Introduction to ISO 9001: 2000 and Related Standards
ISO (International Organization for Standardization) is a worldwide federation of national standards bodies.
ISO 9001: 2000 was develop by a technical committee of ISO known as ISO/TC 176, Quality management and quality assurance, Subcommittee SC 2, Quality systems.
ISO 9001: 2000 was developed to give a generic set of requirements for a quality management system (or QMS) that will apply to a wide variety of organizations.
ISO 9001: 2000 replaces ISO 9001: 1994, ISO 9002: 1994, ISO 9003: 1994 and ISO 9004: 1994Why
Was the Standard Revised?
Continual improvement is built into the standard, just like the systems it governs.
An important focus has been to make the language more applicable to a wider range of organizations.
The standard has been changed to follow a 'Process Model'rather than being 'Element Based'as in the previous version.The Old ISO 9000
Revised ISO 9000 Series and Related Standards
The Process Model
An organization is a system of interlinked processes The new standard is geared at managing and improving those processes Key processes • those that lead to products and services- must be identified Methods to measure and control these processes must now be included The focus is on Customer Satisfaction
Implementation of ISO 9001 ~ Preparing For Registration Audit
Implementing ISO 9001 is much like preparing a meal from a recipe and serving it to a registration auditor. You will need system documentation and auditors training to be able to successfully audit and maintain the QMS. The following task list assumes that both of these items have been accomplished and are in place.
So what needs to be done in order to be prepared?
1) Your company processes must be identified. These must be reviewed and revised as necessary.
2) Your company must monitor and measure these processes. You must have data that shows that each of these process objectives is being met. The objectives must be measurable.
3) Your company must have a quality manual. It must be reviewed and everyone must be familiar with it.
4) Your company must have a document control procedure. You must implement what is written in the procedure. If you have issues with the procedure, then they should be discussed and revisions made if necessary.
5) Your company must have a record control procedure. A record control matrix is a useful format and outline for this procedure. Complete this matrix for every type of record you keep. This must be completed.
6) Your company's upper management must be involved in the entire implementation process. Your registration auditor should spend a good deal of time determining how they have participated in the ISO system.
7) Your company must have a quality policy statement that includes wording about how you meet your customer's requirements and intend to improve your management system. The wording must also include how the company's measurable objectives are set and monitored. Once the wording of the policy is finalized, everyone must know the policy.
8) Responsibilities and authority must be clearly defined. An organizational chart indicating each of your processes has to clearly define responsibilities as well. These must be reviewed for accuracy and revised if necessary.
9) Your company must appoint a management representative. It is this person's responsibility to implement and manage the system.
10) Your company must perform and record a management review. The various details of what is required in this review can be found in section 5.6 of the ISO 9001:2000 standard.
11) Your company must implement a training process. You must develop a documented process for this activity that is reviewed and revised if necessary. Evidence of training is vital. You must gather records that show each person's background (diplomas, certifications, résumé's, applications, etc.), evidence of continuing training (external or using a special form), and then a regular evaluation must be performed on everyone and records maintained.
12) Your company must have a process for reviewing customer or project requirements and must keep a record of this activity. A documented process that must be reviewed and revised if necessary. If the documented process is acceptable, then you must be able to show evidence that you have followed the process.
13) When applicable, your company must have a design process. It must be a documented process that must be reviewed and revised if necessary. You may provide a checklist that can be used as a record to show as evidence that you have followed your process. If the documented process is acceptable, then you must show evidence that you have followed the process.
The design process must address:
a) Design inputs • What does your company need to initiate a design? b) Design outputs • What does your company develop as a formal design? c) Design reviews • How and when does your company review designs to monitor their progress and proper development? d) Design verification • How does your company approve designs prior to beginning actual construction? e) Design validation • How does your company confirm that the design meets the customers needs? f) Design changes • How does your company handle changes during the design process?
14) Your company must have a supplier qualification and monitoring process. A documented process that must be reviewed and revised if necessary. This includes a form to track suppliers and supplier issues. If the documented process is acceptable, then you must start identifying what your expectations are of your suppliers and then monitoring their performance against those expectations and keeping a record of this performance on the form you provide.
15) Your company must have a purchasing process. A documented process that must be reviewed and revised if necessary. If the documented process is acceptable, then you must start keeping records of purchases made from suppliers identified in step 14 above. The records must include what was originally purchased and what was received.
16) All of the documented processes that are developed should include reference to what type of information is available to personnel throughout each actual process, what type of work instructions may exist, what type of equipment is used, what monitoring devices are utilized (if any) and how a project progresses from beginning to end both overall and within individual process steps.
The documented processes that you provide should be reviewed to ensure that these issues are addressed accurately. Your company must be able to provide evidence (records) where appropriate, that these processes are being followed.
17) Your company's overall processes must include how materials and components are identified and traced, what you does with any components or materials that might be supplied by a customer and how components or materials are to be protected. These issues should be identifiable in the various processes documented and should be reviewed for accuracy and completeness. You also must be able to show evidence (records) where appropriate, that these processes are being followed.Your company must have a defined process for determining and analyzing customer satisfaction. I have already provided you with a documented process and form for this activity. The process must be reviewed and revised if necessary and then you must show evidence (records) that it has implemented this process. Customer satisfaction surveys must be issued to customers, returned, information tallied, results analyzed and action taken if there are any problems.
18) Your company must have and implement an internal audit procedure. The procedure should be reviewed and revised if necessary, the schedule completed and then the internal audit conducted and records maintained. Your internal audit must include an audit of your processes and an audit of your projects.
19) Your company must have a procedure for how it addresses any non-conformances encountered during a project. It must be implemented and records maintained.
20) Company management must be regularly collecting data based on the process objectives described in item 2 above and be analyzing this data for performance trends. The analysis results should be posted so everyone can see how the company is doing with regard to its process objectives.
21) Your company must have a procedure for both corrective and preventive action. They should be reviewed and revised if necessary. Also, a corrective and preventive action form must be available. Your company must have implemented, some corrective and preventive actions prior to the registration audit and maintained a record of these activities.
The list above should not be construed, as "all that needs to be done". There are many minute details that will need to be addressed in order to complete the overall tasks described. Ask your Assigned Consultant about further details.
Once everything is complete, implemented and company personnel are completely trained in the details of the system, then typically 2.5 to 3 months must pass in which the system is used and records are generated. Only then can you conduct your own internal audit and seek registration.
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