So far, in this series, we have explored the evolution of the Standards and History of Quality Systems. We have answered the question of what documentation is needed (recommended – remember, these are my opinions and nothing in life is guaranteed beyond that.) We have talked about Organizational Context (section 4.1) and last time we identified our Interested Parties (section 4.2.) Now, we will look at QMS Scope and Boundaries (section 4.3.) Today’s discussion will be in two parts, if for no other reason but to limit the size of the post – we are all busy and no one wants to read a ‘book’… or do you?
Step 1 Getting Started
The initial ‘push’ for implementing a quality management system (QMS) may come from your customers, management or other sources, but in any case, top management must be committed to the effort for it to be successful.
Getting started begins with identifying the benefits to the organization, setting out a clear plan for implementation, and understanding the basics of QMS documentation. In addition, the organization will need to identify its internal and external influencers and understand how the quality management system will affect them.
Top management is responsible for developing the quality policy that communicates the importance of customer focus in the organization’s strategic plans and objectives.
Top management appoints a champion / customer advocate (formerly referred to as Management Representative – MR) who has overall responsibility for assembling the implementation team, and developing, implementing and maintaining the QMS. This individual works with top management to establish and document the scope and boundaries for the QMS
The implementation team, with top management’s input, lays out the plan for QMS development and implementation. The plan considers the overall time line for implementation, other organizational goals and priorities, and integration with other management systems (if applicable). It also considers available resources and designates responsibilities. Communication channels are established to make team assignments, provide guidance and support, check progress and report status. Information will need to flow in both directions between top management and organizational personnel and should include the sharing of successes at all levels of the organization.
Another element of getting started on QMS implementation is gaining an understanding of the role of documents and records in the system and the decisions the organization must make about its QMS documentation. There are a number of common misconceptions about the extent of documentation needed for a management system based on an ISO standard. For an ISO 9001 QMS, a variety of records must be maintained, but only a few documents are explicitly required. Organizations have a great deal of flexibility, but also responsibility, in determining what documents and records are needed to support their QMS. If you have been following my posts, you should have a good handle on this. If you are new to the blog, you may want to look at earlier postings to catch up.
Step 2 Identify Key Internal Influencers
Internal influencers are individuals in the organization who do or could have interest or influence on decisions related to quality. To gain support for the development and operation of the QMS, these individuals should be identified and their needs understood and addressed.
Management – Management wants the business to operate smoothly and must provide resources to ensure that the organization is efficient; employees are productive; regulatory requirements are addressed; and, shareholders are satisfied. An ISO 9001 QMS provides a mechanism for addressing management’s quality related issues. However, each manager is likely to have a different perspective relative to quality based upon their areas of influence (i.e. Sales, Purchasing, Design, Production, etc.) Consider each position or function and identify how quality is important and what would encourage their support and participation.
Employees – Employees want to be productive and use the most efficient methods and equipment. They want management to provide the resources so they can work smarter, not harder. Employees want a system in place to correct problems and continually improve efficiency without undue delay.
When identifying key internal influencers, determine the individuals in the organization whose responsibilities or activities will affect or be affected by the organization’s quality position.
In Part 2 we will look at the business drivers that influence and determine strategy and objectives. See you in Part 2.