Tag: joe tsiakals

ISO 9001:2008 and Reasons to Obtain Third-Party Certification

Reviewing confidential files, training records, human resources files

Q: I have a question regarding an excerpt about ISO 9001:2008 — Quality management systems –Requirements, from the ISO webpage, which is below:

“…Although certification is not a requirement of the standard, the quality management systems of about one million organizations have been audited and certified by independent certification bodies (also known in some countries as registration bodies)…”

Our ISO 9001 quality management system (QMS) has been registered through third-party audits since 1994. But according to this statement, we should be able to represent ourselves as an ISO 9001 organization by simply meeting the requirements of the standard. These requirements, of course, don’t require third-party certification.

Is this the case? If not, isn’t the statement on the website misleading, in as much as certification is an implicit requirement of the standard?

A: I am a U.S. Technical Expert for ISO 9001 and associated QMS standards, have been involved with QMS standards since 1975 and am a published Quality Press author.

You are correct when you state, “we should be able to represent ourselves as an ISO 9001 organization by simply meeting the requirements of the standard. These requirements, of course, don’t require third party certification.” Many organizations use ISO 9001 as the basis for their quality management system without engaging in third-party audits. If you want to claim certification, I guess you could claim that you are “self-certified,” but I am not sure this would mean anything to anybody.

There are a variety of reasons for incurring the cost associated with obtaining an ISO 9001 certification:

  • Internal use: Many do this based on a perception of market advantage and use the certificates in advertisements promoting their goods and services. Some organizations use third party audits and certification to verify for their own management the adequacy of their quality management system.
  • Supplier qualification: The historical use for a quality management system standard is as a basis for qualifying the quality management system of suppliers. Development of quality management system standards dates to the 1950s. One of the early standards of this type was MIL-Q-9858A used by the Department of Defense for use in qualifying some of their suppliers.

Today, ISO 9001 is widely used as a qualification requirement for suppliers in many different product and service sectors. The automotive, aerospace, telecommunications and other industries have sector specific versions of ISO 9001 that are used with suppliers. These all require third-party certification.

  • Regulatory requirement: The European Union, FDA, Japan, Australia, Canada and many other countries use ISO 9001 as the quality management system for meeting certain regulatory requirements. Some regulatory bodies require third-party certification, others conduct their own audits (second-party audits) to verify compliance.

Bottom line: you should determine for yourself if you have a need for certification to ISO 9001 and act accordingly.

Joseph Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 on Quality Management and Quality Assurance (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 Quality Management and Corresponding General Aspects for Medical Devices (AAMI)

For more on this topic, please visit ASQ’s website.

OHSAS 18001 and ISO 9001 Work Environment Requirements

Workplace safety, OHSAS 18001, work environments

Q: We had the opportunity to get the certification for OHSAS 18001:2007 Occupational health and safety management systems — Requirements. While looking at the clause interaction between ISO 9001 Quality management systems–Requirements and OHSAS 18001 given at the end of the standard, I did not find any interaction between the standards for clause 6.4 work environment in ISO 9001.

Am I missing anything or is there any reason for it?

A: I am a U.S. Technical Expert for ISO 9001 and associated  quality management system (QMS) standards and have been involved with QMS standards since 1975.

In my opinion, the answer to your question is that the developers of OHSAS 18001:2007 did not feel that ISO 9001 clause 6.4 related to 18001. This, incidentally, I find puzzling.

The requirement in ISO 9001:2008 Quality management systems–Requirements clause 6.4 reads: The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

In other words, you should make sure that your employees have an adequate work environment for producing your products. They should have adequate room temperature, lighting, and etc.

The 2005 report: Integrated Management Systems (IMS) – Potential Safety Benefits Achievable from Integrated Management of Safety, Health, Environment and Quality (SHE&Q) from Environment Directorate, Organisation For Economic Cooperation And Development, Paris, includes the following which might be of interest to you:

“OHSAS 18001 and National Standards

During drafting of the original BS 8800 a major division of opinion arose as to whether or not independent assessment and certification of an organisation’s OSHMS should be encouraged, as for QMS and EMS.  Some viewed such certificates as valuable, particularly in the context of effective supply chain management, others believed that existing certification processes: added minimal value, required excessive resources and resulted in unused manuals – so new certification processes should be resisted.  It proved impossible to reconcile these views within BS8800, which was structured and published as a non-certifiable standard.

As a result, an international consortium of certification bodies, including the commercial arm of BSI, produced the OHSAS 18001 specification in 1999, followed by implementation guidelines OHSAS 18002 in 2000.  Neither document is an official British Standard, but OHSAS 18001 either is, or is likely to become, a national standard in other countries, notably in Pacific Rim.  A recent survey by BSI identified that over 8000 OSHMS certificates have been issued in 70 countries, to many different standards and guidance, and that some 46% are to OHSAS 18001.

With the revision of BS 8800, from which it is derived, it might be presumed that OHSAS would be updated automatically.  A review is indeed planned, but the decision on when to publish a revision will take into account other factors, including the needs of current new users to have time to ‘bed down’ their internal processes before revising them to meet an improved standard.  When a revision is agreed, it is likely to include some alignment with other high-quality national standards such as AUS/NZ 4801, to aid recognition as a truly global standard.

A new US standard was published in 2005: ANSI/AIHA Z10 – Occupational Health and Safety Systems.  The format includes both a standard and associated guidance, but is not intended as a basis for certification.  It is fully compatible with ISO 9001/14001 and takes account of the other national/global OSHMS documents outlined in this section.”

