The Healthcare Industry's Recognized Four-Phased Approach

Explaining the Healthcare Industry Recognized Four-Phased Approach to ISO 9001 Implementation

As ISO 9001 becomes more recognized in the healthcare industry, proper implementation becomes crucial for those organizations that intend for their newly implemented ISO 9001 Quality Management System to be a performance versus a compliance based tool.

To help us in this endeavor, there is an industry recognized Four Phased Approach to implement ISO 9001 in healthcare organizations.  By following this Four Phased Approach that the healthcare industry recognizes to deliver the best results and, more importantly, results in a performance driven system that not only complies with the standard, but also produces consistent service delivery, customer (patient) satisfaction and continual improvement.

The four industry recognized phases:

• Phase 1 – Foundation and Documentation
• Phase 2 – Leadership Alignment
• Phase 3 – Organization Integration
• Phase 4 – System Validation

See our latest Newsletter Article for a more detailed explanation of the Industry Recognized Four-Phased Approach:  Click Here for the November Newsletter

What If?

ISO 9001 is a journey with the direction and destination established by the organization.  Ultimately, each organization must determine if the trip will be a short one that ends after the celebration of ISO 9001 certificate being hung on the wall or a long rewarding journey with stops along to way to enjoy the incremental achievements determined by the measures of success and reach the intended destination of improved patient outcomes.

What if hundreds or even thousands of hospitals, long-term care and assisted living facilities all decided to embark on the long rewarding journey of ISO 9001 improvement?   I have to confess, I get goose bumps just thinking about being a part of such a movement in healthcare!  

How about you?

The Next Level of Accreditation

Holding Consultants Accountable

Healthcare professionals and hospitals are all too familiar with accreditation whether it be from The Joint Commission (TJC), Det Norske Veritas (DNV) Healthcare Facilities Accreditation Program (HFAP), College of American Pathologists (CAP) or others.  Being accredited carries with it many benefits such as validation that you are providing quality care, a competitive edge, and maybe most important is reimbursement from the Centers of Medicare and Medicaid Services (CMS).  But does the importance of accreditation from one the above mentioned accrediting bodies end there?

While being accredited is important for many reasons, it is important for hospitals and healthcare systems to think beyond their own accreditation if they really want to drive performance and patient outcomes.  They need to consider the accreditation of their vendors and the products and services their vendors provide.

A common practice in healthcare is to use the services of third party consultants to assist in meeting the requirements of accreditation and /or certification from accreditation and other regulatory bodies.  However if the consultant you just contracted with is not accredited or certified will this affect your results?  And what about the materials and tools the consultants use, are they recognized by a certification or accreditation body?  For example, ICH's ISO 9001 Lead Auditor for Health Care workshop is the only RABQSA recognized ISO 9001 lead auditor for healthcare course in existence.  So, the bigger question is, if your hospital has to meet a set of requirements in order to be accredited, shouldn’t the consultant that is assisting you to meet these requirements also be accredited as well as their materials?

ISO 9001 continues to gain recognition in the healthcare industry even as its implementation remains foreign and can seem overwhelming to healthcare professionals.  As a result, we are seeing an increase in the number of ISO 9001 consultants rushing into the healthcare market.  This competition is good, but it does force hospitals to do their due diligence in choosing consultants that are certified and use materials that are also recognized by a certification body.

More importantly it is important that the consultant you choose practices what they preach.  Within the ISO family of standards there are specific clauses that prevent certification bodies from also providing consultation: ISO/IEC 17021:2011, clauses 5.2.5, 5.2.6 and 5.2.7 (see clauses below).   This is similar in concept to ISO 9001 clause 8.2.2 Internal Audits that indicates: “The selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process.  Auditors shall not audit their own work.”   In other words, accrediting bodies shall not audit or survey their own work, which means that they cannot consult with hospitals that they also audit, survey, and/or provide accreditation to.

If your hospital or healthcare system is held to a set of requirements in order to be accredited shouldn’t the consultants you use also be accredited/certified and held to meet the requirements of their own certification?

ISO/IEC 17021:2011, clauses 5.2.5, 5.2.6 and 5.2.7

5.2.5                       The certification body and any part of the same legal entity shall not offer or provide management system consultancy. This also applies to that part of government identified as the certification body.

5.2.6                       The certification body and any part of the same legal entity shall not offer or provide internal audits to its certified clients. The certification body shall not certify a management system on which it provided internal audits within two years following the end of the internal audits. This also applies to that part of government identified as the certification body.

NOTE      See Note to 5.2.2.

5.2.7                       The certification body shall not certify a management system on which a client has received management system consultancy or internal audits, where the relationship between the consultancy organization and the certification body poses an unacceptable threat to the impartiality of the certification body.

