Implementing ISO 9001 (Quality Management System)

In pursuit of ISO 9001 Certification - one must start with a list of all mandatory and non-mandatory documents as specified in the ISO 9001:2015 Standard.

During our consulting endeavors we often advise the customer to follow the following steps:

Steps for ISO 9001 Implementation

Step 1. Conduct a detailed audit and create a gap report.

Step 2. Form ISO 9001 teams

Step 3. Train people on relevant sections of ISO 9001 Standard - depending on their role in the firm.

Step 4. Once Step 3 is done - commence creating documents and records as mandated by the standard and also desired by the Organizational leadership.

Step 5. Step 5 would be about implementing the laid down processes and commence to capture evidence in terms of records and data.

Step 6: Once the implementation has been done and teams are confident - the next step would be to conduct the Internal audit - audit must be conducted for adequacy (documentation audit) and implementation. 

Step 7: If everything is found okay during the internal we go ahead and get the external audit done. 

Step 1. Conduct a detailed audit and create a gap report.

Before you commence the ISO 9001 implementation journey - you must create a list of all mandatory and non-mandatory documents. Check for the existence of these documents within the firm (very likely that the firm will not have them as ISO 9001 has very peculiar needs). Once you have the list - get in touch with the department POCs and conduct the audit and publish the Gap report. Very rarely would you be able to conduct an implementation audit at this stage - mostly the audit will be for the adequacy i.e. existence of the mandatory documents as specified by the ISO 9001 Standard.

Step 2. Form ISO 9001 teams.

ISO 9001 implementation shall need considerable participation of the entire firm. Hence we advise you to form 3 different teams represented by people in the firm.

Team 1 should be a steering committee - represented by the Top Management. This team should be the team to reach out to for Project Status reporting, escalations (if things aren't working as per plan).  

Team 2: HODs Team - This group should be represented by HODs of each department and their respective Point of Contact (POC) for each department. 

Team 3: Doing Group - This is a critical workgroup that shall work with ISO 9001 Consultant. They must include representatives from each department, and their numbers must be representative of the department Head Count. This team shall be needed for the creation of documents etc as mandated by ISO 9001 as also sometimes you want to create an internal audit team.

******* to be continued **********