achieved by applying PDCA to processes at all levels within the organization – from the executive high-level strategic processes, such as business planning or management review to operational processes such as product realization or calibration.

(PLAN) – For each QMS process you must establish:

• Process owner and his/her accountability
• Process inputs, outputs, value adding or conversion activities and     sequence/interaction of these activities (sub-processes) within the process. Many of the COP’s and SOP’s may have sub-processes.
• Process policies, responsibilities and accountability.
• Process objectives and performance indicators and methods to monitor andmeasure process performance to these objectives and indicators.
• Resources needed (e.g. facility, equipment, labor, materials, time, etc).
• Preventive and detective controls needed for process activity, input, output andresources used.
• Process documentation (e.g. procedures, forms, work instructions,     specification, etc.)
• The nature, method, frequency and timing of interaction with other processesand where this interaction will occur – input, output, use of resources,conversion activity, etc.
• You must pay a lot of attention to this stage of your QMS development. Planning must also consider how you will meet customer, applicable regulatory, and your own organizational requirements, in addition to ISO 9001 requirements. We will look at QMS planning in more detail when we review clause 4.1 requirements.

(DO) – Deploy and implement your QMS processes and manage and control them according to your plan as documented above.

(CHECK) – Monitor and measure the effectiveness of your QMS processes against policies and objectives that you established under PLAN. Monitoring and measuring activity may focus on any or all of a process’s inputs; outputs; use of resources for conversion; and interaction with other processes.

(ACT) – Collect and analyze your monitoring and measurement information and use it to determine the effectiveness of each process as well as your overall QMS in meeting requirements. Use the information to correct problems and continually improve individual processes.

As mentioned above PDCA is a dynamic cycle and so continual improvement must be an on-going process for improving your QMS and enhancing customer satisfaction.

What is the Continual Improvement Process model for QMS implementation?

The macro level application of the PDCA model to an entire organization. The organization’s QMS is used to PLAN the controls over all inputs, resources, value-adding activities and outputs.
We DO – implement our plan by using various resources to convert customer inputs (requirements) into outputs (product) that meet customer requirements. WeCHECK – by monitoring and measuring QMS performance and through customer feedback.
We ACT – by using this information to continually improve QMS effectiveness. At the micro level, this same model can be applied to each QMS process.

Controls for your processes come from the ISO 9001 standard, customer requirements, your organization or applicable regulatory requirements.. The five clauses of ISO 9001 provide control requirements for PDCA – planning, implementation; monitoring and measurement; and for improvement of each QMS process. The applicable requirements of these five clauses must be applied to each process (inputs; outputs; resources used; transformation activities; interaction with other processes) for effective control. In clause 4.1 we will discuss this in further detail.

Unfortunately, many organizations find themselves in stagnating bureaucracies which have implemented in the name of quality. At Paradigm Consulting , we make quality systems solutions simple and manageable. We believe that client needs come first and our goal is to ensure total client satisfaction is achieved as we approach our goals.

The Paradigm Difference – Why Choose Us

Resources
Our consultants are highly qualified professionals with industrial background and diverse industry experience.  We act as project managers to ensure the consistency and stability throughout your quality management system implementation.  Our consultants are familiar and can appreciate the business realities that clients face on a day-to-day basis, and understand that there is more than one way to comply with standard requirements.

Solution Ownership
One of the most critical ingredients in any process requiring organizational change is what we call “Solution Ownership”.  We respect the face that our clients know their business best and rather dictating to your staff what is required, we arrive at a solution in conjunction with your staff.  This process ensures that your organization has some “ownership” of the solution being implemented.  Our clients are able to view their results at each of the process, allowing for timely improvements to their quality management systems.

Project Management
Your business goals are unique as well as your needs and we offer a solution as unique and tailored to meet your business expectations.  We do not believe in providing standard templates to assist in the development of your processes.  We offer a customized tailored consulting solution to suit the uniqueness of your organization’s needs.  Whether your organization has 1 or 1000 employees, you will be assigned a consultant that has direct experience in your industry who will make the consulting process a rewarding experience.

Confidentiality
Any and all information that comes into possession of Paradigm Consulting, its employees and iso agents from start to finish will be treated as strictly confidential.  We will not disclose any or all information concerning your business organization with any third parties without the prior written consent of the client.

What We Offer

At Paradigm our business philosophy is quite simple “Client for life”.  Quality Management Consultants are a valuable resource and excellent investment to any business.  We take the pain out of the implementation process, help you successfully design your QMS, prepare for your compliance audit and help achieve certification within the first attempt.

Our commitment to total client satisfaction is achieved by the level of service we provide to each of our clients  as follows:

• Personnel Attention (1-1)
• Resources
• Our Approach
• Minimal Disruption
• Expertise

• Complete Guidance
• Continual Improvement
• Flexibility
• Timely Registration
• Ongoing Client Support

1.  ISO 9001 provides a framework for organizations to operate and manage their organizations more effectively irrespective of size or industry class.

2. Improved internal efficiency and better management of resources

3. Competitive advantage over organizations which have no systems in place.

4. International credibility across all industry sectors.

5. Increased profitability as a result of streamlined processes leading to reduction of costs and wastage.

6. Ability to participate in Government Tender process or other organizational tender processes.

7. Implementation of Industry Best Practices.

8. Improved customer satisfaction and customer loyalty.

9. Consistency in business processes and overall performance

10. Factual Approach to Decision Making.

Learn about opportunities ISO certification gives you.

Our trained consultants can facilitate the internal auditing process to ensure continued conformance to standard requirements.  The benefits of internal audit outsourcing is that it removes any conflict of interest with concerned parties (ie. you cannot audit yourself).  Also since we are not the process owners, this allows for complete independence in performing internal audits of the complete QMS.  Lastly we provide an independent professional approach of auditing your processes and provide feedback for best industry practices.

Maintaining your Quality Management System (QMS) takes up valuable company resources, this solution is geared towards organizations which have limited resources in maintaining their iso quality management system.  Our trained professional consultants will look after all aspects of the quality management system and provide the necessary feedback for continued performance.  We work with your organization to meet the standard requirements and provide value added feedback for continual improvement.

What We Offer

At Paradigm our business philosophy is quite simple “Client for life”.  Quality Management Consultants are a valuable resource and excellent investment to any business.  We take the pain out of the implementation process, help you successfully design your QMS, prepare for your compliance audit and help achieve certification within the first attempt.

Our commitment to total client satisfaction is achieved by the level of service we provide to each of our clients  as follows: