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Slide 66 of 262
This is meant to give you a basic idea of the intention / requirements. A detailed discussion is presented in Clause_Interp_and_Upgrading.doc.
5.4 Planning
5.4.1 Quality Objectives
Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the company. The quality objectives shall be measurable and consistent with the quality policy.
Element 5.4.1, Quality Objectives, correlates to element 4.1.1 and 4.2.1 of the old standard.
This reference requires multiple quality objectives in addition to what is stated in the quality policy. Remember, each objective requires a measurable for that objective. Most companies have quality measurables of some type established in each department. The requirement is typically met with an explanation of how one or more of these measurables is relevant to a quality objective.
NOTE: Can you distinguish between quality objectives and business objectives?
5.4.1 also states that top management must ensure that quality objectives, including those needed to meet requirements for product are established at relevant functions and levels within the company. It also says that the quality objectives shall be measurable and consistent with the quality policy.
This clause can be broken down into four parts:
1) Management must establish quality objectives at relevant functions and levels within the company.
2) As a minimum, the quality objectives must include those needed to meet specified product requirements.
3) The objectives must be measurable.
4) The objectives must be consistent with the Quality Policy.
Let's look at each of these in more detail...
1) Management must establish quality objectives at relevant functions and levels within the company.
This is a new requirement. High level objectives must now be supported by detailed objectives that are directly connected to the company. People and departments must now have applicable quality objectives. The company chart should include a summary by department and level, which identifies the quality objectives of each. The quality objectives of personnel should be included as part of their job descriptions.
2) As a minimum, the quality objectives must include those needed to meet specified product requirements.
Remember: This Requirement applies to all companies even if it does not specifically provide 'products'. According to ISO 9001:2000, the term 'product' means the result of a process and includes:
a) Hardware;
b) Software;
c) Services;
d) Processed materials.
3) The objectives must be measurable.
Your company must define how it measures progress towards its objectives. Examples of specific objectives include:
a) More efficient customer service,
b) Faster design and development of new products,
c) Reduction of shipping errors, and
d) Effective production scheduling.
4) The objectives must be consistent with the Quality Policy.
The objectives should be reviewed regularly, according to Management Review, in order to ensure they remain consistent with the quality policy and commitment to continual improvement.
Potential Audit Questions
1. Has your company's top management defined Quality Objectives at each relevant function and level of the company? If so, please provide some examples of your company's quality objectives.
2. How does your company measure whether or not these quality objectives are being achieved?
3. Do you think that the addition of this requirement to the ISO 9001:2000 standard is a valuable addition?
5.4.2 Quality Management System Planning
Top management shall ensure that
a) The planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and
b) The integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.
Quality Planning and Service aspect of the ISO 9001:2000 standard. Specifically, how you gather information to form a quality plan for a service. The following procedure is an example:
QSP 120 Service Quality Planning
1 Purpose
1.1 To describe the process to prepare and maintain Service / Quality Plans used by CO LTD.
2 Scope
2.1 A service plan is used, within the constraints of the business operating parameters, to identify the quality system activities required for product and service quality.
2.2 The service plan is typical for all contracts unless a specific contract requires the procedures to differ in which case the service plan is customized to meet the requirements of the contract.
2.3 We provide a copy of the service plan to the customer if required by the contract.
2.4 The typical service plan format is reviewed and updated during the Management Review meeting.
2.5 Unless otherwise agreed during contract negotiations, the format of the service plan is a flow chart illustrating the necessary steps required to effect the Service delivery.
2.6 The Quality Assurance Manual (QAM), the Quality System Procedures (QSP), and the Work Instructions (WI) are integral parts of the Service/Quality Plan.
2.7 Service plans and the associated parts are updated and controlled as required and described in QSP 510, Control of Documents and are retained as quality records, per QSP 1260, Control of Quality Records.
2.8 The major product service categories which follow similar practices is associated with:
a. Scientific Research & Experimental Development (S.R. & E.D.) services associated with components, assemblies and products for the toy industry.
b. Non-ferrous toy components and assemblies.
c. Ferrous toy components, assemblies and products.
3 Responsibility
3.1 The responsibility for the preparation and maintenance of the Service Plan for the above product categories is with the ISO Management Representative.
4 Flow Charts
4.1 Service plan flow charts, form #120-1 is shown as documentation in paragraph 6.1 of this procedure and describe a generic Service Plan for the provision of the product and service categories, per above paragraph 2.8.
4.2 For SR & ED projects, per above paragraph 2.8 a, the generic format for service plans applies. For complex projects where the activities may fall outside the flow chart service plan method, the project management planning and tracking is determined by the Sales & Marketing Manager and the customer during contract review, per QSP 610, and handled per QSP 710, Design and Development.
4.3 As applicable, service planning and the service plan flow chart #120-1, shown in paragraph 6.1, takes into consideration the following integral parts of the quality system:
a. the revision of documentation for an existing service plan or the preparation of a new service plan to meet the quality objectives...ref QSP 510.
b. the identification and allocation of specific resources, responsibilities and authority required to provide the requested services...ref QSP 310, and QSP 410.
c. the identification and assessment of requirements and customer communications to confirm capability to meet customer needs and requirements...ref QSP 610.
d. the development of process control work order instructions for the S.R. & E.D. and Production operations and the identification and acquisition of any equipment, resources and skills needed...ref QSP 710 and QSP 910.
e. the verification of products at the appropriate stages for incoming, in-process, and final operations...ref QSP 1220-30-40.
f. the clarification of acceptance criteria in the form of sketches, drawings, specifications, physical samples or written instructions...ref QSP 610 and QSP 910.
g. the identification of the quality records...ref QSP 1260.
4.4 When required to provide additional details the quality system procedures referenced in above par 4.3 may be outlined in flow chart format and used to supplement the main quality/service plan, form #120-1.
References
5.1 QSP 310, Deployment of Personnel
5.2 QSP 410, Management of processes
5.3 QSP 510, Document control
5.4 QSP 610, Contract review
5.5 QSP 710, Design control
5.6 QSP 910, Process control
5.7 QSP 1220-30-40, Inspection and test
5.8 QSP 1260, Quality records
6 Documentation
Service Plan Flow Chart, form #120-1.
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