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Slide 60 of 262


4.1 General Requirements

There are no new requirements for General Requirements.
Also see: 5.4.2a, 7.1

The company shall establish, document, implement and maintain a quality management system and continually improve its effectiveness in accordance with the requirements of ISO 9001:2000.

2 What is a "document"? - Definitions and references

The following are some of the main objectives of an organization’s documentation, independent of whether or not it has implemented a formal QMS;

a) Communication of Information
* as a tool for information transmission and communication. The type and extent of the documentation will depend on the nature of the organization’s products and processes, the degree of formality of communication systems and the level of communication skills within the organization, and the organizational culture.

b) Evidence of conformity
* provision of evidence that what was planned, has actually been done.

c) Knowledge sharing
* in order to disseminate and preserve the organization’s experiences. A typical example would be a technical specification, which can be used as a base for design and development of a new product.

A list of commonly used terms relating to documentation is presented in Annex A (taken from ISO 9000:2000). It must be stressed that, according to ISO 9001:2000 clause 4.2 Documentation requirements documents may be in any form or type of medium, and the definition of "document" in ISO 9000:2000 clause 3.7.2 gives the following examples:
* paper
* magnetic
* electronic or optical computer disc
* photograph
* master sample

Also see ISO/TR 10013 Guidelines for quality management systems documentation for further guidance.

The company shall:

a) Identify the processes needed for the quality management system and their application throughout the company (see 1.2),
ISO 9001:2000 actually defines the minimal processes related to a company. Essentials such as a nonconformance system and control of customer supplied product.

• Determine the sequence and interaction of these processes,
Use Process Mapping to comply. This is the reason we go through the process of asking what your products and processes are. We are looking at what is done, how it is done and what effect one system has upon another.

• Determine criteria and methods needed to ensure that both the operation and control of these processes are effective,
This talks about criteria and methods of control. It comes into play where we discuss how checks are decided upon such as content of audits performed (e.g. Customer Service Audit Form). A ‘process audit’ is one methodology. The audit criteria is the audit content. Note that both effective and control are key words here.

• Ensure the availability of resources and information necessary to support the operation and monitoring of these processes,
This requires feedback from a number of sources including management reviews. The contents of management review meetings as determined by the standard (the ‘minimum’) can not be static. This is to say you must be able to show that you react to information. One might interpret this to require that management reviews have information inputs from processes such as internal audits and process audits, not to mention performance and other data. Key word is availability.

e) Monitor, measure and analyze these processes, and
(See: Section 8)

f) Implement actions necessary to achieve planned results and continual improvement of these processes.
This is a reference to a number of sections of the requirements including corrective action. Note that continual improvement is essentially first used here. This requirement is new to the year 2000 version.
This is a ‘standard’ intro. In general the standard defines the required elements. However, those in section 7 may be ‘opted out of [See 5.4.2 (a) and 1.2 herein]. But beware – if you decide one or more of the paragraphs in section 7 are not applicable to your company, you will have some explaining to do.

Design is one area often opted out of particularly by companies in a service industry. I suggest that you take a serious look at design in your company. There are several basic discussions on design in the service industry at Food for thought.

These processes shall be managed by the company in accordance with the requirements of ISO 9001:2000.

Where a company chooses to outsource any process that affects product conformity with requirements, the company shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

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

The General Requirements of clause 4.1 are met if the specific requirements of clauses 5 through 8 are met (i.e. have you established a system that meets the requirements of ISO 9001:2000) - Could be audited as follows:

Review quality manual to determine if a systematic approach is defined for:

1) Identifying and managing QMS processes (or elements) in accordance with the "process approach" defined in clause 0.2 and Figure 1 of ISO 9001:2000 identifying and showing the relationship between the following QMS processes (or elements) and their related sub-processes: Clause:

* Management Responsibility
* Resource Management
* Product Realization
* Measurement, Analysis and
* Improvement

2) Ensuring the criteria, methods, information and responsibilities for managing QMS processes are in place.

3) Ensuring that data is collected, analyzed and used to assess QMS process effectiveness and to identify needed actions or improvements.

Likewise, The General Documentation Requirements of clause 4.2 could be audited as follows:

Review quality manual to ensure required procedures are included or referenced.

Review QMS documentation to determine if documented procedures are appropriate for the size and type of the company, the complexity and interaction of processes, and competence of personnel.

Review QMS processes to ensure they are adequately defined in procedures, process or job descriptions, work instructions, or other appropriate system documentation.

Procedures may also be "needed" for:
* Planning (5.4, 7.1, 8.1, 8.5.1)
* Communications 7.2.3
* Management Review (5.6)
* Resource Management (6)
* Training (6.2.2)
* Customer Processes (7.2)
* Design and Development (7.3)
* Purchasing(7.4)
* Operations Control (7.5.1)
* Product ID/Traceability ( 7.5.2)
* Customer Property (7.5.4)
* Preservation of Product (7.5.5)
* Validation of Processes (7.5.2)
* Process Measurement/Monitoring (8.2.3)
* Product Measurement/Monitoring (8.2.4)
* Analysis/ Improvement (8.4, 8.5)

Review applicable standards and statutory/regulatory documents to determine if the QMS identifies required documentation and records.

Review other external or internal documents to ensure QMS identifies documentation and records needed to effectively manage the company's products, processes and activities.
Your QMS can be illustrated in a number of ways. One way to think of it is as a standard fishbone. You have quote review to customer receives product. Along the way there are various inputs. In the extreme, as in starting an entirely new and unrelated product, there will be basics of design including determining processes, inspections and tests, etc. Once established you still review these basics - typically during contract review or RFQ review. Are current inspections and tests sufficient, etc. Your design change process should handle a lot of the documentation (assuming it's not a 'catalogue' item). I.e.: Special length, special hydraulic fittings, special attachments at each end, etc.

If you look at your business as a set of processes and inter-relate them this is not all that hard. The important part is ensuring you are clear about inputs and outputs and intra / inter-system communications.

Remember - if you are looking at a sub-contracted process, you are still responsible for determining critical characteristics and such. While you send the item out for sub-processing (for example plating), it is still a process step and is subject to QMS requirements.

-> 5.5.3 Internal Communication
-> Top management shall ensure that appropriate
-> communication processes are established within the
-> company and that communication takes place regarding the
-> effectiveness of the quality management system.

Communications channels are represented in procedures. Management reviews, for example, are communication conduits. Staff meetings are conduits. Shift meetings are conduits. This should be only an issue of being ready to discuss the issue and to be ready with specific examples.

Remember - communication with suppliers is as important as communication with customer and internal communication.

You may want to look through process mapping.

Your QMS is a sub-set of all processes, so if you can illustrate your company processes they will be there. Most of your processes will be QMS related with the exception of some finance and such.

If you're making specialty items on a low volume level your 'process documentation' will be a lot different than in a high volume operation. Other factors are important as well, such as how much training your company does or does not do. My point here is only to say each company is different in how their systems are designed - which is a big reason I warn against canned documentation solutions.

You can do this from the product view, but my recommendation is you do it from a process view.


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