NOTE 1   Allowing a minimum period of two years to elapse following the end of the management system consultancy is one way of reducing the threat to impartiality to an acceptable level.

NOTE 2   See Note to 5.2.2.

               5.2.2. NOTE           A relationship that threatens the impartiality of the certification body can be based on                
                                              ownership, governance, management, personnel, shared resources, finances, contracts,  
                                              marketing and payment of a sales commission or other inducement for the referral of new clients,               
                                              etc.

The Centers for Medicare & Medicaid (CMS) recently announced a major change in the way providers will be reimbursed. In an article posted 4/29/11 on www.healthcare.gov; "Starting in October 2012, Medicare will reward hospitals that provide high quality care for their patients through the new Hospital Value-Based Purchasing Program. This program marks the beginning of an historic change in how Medicare pays healthcare

providers and facilities-for the first time, hospitals across the country will be paid for inpatient acute care services based on care quality, not just the quantity of the services they provide." Click here for full article. This moves clinical care straight to the center of the bull's-eye and maintains a focus on the healthcare outcomes. This is great; however a serious point of discussion must be the impact of supporting processes on such outcomes.

What is the Quality Manual, Really?

Only the most important document of your Quality Management System!

Before we get into the technical definitions and specific clause numbers that define, describe and require an organization to have a Quality Manual, let's first discuss in layman terms what the Quality Manual is and its purpose. In very basic terms, the Quality Manual is a document that states who the organization is and what they do at a very high "100,000 foot" level.

Now, for the more technical description we have to begin with ISO 9000:2005 Clause 3.7.4 which defines a Quality Manual as a "document specifying the Quality management system of an organization".

Your Hospital's Quality Manual is a requirement of the ISO9001 standard, Clause 4.2.2 to be exact. We will discuss Clause 4.2.2 exclusively in this newsletter's edition of Clause Chat and is a document that has to be controlled in accordance with the requirements of Clause 4.2.3.

Your Quality Manual is a document that clearly states your organization's intentions for operating the Quality Management System (QMS).

One fact to keep in mind is that the format and structure of the Quality Manual is an important decision for each hospital or healthcare organization. No guidelines exist regarding the format, structure or organization of the Manual. In fact, in the introduction of the standard under the "general" Clause 0.1 it is stated: "It's not the intent of this international standard to imply uniformity in the structure of the quality management systems or uniformity of documentation." These decisions are left up to your hospital or health organization to determine how exactly your Quality Manual will be structured to best support your hospital depending on its size, culture, and complexity. Some organizations may choose to include components other than the baseline requirements within the Quality Manual, and this is fine.

A clear distinction should be made between the contents of the Quality Manual and operating procedures.

With this said, there are a few content requirements your Quality Manual MAY include:

• Your hospital's quality policy stating its commitment to quality
• Policy statements indicating management's intention to comply with the standard's and must include all areas of the standard. These policies must include:
  • How management expects operations to function
  • Who is responsible (process owners) to implement these expectations
  • Where and when the policies are applicable within the organization
  • What inter-dependencies exist between functions and processes

NOTE: Your Quality Manual needs to be made available to customers and third party auditors such as your accreditation surveyors.

When it comes to creating and/or maintaining the Quality Manual within a healthcare setting, we are asked 5 questions on a regular basis:

1) How long does our Quality Manual have to be?

A "manual" in healthcare is not necessarily a "Quality Manual" in ISO9001, Many times the word manual invokes a thought of a 300-page work of dissertation. This is not necessarily the case within ISO9001. The typical Quality Manual could be anywhere from 3-10 pages. The organization however needs to ensure that all required components are included.

2) Do we have to identify the Management Representative within the Quality Manual?

There is not a requirement within ISO9001 4.2.2 for the Quality Management Representative (ISO9001 5.5.2) to be identified within the Quality Manual. The Standard requires that this position be "appointed".

3) Do we have to address all clauses within the ISO Standard within our Quality Manual?

The answer is no, because there is no requirement to restate the contents of the ISO standard within the Quality Manual.

4) Does our Quality Manual have to be approved? By who?

Yes, your Quality Manual needs to be approved and it is approved according to the document control process established by the ISO required policy stated in clause 4.2.3.

5) Where do we find the contents for our Quality Manual?

While the Quality Manual is a new document for your hospital, the contents for it are probably not. The content used to create you Quality Manual will come from previous and/or existing documents within your organization such as: Current quality/performance plans, high level strategic plans, etc.

The bottom-line, when it comes to your Quality Manual, is that it is a required document by the ISO standard that identifies who your organization is and what it does. The contents needed to create your Quality Manual probably already exist within your organization, and the overall structure of your Quality Manual is up to you. Overall, your Quality Manual serves as a guideline for your organization as it implements and maintains the Quality Management System.