ISO 9001 Standards Document control procedures

ISO 9001 Standards Document control procedures
The ISO 9001 Standards requires that a documented procedure be established to define the controls needed.

This requirement means that the methods for performing the various activities required to control different types of documents should be defined and documented.

Although the ISO 9001 standards implies that a single procedure is required, should you choose to produce several different procedures for handling the different types of documents it is doubtful that any auditor would deem this noncompliant. Where this might be questionable is in cases where there is no logical reason for such differences and where merging the procedures and settling on a best practice would improve efficiency and effectiveness.

Documents are recorded information and the purpose of the document control process is to firstly ensure the appropriate information is available where needed and secondly to prevent the inadvertent use of invalid
information. At each stage of the process are activities to be performed that may require documented procedures in order to ensure consistency and predictability. Procedures may not be necessary for each stage in the process.

Best Ways Of Implementing ISO 9001 Standards

Best Ways Of Implementing ISO 9001 Standards

While each implementation is dependent on the company, the industry, customers, etc., here’s a good starting point:

1.) Identify what your customer expects of your company. Consider both sales and after-sales aspects, from the customer’s point of view.

2.) Develop a philosophy (Quality Policy) that addresses (1). This means clause 5.3.

3.) Identify your processes, keeping in mind the importance of each as compared to (1) above. This means clause 4.1.

4.) Identify your management structure, being sure it supports and does not conflict with (1), (2) or (3). This means the rest of Clause 5 in the standard.

5.) Figure out resource issues. This means all of Clause 6.

7.) From there, work on clauses 7 & 8. This part is particularly hard to define as a generic plan, because how it is done is unique to each company, and the results of (1) through (6) above.

Tips:

(a) Keep documentation to the absolute minimum.

(b) Put “required procedures” and process maps in your Quality Manual, instead of subordinate documents. This makes the QM useful, instead of just a throwaway restatement of the standard. Limits documentation overall.

(c) Spend a lot of time on process identification and definition, so that you understand them and can manage them

(d) Develop an internal audit program (process!) that reflects your company needs, not a checklist method used by registrars

10 steps on the implementation of ISO 9001 Standards are as below:

1. Analyze your businesses’ core process(es) for converting customer needs into cash at a high level to show the sequence and interaction of the key processes within the core process (one page).

2. Identify (and assign a code) each of the key processes within your system (as-is) and the new ones necessary for the system to be used to add value faster and prevent loss sooner (the chosen system standard is very helpful for listing the missing processes). Expect 20 to 50 key processes.

3. Analyze each of the key processes by working with the process owner to determine each processes’ objective, team, inputs, value-adding steps (tasks, meetings, decisions), outputs; then link the procedure to the other controls and process with which it interacts (one page each).

4. Leaders explain their policy, the obligations of the system (already 85% or so implemented) and its benefits.

5. Train process teams in any new processes so they are working effectively from day one.

6. Describe the system and how it works, the policy and objectives in a less than 10 page manual.

7. Launch the system and invite lots of suggested improvements.

8. Gather and analyze data to become information for use by decision makers to improve products, processes and the system.

9. Audit the performance of the system independently of any other process control to provide impartial information on how well the system is helping employees to do their jobs.

10. Use and improve the system, its processes and your products so your organization adds value faster and prevent loss sooner.

ISO 9001 Standards – Control of Measuring and Monitoring Equipment

ISO 9001 Standards - Control of Measuring and Monitoring Equipment

Determine the monitoring and measurements to be made, and the required equipment, to provide evidence of product conformity. Use and control the monitoring and measuring devices to ensure that measurement capability is consistent with monitoring and measurement requirements.

Where necessary to ensure valid results:

- Calibrate and/or verify the measuring equipment at specified intervals or prior to use

- Calibrate the equipment to national or international standards (or record other basis)

- Adjust or re-adjust as necessary

- Identify the measuring equipment in order to determine its calibration status

- Safeguard them from improper adjustments

- Protect them from damage and deterioration

Assess and record the validity of prior results if the device is found to not conform to requirements. Maintain records of the calibration and verification results.

Confirm the ability of software used for monitoring and measuring for the intended application before its initial use (and reconfirmed as necessary).

NOTE: Confirming the ability of software to satisfy the intended application would typically include its verification and configuration management to maintain its suitability for use.

For More Information Please Visit http://www.iso9001-standard.us