OHSAS 18001:2007 is not an ISO standard. It appears to be simply an update of OHSAS 18001:2000. Its development was driven by the British Standards Institute which publishes the standard and profits directly from its distribution and sales.

Part of the answer to your question is to evaluate for yourself:

1) Why did you go to the expense to be certified to 18001:2007 and who were the customers that you were satisfying by doing this?

2) What is the expectation of these customers?

From a practical standpoint, consider embracing the concept in ISO 9001 clause 6.4. I would expect that providing your employees adequate conditions for producing products can only improve your product offerings and help to enhance customer satisfaction.

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

Standard Vs. Specification and Guidance Documents

ISO documentation practices, requirements, records

Question

What is the difference between a standard and a specification?

Answer

There is no single or simple answer to your question. The answer depends upon the context of the question. Relative to the ANSI/ISO/ASQ Q9000 Series: Quality management standards, I direct you to ANSI/ISO/ASQ Q9000:2005 Quality management systems – Fundamentals and vocabulary.

ISO 9000:2005 defines specification as a document that states requirements. A specification can be related to activities (e.g. procedure document, process specification and test specification), or products (e.g. product specification, performance specification and drawing).

ISO 9000:2005 does not define “standard”. The first part of the ISO 9000:2005 introduction reads:

“The ISO 9000 family of standards listed below has been developed to assist organizations, of all types and sizes, to implement and operate effective quality management systems.

— ISO 9000 describes fundamentals of quality management systems and specifies the terminology for quality management systems.

— ISO 9001 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide products that fulfill customer and applicable regulatory requirements and aims to enhance customer satisfaction.

— ISO 9004 provides guidelines that consider both the effectiveness and efficiency of the quality management system. The aim of this standard is improvement of the performance of the organization and satisfaction of customers and other interested parties.

— ISO 19011 provides guidance on auditing quality and environmental management systems.

Together they form a coherent set of quality management system standards facilitating mutual understanding in national and international trade.”

In other words…

ISO 9000 is a standard that describes fundamentals and specifies the terminology.

ISO 9001 is a standard that specifies requirements.

ISO 9004 is a standard that provides guidelines.

ISO 19011 is a standard that provides guidance.

This implies that a standard is a formal document that establishes uniform criteria, methods, processes and practices — which may or may not be requirements.

ISO 9000:2005 also makes a distinction between quality management system requirements and requirements for products using the terms “specifications” and “standards.” It states:

“The ISO 9000 family distinguishes between requirements for quality management systems and requirements for products.

Requirements for quality management systems are specified in ISO 9001. Requirements for quality management systems are generic and applicable to organizations in any industry or economic sector regardless of the offered product category. ISO 9001 itself does not establish requirements for products.

Requirements for products can be specified by customers or by the organization in anticipation of customer requirements, or by regulation. The requirements for products and in some cases associated processes can be contained in, for example, technical specifications, product standards, process standards, contractual agreements and regulatory requirements.”

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

ISO 9001 Clause 7.5.1 Work Instructions

Mr. Pareto Head and standard work

Q: Within my organization there has been much debate on what a work instruction is. The term work instruction is not defined in the ISO 9001-2008 Quality management systems—Requirements standard (appears in clause 7.5.1).

Our question is that if the organization is providing services such as maintenance and repair of the customer’s equipment, and the customer provides maintenance and repair manuals and publications for this equipment to the organization, would this literature satisfy the requirements of ISO 9001:2008 as work instructions? Any assistance provided would be greatly appreciated.

A: You are correct when you state that “work instructions” is not defined in ISO 9001:2008, nor is it in ISO 9000:2005 Quality management systems–Fundamentals and vocabulary.

Terms are not defined by the Technical Advisory Group (the standard developers)  when it is felt that the general accepted usage is clear and unambiguous. Such is the case with this term. A work instruction is simply what the name implies, instructions to do work. Written instructions might not be necessary and so the phrase “as necessary” is in the text of the standard. It depends on your specific situation.

The challenge to comply with the requirements of clause 7.5.1 is not in the definition (or lack of definition) of work instructions. It is planning and carrying out production and service work under controlled conditions.

Are your work processes controlled? This clause identifies six elements that need to be considered. Work instructions are one of the six elements. Do your operators know what to do? Are they trained? Do they need written instructions? In general, you must make this call, not an auditor. If you are challenged by an auditor, you need to be able to defend you position. But there is no hard and fast rule here.

Let me note that telltale signs of lack of control are frequent errors, defects and rejects. This indicates to an auditor that you don’t have a controlled process. You need to tighten things down including addressing those of the six elements that are at the root cause of your process failures. You might need work instructions or improved work instructions based on process performance.

You mention that your organization maintains customer equipment and that the customer provides manuals. These manuals might be adequate. They might not. Let’s say that part of your maintenance is changing the oil on a gasoline engine. The manual, hopefully, states when this needs to occur. It might not. You probably need to establish a maintenance schedule for changing the oil and lubricating the machine, recording when this is done. Do you need a detailed work instruction on how to change the oil? Probably not. However, the machine might be complicated and have many lubrication points, a number of them not at all obvious. In such a case, a simple work instruction might be useful.

The key is to control your process and use whatever is needed to do so.

Joe Tsiakals
Voting member of the U.S. TAG to ISO/TC 176 (ASQ)
Voting member of the U.S. TAG to ISO/TC 210 (AAMI)

For more on this topic, visit ASQ’s website.