HKTIC Seminar on ISO 17025 Revision

The Seminar on ISO 17025 Revision was organized by the Hong Kong Association or Testing, Inspection and Certification (HKTIC) on 14 Jun 2017. The seminar aims to share the last review of ISO/IEC 17025:2005 in 2010 and some key changes in ISO/IEC DIS 17025 in this year.  Before the seminar, I took a photo with speaker Dr. John Ho.

I met Mr. SL Mak (OUHK) and also took a photo for memory.

In the beginning, Mr. K.L. Tsang (HKTIC representative) gave an opening speech and introduced the speaker Dr. John Ho.

Dr. John Ho (Senior Accreditation Officer, HKAS) presentation entitled “Revision of ISO/IEC 17025” and its content included history of the revision, work plan of ISO CASCO/WG44 and main changes in ISO/IEC DIS 17025.  He said the ISO/IEC 17025:2005 was adopted over 10 years which published by the ISO Committee on Conformity Assessment (ISO/CASCO) and it was reviewed in 2010 that no revision was proposed.  However, new work item was proposed for revising the standard by ISO/CASCO working group (WG44) and approved in October 2014.

The progress of WG44 was showed as following diagram that DIS version issued in November 2016.  The WG44 would meet in July 2017 in Geneva to work on 1800 comments.  The transition period of 3 years from the date of publication of ISO/IEC 17025:2017 was adopted by ILAC General Assembly (GA).

Then Dr. John Ho briefed the new structure of DIS to us from clause 1 to 8, as well as, Annex A – Metrological traceability and Annex B – Management System.  Then he quoted the standard about relationship with ISO 9001 that the new statement was “Laboratories that conform to this International Standard will also operate generally in accordance with the principles of ISO 9001”.  Another new item was risk management that addresses risks and opportunities for increasing the effectiveness of the QMS, achieving improved results and preventing negative effects.

Dr. John Ho said there were 3 pillars of the standard and they were “Competence”, “Impartiality” and “Consistent”.  He advised us to evaluate the risk of impartiality.  He said the laboratory had less risk than Inspection and Certification Body because laboratory seldom had on-site decision making.  Some notes were removed from Scope which aimed to be in line with ISO’s Neutrality Principle.

Then he mentioned some terms and definitions and I selected some as follows:

3.1 Impartiality – Presence of objectives (ISO 17021-1, cl.3.2)

3.6 Laboratory – body that performs one or more of the following activities:

- calibration,

- testing,

- sampling, associate with subsequent calibration and testing.

3.7 Decision rule – rule that describes how measurement uncertainty will be accounted for when stating conformity with a specified requirement

4. General requirements

4.1 Impartiality (Identify risks to its impartiality)

4.2 Confidentiality

5. Structure requirements

- Not mentioning “quality manager” but state similar in 5.6

- “laboratory management” replaces “top management”

The comparison table between the DIS and 2005 version was showed as following diagram. (It is only rough comparison.)

6. Resource requirements

6.2 Not mention staff under training and job description, but it still suggested to keep it by speaker.

6.3 When the laboratory performs activities at facilities outside its permanent control that should ensure its requirement still fulfilled the standard.

- “to ensure good housekeeping in the laboratory” was removed.

6.4.1 … Equipment includes measuring instruments, software, measurement standards, reference materials, reference data, reagents and consumables or auxiliary apparatus or combination thereof necessary for laboratory activities and which can influence the result.

6.4.6 “metrological traceability is a requirement” comes from ISO 9001:2015.

6.4.7 … The calibration program shall be reviewed and adjusted as necessary in order to maintain confidence in the status of calibration.

6.4.8 Labels in equipment about calibration period of validity and the status of calibration were requested.

6.5.2 Measurement results are traceable to SI unit. (e.g. CRM with stated metrological traceability to the SI)

7. Process requirements

7.1.1.2 The laboratory shall inform the customer when the method requested by the customer is considered to be inappropriate or out of date. (5.4.2 of 2005 version)

7.1.1.3 … the decision rule shall be clearly defined. Unless inherent in the requested specification or standard, the decision rule selected shall be communicated to the customer.

7.1.1.4 … Deviations (from the contract) requested by the customer shall not jeopardize (harm) the integrity of the laboratory or the results.

7.1.2.1 … specific laboratory activities to be performed by the external provider (that shall advise the customer and gain his/her approval).

7.6.2 A laboratory performing sampling or testing activities shall evaluate measurement uncertainty. (Arguable on sampling MU)  Sampling does not have MU by itself in standalone situation.

7.7 Assuring the quality of results

- a) participation in PT

- b) participation in Inter-laboratory comparison test (ILC) other than PT.

7.8.5.1 …the laboratory shall document the decision rule employed, taking into account the level of risk associated with the decision rule…

7.9 Complaints

7.9.6 The outcomes to be communicated to the complainant shall be made by, or reviewed and approved by, individual(s) not involved in the original laboratory activities in question. 

Dr. John Ho said small-size lab would have problem because of HR limitation.

7.11 Control of data – Information management

7.11.4 When the laboratory information management system (LIMS) are managed and maintained off-site or through an external provider, the laboratory shall ensure that the provider or operator of the system complies with all applicable requirements of this International Standard.

8. Management requirements

8.5 Actions to address risks and opportunities (similar requirements are found in ISO 15189)

8.6 Improvement

- Note: Opportunities for improvement can be identified through the review of the operational procedures, the use of the policies, overall objectives, audit results, corrective actions, management review, risk assessment, analysis of data, and PT results… 

For new option B, if laboratory employed ISO 9001, they could demonstrate the consistent fulfilment of the requirement of clauses 4 to 7 of ISO/IEC 17025.

Q&A session

Many participants are here. I asked how depth the risk and opportunities assessment to be performed. Dr. John Ho replied at least to assess the risk of impartiality.  Dr. Eric Sze asked about Sampling MU.  

At the end, Mr. K.L. Tsang represented HKTIC gave a certificate to Dr. John Ho to appreciate his contribution. 

Reference:

HKAS - http://www.itc.gov.hk/en/quality/hkas/about.htm

HKTIC - http://www.hktic.org/