QMS Developement and Implementation
2.
ISO 9001
Certification Preparation
4.
Training of Personnel
How to develop QMS that works for you?
Start with the plan.
The plan will define tests, procedures, methods, etc. to be used during the activity.
Everyone involved in delivering the activity needs to be clear about the role they will play and the tasks they need to perform.
SOP Writing Services
SOPs for a new management system or for the existing management system.
SOP Review Services
Review of existing SOPs for accuracy and providing gap analysis report.
SOP Integration Services
Integration SOPs for mergers and acquisitions. Assess necessary and current SOP.
How to write the most effective SOPs?
1. Focus on the process
Focus on the process, SOPs are not work instructions. Work instructions are tool-specific instructions, whereas SOP is the process.
2. SOPs should be short and concise
SOPs should describe how to accomplish a specific task. If there are too many steps, split sub-tasks into separate SOPs that reference each other. You will get SOPs that are easier to read and understand.
3. SOPs must be helpful, relevant and usable
SOPs must be relevant, helpful, and usable for its audience. Write your SOP for your audience. Consider factors like prior knowledge or whether you’re addressing new employees.
The readers of your SOP are looking for guidance and direction, so they may not be familiar with specialized terms associated with the steps of the process. With this in mind, limit the use of jargon or other specialized terminology that may confuse or mislead the reader.
4. Clearly define steps and roles
The SOP should have precise steps to provide clear direction to the reader. Each step should also note the role responsible for carrying out the step. Precise steps make it clear what needs to be done. It is important to identify the roles responsible to avoid situation where people think somebody else is responsible for a task. The SOP should always describe what needs to be done and who should do it.
5. Talk to team members and stakeholders
Seeking additional input isn’t necessary for all SOPs, but it’s worth considering especially because a successful SOP is used by the applicable teams. Talk to them before, during, and after the drafting process for input and feedback.
6. Test your SOP
Once drafted but before it’s put in place, test the SOP to ensure that it is accurate and usable. Have other team members test it too. This will help you identify and deal with any problem areas before it’s put into action.
7. Review regularly
Policies and processes change over time. SOPs should be updated as changes occur, and reviewed on a regular basis for clarity and correctness. Schedule a review of the SOP at least every 6 to 12 months.
Need help with SOPs?
Our QA Director explains how to write SOPs that works for you.
Josipa is QA Director and Principal GCP and GVP auditor at Proqlea Ltd. She has done more than 80 Sponsor audits over the years with more than 20 unique audit types and mock inspections.
See Josipa’s Linkedin Profile for more information on her work expirience in “QA World”.
How to prepare your company for ISO 9001 certification?
1. Study the ISO 9001 standard
Learn about ISO and study ISO materials, or hire a professional consultant. If you are starting from scratch, we can perform a gap analysis on your business to help you plan what needs to be done before your organisation is ready for a next step to get certification.
2. Try to interpret ISO 9001 in context of your business
3. Keep your project plan simple
Focus on implementation steps, target dates, and assign responsibilities. Avoid Gantt charts and other complex solutions.
4. Documentation you need to prepare
This is the most difficult step. Documents have to meet the technical requirements of the ISO 9001 standard. You can’t just copy somebody else’s procedures. If you use templates, pay attention to flexibility and customisation instructions. Avoid “ISO language” and use layout that are visually appealing and easy to understand. Use diagrams and illustrations rather than long-winded text. QMS should consist of following documents:
- Quality policy
- Quality objectives
- Scope statement
- Procedures
- Work instructions
- Forms
- Process maps (flowchart)
5. Introducing the Procedures
Introduce staff to one procedure at a time, starting with document control. You could explain the requirements in staff meetings e.g.
6. Internal Audit – self-inspections to check your ISO 9001 system
Internal audits are typically performed by employees who take on the auditor role as an additional responsibility. In order to be considered for ISO 9001 registration, you have to successfully conclude one complete internal audit. A complete audit covers your entire ISO quality management system, but not every department needs to be checked for compliance with every requirement. The audit doesn’t need to be conducted as a single event but can be split into several partial audits. You may outsource internal audit to an experienced lead auditor. This way you can be confident that each and every issue gets identified.
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Email: info@proqlea.com
Josipa Draženovića 2A, 10 000 Zagreb
Croatia
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