Hi All,

Just want to get some opinions on how 4.2.2(b) is interpretted by the masses. It states 'The organization shall establish and maintain a quality manual that includes the documented procedures established for the quality system , or reference to them. Some colleagues think that this is satisfied by describing the structure of the QS documents, while others feel that this requires a complete list of all QS procedures. I feel that the requirement is to include the document numbers of only those procedures required by the standard (or to support the generation of a required work instructions or records). Here's my list of required procedures (some are N/A for my organization and other are combined into one procedure (CAPA)).
4.2.3 Control of documents
4.2.4 Control of records
6.3 Maintenance Activities
6.4 Health, cleanliness and clothing if come in contact with the product can affect it
6.4 Work environment conditions, monitoring and control
6.4 Control of contaminated or potential contaminated products to prevent product contamination
7.1 Risk Management
7.3.1 Design and development
7.4.1 Purchasing process
7.5.1.2.1 Product cleanliness
7.5.1.2.2 Installation activities
7.5.1.2.3 Servicing activities
7.5.2.1 Validation of the application of the computer S/W
7.5.2.2 Sterilization process validation
7.5.3.1 Product identification
7.5.3.1 Product return identification from normal production
7.5.3.2 Product traceability
7.5.5 Product preservation
7.5.5 Control of limited shelf life products
7.6 Control of monitoring and measuring equipment
8.2.1 Feedback system (including customer complaint)
8.2.1 Post-production phase experience
8.2.2 Internal audit
8.2.4.1 Monitoring and measurement of product
8.3 Control of nonconforming product
8.4 Analysis of data
8.5.1 Advisory notice
8.5.1 Vigilance system
8.5.2 Corrective action
8.5.3 Preventive action

Look forward to hearing your thoughts.....

The list looks complete. To make life easier, you could combine several procedures such as corrective & preventive action.

If you are trying to sell the medical device to other countries which have specific requirements, you may want to add procedures in Mandatory Problem Reporting, Recalls and Technical files.

Danny

Hi All,

Just want to get some opinions on how 4.2.2(b) is interpretted by the masses. It states 'The organization shall establish and maintain a quality manual that includes the documented procedures established for the quality system , or reference to them. Some colleagues think that this is satisfied by describing the structure of the QS documents, while others feel that this requires a complete list of all QS procedures. I feel that the requirement is to include the document numbers of only those procedures required by the standard (or to support the generation of a required work instructions or records)......

Hi Qualitytrainer,

The choice is yours - the standard wants documented procedures or reference to them; but for better administration, it is recommended to sepearte the procedures from the manual.

You could change the procedures without changing the manual and save time, resources and money :cool:

For eg. you could state in the manual that -

All material/products that are found to be nonconforming are identified and segregated and/or quarantined, and appropriately dispositioned per the Control of Nonconforming Product Procedure, ABC/123

Hope this helps.